BERKELEY, CA OCT. 1, 1997 -- BioTime, Inc. (BTIM - NASDAQ) announced that all the surgical procedures have been completed in its pivotal Phase III double-blinded randomized clinical trials. The trials, consisting of 120 patients, were designed to test whether Hextend®, a proprietary blood volume plasma expander, can be used to replace substantial amounts of blood volume lost during major elective surgeries. The Phase III clinical trials, conducted at Mt. Sinai Medical Center in New York and the Duke University Medical Center in Durham, NC, studied the use of Hextend® in a variety of surgical procedures including gastrointestinal, urological, gynecological and orthopedic surgery, without the use of albumin. The next step will be to unblind the trials, analyze the data gathered and use it to compile a New Drug Application for FDA submission.
Separately, the Company announced that it will effect a three for one stock split by distributing to its shareholders of record on the record date two additional common shares for each share owned by them. The Company has set October 9, 1997 as the record date, and October 30, 1997 as the payment date, for the distribution of the shares. The Company has been informed by Nasdaq that the common shares will trade ex-dividend on October 31, 1997.
BioTime, headquartered in Berkeley, California, is engaged in the research and development of synthetic blood plasma expanders and hypothermic blood substitute solutions and technology for use in surgery, emergency trauma treatment, the preservation of organs awaiting transplant, and for other biomedical applications.
Statements contained herein 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. These factors include the results of clinical trials of Hextend®, BioTime's ability to obtain FDA and foreign regulatory approval to market Hextend®, the availability and terms of additional financing, competition from products manufactured and sold or being developed by other companies, and the price of and demand for any BioTime products that are ultimately sold.
CONTACT: Victoria Bellport (510) 845-9535