|BioTime’s Renevia® Achieves Primary Endpoint in European Pivotal Trial|
• Data Reinforce Renevia’s Potential in Multi-Billion Dollar Facial Aesthetics Market
• Conference Call Today with Lead Investigator at
“In the Renevia pivotal trial, we studied patients with HIV-associated
facial lipoatrophy, which is a very severe form of facial volume loss,”
“There were further encouraging data at the 12-month time-points for seven of the trial’s run-in patients, which followed the exact same clinical trial protocol as enrolled patients, but were considered training patients for the clinical sites,” continued Mr. Mohanty. “This run-in group, on average, had 96% volume retention at six months and 93% volume retention at 12 months, which suggests the potential of even longer lasting volume retention in this patient population. Additional data from the pivotal trial, including 12-month performance and secondary endpoints, should be received in the third quarter of 2017.”
“Renevia was used to enable the transfer of a patient’s own autologous
fat precursor cells as a means of possibly creating a sustained volume.
The retention of the transfer volume after six months in patients is
quite impressive and we look forward to evaluating the 12-month data,”
About the Trial
The current Renevia Pivotal Trial was designed to demonstrate the safety and efficacy of Renevia for treating facial lipoatrophy (abnormal fat loss in the face) in HIV patients. The pivotal trial was a multi-center, randomized, evaluator-blinded, delayed-treatment-controlled study of the effectiveness and safety of Renevia. Renevia was used to deliver the subject’s own fat-derived cells harvested via liposuction and implanted under the skin (subcutaneously) into areas of the patient’s face where there has been a loss of fat (lipoatrophy).
The study enrolled nine run-in patients and an additional 47 patients have completed their six months follow up. Of these 47 trial patients, 26 were in the treated arm and 21 were in the delayed treatment, control arm. The primary endpoint was the change in hemifacial volume at six months in treated patients compared to patients in the delayed treatment arm as measured by 3D photographic volumetric assessment. Participants in the delayed treatment group are being offered treatment after an evaluation at six months.
Renevia Program Next Steps
The next steps for the Renevia program include submission of an
application for CE mark by the end of the year and conclusion of partner
selection to begin preparing for European commercial launch next year.
At the same time,
“There are approximately 350,000 HIV patients in
Conference Call Information
BioTime is hosting a conference call and webcast today, Wednesday, June
14, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss the
top line data from the Company’s Renevia European pivotal trial. The
conference call dial-in number in the U.S./Canada is 1-877-407-0784. For
international participants outside the U.S./
A replay of the conference call will be available for seven business
days beginning about two hours after the conclusion of the live call, by
calling toll-free from U.S./
Renevia is an investigational medical device that is being developed as a replacement for whole adipose tissue in cell assisted lipotransfer (CAL) procedures. Renevia’s hydrogel polymer network provides the requisite amino acid sequences for adipose stromal vascular cell attachment and may support proliferation, localization and adipogenic differentiation. Renevia is part of the HyStem hydrogel family of proprietary injectable matrices, which are designed to facilitate the survival and growth of transplanted cells. To learn more about Renevia, click here. To learn more about the HyStem hydrogel technology, click here.
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Certain statements contained in this release are “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Statements pertaining to future financial and/or
operating results, future growth in research, technology, clinical
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