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): June
4, 2012
BioTime,
Inc.
(Exact name of registrant as specified in its charter)
California |
1-12830 |
94-3127919 |
(State or other jurisdiction
|
(Commission File Number)
|
(IRS Employer Identification No.) |
1301
Harbor Bay Parkway
Alameda,
California 94502
(Address of principal executive offices)
(510)
521-3390
(Registrant's telephone number, including area
code)
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:
⃞
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))
Statements made in this Report that are not historical facts may constitute forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed. Such risks and uncertainties include but are not limited to those discussed in this report and in BioTime's other reports filed with the Securities and Exchange Commission. Words such as “expects,” “may,” “will,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions identify forward-looking statements.
Section 7 - Regulation FD
Item 7.01 - Regulation FD Disclosure
Chief Executive Officer, Michael D. West, Ph.D., will provide a corporate update at the Jefferies 2012 Global Healthcare Conference in New York City on Monday, June 4, 2012 at 3:30 p.m. ET. The presentation will be webcast and may be accessed at http://wsw.com/webcast/jeff68/btx/ or under “Investor Presentations” on BioTime's website at www.biotimeinc.com. The webcast can be viewed live and will be available for replay for 90 days after the presentation.
Dr. West’s presentation will include an update on BioTime’s plans for seeking regulatory approval to market ReneviaTM for use with autologous adipose cells to restore subcutaneous tissue lost as a result of injury, oncologic resection, or congenital defects. BioTime’s goals for the launch of ReneviaTM include obtaining the CE mark necessary for marketing ReneviaTM in European Union countries by year-end 2013. BioTime currently plans a prospective, non-randomized, non-comparative, consecutive, open investigation trial of approximately 25 patients with a 12 month follow-up period to evaluate the efficacy and any side-effects of the treatments with ReneviaTM. The currently planned primary endpoint will be efficacy as judged by an aesthetic improvement score and photographic review. The secondary endpoint is expected to be patient satisfaction, self esteem improvement, and a measure of pain and swelling. Currently, a single site in Palma de Mallorca, Spain is planned.
Renevia™ (formerly known as HyStem®-Rx) is a clinical grade biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. As an injectable product, Renevia™ may address an immediate need in cosmetic and reconstructive surgeries and other procedures by improving the process of transplanting adipose derived cells, mesenchymal stem cells, or other adult stem cells. We will need to obtain approval by the U.S. Food and Drug Administration and comparable regulatory agencies in foreign countries in order to market Renevia™ as a medical device.
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.
BIOTIME, INC. |
||||
Date: |
June 4, 2012 |
By: |
/s/ Michael D. West |
|
|
Chief Executive Officer |
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