|Additional Renevia Data From the Successful Pivotal Trial Was Presented at the IFATS Conference|
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
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.
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
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.
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
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,
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