BioTime Submits CE Mark Application for European Approval of Renevia®
ALAMEDA, Calif.--(BUSINESS WIRE)--Mar. 13, 2018--
BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology
company focused on addressing degenerative diseases, announced today the
submission of a design dossier application for CE Mark approval to
market Renevia® in Europe. BioTime anticipates CE Mark
approval in the second half of 2018.
“Submission of the CE Mark application establishes an important
milestone for BioTime and we are delighted with the achievements made in
the clinical performance of Renevia, as demonstrated in the pivotal
trial,” said Adi Mohanty, Co-Chief Executive Officer of BioTime. “We
look forward to approval in the EU and, provided appropriate clinical
data support, expanding the label into other indications and
geographies, including the U.S.”
The CE Mark application was based on Renevia® successfully
meeting its primary endpoint with treated patients retaining
approximately 100% of transplanted volume at six months. In addition to
strong product performance at 6 months, 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 generally
well tolerated and there were no device-related serious adverse events
noted during this trial.
BioTime views the European pivotal trial in HIV-associated lipoatrophy
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. Exploration of Renevia®’s performance (known as
Premvia™ in the U.S.) into the broader facial aesthetics market has
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.
In combination with the U.S. investigator-led trial, we believe we can
build upon the European trial data with additional appropriate clinical
evidence to expand the potential utility of Renevia® and
enter other geographies, including the U.S.
Renevia® is an investigational medical device that is being
developed as an alternative for whole adipose tissue transfer (fat
grafting) procedures. Renevia® is part of the Hystem®
hydrogel family of proprietary injectable matrices, being developed as
devices for wound management, cell and drug delivery.
Premvia™ is indicated for the management of wounds including:
partial-thickness, full-thickness, tunneling wounds, pressure ulcers,
venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin
graft sites, post-Moh’s surgery, post-laser surgery, podiatric wounds,
wound dehiscence, abrasions, lacerations, second degree burns, skin
tears, and draining wounds.
Premvia™ is contraindicated for patients with severe allergies,
indicated by a history of anaphylaxis or presence of multiple severe
Premvia™ is specifically contraindicated for patients with known
allergies to products containing either hyaluronan or collagen
Premvia™ is not indicated for use in third degree burns.
Important Safety Information
Complications that may arise from wound management products may
include: infection, chronic inflammation, allergic reaction, excessive
redness, pain, or swelling. If any of these complications are present,
product should be removed from the wound area.
Federal law restricts this device to sale by or on the order of a
physician or practitioner.
Only the vial contents are sterile – outside of vials are not sterile.
Do not add additional components or additives to Premvia™.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company focused on
degenerative diseases. Its clinical programs are based on two platform
technologies: cell replacement and cell/drug delivery. With its cell
replacement platform, BioTime is creating new cells and tissues with its
proprietary pluripotent cell technologies. These cells and tissues are
developed to replace those that are either rendered dysfunctional or
lost due to degenerative diseases. BioTime’s cell/drug delivery programs
are based upon its proprietary HyStem® cell and drug delivery matrix
technology. HyStem® was designed to provide for the transfer, retention,
engraftment and metabolic support of cellular replacement therapy.
BioTime’s lead cell delivery clinical program, Renevia®, which consists
of our proprietary HyStem® cell-transplantation delivery matrix combined
with the patient's own adipose progenitor cells (Fat), met its primary
endpoint in an EU pivotal clinical trial for the treatment of facial
lipoatrophy in HIV patients in 2017. Submission for approval of Renevia®
in the EU occurred in the second quarter of 2018, with possible approval
in 2018. There were no device related serious adverse events reported to
date. Our lead cell replacement clinical program, OpRegen®, which is 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 to date. 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
BioTime common stock is traded on the NYSE American and TASE under the
symbol BTX. For more information, please visit www.biotime.com or
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Source: BioTime, Inc.
David Nakasone, 510-871-4188