Full Press Release Details
Renevia Achieves Primary Endpoint in European Pivotal Trial
Reinforce Renevia's Potential in Multi-Billion Dollar Facial Aesthetics
on Track to File for Renevia CE Mark by End of 2017
Call Today with Lead Investigator at 4:30 p.m. ET
ALAMEDA, Calif.--(BUSINESS WIRE)--June 14, 2017--BioTime, Inc. (NYSE
MKT:BTX), a clinical-stage biotechnology company developing and
commercializing products addressing degenerative diseases, today
reported that, based on the analysis of top line data, the Renevia
pivotal trial in Europe has met its primary endpoint. The primary
endpoint was the change in hemifacial volume at six months in the
treated patients compared to patients in the delayed treatment arm as
measured by 3D photographic volumetric assessment. Treated patients
received approximately 5cc of Renevia in each side of the face
(hemifacial). On average, 5.1cc of hemifacial volume was measured after
six months, which represents an approximate 100% retention of
transplanted volume. Untreated patients had no incremental hemifacial
volume after six months. Comparison of the two trial arms had a
statistical p value <.001. All Renevia transplants were shown to be safe
and well tolerated. There were no serious adverse events during the
"In the Renevia pivotal trial, we studied patients with HIV-associated
facial lipoatrophy, which is a very severe form of facial volume loss,"
stated Adi Mohanty, Co-CEO of BioTime. "In this clinical study, Renevia
has proven to be safe and effective in these patients. We believe the
data announced today, positions us to proceed with our planned CE mark
"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,"
said Ramon Llull, MD, PhD, Director of Stem Europe Mallorca Center,
Mallorca, Spain and the primary investigator of the Renevia trial.
"Given the compromised tissue of the patients participating in this
study, I believe it is possible that Renevia could perform even better
in patients without HIV, and I am beginning studies now with this larger
population to test this theory."
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, BioTime will initiate additional pilot trials studying
various dosages of Renevia by itself, Renevia in combination with
autologous fat, and Renevia in combination with stromal vascular
fraction cells (SVF) for any facial volume loss. Besides the studies
mentioned by Dr. Llull, during the third quarter, BioTime will support a
U.S. investigator initiated study by a leading plastic surgeon who will
treat patients in need of facial volume restoration without underlying
HIV disease. These patients will be treated with larger volumes of
Renevia than in the European pivotal trial in combination with their own
fat precursor cells obtained from a liposuction procedure. Successful
results from this as well as additional trials with Renevia would
position BioTime to quickly enter the global facial aesthetics market
which is estimated to be $7 billion annually.
"There are approximately 350,000 HIV patients in Europe suffering from
significant facial lipoatrophy and our objective is to make Renevia
available to these patients next year," said Mr. Mohanty. "If we achieve
our goals, then we should be helping these patients and generating
revenue in 2018, while at the same time working to expand Renevia's
addressable markets."
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./Canada, the dial-in number
is 1-201-689-8560. For all callers, please refer to the "BioTime, Inc.
Conference Call." The live webcast can be accessed on the "Events &
Presentations" page of the "Investors & Media" section on the company's
website at http://www.biotimeinc.com/.
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./Canada: 1-844-512-2921; international
callers dial 1-412-317-6671. Use the Conference ID 13664249.
Additionally, the archived webcast will be available on the "Events &
Presentations" page of the "Investors & Media" section on the company's
website at http://www.biotimeinc.com/.
Renevia is an investigational medical device that is being developed as