Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
________________________
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of
Report (Date of earliest event reported): June
30, 2006
GLIDER
ENTERPRISES, INC.
(Exact
name of registrant as specified in its charter)
Nevada
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000-51038
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98-0373793
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(State
or other jurisdiction
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(Commission
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(I.R.S.
Employer
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of
incorporation)
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File
Number)
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Identification
Number)
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7
Deer
Park Drive, Suite K, Monmouth Junction, New Jersey 08852
(Address
of principal executive office) (Zip Code)
Registrant’s
telephone number, including area code: (732)
329-8885
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2.below):
[_]
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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[_]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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[_]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange
Act
(17 CFR 240.14d-2(b))
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[_]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13c-4(c))
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Item
1.01. Entry
into a Material Definitive Agreement.
Merger
On
June
30, 2006, Gilder Enterprises, Inc., a Nevada corporation (“Registrant”)
completed the acquisition of MedaSorb Corporation, a Delaware corporation
(“MedaSorb”), pursuant to an Agreement and Plan of Merger (the “Merger
Agreement”) by and among the Registrant, MedaSorb Acquisition Inc., a Delaware
corporation (“Acquisition Sub”) and MedaSorb. A copy of the Merger Agreement is
filed as Exhibit 2.1 to this Current Report on Form 8-K.
The
principal terms of the merger and a description of the business of MedaSorb
is
set forth below in Item 2.01.
Private
Placement
Immediately
following the merger, we sold 5,250,000
shares of our Series A 10% Cumulative Convertible Preferred Stock, par value
$.001 per share (“Series A Preferred Stock”), to three institutional investors
pursuant to a Subscription Agreement filed as Exhibit 4.3 to
this
Current Report on Form 8-K and
incorporated herein by reference,
in a
private offering exempt from registration pursuant to Section 4(2) and
Regulation D (Rule 506) under the Securities Act of 1933, as amended (the
“Securities Act”). The 5,250,000 shares of Series
A
Preferred
Stock are initially convertible into 4,200,000 shares
our
common stock, par value $.001 per share (“Common Stock”).
The
Series A Preferred Stock has a stated value of $1.00 per share and was sold
for
a purchase price equal to the stated value. The Series A Preferred Stock is
not
redeemable at the holder’s option but may be redeemed by us at our option
following the third anniversary of the issuance of the Series A Preferred Stock
for 120% of the stated value thereof plus any accrued but unpaid dividends
upon
30 days' prior written notice (during which time the Series A Preferred Stock
may be converted), provided a registration statement is effective under the
Securities Act with respect to the shares of our Common Stock into which such
Series A Preferred Stock is then convertible, and an event of default, as
defined in the Certificate of Designations relating to the Series A Preferred
Stock (the “Certificate of Designations”), is not then continuing. A copy of the
Certificate of Designations is filed as Exhibit 4.1 to
this
Current Report on Form 8-K
and
incorporated herein by reference.
The
Series A Preferred Stock has a dividend rate of 10% per annum, payable
quarterly. The dividend rate increases to 20% per annum upon the occurrence
of
the events of default specified in the Certificate of Designations. Such
dividends may be paid in cash or, provided no event of default is then
continuing, with additional shares of Series A Preferred Stock valued at the
stated value thereof. The Series A Preferred Stock is convertible into Common
Stock at the conversion rate of one share of Common Stock for each $1.25 of
stated value or accrued but unpaid dividends converted.
In
conjunction with the issuance of the Series A Preferred Stock to the investors,
we issued to them, for no additional consideration, five-year warrants (the
“Warrants”) to purchase an aggregate of 2,100,000 shares of Common Stock at an
exercise price of $2.00 per share. The form of the Warrants is filed as Exhibit
4.2 to this Current Report on Form 8-K and incorporated herein by reference.
The
aggregate number of shares of Common Stock covered by the Warrants equals,
at
the date of issuance thereof, one-half the number of shares of Common Stock
issuable upon the full conversion of the Series A Preferred Stock issued to
the
investors on such date. We have agreed to file a registration statement under
the Securities Act covering the Common Stock issuable upon conversion of the
Series A Preferred Stock and exercise of the Warrants within 120 days following
closing of the private placement and to cause it to become effective within
240
days of such closing. We also granted the investors demand and piggyback
registration rights with respect to such Common Stock.
Both
the
conversion price of the Series A Preferred Stock and the exercise price of
the
Warrants are subject to “full-ratchet” anti-dilution provisions, so that upon
future issuances of our Common Stock or equivalents thereof, subject to
specified customary exceptions, at a price below the conversion price of the
Series A Preferred Stock and/or exercise price of the Warrants, such conversion
price and/or exercise price will be reduced to such lower price.
In
connection with the sale of the Series A Preferred Stock and Warrants to the
investors, Margie Chassman, the beneficial holder of approximately 42% of our
outstanding shares of Common Stock, agreed to pledge certain securities held
by
her to the investors, which such investors may sell to ensure they do not suffer
a loss on their investment in the first year following the date of their
investment. In consideration of her pledge to these investors, we agreed to
pay
Ms. Chassman (i) $525,000 in cash, and (ii) five-year warrants to purchase
10%
of the shares of Series A Preferred Stock and 10% of the Warrants sold to these
investors for an exercise price equal to the price paid by the investors in
the
private placement for the Series A Preferred Stock and Warrants.
We
anticipate that our other fees and expenses in connection with the sale of
the
Series A Preferred Stock and Warrants will amount to approximately
$775,000.
Additionally,
in connection with the merger, certain stockholders of ours, including our
former principal stockholder, sold an aggregate of 3,617,500 shares of our
common stock to several purchasers, and forfeited 4,105,000 shares of Common
Stock, which we cancelled, so that prior to giving effect to the merger, we
had
outstanding 3,750,000 shares of Common Stock.
After
giving effect to the merger, the surrender of shares described above and the
sale of the Series A Preferred Stock and Warrants, we had issued and outstanding
24,090,929 shares of Common Stock and convertible securities, options and
warrants that may be converted into or exercised for 9,624,648 additional shares
of Common Stock. In addition, the holders of 240,929 shares of Common Stock
and
warrants to purchase an additional 240,929 shares of Common Stock have the
right
to exchange such shares of Common Stock and warrants for approximately 800,000
shares of Series A Preferred Stock and Warrants to purchase 400,000 shares
of
Common Stock at a price of $2.00 per share.
The
securities we sold in the private placement have not be registered under the
Securities Act, and may not be offered or sold in the United States absent
registration or an applicable exemption from registration requirements under
the
Securities Act.
In
connection with the closing of the private placement, we agreed to make a
short-term advance to Ms. Chassman in the amount of $500,000 bearing interest
at
the rate of 6% per annum, the repayment of which may be offset against amounts
owed by us to Ms. Chassman under the $1,000,000 advance previously made by
her
to MedaSorb. The short-term advance will be secured by a pledge of
publicly-traded securities with a market value equal to $500,000.
Termination
of Joint Venture
On
June
30, 2006, we also terminated our joint venture agreement with 5G Wireless
pursuant to a Termination and Release Agreement, and in connection therewith,
we
sold our 51% interest in Nex Connectivity Solutions, Inc. to Dennis Tan, a
Singapore national for $18,000 (Canadian). Accordingly, we are no longer engaged
in the business of providing Internet access to hotels or other
properties.
Item
2.01. Completion
of Acquisition or Disposition of Assets.
Principal
Terms of the Reverse Merger
Pursuant
to the Merger Agreement, on June 30, 2006, we completed the acquisition of
MedaSorb through a reverse triangular merger in which Acquisition Sub, a wholly
owned subsidiary of ours formed solely for the purpose of facilitating the
merger, merged with MedaSorb. MedaSorb is now a wholly owned
subsidiary of ours, and its business (which is described below) is now our
only
business.
In
connection with the merger (i) the former stockholders of MedaSorb were issued
an aggregate of 20,340,929 shares of Common Stock in exchange for the same
number of shares of MedaSorb common stock previously held by such stockholders,
(ii) outstanding
warrants and options to purchase a total of 1,697,648 shares of the common
stock
of MedaSorb were cancelled in exchange for warrants and stock options to
purchase the same number of shares of our Common Stock at the same exercise
prices and otherwise on the same general terms as the MedaSorb options and
warrants that were cancelled (the options issued to the employees, directors
and
consultants of MedaSorb being issued under our 2006 Long Term Incentive Plan),
and (iii) certain providers of legal services to MedaSorb who previously had
the
right to be issued approximately 997,000 shares
of
MedaSorb common stock as payment toward accrued legal fees, became entitled
to
instead be issued the same number of shares of our Common Stock as payment
toward such services. Immediately prior to the merger, after giving effect
to
the share cancellation transaction referred to above, we had outstanding
3,750,000 shares of Common Stock and no warrants or options to purchase Common
Stock.
Concurrently
with the closing of the merger, Joseph G. Bowes, our sole director and officer
prior to the merger, appointed Al Kraus, Joseph Rubin, Esq., and Kurt Katz
to
the Board of Directors, and then resigned from the Board and from his positions
as an officer. In addition, at such time, Al Kraus was appointed our President
and Chief Executive Officer, James Winchester, MD was appointed our Chief
Medical Officer, Vincent Capponi was appointed our Chief Operating Officer
and
David Lamadrid was appointed our Chief Financial Officer. Additional information
with respect to our new directors and officers is provided in Item 2.01 of
this
Current Report on Form 8-K.
For
accounting purposes, the merger is being accounted for as a reverse merger,
since we
were a
shell company prior to the merger, the former stockholders of MedaSorb now
own a
majority of the issued and outstanding shares of our Common Stock, and the
directors and executive officers of MedaSorb became our directors and executive
officers. Accordingly, MedaSorb is treated as the acquiror in the merger, which
is treated as a recapitalization of MedaSorb, and the pre-merger financial
statements of MedaSorb will now be deemed to be our historical financial
statements.
In
connection with the merger, we also changed our principal executive offices
to
those of MedaSorb, which are located at 7 Deer Park Drive, Suite K, Monmouth
Junction, New Jersey 08852.
Form
10-SB Disclosure - Description of MedaSorb
Prior
to
closing of the merger, Registrant was a “shell company” (as such term is defined
in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, (the
“Exchange Act”). Accordingly, set forth below is the information that would be
required if Registrant were filing a general form for registration of securities
on Form 10-SB under the Exchange Act.
Unless
otherwise indicated or the context otherwise requires, all references below
to
“we,” “us,” “MedaSorb” and the “Company” are to Registrant together with
MedaSorb, its wholly-owned subsidiary.
General
We
are a
medical device company that is currently in the development stage, headquartered
in Monmouth Junction, New Jersey (near Princeton). We have developed and are
preparing to commercialize a breakthrough blood purification technology that
efficiently removes toxic compounds from circulating blood. Current
state-of-the-art blood purification technology (such as dialysis) is incapable
of effectively clearing these toxins.
Our
products, which have not yet been introduced to the market, are known medically
as hemoperfusion devices, and incorporate our proprietary adsorbent polymer
technology. We believe that there are many potential healthcare applications
for
our products, including:
· |
Adjunctive
treatment and/or prevention of sepsis (bacterial infection of the
blood);
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· |
prevention
of damage to organs donated for transplant prior to organ
harvest;
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· |
prevention
of post-operative complications of cardiac surgery;
and
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· |
long-term
treatment of chronic kidney
failure.
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Product
Strategy
MedaSorb
is developing two product lines, CytoSorb™ and BetaSorb™, for use in acute and
chronic treatments, respectively. CytoSorb™ will initially be targeted for
use as an adjunctive therapy in the acute treatment of the systemic
inflammatory response syndrome (SIRS). BetaSorb™ is intended to be used as a
complement to dialysis in the treatment of chronic end stage renal
disease (ESRD). We will first focus our efforts on commercializing
CytoSorb™, which we believe will provide a relatively faster regulatory pathway
to market. BetaSorb™’s potential for usage in chronic conditions such as ESRD is
anticipated to have a longer and more complex regulatory pathway and will be
pursued after commercialization of the CytoSorb™ product.
The
first
indication for CytoSorb™ will be in the treatment of sepsis, as an
adjunctive therapy to the current standard of care.
Following the sepsis indication, we intend to continue our research in other
acute conditions where CytoSorb™ has indicated potential, such as for use in
cardiopulmonary bypass surgery addressing post operative complications
of inflammation, and organ donation from brain dead organ donors,
addressing the so-called cytokine storm associated with the decrease
of viable organs from donors. We are also exploring the potential benefits
the CytoSorb™ device may have in removing drugs from blood in situations such as
patient overdoses.
We
had
initially identified end stage renal disease as the target market for our
polymer-based adsorbent technology. End stage renal disease affects more than
1.3 million people worldwide and is the single most common application of blood
purification technology today, namely hemodialysis. Hemodialysis is a life
saving intervention, but is not nearly as effective as a healthy kidney in
removing toxins from the bloodstream.
During
the development of our end stage renal product (BetaSorb™), we identified
several applications for our adsorbent technology in the treatment of critical
care patients and recognized that our absorbent polymer represented
a platform
of broad application in medicine, well beyond the treatment of patients
suffering from renal disease. As a result, we shifted our priorities to pursue
critical care applications (such as for the treatment of sepsis) for our
technology. We believe that, compared with the chronic renal application for
our
technology,
· |
we
will able to obtain the necessary regulatory approvals in a shorter
period
of time, allowing us to bring our CytoSorb™ product to market in a shorter
time frame;
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· |
the
production of CytoSorb™ will entail a lower capital requirement for
manufacturing and generate significantly higher gross margins; and
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· |
the
use of CytoSorb™ in critical care applications will result in quicker
reimbursement because the use of our products in these situations
(generally on an in-patient basis) will generally not be subject
to
pre-approval, or require a separate decision, by Medicare or the
relevant
HMO or other providers of medical
benefits.
|
However,
we continue to remain confident of the commercial potential of our BetaSorb™
device for chronic applications and will continue its development as a secondary
product.
Corporate
History
MedaSorb
was organized as a Delaware limited liability company in August 1997 as Advanced
Renal Technologies, LLC. MedaSorb changed its name to RenalTech International,
LLC in November 1998, and to MedaSorb Technologies, LLC in October, 2003.
In
December 2005, MedaSorb converted from a limited liability company to a
corporation, changing its name to MedaSorb Corporation.
MedaSorb
has engaged in research and development since its inception, and prior to the
merger, we had raised approximately $53 million from
investors. These proceeds have been used to fund the development of multiple
product applications and to conduct clinical trials. These funds have also
been
used to establish in-house manufacturing capacity to meet clinical testing
needs, expand our intellectual property through additional patents and to
develop extensive proprietary know-how with regard to our products.
Gilder
Enterprises, Inc., a Nevada corporation, was incorporated on April 25, 2002.
Prior to the merger, through a 51% interest in Nex Connectivity Solutions under
a joint venture arrangement with 5G Wireless Communications Pte. Ltd, the
Registrant was engaged in the business of installing and operating computer
networks that enabled business travelers to have high-speed access to the
Internet. In connection with the merger, we terminated the joint venture
arrangement and disposed of our interest in Nex Connectivity Solutions, which
had generated minimal revenues and no profits. At the effective time of the
merger, the Registrant fell within the definition of a “shell company” under the
Exchange Act.
Technology,
Products and Applications
For
approximately the past half-century, the field of blood purification has been
focused on hemodialysis, a mature, well accepted medical technique primarily
used to sustain the lives of patients with permanent or temporary loss of kidney
function. It is widely understood by the medical community that dialysis has
inherent limitations in that its ability to remove toxic substances from blood
drops precipitously as the size of toxins increases. Our
hemocompatible adsorbent technology addresses this shortcoming by efficiently
removing toxins largely untouched by dialysis.
Our
products are known in the medical field as hemoperfusion devices. During
hemoperfusion, blood is removed from the body via a catheter or other blood
access device, perfused through a filter medium where toxic compounds are
removed, and returned to the body.
We
believe that our polymer adsorbent technology represents an effective
therapeutic approach to severe health complications caused or complicated by
large toxins circulating in the blood. Our technology has many potential
applications in the treatment of common, chronic and acute healthcare
complications including the treatment and/or prevention of sepsis; drug
detoxification; the treatment of chronic kidney failure; the treatment of organ
dysfunction resulting from trauma and severe burns; the treatment of liver
failure; the prevention of post-operative complications of cardiopulmonary
bypass surgery; and the prevention of damage to organs donated by brain-dead
donors prior to organ harvest. These applications vary by cause and complexity
as well as by severity but share a common characteristic i.e. high
concentrations of toxins in the circulating blood.
Our
products will be easy to use and will be able to be incorporated into existing
extracorporeal blood handling equipment, including heart-lung bypass circuits
and hemodialysis machines. They will require no additional, expensive equipment
and require minimal training.
Markets,
Size and Economic Potential
Sepsis
In
the
United States alone, there are more than one million new cases of sepsis
annually; extrapolated to a global population, the worldwide incidence is
several million cases per year. Severe trauma and community acquired pneumonia
are often associated with sepsis.
Sepsis
patients are critically ill and suffer a very high mortality rate of between
28%
and 60%. Because they are so expensive to treat, we believe that efficacy rather
than cost will be the determining factor in the adoption of CytoSorb™ in the
treatment of sepsis. Our current pricing model represents a fraction of what
is
currently spent on the treatment of a sepsis patient. Critical care specialists
project that the average sepsis patient may require 10 CytoSorb™ (single-use,
disposable) devices during a treatment regimen, based on the median number
of
days for which patients typically require ventilator support. Assuming only
2%
of the sepsis patient population received CytoSorb™ therapy, based on a pricing
model of $500 per device and 10 devices per episode, the annual revenue
potential is $100 million in the U.S. alone and $200 million
worldwide.
Brain-Dead
Organ Donors
There
are
approximately 6,000 to 12,000 brain dead organ donors each year in the United
States; worldwide, the number of these organ donors is estimated to be at least
double the U.S. brain dead organ donor population. There is a severe shortage
of
donor organs. Currently, there are more than 85,000 individuals on transplant
waiting lists in the United States. We expect that the use of our CytoSorb™
device in brain dead organ donors will increase the number of viable organs
harvested from the donor pool and improve the survival of transplanted organs.
At $500 per device, the worldwide revenue potential for this application is
currently estimated at $12 million annually.
Cardiopulmonary
Bypass Procedures
There
are
approximately 400,000 cardiopulmonary bypass (CPB) and cardiac surgery
procedures performed annually in the U.S. and more than 800,000 worldwide.
Nearly a third of all patients suffer from post-operative complications of
cardiopulmonary bypass surgery, including complications from infection,
pneumonia, pulmonary, and neurological dysfunction. Extended surgery time leads
to longer ICU recovery time and hospital stays, both leading to higher costs
-
approximately $35,000 per coronary artery bypass graft procedure. We believe
that the use of CytoSorb™ during and after the surgical procedure will prevent
or mitigate post-operative complications for many CPB patients.
We
anticipate that the CytoSorb™ device, incorporated into the extracorporeal
circuit used with the by-pass equipment during surgery, and/or employed
post-operatively for a period of time, will mitigate inflammation and speed
recovery. At $500 per CytoSorb™ device and one device per procedure, and
assuming 50% of the patient population receives CytoSorb™ treatment, the annual
revenue potential for this application is $100 million in the U.S. and $200
million worldwide.
Chronic
Kidney Failure
The
National Kidney Foundation estimates that more than 20 million Americans have
chronic kidney disease. Left untreated, chronic kidney disease can ultimately
lead to chronic kidney failure, which requires a kidney transplant or chronic
dialysis (generally three times per week) to sustain life. There are
approximately 300,000 patients in the United States currently receiving chronic
dialysis and more than 1.3 million worldwide. Approximately 85% of patients
with
chronic kidney disease are treated with hemodialysis.
Our
BetaSorb™ device has been designed for use in conjunction with standard
dialysis. Standard dialysis care typically involves three sessions per week,
averaging approximately 150 sessions per year. Assuming BetaSorb™ use in each
session, every 100,000 patients would require approximately 15 million devices
annually.
Our
pricing model for the BetaSorb™ device is based on a variety of cost/benefit
assumptions. The current BetaSorb™ end-user pricing model is $35 per device, or
$5,250 per patient per year. Based on high-volume finished product cost
assumptions and the terms of our existing marketing and distribution agreement
with Fresenius Medical Care (which owns more than 1,600 dialysis clinics with
over 130,000 patients), we estimate annual revenue potential for the application
of our technology to chronic kidney failure at approximately $780 million in
the
U.S. and $2.5 billion worldwide.
Other
Applications
Additional
applications for the critical care market have been identified. These promising
areas include:
· |
Regional
high-dose chemotherapy
|
· |
Acute
Respiratory Distress Syndrome
(ARDS)
|
· |
Severe
Acute Respiratory Syndrome (SARS)
|
Products
(Currently in Development)
The
CytoSorb™ Device (Critical Care)
APPLICATION:
Treatment and Prevention of Sepsis
Sepsis
is
defined by high levels of toxic compounds (“cytokines”)
which are released into the blood stream as part of the body’s auto-immune
response to severe infection or injury. These toxins cause severe inflammation
and damage healthy tissues, which can lead to organ dysfunction and failure.
Sepsis is very expensive to treat and has a high mortality rate.
Potential
Benefits:
By
preventing or reducing the accumulation of cytokines in the circulating blood,
we believe our adsorbent blood purification technology will prevent or mitigate
severe inflammation, organ dysfunction and failure in sepsis patients.
Therapeutic goals as an adjunctive therapy include reduced ICU and total
hospitalization time.
Background
and Rationale for Efficacy:
We
believe that the effective treatment of sepsis is the most valuable potential
application for our technology. Sepsis carries mortality rate of between 28%
and
60%. Death can occur within hours or days, depending on many variables,
including cause, severity, patient age and co-morbidities. Researchers estimate
that there are approximately one million new cases of sepsis in the U.S. each
year; extrapolated to a global population, this equates to several million
new
cases annually. In the U.S. alone, treatment of sepsis costs nearly $20 billion
annually. According to the Centers for Disease Control, sepsis is the tenth
leading cause of death in the U.S., as reported by (CDC). More than 1,000 people
die each day from sepsis.
An
effective treatment for sepsis has been elusive. Pharmaceutical companies have
been trying to develop drug therapies to treat the condition. With the exception
of a single drug, Xigris® from Eli Lilly, which demonstrated a small improvement
in survival in a small segment of the patient population, to our knowledge,
all
other efforts to date have failed to significantly improve patient
survival.
Our
technology presents a new therapeutic approach in the treatment of sepsis,
and
its potential efficacy is supported by scientific research. The potential
benefits of blood purification in the treatment of sepsis patients are widely
acknowledged by medical professionals and have been studied using dialysis
and
hemofiltration technology. These studies, while encouraging, demonstrated that
dialysis alone produced only limited benefit to sepsis patients. The reason
for
this appears to be rooted in a primary limitation of dialysis technology itself:
the inability of standard dialysis to effectively and efficiently remove larger
toxins from circulating blood. Our CytoSorb™ device efficiently removes these
larger toxins. CytoSorb’s™ toxin clearing ability and the ability to interact
safely with blood (hemocompatibility) has been demonstrated clinically. Data
collected during the “emergency and compassionate use” treatment of a single
sepsis patient has been encouraging to us.
CytoSorb™
has been designed to achieve broad-spectrum removal of both pro- and
anti-inflammatory cytokines, preventing or reducing the accumulation of high
concentrations in the bloodstream. This approach is intended to modulate the
immune response without blocking or suppressing the function of any of its
mediators. For this reason, researchers have referred to the approach reflected
in our technology as ‘immunomodulatory’ therapy.
Projected
Timeline and Budget Requirements:
Previous
clinical studies in patients with chronic kidney failure have provided valuable
data which underpin the development of the critical care applications for our
technology. Our current device design has been extensively studied and shown
to
be efficacious in humans with kidney failure (in multiple treatment sessions
lasting up to 4 hours, three times per week for up to 24 weeks in some
patients). This same device design was tested on a single patient with bacterial
sepsis, producing results that we found very encouraging and confirming to
us
that our device design is appropriate for a more extensive sepsis study. Our
plans for the development of CytoSorb™ to treat sepsis patients are summarized
in the table below.
Task
|
Estimated
Time Required
|
Estimated
Budget
Requirements
|
1.
Design pilot study
|
4
to 6 months
|
(nominal)
|
2.
Conduct pilot study
|
6
to 9 months
|
$1.2
million
|
3.
Design pivotal study
|
Concurrent
with item 2
|
(nominal)
|
4.
Conduct pivotal study
|
9
to 12 months
|
$1.8
million
|
5.
Approval
time following submission
|
6
to 9 months
|
|
Total
|
Approximately
25 to 36 months
|
$3.0
million
|
Because
our technology pertains to a medical device, the regulatory pathway and approval
process are faster and more straightforward than the process related to the
approval of a drug.
APPLICATION:
Prevention
and treatment of organ dysfunction in brain-dead organ donors to increase the
number and quality of viable organs harvested from donors
Potential
Benefits:
By
preventing or reducing high-levels of cytokines from accumulating in the
bloodstream of a brain-dead organ donor, CytoSorb™ aims to mitigate organ
dysfunction and failure which results from severe inflammation following
brain-death. The primary goals for this application are
· |
Improving
the viability of organs which can be harvested from brain-dead organ
donors, and
|
· |
increasing
the likelihood of organ survival following
transplant.
|
Background
and Rationale for Efficacy:
When
brain death occurs, the body responds by generating large quantities of
inflammatory cytokines. This process is similar to sepsis. A high percentage
of
donated organs are never transplanted due to this response, which damages
healthy organs and prevents transplant. In addition, inflammation in the donor
may damage organs that are harvested and reduce the probability of graft
survival following transplant.
There
is
a shortage of donated organs worldwide, with approximately 85,000 people
currently on the waiting list for organ transplants in the United States alone.
Because there are an insufficient number of organs donated to satisfy demand,
it
is vital to maximize the number of viable organs donated, and optimize the
probability of organ survival following transplant.
Projected
Timeline and Budget Requirements:
Studies
are currently being conducted under a $1 million grant from the Health Resources
and Services Administration (HRSA), an
agency
of the U.S. Department of Health and Human Services, and extensive development
work has already been completed. Researchers at the University of Pittsburgh
Medical Center and the University of Texas, Houston Medical Center have made
significant progress on the observational and dosing phases of the project.
The
observational portion of the study is ongoing, while the dosing study, involving
eight non-viable donors, has been completed. These initial phases of the study
are expected to be concluded in 2006. The next phase of this study, the
treatment phase, will involve viable donors. In this phase of the
project,
viable
donors will be treated and the survival and function of organs in transplant
recipients will be tracked and measured. The treatment phase will be contingent
upon further discussion with the FDA and HRSA regarding trial design, as well
as
obtaining additional funding.
APPLICATION:
Prevention and treatment of post-operative complications of cardiopulmonary
bypass surgery
Potential
Benefits:
By
preventing or reducing high levels of cytokines from accumulating in the blood
system during and following cardiac surgery, we anticipate that post-operative
complications of cardiopulmonary bypass surgery can be prevented or mitigated.
The primary goals for this application are to
· |
reduce
ventilator and oxygen therapy requirements;
|
· |
reduce
length of stay in hospital intensive care units; and
|
· |
reduce
the total cost of patient care.
|
Background
and Rationale for Efficacy:
Due to
the highly invasive nature of cardiopulmonary bypass surgery, high levels of
cytokines are produced by the body, triggering severe inflammation. By
preventing or reducing the accumulation of cytokines in a patient’s blood
stream, we expect to prevent or mitigate post-operative complications caused
by
an excessive or protracted inflammatory response to the surgery. While not
all
patients undergoing cardiac surgery suffer these complications, it is impossible
to predict before surgery which patients will be affected.
Projected
Timeline:
We have
completed an observational study of 32 patients to obtain information with
respect to the onset and duration of cytokine release. We expect that this
information will aid us in defining the appropriate time to apply the CytoSorb™
device to maximize therapeutic impact. We are not currently focusing our efforts
on the commercialization of our technology for application to cardiac surgery.
Upon successful commercialization of the sepsis application, we will pursue
the
use of our polymer absorbent technology for other critical care uses, such
as
cardiopulmonary bypass surgery.
The
BetaSorb™ Device (Chronic Care)
APPLICATION:
Prevention and treatment of health complications caused by the accumulation
of
metabolic toxins in patients with chronic renal failure
Potential
Benefits:
By
preventing or reducing high levels of metabolic waste products from accumulating
in the blood and tissues of long-term dialysis patients, we anticipate that
the
health complications characteristic to these patients can be prevented or
mitigated. The primary goals for this application are to
· |
improve
and maintain the general health of dialysis patients;
|
· |
improve
the quality of life of these
patients
|
· |
reduce
the total cost of patient care; and
|
· |
increase
life expectancy.
|
Background
and Rationale for Efficacy:
Our
BetaSorb™ device is intended for use on patients suffering from chronic kidney
failure, who rely on long-term dialysis therapy to sustain life. Due to the
widely recognized inability of dialysis to remove larger proteins from blood,
metabolic waste products, such as Beta-2 microglobulin, accumulate to toxic
levels and are deposited in the joints and tissues of patients. Specific toxins
known to accumulate in these patients have been linked to their severe health
complications, increased healthcare costs, and reduced quality of life.
Researchers
also believe that the accumulation of toxins may play an important role in
the
significantly reduced life expectancy experienced by dialysis patients. In
the
U.S., the average life expectancy of a dialysis patient is five years. Industry
research has identified links between many of these toxins and poor patient
outcomes. By routinely removing these toxins during dialysis and preventing
or
reducing their accumulation, we expect our BetaSorb™ device to maintain or
improve patient health in the long-term. We believe that by reducing the
incidence of health complications, the annual cost of patient care will be
reduced and life expectancy increased.
The
poor
health experienced by chronic dialysis patients is illustrated by the fact
that
in the U.S. alone, more than $20 billion is spent annually caring for this
patient population. While the cost of providing dialysis therapy alone is
approximately $23,000 per patient per year, the total cost of caring for a
patient ranges from $60,000 to more than $120,000 annually due to various health
complications associated with dialysis.
Projected
Timeline:
We have
collected a significant amount of empirical data for the development of this
application. As the developer of this technology, we had to undertake extensive
research, as no comparable technology was available for reference purposes.
We
have completed several pilot studies, and most recently a clinical pilot of
six
patients in California for up to 24 weeks in which our BetaSorb™ device removed
the targeted toxins as expected.
As
discussed above, due to practical and economic considerations, we are now
focusing our efforts and resources on commercializing our CytoSorb™ device for
critical care application. Following commercial introduction of the CytoSorb™
device, we expect to conduct additional clinical studies using the BetaSorb™
device in the treatment of end stage renal disease patients.
Commercial
and Research Partners
University
of Pittsburgh Medical Center
We
are
working
with researchers at the University of Pittsburgh - Critical Care Medicine
Department in the development of critical care applications for technology.
Consisting of more than twenty physicians, as well as numerous full-time
scientists, educators and administrative assistants, the Critical Care Medicine
Department at the University of Pittsburgh is one of the largest organizations
of its type in the world and has established an international reputation for
excellence in clinical care, education, and research.
Researchers
at UPMC have participated in nearly every major clinical trial of potential
sepsis intervention during the past twenty years. Drs. Derek Angus and John
Kellum were investigators for Ely Lilly’s
sepsis
drug, Xigris®. Dr. Kellum, a member of the UPMC faculty since 1994, is our
principal investigator for CytoSorb™. Dr. Kellum, together with several other
researchers at UPMC, serve on our Critical Care Advisory Board. Dr. Kellum’s
research interests span various aspects of Critical Care Medicine, but center
on
critical care nephrology (including acid-base, and renal replacement therapy),
sepsis and multi-organ failure, and clinical epidemiology. He is Chairman of
the
Fellow Research Committee at the University of Pittsburgh Medical
Center and has
authored more than 70 publications and has received numerous research grants
from foundations and industry.
Fresenius
Medical Care
AG
We
have
entered into an
exclusive, long-term agreement with Fresenius Medical Care for the global
marketing and distribution of our BetaSorb™ device and any similar product we
may develop for the treatment of renal disease. The agreement, which we entered
into in 1999 is a profit sharing plan under which both we and Fresenius are
incentivized to minimize costs and maximize the price to end-users. In
particular, under the agreement, to the extent that sales of our products by
Fresenius results in gross margins to Fresenius in excess of targeted levels,
we
would share with Fresenius a portion of the revenues attributable to such
excess.
With
Fresenius as our exclusive distributor of our renal products, we believe that
our agreement with Fresenius will maximize the potential for rapid product
introduction and penetration of the chronic kidney failure market.
Today,
Fresenius Medical Care is the world's largest, integrated provider of products
and services for individuals with chronic kidney failure. Through its network
of
more than 1,600 dialysis clinics in North America, Europe, Latin America and
Asia-Pacific, Fresenius Medical Care provides dialysis treatment to more than
130,000 patients around the globe. Fresenius Medical Care is also the world's
largest provider of dialysis products, such as hemodialysis machines, dialyzers
and related disposable products.
Royalty
Agreement
In
August
2003, in order to induce Guillermina Vega Montiel, a principal stockholder
of
ours, to make an additional investment in MedaSorb, we granted Ms. Montiel
a
perpetual royalty equal to three percent of all gross revenues received by
us
from sales of CytoSorbTM
in
the
applications of sepsis, cardiopulmonary bypass surgery, organ donor,
chemotherapy and inflammation control application.
Product
Payment & Reimbursement
Critical
Care Applications
Payment
for our
CytoSorb™ device in the treatment and prevention of sepsis and other related
acute care applications is anticipated to fall under the “diagnosis-related
group” (DRG) in-patient reimbursement system, which is currently the predominant
basis of hospital medical billing in the United States. Under this system,
predetermined payment amounts are assigned to categories of medical patients
with respect to their treatments at medical facilities based on the DRG that
they fall within (which is a function of such characteristics as medical
condition, age, sex, etc.) and the length of time spent by the patient at the
facility. Reimbursement is not determined by the actual procedures used in
the
treatment of these patients, and a separate reimbursement decision would not
be
required to be made by Medicare, the HMO or other provider of medical benefits
in connection with the actual method used to treat the patient.
Critical
care applications such as those targeted by our CytoSorb™ device involve a high
mortality rate and extended hospitalization, coupled with extremely expensive
ICU time. In view of these high costs and high mortality rates, we believe
acceptance of our proprietary technology by critical care practitioners and
hospital administrators will primarily depend on safety and efficacy factors
rather than cost.
Chronic
Renal Failure
In
the
U.S.,
over
80% of chronic dialysis patients are Medicare-eligible, regardless of age.
Therefore, it is expected that Medicare will be the primary payer for the
BetaSorb™ device, either through the current “fee for service” mechanism or
managed care programs. The large majority of costs not covered by federal
programs are covered by the private insurance sector.
While
the
fee-for-service composite rate system is currently the dominant payment
mechanism, many industry participants believe that a managed care system will
become the dominant payment mechanism. We believe that movement to a full or
shared-risk managed care system would speed market acceptance of BetaSorb™
because, under such a system, providers will have a strong incentive to adopt
technologies that lower overall treatment costs. Fresenius is a leading
participant in the move to managed care and will play a leading role in the
demonstration and introduction of our product to Medicare.
Competition
Sepsis
We
believe that our products represent a unique approach to disease states and
health complications associated with sepsis, which is sometimes also referred
to
as systemic inflammatory response syndrome (SIRS). Researchers have explored
the
potential of using existing membrane-based dialysis technology to treat patients
suffering from sepsis. These techniques are unable to effectively remove the
larger toxins which leading researchers have shown to cause and complicate
sepsis. The same experts believe that a blood purification technique that
efficiently removes, or significantly reduces, the circulating concentrations
of
such toxins might represent a successful therapeutic option.
The
CytoSorb™ device is highly efficient in the removal of large toxins from
circulating blood. Since the adsorbent device does not rely on fluid extraction
for blood purification, it does not necessitate the use of replacement fluid.
This represents a major advantage over any dialysis technique. A study conducted
on a single patient with bacterial sepsis produced results that we believe
demonstrate the ability of the CytoSorb™ device to remove the toxins acting in
sepsis.
Medical
research during the past two decades has focused on drug interventions aimed
at
chemically blocking or suppressing the function of one or two inflammatory
agents. In hindsight, some
researchers now believe this approach has little chance of significantly
improving patient outcomes because of the complex pathways and multiple chemical
factors at play. Clinical studies of these drug therapies have been largely
unsuccessful. An Ely Lilly drug, Xigris®, cleared by the FDA in November 2001,
is the first and only drug to be approved for the treatment of severe sepsis.
Clinical studies demonstrated that use of Xigris® resulted in a 6% reduction in
the absolute risk of death, and a 13% risk reduction in the most severe sepsis
patients. The drug remains controversial and is considered extremely expensive
when compared to the percentage of patients who benefit.
While
studies of other potential sepsis drug therapies are in progress, we are not
aware of any other broad-spectrum blood detoxification therapy under development
for this application that could be considered directly competitive with our
approach.
Cardiopulmonary
Bypass Surgery
We
are
not aware of any practical competitive approaches for removing cytokines in
CPB
patients. Alternative therapies such as “off-pump” surgeries are available but
“post-bypass” syndrome has not been shown to be reduced in this less invasive
procedure. If successful, the CytoSorb™ is expected to be useful in both on-pump
and off-pump procedures.
Chronic
Dialysis
We
know
of no other device, medication or therapy considered directly competitive with
our technology. Research and development in the field has focused primarily
on
improving existing dialysis technologies. The introduction of the high-flux
dialyzer in the mid-1980s and the approval of Amgen’s Epogen™, a recombinant
protein used to treat anemia, are the two most significant developments in
the
field over the last two decades.
Efforts
to improve removal of larger toxins with enhanced dialyzer designs have achieved
only marginal success. Many experts believe that dialyzer technology has reached
its limit in this respect. A variation of high-flux hemodialysis, known as
hemodiafiltration, has existed for many years. However, due to the complexity,
cost and increased risks, this dialysis technique
has not gained significant acceptance worldwide. In addition, many larger toxins
are not effectively filtered by hemodiafiltration, despite its more open pore
structure. As a result, hemodiafiltration does not approach the quantity of
toxins removed by the BetaSorb™ device.
Treatment
of Organ Dysfunction in Brain-Dead Organ Donors
We
are not
aware of any directly competitive products to address the application of our
technology for the mitigation of organ dysfunction and failure resulting from
severe inflammation following brain-death.
Clinical
Testing
Our
first
clinical studies were conducted in patients with chronic renal failure. The
health of these patients is challenged by high levels of toxins circulating
in
their blood but, unlike sepsis patients, they are not at imminent risk of death.
The toxins involved in chronic renal failure are completely different from
those
involved in sepsis, eroding health gradually over time. The treatment of
patients with chronic renal failure is a significant target market for us,
although not the current focus of our efforts and resources. Our clinical
testing and product development work in this application functioned as a low
risk method of evaluating the safety of the technology in a clinical setting,
with direct benefit to development of the critical care applications on which
we
are now focusing our efforts.
We
believe that our device design, which has been tested in approximately 350
sessions, combined with hemodialysis, has been identified as a suitable
candidate to pilot in clinical studies in the treatment of sepsis. We used
this
design in our first clinical experience treating a septic patient, which has
produced results that we have found encouraging and indicative of the efficacy
of our technology in the treatment of sepsis.
Government
Research Grants
Three
government research grants by the National Institutes of Health (NIH) and Health
and Human Services (HHS) have been awarded to investigators to explore the
use
of our technology in sepsis and transplant organ preservation.
A
grant
of $1 million
was awarded to the University of Pittsburgh Medical Center in 2003. The project
seeks to improve the quantity and viability of organs donated for transplant
by
using CytoSorb™ to detoxify the donor’s blood. This clinical study is in
progress.
The
second grant, a $100,000 Phase I Small Business Technology Transfer grant from
the National Institutes of Health, was directly awarded to us for the study
of
blood purification on survival time using a septic model.
Finally,
University of Pittsburgh Medical Center was awarded a $7,000,000 grant from
NIH
entitled “Systems Engineering of a Pheresis Intervention for Sepsis
(SEPsIS)”
to study
the use of our adsorbent polymer technology in the treatment of severe sepsis.
These grants represent a substantial research cost savings to us and demonstrate
the strong interest of the medical and scientific communities in our
technology.
Regulation
The
medical devices that we manufacture are subject to regulation by numerous
regulatory bodies, including the FDA and comparable international regulatory
agencies. These agencies require manufacturers of medical devices to comply
with
applicable laws and regulations governing the development, testing,
manufacturing, labeling, marketing and distribution of medical devices. Devices
are generally subject to varying levels of regulatory control, the most
comprehensive of which requires that a clinical evaluation program be conducted
before a device receives approval for commercial distribution.
In
the
U.S., permission to distribute a new device generally can be met in one of
two
ways. The first process requires that a pre-market notification (510(k)
Submission) be made to the FDA to demonstrate that the device is as safe and
effective as, or substantially equivalent to, a legally marketed device that
is
not subject to pre-market approval (PMA). A legally marketed device is a device
that (i) was legally marketed prior to May 28, 1976, (ii) has
been reclassified from Class III to Class II or I, or (iii) has been
found to be substantially equivalent to another legally marketed device
following a 510(k) Submission. The legally marketed device to which equivalence
is drawn is known as the “predicate” device. Applicants must submit descriptive
data and, when necessary, performance data to establish that the device is
substantially equivalent to a predicate device. In some instances, data from
human clinical trials must also be submitted in support of a 510(k) Submission.
If so, these data must be collected in a manner that conforms with specific
requirements in accordance with federal regulations. The FDA must issue an
order
finding substantial equivalence before commercial distribution can occur.
Changes to existing devices covered by a 510(k) Submission which do not
significantly affect safety or effectiveness can generally be made by us without
additional 510(k) Submissions.
The
second process requires that an application for PMA be made to the FDA to
demonstrate that the device is safe and effective for its intended use as
manufactured. This approval process applies to certain Class III devices.
In this case, two steps of FDA approval are generally required before marketing
in the U.S. can begin. First, investigational device exemption (IDE) regulations
must be complied with in connection with any human clinical investigation of
the
device in the U.S. Second, the FDA must review the PMA application which
contains, among other things, clinical information acquired under the IDE.
The
FDA will approve the PMA application if it finds that there is a reasonable
assurance that the device is safe and effective for its intended purpose.
In
the
European Union, distributors of medical devices are required to comply with
the
Medical Devices Directive and obtain CE Mark certification in order to market
medical devices. The CE Mark certification, granted following approval from
an
independent Notified Body, is an international symbol of adherence to quality
assurance standards and compliance with applicable European Medical Devices
Directives. Distributors of medical devices may also be required to comply
with
other foreign regulations such as Ministry of Health Labor and Welfare approval
in Japan. The time required to obtain these foreign approvals to market our
products may be longer or shorter than that required in the U.S., and
requirements for those approvals may differ from those required by the FDA.
In
the
United States, our CytoSorb™ and BetaSorb™ devices are classified as Class III
(CFR 876.5870—Sorbent Hemoperfusion System) and will require 501(k) Submissions
to the FDA. However, because the BetaSorb™ device is intended for chronic use,
the FDA may require pre-market approval (PMA), which we will submit if required.
In the case of CytoSorb™, because the application is for acute care (short term,
less than 30 days), management believes that FDA approval for this product
may
be obtained based solely on the 510(k) Submission accompanied with clinical
data. In Europe, our devices are expected to be classified as class IIb, and
will conform to the ISO 13485 Quality Standard in support of our planned
applications to obtain CE Mark certification in Europe, and applicable approvals
in Canada and Japan.
The
process of obtaining clearance to market products is costly and time-consuming
in virtually all of the major markets in which we expect to sell products and
may delay the marketing and sale of our products. Countries around the world
have recently adopted more stringent regulatory requirements which are expected
to add to the delays and uncertainties associated with new product releases,
as
well as the clinical and regulatory costs of supporting those releases. No
assurance can be given that any of our medical devices will be approved on
a
timely basis, if at all. In addition, regulations regarding the development,
manufacture and sale of medical devices are subject to future change. We cannot
predict what impact, if any, those changes might have on our business. Failure
to comply with regulatory requirements could have a material adverse effect
on
our business, financial condition and results of operations.
Given
adequate funding, we expect that it will take approximately six months to begin
the treatment phase of a pilot clinical study on the efficacy of our products
in
the treatment of sepsis. The pilot phase is expected to span six to nine months,
and an additional one year pivotal study would then be undertaken for the
purpose of compiling sufficient data to support both the U.S. 510(k) Submission
and the application to obtain CE Mark certification in Europe. In the U.S.,
another six to nine months is anticipated for FDA review and approval of the
510(k) submission. Concurrent with these activities, we plan to pursue CE Mark
certification of our products. Upon successful completion of a “quality systems
audit” in combination with clinical data and the assembly of a technical file,
we anticipate that CytoSorb™ device will receive CE Mark certification,
allowing
it
to be sold in Europe.
The
FDA
can ban certain medical devices, detain or seize adulterated or misbranded
medical devices, order repair, replacement or refund of these devices and
require notification of health professionals and others with regard to medical
devices that present unreasonable risks of substantial harm to the public
health. The FDA may also enjoin and restrain certain violations of the Food,
Drug and Cosmetic Act and the Safe Medical Devices Act pertaining to medical
devices, or initiate action for criminal prosecution of such violations.
International sales of medical devices manufactured in the U.S. that are not
approved by the FDA for use in the U.S., or are banned or deviate from lawful
performance standards, are subject to FDA export requirements. Exported devices
are subject to the regulatory requirements of each country to which the device
is exported. Some countries do not have medical device regulations, but in
most
foreign countries medical devices are regulated. Frequently, regulatory approval
may first be obtained in a foreign country prior to application in the U.S.
to
take advantage of differing regulatory requirements.
Sales
and Marketing
We
currently estimate, provided that we receive adequate funding to support our
planned activities and that our products perform as expected in clinical
studies, that we will obtain FDA approval of our CytoSorb™ device in the
treatment of sepsis in 25 to 36 months from funding. As we approach regulatory
approval, we plan to initially build a sales organization of approximately
15
representatives in the U.S. In addition, we plan on pursuing localized
distribution agreements in rural areas.
We
also
plan to initiate sales in several European countries which are known as early
adopters of new medical device technology. These countries primarily include
Italy, Germany and the United Kingdom. We plan to initially operate through
local distributors in each European country where we launch sales operations.
Only after establishment of a limited network of local distributors and actual
generation of sales, will we formulate a broader distribution strategy on a
global basis.
Intellectual
Property and Patent Litigation
The
medical
device
market in which we primarily participate is in large part technology driven.
As
a result, intellectual property rights, particularly patents and trade secrets,
play a significant role in product development and differentiation. However,
intellectual property litigation to defend or create market advantage is
inherently complex, unpredictable and is expensive to pursue. Litigation often
is not ultimately resolved until an appeal process is completed and appellate
courts frequently overturn lower court patent decisions.
Moreover,
competing parties frequently file multiple suits to leverage patent portfolios
across product lines, technologies and geographies and to balance risk and
exposure between the parties. In some cases, several competitors are parties
in
the same proceeding, or in a series of related proceedings, or litigate multiple
features of a single class of devices. These forces frequently drive settlement
not only of individual cases, but also of a series of pending and potentially
related and unrelated cases. In addition, although monetary and injunctive
relief is typically sought, remedies are generally not determined until the
conclusion of the proceedings, and are frequently modified on appeal.
Accordingly, the outcomes of individual cases are difficult to time, predict
or
quantify and are often dependent upon the outcomes of other cases in other
forums, both domestic and international.
We
rely
on a combination of patents, trademarks, trade secrets and non-disclosure
agreements to protect our intellectual property. We hold 21 U.S.
patents, some of which have foreign counterparts, and additional patent
applications pending worldwide that cover various aspects of our technology.
There can be no assurance that pending patent applications will result in issued
patents, that patents issued to us will not be challenged or circumvented by
competitors, or that such patents will be found to be valid or sufficiently
broad to protect our technology or to provide us with a competitive advantage.
We
rely
on non-disclosure and non-competition agreements with employees, consultants
and
other parties to protect, in part, trade secrets and other proprietary
technology. There can be no assurance that these agreements will not be
breached, that we will have adequate remedies for any breach, that others will
not independently develop equivalent proprietary information or that third
parties will not otherwise gain access to our trade secrets and proprietary
knowledge.
We
may
find it necessary to initiate litigation to enforce our patent rights, to
protect our trade secrets or know-how and to determine the scope and validity
of
the proprietary rights of others. Patent litigation can be costly and
time-consuming, and there can be no assurance that our litigation expenses
will
not be significant in the future or that the outcome of litigation will be
favorable to us. Accordingly, we may seek to settle some or all of our pending
litigation described below. Settlement may include cross-licensing of the
patents which are the subject of the litigation as well as our other
intellectual property and may involve monetary payments to or from third
parties.
Employees
and Properties
We
currently have six employees
and operate a 6,575 sq. ft. facility near Princeton, New Jersey, housing
research laboratories, clinical manufacturing operations and administrative
offices, under a lease agreement which expires in February 2007. In the opinion
of management, the leased properties are adequately insured, are in good
condition and suitable for the conduct of our business. We also collaborate
with
numerous institutions, universities and commercial entities who conduct research
and testing of our products at their facilities.
Legal
Proceedings
Purolite
For
a
period of time beginning in December 1998, Purolite engaged in efforts to
develop and optimize the manufacturing process needed to produce our polymer
products on a commercial scale. However, the parties eventually decided not
to
proceed. In January, 2003, Purolite commenced an action against us in United
States District Court for the Eastern District of Pennsylvania asserting
that our adsorbent technology was developed in part using Purolite’s technology,
that two of its employees should be included as co-inventors on some of our
patents, and that Purolite was therefor a joint owner of the technology and
had
rights to the use of the technology. Purolite recently expanded its claims,
alleging they are the sole owner of these patents, and that we misappropriated
these patents from them. Purolite now seeks equitable relief declaring that
it
is the exclusive owner of our technology, as well as monetary
damages.
We
have
filed a motion for summary judgment, which is pending before the Court, and
have
also engaged in efforts to settle the case. In addition, the Court has
ordered the matter to be mediated before a magistrate judge. Although there
has
been some progress in seeking a resolution of the litigation, to date no
agreement has been reached, and there can be no assurance that the parties
will
be able to reach an accord. If the case is not settled, the Court will rule
on
our summary judgment motion. If the motion is denied, we expect that the
matter will go to trial within a few months following the Court’s ruling on our
summary judgment motion.
Former
Employee
In
May
2006, a former employee of ours initiated a legal action against us in the
United States District Court for the Southern District of New York, seeking
damages in an amount exceeding $245,500. The employee alleges that we are
required to pay or reimburse him for (as applicable) credit card charges to
his
account made by another former employee of ours and a related party. The matter
is currently under review by our legal counsel.
Dow
Chemical
Several
years ago we engaged in discussions with the Dow Chemical Company, which had
indicated a strong interest in being our polymer manufacturer. After a Dow
representative on our Advisory Board resigned, Dow filed and received several
patents naming our former Advisory Board member as an inventor. In management’s
view the Dow patents improperly incorporate our technology and should not have
been granted to Dow. The existence of these Dow patents could result in a
potential dispute with Dow in the future and additional expenses for us.
RISKS
FACTORS
MedaSorb
currently has no commercial operations and there can be no assurance that it
will be successful in developing commercial operations.
We
are a
development stage company and have been engaged primarily in research and
development activities and have not generated any revenues to date. There can
be
no assurance that we will be able to successfully manage the transition to
a
commercial enterprise. Potential investors should be aware of the problems,
delays, expenses and difficulties frequently encountered by an enterprise in
the
early stage of development, which include unanticipated problems relating to
development of proposed products, testing, regulatory compliance, manufacturing,
competition, marketing problems and additional costs and expenses that may
exceed current estimates. Our proposed products will require significant
additional research, development, testing and financing and we will need to
overcome significant regulatory burdens prior to commercialization. There can
be
no assurance that after the expenditure of substantial funds and efforts, we
will successfully develop and commercialize any products, generate any revenues
or ever achieve and maintain a substantial level of sales of our products.
MedaSorb
has a History of Losses and Expects to Incur Substantial Future Losses, and
the
Report of its Auditor
on its Consolidated Financial Statements Expresses Substantial Doubt About
its
Ability to Continue as a Going Concern.
MedaSorb
has experienced substantial operating losses since inception. As of March 31,
2006, MedaSorb had an accumulated deficit of $59,994,884, which included losses
from operations of $3,665,596 for the year ended December 31, 2005 and
$1,015,377 for the three-month period ended March 31, 2006. Due to these losses,
MedaSorb’s
audited consolidated financial statements have been prepared assuming MedaSorb
will continue as a going concern, and the auditors’ report on those financial
statements express
substantial doubt about its ability to continue as a going concern. MedaSorb’s
losses have resulted principally from costs incurred in the research and
development of our polymer technology and general and administrative expenses.
Because MedaSorb was a limited liability company until December 2005,
substantially all of these losses were allocated to its members and will not
be
available for tax purposes to us in future periods. We intend to conduct
significant additional research, development, and clinical testing activities
which, together with expenses incurred for the establishment of manufacturing
arrangements and a marketing and distribution presence and other general and
administrative expenses, are expected to result in continuing operating losses
for the foreseeable future. The amount of future losses and when, if ever,
we
will achieve profitability are uncertain. Our ability to achieve profitability
will depend, among other things, on successfully completing the development
of
our technology and commercial products, obtaining the requisite regulatory
approvals, establishing manufacturing and sales and marketing arrangements
with
third parties, and raising sufficient funds to finance our activities. No
assurance can be given that our product development efforts will be successful,
that required regulatory approvals will be obtained, that any of our products
will be manufactured at a competitive cost and will be of acceptable quality,
or
that the we will be able to achieve profitability or that profitability, if
achieved, can be sustained.
We
may have
difficulty raising needed capital in the future because of our limited operating
history and business risks associated with MedaSorb.
We
generate no revenues from our proposed products or otherwise, and have expended
and will continue to expend substantial funds in the research, development
and
clinical and pre-clinical testing of our polymer products. Following the merger,
we completed a private placement of securities raising gross proceeds of $5.5
million. We anticipate that the net proceeds of the private placement will
fund
our operations for the next 15 months, following which we will need additional
financing. However, there can be no assurance that financing will be available
on acceptable terms or at all. Our future capital requirements will depend
upon
many factors, including, but not limited to, continued progress in our research
and development activities, costs and timing of conducting clinical trials
and
seeking regulatory approvals and patent prosecutions, competing technological
and market developments, and our ability to establish collaborative
relationships with third parties. If adequate funds are unavailable, we may
have
to delay, reduce the scope of or eliminate one or more of our research or
development programs or product launches or marketing efforts or cease
operations.
Our
long-term capital requirements are expected to depend on many factors,
including:
· |
continued
progress and cost of our research and development
programs;
|
· |
progress
with pre-clinical studies and clinical
trials;
|
· |
the
time and costs involved in obtaining regulatory
clearance;
|
· |
costs
involved in preparing, filing, prosecuting, maintaining, defending
and
enforcing patent claims;
|
· |
costs
of developing sales, marketing and distribution
channels;
|
· |
market
acceptance of our products; and
|
· |
costs
for training physicians and other health care
personnel.
|
In
addition, in the event that additional funds are obtained through arrangements
with collaborative partners or other sources, we may have to relinquish economic
and/or proprietary rights to some of our technologies or products under
development that we would otherwise seek to develop or commercialize by ourself.
We
depend upon key personnel who may terminate their employment with us at any
time.
We
currently have only six employees. Our success will depend to a significant
degree upon the continued services of key management and advisors of MedaSorb,
including Al Kraus, Dr. James Winchester, David Lamadrid and Vincent
Capponi.
These
individuals, other than Mr. Kraus, whose employment agreement terminates in
July
2008, do not have long-term employment agreements, and there can be no assurance
that they will continue to provide services to us. In addition, our success
will
depend on our ability to attract and retain other highly skilled personnel.
We
may be unable to recruit such personnel on a timely basis, if at all. Management
and other employees may voluntarily terminate their employment with us at any
time. The loss of services of key personnel, or the inability to attract and
retain additional qualified personnel, could result in delays in development
or
approval of our products, loss of sales and diversion of management
resources.
Acceptance
of MedaSorb’s medical
devices in the marketplace is uncertain, and failure to achieve market
acceptance will prevent or delay our ability to generate
revenues.
Our
future financial performance will depend, at least in part, upon the
introduction and customer acceptance of our polymer products. Even if approved
for marketing by the necessary regulatory authorities, our products may not
achieve market acceptance. The degree of market acceptance will depend upon
a
number of factors, including:
· |
the
receipt of regulatory clearance of marketing claims for the uses
that we
are developing;
|
· |
the
receipt of regulatory clearance of marketing claims for the uses
that we
are developing;
|
· |
the
establishment and demonstration of the advantages, safety and efficacy
of
the our polymer technology;
|
· |
pricing
and reimbursement policies of government and third-party payers such
as
insurance companies, health maintenance organizations and other health
plan administrators;
|
· |
our
ability to attract corporate partners, including medical device companies,
to assist in commercializing our products;
and
|
· |
our
ability to market our products.
|
Physicians,
patients, payers or the medical community in general may be unwilling to accept,
utilize or recommend any of our products. If we are unable to obtain regulatory
approval or commercialize and market our products when planned, we may not
achieve any market acceptance or generate revenue.
We
face
litigation from third parties which claim that our products infringe on their
intellectual property rights, or
seek
to challenge the validity of our patents.
Our
future success is also dependent on the strength of our intellectual property,
trade secrets and know-how, which have been developed from years of research
and
development. In addition to the “Purolite” litigation discussed below, we may be
exposed to additional future litigation by third parties seeking to challenge
the validity of our rights
based on claims that our technologies, products or activities infringe the
intellectual property rights of others or are invalid, or that we have
misappropriated the trade secrets of others.
Since
our
inception, we have sought to contract with large, established manufacturers
to
supply commercial quantities of our adsorbent polymers. As a result, we have
disclosed, under confidentiality agreements, various aspects of our technology
with potential manufacturers. We believe that these disclosures, while necessary
for our business, have resulted in the attempt by potential suppliers to assert
ownership claims to our technology in an attempt to gain an advantage in
negotiating manufacturing rights.
We
have
previously engaged in discussions with the Brotech Corporation and its
affiliate, Purolite International, Inc. (collectively “Purolite”), which had
demonstrated a strong interest in being our polymer manufacturer. For a period
of time beginning in December 1998, Purolite engaged in efforts to develop
and
optimize the manufacturing process needed to produce our polymer products on
a
commercial scale. However, the parties eventually decided not to proceed. In
2003, Purolite filed a lawsuit against us asserting, among other things,
co-ownership and co-inventorship of certain of our patents. Purolite recently
expanded its claims alleging they are the sole owner of these patents, and
that
we misappropriated these patents from them. We believe these claims are without
merit. In management’s view, the suit was initiated to pressure us to reach an
exclusive manufacturing agreement. Several negotiation efforts have been made
to
settle the case without success. The discovery phase has been completed and
we
have made an application to the court to dismiss the action, which is currently
pending before the court. If our application is not granted, we expect that
the
matter will be tried in early 2006.
Several
years ago we engaged in discussions with the Dow Chemical Company, which had
indicated a strong interest in being our polymer manufacturer. After a Dow
representative on our Advisory Board resigned, Dow filed and received several
patents naming our former Advisory Board member as an inventor. In management’s
view the Dow patents improperly incorporate our technology and should not have
been granted to Dow. The existence of these Dow patents could result in a
potential dispute with Dow in the future and additional expenses for
MedaSorb.
The
failure to obtain government approvals, including required FDA approvals, for
our polymer products, or to comply with ongoing governmental regulations could
prevent, delay or limit introduction or sale of our products and result in
the
failure to achieve revenues or maintain our
operations.
The
manufacturing and marketing of our products will be subject to extensive and
rigorous government regulation in the United States, in various states and
in
foreign countries. In the United States and other countries, the process of
obtaining and maintaining required regulatory approvals is lengthy, expensive,
and uncertain. There can be no assurance that we will ever obtain the necessary
approvals to sell our products. Even if we do ultimately receive FDA approval
for any of our products, we will be subject to extensive ongoing regulation.
Our
products will be subject to regulation as medical devices under the Federal
Food, Drug, and Cosmetic Act. In the United States, the FDA enforces, where
applicable, development, clinical testing, labeling, manufacturing,
registration, notification, clearance or approval, marketing, distribution,
record keeping, and reporting requirements for medical devices. Different
regulatory requirements may apply to our products depending on how they are
categorized by the FDA under these laws. Current FDA regulations classify our
CytoSorb™ device (the first product we intend to seek FDA approval for) as a
Class III device (CFR 876.5870—Sorbent Hemoperfusion System). We intend to
submit a 510(k) pre-market notification to the FDA for approval to market this
product. There can be no assurance, however, that the FDA will grant clearance
to market CytoSorb™ in a timely manner, if at all, or that the FDA will not
require the submission of additional clinical data or a pre-market approval
application ("PMA"), which is a lengthier process. There can be no assurance
that the clinical trials we conduct will demonstrate sufficient safety and
efficacy to obtain the required regulatory approvals for marketing, or that
we
will be able to comply with any additional FDA, state or foreign regulatory
requirements. In addition, there can be no assurance that government regulations
applicable to our products or the interpretation of those regulations will
not
change. We also are and will be subject to other Federal, state, and local
laws,
regulations and recommendations relating to laboratory and manufacturing
practices as well as Medicare, Medicaid and anti-kickback laws. Non-compliance
with applicable requirements can result in civil penalties, the recall,
injunction or seizure of products, an inability to import products into the
United States, the refusal by the government to approve or clear product
approval applications, the withdrawal of previously approved product
applications and criminal prosecution. The extent of potentially adverse
government regulation that might arise from future legislation or administrative
action cannot be predicted.
Data
obtained from clinical and
pre-clinical trials is susceptible to varying interpretations, which could
delay, limit or prevent regulatory clearances.
There
can
be no assurance that we will successfully complete the clinical trials necessary
to receive regulatory approvals. While tests conducted by us and others have
produced results we believe to be encouraging
and indicative of the efficacy of our products and technology, data already
obtained, or in the future obtained, from pre-clinical studies and clinical
trials do not necessarily predict the results that will be obtained from later
pre-clinical studies and clinical trials. Moreover, pre-clinical and clinical
data is susceptible to varying interpretations, which could delay, limit or
prevent regulatory approval. A number of companies in the medical device and
pharmaceutical industries have suffered significant setbacks in advanced
clinical trials, even after promising results in earlier trials. The failure
to
adequately demonstrate the safety and effectiveness of an intended product
under
development could delay or prevent regulatory clearance of the device, resulting
in delays to commercialization, and could materially harm our business.
We
rely
extensively on research and testing facilities at various universities and
institutions, which could be adversely affect us should we lose access to those
facilities.
Although
we have our own research laboratories and clinical facilities, we collaborate
with numerous institutions, universities and commercial entities to conduct
research and testing of our products. We currently maintain a good working
relationship with these parties. However, should the situation change, the
cost
and time to establish or locate alternative research and development could
be
substantial and delay gaining FDA approval and commercializing our
products.
We
are
and
will
be exposed to product liability risks, and clinical and preclinical liability
risks, which could place a substantial financial burden upon us should we be
sued.
Our
business exposes us to potential product liability and other liability risks
that are inherent in the testing, manufacturing and marketing of medical
devices. We cannot be sure that claims will not be asserted against us. A
successful liability claim or series of claims brought against us could have
a
material adverse effect on our business, financial condition and results of
operations.
We
do not
currently have any product liability insurance or other liability insurance
relating to clinical trials or any products. We cannot give assurances that
we
will be able to obtain or maintain adequate product liability insurance on
acceptable terms, if at all, or that such insurance will provide adequate
coverage against potential liabilities. Claims or losses in excess of any
product liability insurance coverage that we may obtain could have a material
adverse effect on our business, financial condition and results of
operations.
Certain
university and other relationships are important to our
business and may potentially result in conflicts of
interests.
Dr.
John
Kellum and Dr. David Powner,
among others, are critical care advisors and consultants of ours and are
associated with University of Pittsburgh Medical Center and University of Texas,
respectively. Their association with these institutions may currently or in
the
future involve conflicting interests in the event they or these institutions
enter into consulting or other arrangements with competitors of
ours.
We
have
limited
manufacturing experience, and once our products are approved, we may not be
able
to manufacture sufficient quantities at an acceptable cost, or without
shut-downs or delays.
We
remain
in the research and development and clinical and pre-clinical trial phase of
product commercialization. Accordingly, once our products are approved for
commercial sale, we will need to establish the capability to commercially
manufacture our products in accordance with FDA and other regulatory
requirements. We have limited experience in establishing, supervising and
conducting commercial manufacturing. If we or the third-party manufacturers
of
our products fail to adequately establish, supervise and conduct all aspects
of
the manufacturing processes, we may not be able to commercialize our products.
Due
to
our
limited marketing, sales and distribution experience, we may be unsuccessful
in
our efforts to sell our products.
We
expect
to enter into agreements with third parties for the commercial manufacture
and
distribution of our products. There can be no assurance that parties we may
engage to market and distribute our products will:
· |
satisfy
their financial or contractual obligations to
us;
|
· |
adequately
market our products; or
|
·
|
not
offer, design, manufacture or promote competing
products.
|
If
for
any reason any party engage is unable or chooses not to perform its obligations
under our marketing and distribution agreement, we would experience delays
in
product sales and incur increased costs, which would harm our business and
financial results.
If
we are unable to convince physicians and other health care providers as to
the
benefits of our products, we may incur delays or additional expense in our
attempt to establish market acceptance.
Broad
use
of our products may require physicians and
other
health care providers to be informed about our products and their intended
benefits. The time and cost of such an educational process may be substantial.
Inability to successfully carry out this education process may adversely affect
market acceptance of our products. We may be unable to educate physicians
regarding our products in sufficient numbers or in a timely manner to achieve
our marketing plans or to achieve product acceptance. Any delay in physician
education may materially delay or reduce demand for our products. In addition,
we may expend significant funds towards physician education before any
acceptance or demand for our products is created, if at all.
The
market for our
products is rapidly changing and competitive, and new devices and drugs which
may be developed by others could impair our ability to maintain and grow our
business and remain competitive.
The
medical device and pharmaceutical industries are subject to rapid and
substantial technological change. Developments by others may render our
technologies and products noncompetitive or obsolete. We also may be unable
to
keep pace with technological developments and other market factors.
Technological competition from medical device, pharmaceutical and biotechnology
companies, universities, governmental entities and others diversifying into
the
field is intense and is expected to increase. Many of these entities have
significantly greater research and development capabilities and budgets than
we
do, as well as substantially more marketing, manufacturing, financial and
managerial resources. These entities represent significant competition for
us.
If
users
of our
products are unable to obtain adequate reimbursement from third-party payers,
or
if new restrictive legislation is adopted, market acceptance of our products
may
be limited and we may not achieve anticipated revenues.
The
continuing efforts of government and insurance companies, health maintenance
organizations and other payers of healthcare costs to contain or reduce costs
of
health care may affect our future revenues and profitability, and the future
revenues and profitability of our potential customers, suppliers and
collaborative partners and the availability of capital. For example, in certain
foreign markets, pricing or profitability of medical devices is subject to
government control. In the United States, given recent federal and state
government initiatives directed at lowering the total cost of health care,
the
U.S. Congress and state legislatures will likely continue to focus on health
care reform, the cost of medical devices and on the reform of the Medicare
and
Medicaid systems. While we cannot predict whether any such legislative or
regulatory proposals will be adopted, the announcement or adoption of these
proposals could materially harm our business, financial condition and results
of
operations.
Our
ability to commercialize our products will depend in part on the extent to
which
appropriate reimbursement levels for the cost of our products and related
treatment are obtained by governmental authorities, private health insurers
and
other organizations, such as health maintenance organizations (“HMOs”).
Third-party payers are increasingly challenging the prices charged for medical
care. Also, the trend toward managed health care in the United States and the
concurrent growth of organizations such as HMOs, which could control or
significantly influence the purchase of health care services and medical
devices, as well as legislative proposals to reform health care or reduce
government insurance programs, may all result in lower prices for our products.
The cost containment measures that health care payers and providers are
instituting and the effect of any health care reform could materially harm
our
ability to operate profitably.
Directors,
executive officers and principal stockholders are expected to own a significant
percentage of the shares of Common
Stock, which will limit your ability to influence corporate
matters.
Our
directors,
executive officers and principal stockholders together beneficially own
approximately 75% of our outstanding shares of Common Stock. Accordingly, these
stockholders could have a significant influence over the outcome of any
corporate transaction or other matter submitted to stockholders for approval,
including mergers, consolidations and the sale of all or substantially all
of
our assets and also could prevent or cause a change in control. The interests
of
these stockholders may differ from the interests of our other stockholders.
Third parties may be discouraged from making a tender offer or bid to acquire
us
because of this concentration of ownership.
Our
Series A Preferred Stock Provides for the Payment of Penalties;
Dilution.
Immediately
following the merger, we issued 5,250,000 shares of Series
A
10% Cumulative Convertible Preferred Stock
with an
aggregate stated value of $5,250,000, and we may issue additional shares of
this
series of preferred stock. The Certificate of Designation designating the Series
A Preferred Stock provides that upon the following events, among others, the
dividend rate with respect to the Series A Preferred Stock increases to 20%
per
annum, which dividends would then be required to be paid in cash:
· |
the
occurrence of “Non-Registration Events” including, the failure to cause a
registration statement registering the shares of Common Stock underlying
the Series A Preferred Stock and Warrants issued in connection therewith
to be effective within 240 days following the closing of the private
placement;
|
· |
an
uncured breach by us of any material covenant, term or condition
in the
Certificate of Designation or any of the related transaction documents;
and
|
· |
any
money judgment or similar final process being filed against us for
more
than $100,000.
|
The
registration rights provided for in the subscription agreement we entered into
with the purchasers in this offering:
· |
require
that we file a registration statement with the SEC on or before 120
days
from the closing to register the shares of Common Stock issuable
upon
conversion of the Series A Preferred Stock and exercise of the Warrants,
and cause such registration statement to be effective within 240
days
following the closing; and
|
· |
entitles
each of these investors to liquidated damages in an amount equal
to two
percent (2%) of the purchase price of the Series A Preferred Stock
if we
fail to timely file that registration statement with, or have it
declared
effective by, the SEC.
|
The
Certificate of Designation, Subscription Agreement and related transaction
documents also provide for various penalties and fees for breaches or failures
to comply with provisions of those documents, such as the timely payment of
dividends, delivery of stock certificates, and obtaining and maintaining an
effective registration statement with respect to the shares of Common Stock
underlying the Series A Preferred Stock and Warrants sold in the
offering.
In
addition, both
the
conversion price of the Series A Preferred Stock and the exercise price of
the
Warrants are subject to “full-ratchet” anti-dilution provisions, so that upon
future issuances of our Common Stock or equivalents thereof, subject to
specified customary exceptions, at a price below the conversion price of the
Series A Preferred Stock and/or exercise price of the Warrants, such conversion
price and/or exercise price will be reduced to such lower price, further
diluting holders of our Common Stock.
There
is no public market for our Common Stock.
Although
our shares of Common Stock are eligible for quotation on the OTC Bulletin Board
under the symbol “GDRE,” there is currently no public market for the Common
Stock and there can be no expectation or assurance that a trading market will
develop or, if a market develops, that it will be active or sustained.
Future
Sales of Common Stock Could Result in a Decline in Market
Price.
Following
the completion of the merger, the holders 3,750,000
shares of Common Stock are able to sell such shares without registering them
under the Securities Act. In addition, we are required to file a registration
statement under the Securities Act covering the resale of the shares of Common
Stock underlying the Series A Preferred Stock and Warrants sold in the offering,
as well as the shares of Common Stock underlying the warrants we issued to
Margie Chassman in consideration
of her pledge of securities to investors in the offering as described
above.
Sales
of a significant number of shares of Common Stock in the public market could
result in a decline in the market price of our Common Stock (to the extent
a
market develops for our Common Stock).
Penny
Stock Regulations May Affect Your Ability To Sell Our Common
Stock.
To
the
extent our Common Stock trades at a price below $5.00 per share, our Common
Stock will be subject to Rule 15g-9 under the Exchange Act, which imposes
additional sales practice requirements on broker dealers which sell these
securities to persons other than established customers and accredited investors.
Under these rules, broker-dealers who recommend penny stocks to persons other
than established customers and "accredited investors" must make a special
written suitability determination for the purchaser and receive the purchaser's
written agreement to a transaction prior to sale. Unless an exception is
available, the regulations require the delivery, prior to any transaction
involving a penny stock, of a disclosure schedule explaining the penny stock
market and the associated risks. The additional burdens imposed upon
broker-dealers by these requirements could discourage broker-dealers from
effecting transactions in our Common Stock and may make it more difficult for
holders of our Common Stock to sell shares to third parties or to otherwise
dispose of them.
Our
Charter Documents and Nevada Law May Inhibit A Takeover That Stockholders May
Consider Favorable.
Provisions
in our articles of incorporation and bylaws, and Nevada law, could delay or
prevent a change of control or change in management that would provide
stockholders with a premium to the market price of their Common Stock. The
authorization of undesignated preferred stock, for example, gives our board
the
ability to issue preferred stock with voting or other rights or preferences
that
could impede the success of any attempt to effect a change in control of us,
or
otherwise adversely affect holders of Common Stock in relation to holders of
preferred stock.
Once
our Common Stock begins to trade, it may experienced price
fluctuations.
A
decrease in the market price of our Common Stock could result in substantial
losses for investors. The market price of our Common Stock may be significantly
affected by, among other things, one or more of the following
factors:
· |
nnouncements
or press releases relating to the medical device industry or to our
own
business or prospects;
|
· |
regulatory,
legislative, or other developments affecting us or the medical device
industry generally;
|
· |
the
dilutive effect of conversion of our Series A Preferred Stock and
exercise
of our warrants, or the issuance by us of additional shares of Common
Stock or convertible securities, at below current market prices;
and
|
· |
general
market conditions.
|
Compliance
with changing corporate governance and public disclosure regulations may result
in additional expense.
Keeping
abreast of, and in compliance with, changing laws, regulations and standards
relating to corporate governance and public disclosure, including the
Sarbanes-Oxley Act of 2002, new SEC regulations will require an increased amount
of management attention and external resources. In addition, prior to the
merger, our current management team was not subject to these laws and
regulations, as MedaSorb was a private corporation. We intend to continue to
invest all reasonably necessary resources to comply with evolving standards,
which may result in increased general and administrative expense and a diversion
of management time and attention from revenue-generating activities to
compliance activities.
PLAN
OF OPERATIONS
We
are a
development stage company and expect to remain so for at least the next twelve
months. We have not generated revenues to date and do not expect to do so until
we commercialize and receive the necessary approvals to sell our proposed
products. As discussed above, we are preparing to commercialize a blood
purification technology that efficiently removes toxic compounds from
circulating blood using our proprietary polymer-based adsorbent technology.
We
believe that our technology will support novel therapeutic approaches to
critical health conditions, including sepsis, organ transplant, and
post-operative complications of cardiopulmonary bypass surgery.
Our
near
term goal is focused on conducting clinical trials of our CytoSorb™ product in
the treatment of sepsis. Over the next twelve months, provided that we have
sufficient funds for our operations, we expect to design and conduct a pilot
study of the use of our product on at least 10 sepsis patients. We believe
that
submission of data from this pilot study to the FDA will allow us to then
conduct the pivotal study required for FDA approval of our CytoSorb™ product for
sepsis treatment.
Our
research and development costs for the years ended December 31, 2004 and 2005,
were approximately $2,367,407 and $1,526,743, respectively. MedaSorb has
experienced substantial operating losses since inception. As of March 31, 2006,
MedaSorb had an accumulated deficit of $59,994,884, which included losses from
operations of $3,665,596 for the year ended December 31, 2005 and $1,015,377
for
the three-month period ended March 31, 2006. These losses have resulted
principally from costs incurred in the research and development of our polymer
technology, and general and administrative expenses, which together were
approximately $2,162,703 and $426,756 respectively, for the year ended December
31, 2005 and the three months ended March 31, 2006.
Liquidity
and Capital Resources
Since
its
inception, the operations of MedaSorb have been financed through the private
placement of its debt and equity securities. At December 31, 2005, MedaSorb
had
cash of approximately $707,000, an amount sufficient to fund its operations
for
approximately four months. Due to its losses and available cash at that time,
MedaSorb’s
audited consolidated financial statements for its year ended December 31, 2005
have been prepared assuming MedaSorb will continue as a going concern, and
the
auditors’ report on those financial statements expresses
substantial doubt about MedaSorb’s
ability
to continue as a going concern.
Immediately
following the closing of the merger, we closed an offering of our securities
that resulted in net proceeds to us of approximately $4.5 million, which are
expected to be sufficient to fund our operations for the next 15 months,
following which we will be required to raise additional capital. There can
be no
assurance that we will be successful in our capital raising efforts.
In
October
2005, MedaSorb entered into an Investment Agreement with Margie Chassman
pursuant to which she advanced $1,000,000 to MedaSorb to provide it with
operating capital. The advance bears interest at the rate of 6% per annum,
and
at Ms. Chassman’s option, will be repaid in cash or converted into securities in
our next offering of securities no later than December 31, 2006. The advance
is
subject to earlier repayment in the event we complete an offering of our
securities that generates gross proceeds of $5.5 million or more (including
the
offering we completed following the merger, but excluding proceeds received
from
certain existing stockholders of ours), in the amount that those proceeds exceed
$5.5 million; provided, however, that in the event that less than $6.5 million
of gross proceeds are raised in such an offering within 120 days from the date
subscription materials are first circulated to potential investors, the balance
of the advance from Ms. Chassman then outstanding will, at our option, be
converted into the securities sold in that offering.
In
connection with the closing of the private placement, we agreed to make a
short-term advance to Ms. Chassman in the amount of $500,000 bearing interest
at
the rate of 6% per annum, the repayment of which may be offset against amounts
owed by us to Ms. Chassman under the $1,000,000 advance previously made by
her
to MedaSorb. The short-term advance will be secured by a pledge of
publicly-traded securities with a market value equal to $500,000.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
following table sets forth information known to us
with
respect to the beneficial ownership of Common Stock held of record as of June
30, 2006, by (1) all persons who are owners of 5% or more of our Common Stock,
(2) each of our named executive officers (see “Summary Compensation Table”), (3)
each director, and (4) all of our executive officers and directors as a
group.
Each
of
the stockholders can be reached at our principal executive offices located
at 7
Deer Park Drive, Suite K, Monmouth Junction, New Jersey 08852.
|
SHARES
BENEFICIALLY OWNED1
|
|
Number
|
Percent
(%)
|
Beneficial
Owners of more than 5% of Common
Stock (other than directors and executive officers)
|
|
|
Margie
Chassman(2)
|
7,995,000
|
33.1%
|
Guillermina
Montiel(3)
|
5,052,456
|
20.3%
|
Margery
Germain(4) |
2,000,000
|
8.3%
|
Robert
Shipley (5)
|
1,248,372
|
5.0%
|
Directors
and Executive Officers
|
|
|
Al
Kraus
|
1,393,631
|
5.6%
|
David
Lamadrid
|
501,704
|
2.0%
|
Vince
Capponi
|
418,086
|
1.7%
|
Joseph
Rubin(6)
|
127,207
|
*
|
James
Winchester
|
52,519
|
*
|
Kurt
Katz(7)
|
54,077
|
*
|
All
directors and executive officers as a group (six
persons)(8)
|
2,547,224
|
10.2%
|
|
|
1
|
Gives
effect to the shares of Common Stock issuable upon the exercise
of all
options exercisable within 60 days of June 30, 2006 and other
rights
beneficially owned by the indicated stockholders on that date.
Beneficial
ownership is determined in accordance with the rules of the Securities
and
Exchange Commission and includes voting and investment power
with respect
to shares. Unless otherwise indicated, the persons named in the
table have
sole voting and sole investment control with respect to all shares
beneficially owned. Percentage ownership is calculated based
on 24,090,929
shares of the Common Stock outstanding as of June 30, 2006
immediately following the closing of the reverse merger.
|
|
|
2
|
Margie
Chassman is married to David Blech. Mr. Blech disclaims beneficial
ownership of these shares. Since 1980 Mr. Blech has been a founder
of
companies and venture capital investor in the biotechnology sector.
His
initial venture investment, Genetic Systems Corporation, which he
helped
found and served as treasurer and a member of the board of directors,
was
sold to Bristol Myers in 1986 for $294 million of Bristol Myers stock.
Other companies he helped found include DNA Plant Technology, Celgene
Corporation, Neurogen Corporation, Icos Corporation, Incyte
Pharmaceuticals, Alexion Pharmaceuticals and Neurocrine Biosciences.
He
was also instrumental in the turnaround of Liposome Technology, Inc.
and
Biotech General Corporation. In 1990 Mr. Blech founded D. Blech &
Company, which, until it ceased doing business in September 1994,
was a
registered broker-dealer involved in underwriting biotechnology issues.
In
May 1998, David Blech pled guilty to two counts of criminal securities
fraud, and, in September 1999, he was sentenced by the U.S. District
Court
for the Southern District of New York to five years’ probation, which was
completed in September 2004. Mr. Blech also settled administrative
charges
by the Commission in December 2000 arising out of the collapse in
1994 of
D. Blech & Co., of which Mr. Blech was President and sole stockholder.
The settlement prohibits Mr. Blech from engaging in future violations
of
the federal securities laws and from association with any broker-dealer.
In addition, the District Business Conduct Committee for District
No.10 of
NASD Regulation, Inc. reached a decision, dated December 3, 1996,
in a
matter styled District Business Conduct Committee for District No.
10 v.
David Blech, regarding the alleged failure of Mr. Blech to respond
to
requests by the staff of the National Association of Securities Dealers,
Inc. (“NASD”) for documents and information in connection with seven
customer complaints against various registered representatives of
D. Blech
& Co. The decision found that Mr. Blech failed to respond to such
requests in violation of NASD rules and that Mr. Blech should, therefore,
be censured, fined $20,000 and barred from associating with any member
firm in any capacity. Furthermore, Mr. Blech was discharged in bankruptcy
in the United States Bankruptcy Court for the Southern District of
New
York in March 2000.
|
3
|
Includes
58,472 shares issuable upon exercise of stock options.
|
|
|
4
|
Includes
1,700,000 shares of Common Stock held directly by Ms. Germain and 300,000
shares of Common Stock held by her minor children. |
|
|
5
|
Includes
621,727 shares issuable upon exercise of stock options and
warrants.
|
|
|
6
|
Includes
58,598 shares issuable upon exercise of stock options and
warrants.
|
|
|
7
|
Includes
51,817 shares issuable upon exercise of stock options.
|
|
|
8
|
Includes
110,415 shares issuable upon exercise of stock options and
warrants.
|
DIRECTORS
AND EXECUTIVE OFFICERS
The
following table sets forth the names of our directors and executive officers,
their ages and the positions they hold. Each such person became an officer
and/or director of the Registrant immediately after the closing of the merger
and held the same positions set forth below with MedaSorb prior to the merger.
Name
|
Age
|
Position
|
|
|
|
Al
Kraus
|
61
|
President
and Chief Executive Officer, Director
|
|
|
|
James
Winchester, MD
|
62
|
Chief
Medical Officer
|
|
|
|
Vincent
Capponi
|
48
|
Chief
Operating Officer
|
|
|
|
|
|
|
David
Lamadrid
|
35
|
Chief
Financial Officer
|
|
|
|
Joseph
Rubin, Esq.
|
67
|
Director
|
|
|
|
Kurt
Katz
|
73
|
Director
|
Al
Kraus. Mr.
Kraus
has more than twenty-five years’ experience managing companies in the dialysis,
medical device products, personal computer and custom software industries.
He
was the President and Chief Executive Officer of MedaSorb since 2003. Prior
to
joining us, from 2001 to 2003, Mr. Kraus was President and CEO of NovoVascular
Inc., an early stage company developing coated stent technology. From 1996
to
1998, Mr. Kraus was President and CEO of Althin Healthcare and from 1998 to
2000, of Althin Medical Inc., a manufacturer of products for the treatment
of
end stage renal disease. While CEO of Althin, he provided strategic direction
and management for operations throughout the Americas. From 1979 to 1985, Mr.
Kraus was U.S. Subsidiary Manager and Chief Operating Officer of Gambro Inc.,
a
leading medical technology and healthcare company. Mr.
Kraus
was the Chief Operating Officer of Gambro when it went public in the United
States in an offering led by Morgan Stanley.
James
Winchester, M.D.
Prior to
joining MedaSorb in 2000, Dr. Winchester was Professor of Medicine and Director
of Dialysis Programs at Georgetown University School of Medicine for more than
25 years. Dr. Winchester is also the Chief of the Nephrology Division at Beth
Israel Medical Center, a position he has held since July 2004. He has published
more than 200 articles in scientific and medical journals, and has co-authored
eight books in the fields of renal replacement therapy and clinical poisoning
management. Dr. Winchester is editor-in chief of Replacement
of Renal Function,
the
most widely used textbook for nephrology fellows. Dr. Winchester has published
more articles on hemoperfusion than any other nephrologist in the world. He
is
widely recognized as one of the world’s leading experts in hemoperfusion and
toxicology, and is a former member of the Scientific Advisory Board for Total
Renal Care (Davita). Dr. Winchester received his medical degree from the
University of Glasgow and is a Fellow of the Royal College of Physicians and
Surgeons of Glasgow,
and a
Fellow of the American College of Physicians.
Vincent
Capponi.
Mr.
Capponi joined MedaSorb as Vice President of Operations in 2002 and became
its
Chief Operating Officer in July 2005. He has more than 20 years of management
experience in medical device, pharmaceutical and imaging equipment at companies
including Upjohn, Sims Deltec and Sabratek. Prior to joining MedaSorb in 2002,
Mr. Capponi held several senior management positions at Sabratek and its
diagnostics division GDS. Mr. Capponi was interim president of GDS diagnostics
in 2001. From 1998 to 2000 Mr. Capponi was Senior Vice President and Chief
Operating Officer for Sabratek and Vice President Operations from 1996 to 1998.
He received his MS in Chemistry and his BS in Chemistry and Microbiology from
Bowling Green State University.
David
Lamadrid.
Mr.
Lamadrid, has been with MedaSorb since 2000. He
has
over 13 years of business experience in finance and operations. Prior to joining
MedaSorb
in
2000,
Mr. Lamadrid was a financial analyst at Chase Manhattan Bank working in the
Middle Market Banking Group. Mr. Lamadrid received his MBA from New York
University, a BS in Finance from St. John’s University, and an AAS in Accounting
from S.U.N.Y. Rockland.
Joseph
Rubin, Esq. Mr.
Rubin
became a director of MedaSorb in 1997. Mr. Rubin is a founder and Senior Partner
of Rubin, Bailin, and Ortoli, LLP an international and domestic corporate and
commercial law firm in New York City, where he has practiced law since January
2000. Mr. Rubin also teaches at the Columbia University School of International
and Public Affairs, where he is also Executive Director of the International
Technical Assistance Program for Public Affairs (ITAP). Mr. Rubin was Adjunct
Professor at the Columbia University Graduate School of Business from 1973
to
1994, and taught at Columbia Law School in 1996. Mr. Rubin received his law
degree from Harvard Law School, and his B.A., MIA, and M.Phil degrees in
political science and international relations from Columbia
University.
Kurt
Katz, M.Ch.E. Mr.
Katz
became a director of MedaSorb in 1997. Since retiring from Peabody International
Corporation in 1986, Mr. Katz has pursued various business interests. He is
currently the Chairman of Polymeric Resources Corporation, a polymer company
engaged in the manufacture of nylon and compounding. Mr. Katz served as
President and Chief Operating Officer of Peabody, which specializes in energy
and environmental products. Mr. Katz served as Executive Vice President and
Chief Operating Officer of Peabody from 1981 to 1983, and was a Director from
1977 to 1985. Prior to joining Peabody in 1973, Mr. Katz held a variety of
management positions with Westinghouse Electric Corporation, where he served
for
18 years and was directly involved in the launching of new products, divisions
and subsidiaries. .Mr.
Katz
has a B.S. and M.S. in chemical engineering, and an MBA.
Audit
Committee Financial Expert
The
Board
of Directors does not have an Audit Committee, and therefor does not have an
“audit committee financial expert,” as such term is defined in Item 401(e) of
Regulation S-B.
Executive
Compensation
The
following table sets forth for the periods indicated the compensation MedaSorb
paid Al Kraus, our Chief Executive Officer, and each of our other most highly
compensated executive officers during the years ended December 31, 2005, 2004
and 2003.
Summary
Compensation Table
|
|
|
|
Annual
Compensation
|
Long-Term
Compensation
|
Name
and Principal Positions
|
|
Year
|
|
Salary
($)
|
|
Bonus
($)
|
Stock
Awards*
|
|
Securities
Underlying Options
|
|
|
|
|
|
|
|
|
|
|
Al
KrausChief
Executive Officer
|
|
2005
2004
2003
|
|
173,899
152,301
73,710
|
|
150
|
1,090,680
164,665
138,286
|
|
__
__
__
|
|
|
|
|
|
|
|
|
Vincent
Capponi,
Chief
Operating Officer
|
|
2005
2004
2003
|
|
152,504
133,987
195,501
|
|
150
|
374,383
15,070
7,535
|
|
__
__
__
|
David
Lamadrid,
Chief
Financial Officer
|
|
2005
2004
2003
|
|
119,257
100,203
115,742
|
|
150
|
450,155
22,605
15,070
|
|
__
__
__
|
Dr.
James Winchester Chief
Medical Officer
|
|
2005
2004
2003
|
|
116,541
143,319
233,422
|
|
150
|
__
16,954
7,535
|
|
__
__
__
|
*
These
officers were originally issued “Management Units” of MedaSorb Technologies,
LLC, a limited liability company. The Management Units were ultimately converted
into the number of shares of our Common Stock indicated in the table above
following MedaSorb’s conversion to a corporation and reverse merger with
Registrant.
Option
Grants in Last Fiscal Year
No
options were granted to any of the individuals named in the Summary Compensation
Table during 2005.
Aggregated
Option Exercises in Fiscal 2005 and FY-End Option Values
None
of
the individuals named in the Summary Compensation Table held any options to
purchase our Common Stock or the common stock of MedaSorb as of December 31,
2005.
Director
Compensation
Our
directors do not receive any cash compensation for their service on the Board
of
Directors, but from time to time are granted options for their services. In
January 2006, each of our non-employee directors
was granted an option to purchase 10,000 shares of MedaSorb common stock at
an
exercise price of $1.25, and in June 2006, our non-employee directors
were granted options to purchase an aggregate of 62,536 shares of MedaSorb
common stock at an exercise price of $1.25. These options became options to
purchase the same number of shares of our Common Stock at the same exercise
price following the merger. Our directors are reimbursed for actual
out-of-pocket expenses incurred by them in connection with their attendance
at
meetings of the Board of Directors.
Employment
Agreements
Agreement
with Chief Executive Officer
MedaSorb
entered into an Employment Agreement, dated as of July 18, 2003, with Al Kraus,
our Chief Executive Officer. The Employment Agreement provides for an initial
five-year term of employment as our Chief Executive Officer. Under the terms
of
the Employment Agreement, Mr. Kraus receives an annual base salary of $200,000.
Under the Employment Agreement, Mr. Kraus was also granted an option to purchase
5% of the outstanding equity interests of MedaSorb (which
was
then a limited liability company) on a fully-diluted basis, and will be issued
additional options so that Mr. Kraus continues to hold options to purchase
5% of
our outstanding equity on a fully diluted basis until such time as an aggregate
of $20 million of financing has been received by MedaSorb (including Registrant)
following the commencement of his employment. In 2005, MedaSorb’s board approved
the issuance to Mr. Kraus of “Management Units” of the limited liability company
in lieu of the options he was then entitled to under the Employment Agreement.
As a result of the conversion of MedaSorb to a corporation and the merger,
the
Management Units issued under the Employment Agreement were exchanged for
1,393,631 shares of Common Stock. Mr. Kraus will continue to be issued options
to purchase Common Stock pursuant to his Employment Agreement so that the
combined total of his common stock and common stock issuable upon exercise
of
his options equals 5% of the Company’s outstanding common stock on a fully
diluted basis, until such time as an aggregate of $20 million of financing
has
been received by us following the commencement of his employment.
In
the
event that Mr. Kraus’s employment is terminated as a result of his death, his
heirs will be entitled to 120-days of salary. In the event Mr. Kraus is
terminated for “justifiable cause” we will pay him his accrued and unpaid base
salary through the date of termination. If Mr. Kraus’s employment is terminated
without cause or in the event of a Change of Control, he will be entitled to
one-year’s base salary payable monthly over a period of one year.
Mr.
Kraus
is prohibited under the Employment Agreement from disclosing any of our
confidential information (as defined in the agreement) during the term of his
employment and any time thereafter and, following the termination of the
agreement with us, from competing with us and directly or indirectly soliciting
any of our customers or suppliers for a period of one year, and from soliciting
our employees for a period of three years.
Agreement
with Chief Operating Officer
MedaSorb
entered into an Employment Agreement, dated as of July 1, 2005, with Vincent
Capponi, our Chief Operating Officer. The Employment Agreement provides for
an
initial term of one-year, with automatic annual renewal unless either party
provides notice to the other within 120 days prior to the end of the year of
its
intention not to renew. Under the terms of the Employment Agreement, Mr. Capponi
receives an annual base salary of $181,886. Under the Employment Agreement,
Mr.
Capponi was also granted Management Units equal to 1.5% of the outstanding
equity interests of MedaSorb (which was then a limited liability company) on
a
fully-diluted basis, and was entitled to receive additional Management Units
so
that Mr. Capponi continued to hold Management Units equal to 1.5% of the
outstanding equity of MedaSorb on a fully diluted basis until December 31,
2005.
As a result of the conversion of MedaSorb to a corporation and the merger,
these
Management Units were exchanged for 418,086 shares of our Common
Stock
In
the
event that Mr. Capponi’s employment is terminated as a result of his death, his
heirs will be entitled to 120-days of salary. In the event Mr. Capponi is
terminated for “justifiable cause” we will pay him his accrued and unpaid base
salary through the date of termination. If Mr. Capponi’s employment is
terminated without cause or in the event of Change of Control, he will be
entitled to one-year’s base salary payable monthly for a period of one year.
Mr.
Capponi is prohibited under the Employment Agreement from disclosing any of
our
confidential information (as defined in the agreement) during the term of his
employment and any time thereafter, and following the termination of the
agreement with us, from competing with us and directly or indirectly soliciting
any of our customers or suppliers for a period of one year, and from soliciting
our employees for a period of three years.
Agreement
with Chief Financial Officer
MedaSorb
entered into an Employment Agreement, dated as of July 1, 2005, with David
Lamadrid, our Chief Financial Officer. The Employment Agreement provides for
an
initial term of one-year, with automatic annual renewal unless either party
provides notice to the other within 120 days prior to the end of the year of
its
intention not to renew. Under the terms of the Employment Agreement, Mr.
Lamadrid receives an annual base salary of $135,629. Under the Employment
Agreement, Mr. Lamadrid was also granted Management Units equal to 1.8% of
the
outstanding equity interests of MedaSorb (which was then a limited liability
company) on a fully-diluted basis, and was entitled to receive additional
Management Units so that Mr. Lamadrid continued to hold Management Units equal
to 1.8% of the outstanding equity of MedaSorb on a fully diluted basis until
December 31, 2005. As a result of the conversion of MedaSorb to a corporation
and the merger, these Management Units were exchanged for 501,704 shares of
our
Common Stock.
In
the
event that Mr. Lamadrid’s employment is terminated as a result of his death, his
heirs will be entitled to 120-days of salary. In the event Mr. Lamadrid is
terminated for “justifiable cause” we will pay him his accrued and unpaid base
salary through the date of termination. If Mr. Lamadrid’s employment is
terminated without cause or in the event of Change of Control, he will be
entitled to one-year’s base salary payable monthly for a period of one year.
Mr.
Lamadrid is prohibited under the Employment Agreement from disclosing any of
our
confidential information (as defined in the agreement) during the term of his
employment and any time thereafter, and following the termination of the
agreement with us, from competing with us and directly or indirectly soliciting
any of our customers or suppliers for a period of one year, and from soliciting
our employees for a period of three years.
Agreement
with Chief Medical Officer
MedaSorb
entered into an Employment Agreement, dated as of July 1, 2004, with Dr. James
Winchester, our Chief Medical Officer. The Employment Agreement provides for
an
initial term of one-year, with automatic annual renewal unless either party
provides notice to the other within 90 days prior to the end of the year of
its
intention not to renew. Under the terms of the Employment Agreement, Dr.
Winchester receives an annual base salary of $120,000.
Dr.
Winchester is prohibited under his Employment Agreement from disclosing any
of
our confidential information (as defined in the agreement) during the term
of
his employment and any time thereafter, and following the termination of this
agreement with us, from competing with us and directly or indirectly soliciting
any of our customers, suppliers or employees for a period of one year.
During
the period of March 2004 to February 2005, Al Kraus, Vincent Capponi, David
Lamadrid and Dr. James Winchester agreed to forego salary in the amounts of
$66,667, $60,000, $45,000, and $32,772 respectively. These amounts will be
paid
to these individuals at such time as we generate gross proceeds from the sale
of
our securities of $5,000,000, including sales we effected upon completion of
the
merger.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
In
October
2005, MedaSorb entered into an Investment Agreement with Margie Chassman
pursuant to which she advanced $1,000,000 to MedaSorb to provide it with
operating capital. The advance bears interest at the rate of 6% per annum,
and
at Ms. Chassman’s option, will be repaid in cash or converted into securities in
our next offering of securities no later than December 31, 2006. The advance
is
subject to earlier repayment in the event we complete an offering of our
securities that generates gross proceeds of $5.5 million or more (including
the
offering we completed following the merger, but excluding proceeds received
from
certain existing stockholders of ours), in the amount that those proceeds exceed
$5.5 million; provided, however, that in the event that less than $6.5 million
of gross proceeds are raised in such an offering within 120 days from the date
subscription materials are first circulated to potential investors, the balance
of the advance from Ms. Chassman then outstanding will, at our option, be
converted into the securities sold in that offering.
In
consideration for funding the $1 million advance, Ms. Chassman and her designees
were issued
an
aggregate of 10 million shares of Common Stock. These shares of Common Stock
are
subject to a 12-month lock-up agreement and a voting agreement entitling
MedaSorb to voting rights with respect to such shares until the earlier to
occur
of a transfer of those shares to an unrelated third party or the expiration
of
two years.
In
connection with the closing of the private placement, we agreed to make a
short-term advance to Ms. Chassman in the amount of $500,000 bearing interest
at
the rate of 6% per annum, the repayment of which may be offset against amounts
owed by us to Ms. Chassman under the $1,000,000 advance previously made by
her
to MedaSorb. The short-term advance will be secured by a pledge of
publicly-traded securities with a market value equal to $500,000.
In
connection with the sale of the Series A Preferred Stock and Warrants to the
investors, Margie Chassman agreed to pledge certain securities held by her
to
the investors, which such investors may sell to ensure they do not suffer a
loss
on their investment in the first year following the date of their investment.
In
consideration of her pledge to these investors, we agreed to pay Ms. Chassman
(i) $525,000 in cash, and (ii) five-year warrants to purchase 10% of the shares
of Series A Preferred Stock and 10% of the Warrants sold to these investors
for
an exercise price equal to the price paid by the investors in the private
placement.
In
August
2003, in order to induce Guillermina Vega Montiel, a principal stockholder
of
ours, to make an additional investment in MedaSorb, we granted Ms. Montiel
a
perpetual royalty equal to three percent of all gross revenues received by
us
from sales of CytoSorbTM
in
the
applications of sepsis, cardiopulmonary bypass surgery, organ donor,
chemotherapy and inflammation control application.
Joseph
Rubin
is a
director of ours and performs legal services from time to time. At December
31,
2005, we owed Mr. Rubin’s firm approximately $173,000 in respect of legal
services provided by his firm to MedaSorb
DESCRIPTION
OF SECURITIES
Our
total
authorized capital stock consists of 100,000,000 shares of Common Stock, par
value $.001 per share and 100,000,000 shares of preferred stock, par value
$.001
per share. After the closing of the reverse merger and the closing of the
private placement completed on the same date, 24,090,929 shares of Common Stock
were issued and outstanding, and 8,000,000 shares of preferred stock had been
designated as Series
A
10% Cumulative Convertible Preferred Stock,
of
which 5,250,000 shares were issued and outstanding.
The
following description of our capital stock does not purport to be complete
and
is subject to and qualified by our Articles of Incorporation and By-laws, and
by
the provisions of applicable Nevada law.
Common
Stock
Holders
of our Common Stock are entitled to receive dividends out of assets legally
available therefore at such times and in such amounts as the Board of Directors
from time to time may determine. Holders of our Common Stock are entitled to
one
vote for each share held on all matters submitted to a vote of the stockholders.
Cumulative voting with respect to the election of directors is not permitted
by
our Articles of Incorporation. Our Common Stock is not entitled to preemptive
rights and is not subject to conversion or redemption. Upon our liquidation,
dissolution or winding-up, the assets legally available for distribution to
stockholders are distributable ratably among the holders of the Common Stock
after payment of liquidation preferences, if any, on any outstanding stock
having prior rights on such distributions and payment of other claims of
creditors.
Preferred
Stock
Our
Articles of Incorporation authorizes the issuance of shares of preferred stock
in one or more series. Our Board of Directors has the authority, without any
vote or action by the stockholders, to create one or more series of preferred
stock up to the limit of our authorized but unissued shares of preferred stock
and to fix the number of shares constituting such series and the designation
of
such series, the voting powers (if any) of the shares of such series and the
relative participating, option or other special rights (if any), and any
qualifications, preferences, limitations or restrictions pertaining to such
series which may be fixed by the Board of Directors pursuant to a resolution
or
resolutions providing for the issuance of such series adopted by the Board
of
Directors.
The
provisions of a particular series of authorized preferred stock, as designated
by the Board of Directors, may include restrictions on the payment of dividends
on Common Stock. Such provisions may also include restrictions on our ability
to
purchase shares of Common Stock or to purchase or redeem shares of a particular
series of authorized preferred stock. Depending upon the voting rights granted
to any series of authorized preferred stock, issuance thereof could result
in a
reduction in the voting power of the holders of Common Stock. In the event
of
our dissolution, liquidation or winding up, the holders of the preferred stock
will receive, in priority over the holders of Common Stock, a liquidation
preference established by the Board of Directors, together with accumulated
and
unpaid dividends. Depending upon the consideration paid for authorized preferred
stock, the liquidation preference of authorized preferred stock and other
matters, the issuance of authorized preferred stock could result in a reduction
in the assets available for distribution to the holders of Common Stock in
the
event of our liquidation.
Series
A 10% Cumulative Convertible Preferred Stock
We
have
designated 8,000,000 shares of our preferred stock as Series
A
10% Cumulative Convertible Preferred Stock
(“Series
A Preferred Stock”), of which 5,250,000 shares were issued in an offering that
we closed immediately following the consummation of the merger. Each share
of
Series A Preferred Stock has a stated value of $1.00, is convertible at the
holder’s option into that number of shares of our Common Stock equal to the
stated value of such share of Series A Preferred Stock divided by an initial
conversion price of $1.25. Upon the occurrence of a stock split, stock dividend,
combination of our Common Stock into a smaller number of shares, issuance of
any
of our shares or other securities by reclassification of our Common Stock,
merger or sale of substantially all of our assets, the conversion rate will
be
adjusted so that the conversion rights of the Series A Preferred Stock
stockholders will be equivalent to the conversion rights of the Series A
Preferred Stock stockholders prior to such event. In addition, in the event
we
sell shares of our Common Stock (or the equivalent thereof) following the
issuance of shares of Series A Preferred Stock at a price of less than $1.25
per
share, the conversion price of the shares of Series A Preferred Stock will
be
reduced to such lower price.
The
Series A Preferred Stock bears a dividend of 10% per annum payable quarterly,
commencing September 30, 2006, at our election in cash or additional shares
of
our Series A Preferred Stock valued at the stated value thereof; provided,
however, that we must pay the dividend in cash if an “Event of Default” as
defined in the Certificate of Designation designating the Series A Preferred
Stock has occurred and is then continuing. In addition, upon an Event of
Default, the dividend rate increases to 20% per annum. An Event of Default
includes, but is not limited to, the following:
· |
the
occurrence of “Non-Registration Events” including, the failure to cause a
registration statement registering the shares of Common Stock underlying
the Series A Preferred Stock and Warrants issued in connection therewith
to be effective within 240 days following the closing of the private
placement;
|
· |
an
uncured breach by us of any material covenant, term or condition
in the
Certificate of Designation or any of the related transaction documents;
and
|
· |
any
money judgment or similar final process being filed against us for
more
than $100,000.
|
In
the
event of our dissolution, liquidation or winding up, the holders of the Series
A
Preferred Stock will receive, in priority over the holders of Common Stock,
a
liquidation preference equal to the stated value of such shares plus accrued
dividends thereon.
The
Series A Preferred Stock is
not
redeemable at the option of the holder but may be redeemed by us at our option
following the third anniversary of the issuance of the Series A Preferred Stock
for 120% of the stated value thereof plus any accrued but unpaid dividends
upon
30 days' prior written notice, during which time the Series A Preferred Stock
may be converted, provided a registration statement is effective under the
Securities Act with respect to the Common Stock into which such Preferred is
convertible and an Event of Default is not then continuing.
Holders
of Series A Preferred Stock do not have the right to vote on matters submitted
to the holder of our Common Stock.
The
registration rights provided for in the subscription agreement we entered into
with the purchasers of the Series A Preferred Stock:
· |
require
that we file a registration statement with the SEC on or before 120
days
from the closing to register the shares of Common Stock issuable
upon
conversion of the Series A Preferred Stock and exercise of the Warrants,
and cause such registration statement to be effective within 240
days
following the closing; and
|
· |
entitles
each of these investors to liquidated damages in an amount equal
to two
percent (2%) of the purchase price of the Series A Preferred Stock
if we
fail to timely file that registration statement with, or have it
declared
effective by, the SEC.
|
The
transaction documents we entered into with the purchasers of the Series A
Preferred Stock also provide for various penalties and fees for breaches or
failures to comply with provisions of those documents, such as the timely
payment of dividends, delivery of stock certificates, and obtaining and
maintaining an effective registration statement with respect to the shares
of
Common Stock underlying the Series A Preferred Stock and warrants sold in the
offering.
In
addition, both the conversion price of the Series A Preferred Stock and the
exercise price of the Warrants are subject to “full-ratchet” anti-dilution
provisions, so that upon future issuances of our Common Stock or equivalents
thereof, subject to specified customary exceptions, at a price below the
conversion price of the Series A Preferred Stock and/or exercise price of the
Warrants, such conversion price and/or exercise price will be reduced to such
lower price, further diluting holders of our Common Stock.
Market
for Registrant’s Common Equity and Related Stockholder
Matters
Our
Common Stock is quoted on the OTC Bulletin Board under the symbol “GDRE”, but to
date, no trades in our Common Stock have been reported. Immediately following
the closing of the merger, but before giving effect to the private placement,
there were outstanding options and warrants to purchase an aggregate of
1,697,648
shares
of our Common Stock, and certain providers of legal services had the right
to
acquire approximately 997,000 shares of our Common Stock. Of the 24,090,929
shares of our Common Stock outstanding immediately following the merger
3,750,000 shares were eligible for resale under Rule 144 under the Securities
Act. In addition, we are obligated to file a registration statement under the
Securities Act registering the resale of the 7,260,000 shares of Common Stock
underlying the shares of Series A Preferred Stock and Warrants we issued in
the
offering that closed immediately following the merger.
The
number of holders of record for our Common
Stock immediately after giving effect to the merger was approximately
415.
We
have
not paid any dividends on our Common
Stock since our inception and do not intend to pay any cash dividends to our
stockholders in the foreseeable future. In addition, the terms of our Series
A
Preferred Stock prohibit the payment of dividends on our Common
Stock.
Equity
Compensation Plan Information
The
following table summarizes outstanding options as of June 30,
2006, after giving effect to the merger. The Registrant had no options
outstanding prior to the merger, and all of the options below were issued in
connection with the merger to former option holders of MedaSorb.
|
Number
of securities to be issued upon exercise of outstanding
options
|
Weighted-average
exercise price of outstanding options
|
Number
of securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in first
column)
|
Equity
compensation plans approved by stockholders`
|
0
|
n/a
|
400,000(1)
|
|
|
|
|
Equity
compensation plans not approved by stockholders
|
594,003
|
$23.88
|
2,298,300(2)
|
|
|
|
|
Total
|
594,003
|
$23.88
|
2,698,300
|
1.
|
Represents
options that may be issued under our 2003 Stock Option
Plan.
|
|
|
2.
|
Represents
options that may be issued under our 2006 Long-Term Incentive Plan.
|
Changes
in and Disagreements with Accountants.
Effective
on the closing of the merger, our Board of Directors dismissed BDO Dunwoody
LLP
as our independent accountants and engaged WithumSmith+Brown, MedaSorb’s
accountants prior to the merger. For further information on the change in
our accountants, see item 4.01 of this Current Report on Form 8-K.
Recent
Sales of Unregistered Securities
In
connection with the Merger, we issued 20,340,929
shares of our Common Stock to the former stockholders of MedaSorb in exchange
for all the issued and outstanding shares of MedaSorb Common Stock, and issued
stock options and warrants to purchase a total of 1,697,648 shares of our Common
Stock in exchange for the cancellation of all outstanding warrants and stock
options of MedaSorb, with the warrants and options issued by us having the
same
exercise prices and other terms as the cancelled warrants and stock options
to
purchase MedaSorb Common Stock. The shares of Common Stock issued in the merger
were issued in reliance on the exemption from registration afforded by
Regulation D (Rule 506) under the Securities Act and corresponding provisions
of
state securities laws, which exempts transactions by an issuer not involving
any
public offering. Accordingly, all of such shares are “restricted securities” and
may not be offered or sold in the United States absent registration or an
applicable exemption from registration requirements under the Securities Act.
In
addition, immediately following the merger, we sold 5,250,000
shares of our Series A Preferred Stock to four institutional investors
in
a
private offering exempt from registration pursuant to Section 4(2) and
Regulation D (Rule 506) under the Securities Act. The shares of Series A
Preferred Stock we issued are initially convertible into 4,200,000 shares of
our
Common Stock. In
conjunction with the issuance of the Series A Preferred Stock to the investors,
we issued to them, for no additional consideration, five-year Warrants to
purchase an aggregate of 2,100,000 shares of Common Stock at the exercise price
of $2.00 per share, subject to adjustment in certain cases as set forth in
the
Warrants. We
also
granted these purchasers registration rights with respect to the Common Stock
issuable upon conversion of the Series A Preferred Stock and exercise of the
Warrants issued in the private placement. The rights, preferences and other
terms of the Series A Preferred Stock and the private placement of these
securities are described further above under “Series A Preferred Stock”.
Additional information with respect to this offering is provided above in Item
1.01 of this Current Report on Form 8-K.
Indemnification
of Officers and Directors
Our
Articles
of Incorporation eliminates the personal liability of directors to us and our
stockholders for monetary damages for breach of fiduciary duty as a director
to
the fullest extent permitted by Nevada law. Additionally, we have included
in
our By-laws provisions to indemnify our directors, officers, employees and
agents and to purchase insurance with respect to liability arising out of the
performance of their duties as directors, officers, employees and agents as
permitted by Nevada General Corporation Law. The effect of the foregoing is
to
require us, to the extent permitted by law, to indemnify our officers,
directors, employees and agents for any claims arising against such person
in
their official capacities, if such person acted in good faith and in a manner
that he reasonably believed to be in or not opposed to our best interests,
and,
with respect to any criminal action or proceeding, had no reasonable cause
to
believe that his conduct was unlawful. Insofar as indemnification for
liabilities arising under the Securities Act may be permitted to directors,
officers and controlling persons of the company pursuant to the foregoing,
or
otherwise, the company has been advised that the opinion of the Securities
and
Exchange Commission such indemnification is against public policy as expressed
in the Securities Act and is, therefore, unenforceable.
Item
3.02. Unregistered Sales of Equity Securities.
Reference
is made to the disclosure made under Items 1.01 and 2.01 of this Current Report
on Form 8-K, which is incorporated herein by reference.
ITEM
4.01. Changes in Registrant’s Certifying Accountant
Immediately
following the closing of the merger, our Board of Directors dismissed BDO
Dunwoody LLP as our independent accountants and engaged WithumSmith+Brown,
the
accountants of MedaSorb prior to the merger, as our new independent accountants.
The
audit
reports of BDO Dunwoody on the financial statements of Gilder Enterprises,
Inc.
as of May 31, 2005 and 2004 and for the years then ended did not contain any
adverse opinion or disclaimer of opinion, nor were such reports qualified or
modified as to uncertainty, audit scope or accounting principles, except that
such reports were prepared assuming “the Company will continue as a going
concern” and stated that “as discussed in Note 1 to the consolidated financial
statements, the Company had accumulated operating losses of $169,199 since
its
inception and has a working capital deficit of $67,768. These condition raise
substantial doubt about the Company’s ability to continue as a going
concern. Management’s plan in regard to these matters are described in
Note 1. These consolidated financial statements do not include any
adjustments that might result from the outcome of this
uncertainty”.
During
the two most recent fiscal years of Gilder Enterprises, Inc. and the subsequent
interim period through February 28, 2006, there were no disagreements between
Gilder Enterprises, Inc. and BDO Dunwoody as to any matter of accounting
principles or practices, financial statement disclosure, or auditing scope
or
procedure, which disagreements, if not resolved to the satisfaction of BDO
Dunwoody, would have caused BDO Dunwoody to make reference in their reports
on
the financial statements for such years to the subject matter of the
disagreement.
Item
5.01. Changes in Control of Registrant
As
described in more detail under Item 2.01 of this Current Report on Form 8-K,
which is incorporated herein by reference, as a result of the merger, a change
in control of the Registrant has occurred.
Item
5.02 Departure of Directors or Principal Officers; Election of Directors;
Appointment of Principal Officers.
Concurrently
with the closing of the merger, Joseph G. Bowes, who was our sole director
and
officer prior to the merger, appointed Al Kraus, Joseph Rubin, Esq., and Kurt
Katz to the Board of Directors, and then resigned from the Board and from his
positions as an officer. In addition, at such time, Al Kraus was appointed
Registrant’s President and Chief Executive Officer, James Winchester, MD was
appointed Registrant’s Chief Medical Officer, Vincent Capponi was appointed
Registrant’s Chief Operating Officer and David Lamadrid was appointed our Chief
Financial Officer.
For
certain biographical and other information regarding the newly appointed
officers and directors, see the disclosure under the heading “Directors and
Executive Officers” under Item 2.01 of this Current Report on Form 8-K, which is
incorporated herein by reference.
Item
5.03. Amendments to Articles of Incorporation or Bylaws; Change in Fiscal
Year
As
a
result of the merger, our fiscal year was changed to a calendar year. Because
reverse merger accounting dictates that the historical financial statements
of
MedaSorb are now our financial statements, we will not file a transition report.
Exhibit 99.1 to this Current Report on Form 8-K includes MedaSorb’s annual
financial statements for the years ended December 31, 2005 and 2004. Our next
Annual Report on Form 10-KSB will cover the complete 12-month period ended
December 31, 2006.
Item 5.06.
Change in Shell Company Status
Reference
is made to the disclosure set forth under Item 2.01 of this Current Report
on Form 8-K, which disclosure is incorporated herein by
reference.
Item
9.01. Financial Statements and Exhibits.
(a)
Financial Statements of business acquired.
Audited
financial statements of MedaSorb (formerly MedaSorb Technologies, LLC) for
the
fiscal years ended December 31, 2004 and 2005 are filed as Exhibit 99.1 to
this
Current Report on Form 8-K and unaudited financial statements of MedaSorb for
the interim period ended March 31, 2006 are filed as Exhibit 99.2 to this
Current Report on Form 8-K.
(b)
Pro
Forma Financial Information.
Pro
forma
financial statements for the Registrant reflecting the merger are filed as
Exhibit 99.3 to this Current Report on Form 8-K.
(d) Exhibits.
Exhibit
2.1
|
Agreement
and Plan of Merger, dated as of June 29, 2006, by and among Gilder
Enterprises, Inc., MedaSorb Corporation and MedaSorb Acquisition
Inc.
|
|
|
Exhibit
3.1
|
Articles
of Incorporation of Gilder Enterprises, Inc. (filed as Exhibit 3.1
to
Registrant’s Registration Statement on Form SB-2 filed on March 29, 2004,
and incorporated herein by reference).
|
|
|
Exhibit
3.2
|
By-Laws
of Gilder Enterprises, Inc. (filed as Exhibit 3.2 to Registrant’s
Registration Statement on Form SB-2 filed on March 29, 2004, and
incorporated herein by reference).
|
|
|
Exhibit
4.1
|
Certificate
To Set Forth Designations, Voting Powers, Preferences, Limitations,
Restrictions, And Relative Rights Of Series A 10% Cumulative Convertible
Preferred Stock, $.001 Par Value Per Share
|
|
|
Exhibit
4.2
|
Form
of Warrant issued to purchasers of Series A Preferred Stock, dated
June
__, 2006.
|
|
|
Exhibit
4.3
|
Subscription
Agreement, dated as of June 30, 2006, by and among Gilder
Enterprises, Inc. and the purchasers party thereto.
|
|
|
Exhibit
10.1
|
Employment
Agreement, dated as of July 18, 2003, between Al Kraus and MedaSorb
Technologies, LLC.
|
|
|
Exhibit
10.2
|
Employment
Agreement, dated as of July 1, 2005, between Vincent Capponi and
MedaSorb
Technologies, LLC.
|
|
|
Exhibit
10.3
|
Employment
Agreement, dated as of July 1, 2005, between David Lamadrid and MedaSorb
Technologies, LLC.
|
|
|
Exhibit
10.4
|
Employment
Agreement, dated as of July 1, 2004, between Dr. James Winchester
and
MedaSorb Technologies, LLC.
|
|
|
Exhibit
10.5
|
Gilder
Enterprises, Inc. 2006 Long Term Incentive Plan.
|
|
|
Exhibit
99.1
|
Audited
financial statements of MedaSorb for the fiscal years ended December
31,
2004 and 2005.
|
|
|
Exhibit
99.2
|
Unaudited
financial statements of MedaSorb for the three month interim period
ended
March 31, 2006.
|
|
|
Exhibit
99.3
|
Pro
forma financial statements of the Registrant reflecting the
merger.
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Date:
July 6,
2006
|
|
|
|
GILDER
ENTERPRISES, INC. |
|
|
|
|
By: |
/s/ Al
Kraus |
|
Al Kraus,
President and Chief Executive Officer
|
|
|
EXHIBIT
INDEX
No. |
Description |
|
|
Exhibit
2.1
|
Agreement
and Plan of Merger, dated as of June 29, 2006, by and among Gilder
Enterprises, Inc., MedaSorb Corporation and MedaSorb Acquisition
Inc.
|
|
|
Exhibit
3.1
|
Articles
of Incorporation of Gilder Enterprises, Inc. (filed as Exhibit 3.1
to
Registrant’s Registration Statement on Form SB-2 filed on March 29, 2004,
and incorporated herein by reference).
|
|
|
Exhibit
3.2
|
By-Laws
of Gilder Enterprises, Inc. (filed as Exhibit 3.2 to Registrant’s
Registration Statement on Form SB-2 filed on March 29, 2004, and
incorporated herein by reference).
|
|
|
Exhibit
4.1
|
Certificate
To Set Forth Designations, Voting Powers, Preferences, Limitations,
Restrictions, And Relative Rights Of Series A 10% Cumulative Convertible
Preferred Stock, $.001 Par Value Per Share
|
|
|
Exhibit
4.2
|
Form
of Warrant issued to purchasers of Series A Preferred Stock, dated
June
__, 2006.
|
|
|
Exhibit
4.3
|
Subscription
Agreement, dated as of June 30, 2006, by and among Gilder Enterprises,
Inc. and the purchasers party thereto.
|
|
|
Exhibit
10.1
|
Employment
Agreement, dated as of July 18, 2003, between Al Kraus and MedaSorb
Technologies, LLC.
|
|
|
Exhibit
10.2
|
Employment
Agreement, dated as of July 1, 2005, between Vincent Capponi and
MedaSorb
Technologies, LLC.
|
|
|
Exhibit
10.3
|
Employment
Agreement, dated as of July 1, 2005, between David Lamadrid and MedaSorb
Technologies, LLC.
|
|
|
Exhibit
10.4
|
Employment
Agreement, dated as of July 1, 2004, between Dr. James Winchester
and
MedaSorb Technologies, LLC.
|
|
|
Exhibit
10.5
|
Gilder
Enterprises, Inc. 2006 Long Term Incentive Plan.
|
|
|
Exhibit
99.1
|
Audited
financial statements of MedaSorb for the fiscal years ended December
31,
2004 and 2005.
|
|
|
Exhibit
99.2
|
Unaudited
financial statements of MedaSorb for the three month interim period
ended
March 31, 2006.
|
|
|
Exhibit
99.3
|
Pro
forma financial statements of the Registrant reflecting the
merger.
|