Full Press Release Details
Announces Positive Secondary and Additional Positive Long-Term Data from
CE mark by the end of 2017
long-term data in HIV-associated lipoatrophy reinforces Renevia's
potential in multibillion-dollar global facial aesthetics market
ALAMEDA, Calif.--(BUSINESS WIRE)--September 26, 2017--BioTime, Inc.
(NYSE American: BTX), a clinical-stage biotechnology company focused on
developing and commercializing products addressing degenerative
diseases, today announced that treated patients from the Renevia
pivotal trial in Europe retained an average of 70% of the transplanted
volume at 12 months. Additionally, preliminary data for five patients
indicates an average retention of 64% of the transplanted volume at 18
months. These data exceed management expectations for long-term
performance of the Renevia transplant. BioTime remains
on track to file Renevia for CE mark approval by the
The Renevia trial data will be further discussed at the
BioTime presentation at the Ladenburg Thalmann 2017 Healthcare
Conference in New York. The presentation is scheduled for 2:00 pm
ET/11:00 am PT today, September 26, 2017. A live webcast and subsequent
archived replay of the BioTime's presentation may be accessed via the
investor relations section of the BioTime's website at www.investor.biotimeinc.com/phoenix.zhtml?c=83805&p=irol-EventDetails&EventId=5263572.
"These additional positive data further support our confidence that
Renevia may soon become an important, stable long-term
solution, not only for people with HIV-associated lipoatrophy, but for
people with any facial fat loss, whether caused by pharmaceuticals,
trauma or aging," said BioTime's Co-Chief Executive Officer, Adi
Mohanty. "We are moving quickly to submit an application for a CE mark
to the European regulatory agency, with a possible approval and
commercial launch in 2018."
BioTime previously reported meeting the primary endpoint of this pivotal
trial and now has the remaining required data, secondary endpoints and
safety report to complete the clinical data package necessary to file
for a CE mark in Europe. The secondary endpoints, such as qualitative
improvements, trended positive and support the statistically significant
primary endpoint. Secondary data points were not powered for statistical
significance, but positive trends were seen in both the Mid-Face Volume
Deficit Scale and Body Image Quality of Life Inventory. BioTime remains
on track for filing the CE mark application by the end of this year with
possible approval and launch next year.
In this pivotal trial, BioTime studied patients with HIV-associated
lipoatrophy, which is a severe form of lipoatrophy characterized by the
pathological loss of body fat from under the skin. All Renevia
transplants were well tolerated and there were no device-related serious
adverse events noted in this pivotal trial. 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 3-D
photographic volumetric assessment. The 3-D volumetric endpoint directly
measures retained volume over time.
The additional data were encouraging as further supporting the
commercial prospects of Renevia , and its potential for
label expansion into other indications, such as cosmetic facial
aesthetics. The facial aesthetics market is estimated to be over 5
billion dollars and growing at or near double digits.
Treated patients received approximately 5cc of Renevia
in each side of the face (hemifacial) and the following table details
the average (mean) volume measured through 18 months.
| 6 Months | 9 Months | 12 Months | 18 Months | |||||||||
| Patients | 28 | 21 | 15 | 5 | ||||||||
| Mean volume measured (cc) | 5.1 | 4.1 | 3.5 | 3.2 | ||||||||
| Percent of retention | 100% | 82% | 70% | 64% |
While only a small number of patients have been observed through 18
months, the results thus far are encouraging.
This positive data, along with the secondary endpoints and full safety
report, will be presented at the upcoming International Federation for
Adipose Therapeutics and Science (IFATS) conference. The IFATS
conference will be held in Miami, FL. from November 30th
through December 3rd of this year.
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
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/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 trial for the treatment of facial lipoatrophy
in HIV patients earlier this year. Submission for approval of Renevia
is expected later this year, with an anticipated commercial launch in
2018. 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. BioTime also has significant equity holdings in two publicly
traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST)
and OncoCyte Corporation (NYSE American: OCX), and one 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.biotimeinc.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube,
To receive ongoing BioTime corporate communications, please click on the
following link to join the Company's email alert list: http://news.biotimeinc.com.
Forward-Looking Statements
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
development, and potential opportunities for BioTime, Inc. and its
subsidiaries, along with other statements about the future expectations,