UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): March 29, 2005
THERMOGENESIS CORP.
(Exact name of registrant as specified in its charter)
Delaware 0-16375 94-3018487
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(State or other (Commission File Number) (I.R.S. Employer
jurisdiction of Identification No.)
incorporation or
organization)
2711 Citrus Road
Rancho Cordova, California 95742
(Address and telephone number of principal executive
offices) (Zip Code)
(916) 858-5100
(Registrant's telephone number, including area code)
Checkthe 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):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
Section 1 - Registrant's Business and Operations
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Item 1.01 Entry into a Material Definitive Agreement
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On March 29, 2005, ThermoGenesis Corp. (the "Company") entered into a
Supply Agreement with Cell Factors Technology, Inc., an Indiana corporation and
an affiliate of Biomet, Inc. ("CFT") (the "Agreement"). Under the Agreement, the
Company will manufacture a Thrombin disposable and Reagent for the Clotalyst(TM)
system. Clotalyst is CFT's an autologous clotting factor device and blood
processing disposables. The Company assumes the role of manufacture for CFT of
the Clotalyst(TM) device and blood processing disposals for a term of five
years. The Agreement requires CFT, upon FDA clearance, to purchase a minimum
quantity of 20,000 devices. CFT will pay a onetime advance fee for engineering
and development of the product. For more information, see the press release
attached as Exhibit 99 and Agreement attached as Exhibit 10.
Section 9 - Financial Statements and Exhibits
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Item 9.01 Financial Statements and Exhibits.
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Exhibit No. Exhibit Description
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10 Supply Agreement of Clotalyst(TM) Thrombin
Product between ThermoGenesis Corp and Cell
Factors Technologies, Inc. dated March 29, 2005
99 Press release dated April 5, 2005, titled
"ThermoGenesis Corp. to Supply Autologous
Thrombin Kits to Biomet, Inc."
SIGNATURE
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.
THERMOGENESIS CORP.,
a Delaware Corporation
Dated: April 4, 2005 /s/ Renee Ruecker
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Renee Ruecker,
Chief Financial Officer
EXHIBIT INDEX
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Exhibit No. Description
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10 Supply Agreement of Clotalyst(TM) Thrombin
Product between ThermoGenesis Corp and Cell
Factors Technologies, Inc. dated March 29, 2005.
99 Press release dated April 5, 2005, titled
"ThermoGenesis Corp. to Supply Autologous
Thrombin Kits to Biomet, Inc."
EXHIBIT 99
[THERMOGENESIS LOGO OMITTED]
THERMOGENESIS CORP. TO SUPPLY
AUTOLOGOUS THROMBIN KITS TO BIOMET, INC.
Agreement addresses the need for autologous clotting factors
and reduces the risk of exposure to Bovine thrombin
RANCHO CORDOVA, California (April 5, 2005) -- THERMOGENESIS CORP. (Nasdaq: KOOL)
announced today that the Company and Biomet, Inc (NASDAQ: BMET) reached
agreement for the Company to supply Biomet's subsidiary, Cell Factor
Technologies, Inc. (CFT) with disposable kits that produce stable, activated
thrombin from the patients own blood in less than 30 minutes. Approximately $180
million of thrombin annually is consumed worldwide as a blood clotting enzyme
that surgeons use for topical hemostasis, the treatment of pseudoaneurysms, and
to form "platelet gels" for the treatment of damaged tissue.
Kevin Simpson, President & COO of ThermoGenesis noted, "We are very excited
about our new partnership with Biomet's CFT subsidiary to address the many
potential thrombin applications in their orthopedic, neurosurgery,
maxilliofacial, and dental reconstructive markets. This novel disposable device,
based on our technology and patents, allows surgeons to treat patients with
autologous thrombin (thrombin manufactured from their own blood), instead of
bovine thrombin that has been reported to cause adverse reactions in patients as
reported in 28 peer reviewed journal articles. In Europe and Japan, these health
risks and additional concerns about "mad cow disease" have nearly ended the
clinical use of bovine thrombin.
Joel Higgins, Vice President of Technical Affairs for CFT, commented, "Our
agreement with ThermoGenesis will provide a key product for our customers to
create the highest quality and safest biological solutions for enhanced
recovery. This new thrombin device will enable our Gravitational Platelet
Separation System (GPS) system to provide a completely "autologous" platelet gel
that our customers are currently demanding. We look forward to working with
ThermoGenesis to bring this device to market."
Regulatory Status
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An autologous thrombin disposable device manufactured by
THERMOGENESIS has received CE Mark approval from the European Union Competent
Authorities and is being sold in Europe by the Biomet subsidiary, Interpore
International, Inc. This newly configured thrombin disposable device will be
marketed under the Biomet trademarked name, ClotalystTM Thrombin Device, and is
expected to be submitted for CE Mark this year. The regulatory pathway in the
United States is unclear and may require a Pre-Market Approval Application for
the platelet gel product of which the autologous thrombin is a component.
About Biomet Inc.
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Biomet, Inc and its subsidiaries design, manufacture and
market products used primarily by musculoskeletal medical specialists in both
surgical and non-surgical therapy. The company's product portfolio encompasses
reconstructive products, including orthopedic joint replacement devices, bone
cements and accessories, and dental reconstructive implants; fixation products,
including electrical bone growth stimulators, internal and external orthopedic
fixation devices, craniomaxillofacial implants and bone substitute materials;
spinal products, including spinal stimulation devices, spinal hardware and
orthobiologics; and other products, such as arthroscopy products and softgoods
and bracing products. Headquartered in Warsaw, Indiana, Biomet and its
subsidiaries currently distribute products in more than 100 countries.
About THERMOGENESIS CORP.
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After extensive research, THERMOGENESIS CORP.'s newly introduced technology
platforms lead the world in their ability to produce biological products from
single units of blood. Umbilical cord blood banks are utilizing the Company's
BioArchive(R) System as a critical enabling technology for cryogenic archiving
of stem cells for transplant, while its CryoSeal FS System is used to prepare
hemostatic and adhesive surgical sealants from patient blood in about an hour.
THERMOGENESIS CORP. has been a leading supplier of state-of-the-art Ultra-Rapid
Blood Plasma Freezers and Thawers to hospitals and blood banks since 1992.
The statements contained in this release which are not historical facts are
forward-looking statements that are subject to risks and uncertainties that
could cause actual results to differ materially from those expressed in the
forward-looking statements, including, but not limited to, certain delays beyond
the company's control with respect to market acceptance of new technologies and
products, delays in testing and evaluation of products, and other risks detailed
from time to time in the Company's filings with the Securities and Exchange
Commission.
More Information, Contact:
THERMOGENESIS CORP.
Kevin Simpson: (916) 858-5100