Additional Renevia Data From the Successful Pivotal Trial Was Presented at the IFATS Conference
December 04 2017 - 8:00AM
Business Wire
- BioTime expects Europe CE Mark
submission of Renevia in the first quarter of 2018
- Positive data from the pivotal trial of
Renevia reinforces potential in multibillion dollar global
aesthetics market
BioTime, Inc. (NYSE American: BTX), a late-stage, clinical
biotechnology company developing and commercializing products
addressing degenerative diseases, today announced that detailed
data from the successful pivotal trial of
Renevia® in Europe was presented at
the International Federation for Adipose Therapeutics and
Science (IFATS) conference on November 30, 2017. The
Renevia® data was presented by primary investigator Ramon
Llull, MD, PhD, Director of Stem Europe Mallorca Center,
Mallorca, Spain at the “Plenary Session 2 - Clinical
Studies with SVF.”
As we announced earlier this year, Renevia® successfully
met its primary endpoint, and treated patients retained
approximately 100% of transplanted volume at six months. As well as
meeting the primary endpoint, treated patients retained an average
70% of the transplanted volume at 12 months and 64% at 18 months.
All Renevia® transplants were shown to be well tolerated and
there were no device-related serious adverse events noted during
this trial.
The Renevia® application for CE Marking will be submitted next
quarter with an expected approval in the second half of 2018. “With
this submission for CE mark in Europe, we will be one step closer
to becoming a commercial company,” said Adi Mohanty, Co-CEO of
BioTime.
We view this European trial as an entryway into a larger market
opportunity, like cosmetic facial aesthetics. Currently, the
cosmetics facial aesthetics market is estimated to be over 5
billion dollars and growing at or near double digits.
Execution of our label expansion plans into this broader market
have already begun with an investigator-led trial in the U.S. This
ongoing facial aesthetics trial is being conducted by Dr. Joel A.
Aronowitz, who is a leading Beverly Hills plastic surgeon.
We will build upon this investigator-led trial in conjunction
with the EU pivotal trial data to expand the potential label into
other indications and geographies, including the U.S. We plan to
submit our data package to the FDA later this month and expect to
meet with the FDA next quarter to confirm the path for U.S.
approval.
About Renevia®
Renevia® is an investigational medical device that is being
developed as an alternative for whole adipose tissue transfer (fat
grafting) 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.
About BioTime, Inc.
BioTime is a late stage clinical biotechnology company
focused on developing and commercializing products addressing
degenerative diseases. The Company’s current clinical programs are
targeting three primary sectors, aesthetics, ophthalmology and cell
and drug delivery. Its clinical programs are based on two platform
technologies: pluripotent cells, which can become any type of cell
in the human body, and cell/drug delivery. Renevia®, a cell
delivery product, met its primary endpoint in an EU pivotal
clinical trial for the treatment of facial lipoatrophy in HIV
patients earlier this year. Submission for approval of
Renevia® in the EU is expected to be early 2018, with possible
approval and commercial launch in 2018. There were no device
related serious adverse events reported. OpRegen®, a retinal
pigment epithelium transplant therapy, is in a Phase I/IIa
multicenter trial for the treatment of dry age-related macular
degeneration, the leading cause of blindness in developing
countries. There were no related serious adverse events
reported. BioTime also has significant equity holdings in
two publicly traded companies, Asterias Biotherapeutics,
Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE
American: OCX), and a private company, AgeX Therapeutics,
Inc.
BioTime common stock is traded on the NYSE American and
TASE under the symbol BTX. For more information, please
visit www.biotime.com or connect with the company
on Twitter, LinkedIn, Facebook, YouTube,
and Google+.
To receive ongoing BioTime corporate communications,
please click on the following link to join the Company’s email
alert list: http://news.biotime.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20171204005326/en/
Investor Contact:BioTimeDavid Nakasone,
510-871-4188Dnakasone@biotime.comorMedia Contact:JQA
Partners, Inc.Jules Abraham,
917-885-7378jabraham@jqapartners.com
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