ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 2, 2018--
BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology
company focused on degenerative diseases, today reported that Gordon H.
Sasaki, M.D., F.A.C.S., has initiated his independent
investigator-initiated study of Premvia™ combined with the
patient’s own fat for volume augmentation of the hand.
Dr. Sasaki is a board-certified plastic surgeon serving Los Angeles and
Pasadena, California. He is a plastic surgery innovator, educator, and
clinician recognized nationally and internationally whose notable
Enhancing liposuction outcomes and recovery using advanced techniques
such as power-assisted liposuction (PAL) and SAFElipo®.
Pioneering endoscopic techniques for brow lifts and facelifts.
Improving nonsurgical facial rejuvenation by combining fillers, BOTOX,
laser resurfacing, and radiofrequency skin tightening.
Innovating tissue expansion techniques for reconstructive surgery.
Dr. Sasaki has also been cited for his extensive work with fat. Most
notably, his recent papers note the rapid decline in volume retention
rates from fat grafting procedures.
“We are excited at the opportunity for Dr. Sasaki to study Premvia as a
volumizer,” said Dr. Gary S. Hogge, SVP of Clinical and Medical Affairs
at BioTime. “Premvia may potentially provide a long lasting and natural
looking volumizer that many patients desire.”
Premvia™ is a hydrogel medical device that has 510(k)
clearance in the U.S. for wound management. It has the same components
as Renevia®, BioTime’s investigational medical device that is
being developed as an alternative for fat grafting procedures. The
objective of this investigator-initiated study is to evaluate the safety
and performance of Premvia™ plus the patient’s own fat as a
volumizer in the hands. This single arm study is designed to evaluate a
number of subjects. Each subject will receive injections into each hand.
One hand will receive a combination of Premvia™ plus their
own fat, while the other hand will receive an injection of the patient’s
Premvia™ Important Information
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 allergies.
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™.
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 various applications and for cell and drug delivery.
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 producing 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 or injuries. BioTime’s cell/drug
delivery programs are based upon its proprietary HyStem® cell
and drug delivery hydrogel matrix technology. HyStem® was
designed, in part, to provide for the transfer, retention and/or
engraftment of cellular replacement therapies. BioTime’s lead cell
delivery clinical program is Renevia®, which consists of
HyStem® combined with the patient's own adipose (fat)
derived tissue or cells. Renevia® met its primary endpoint in
an EU pivotal clinical trial for the treatment of facial lipoatrophy in
HIV patients in 2017. BioTime has submitted Renevia® for
CE Mark approval in the EU. There were no device related serious adverse
events reported to date. BioTime’s lead cell replacement product
candidate is OpRegen®, a retinal pigment epithelium
transplant therapy, which is in a Phase I/IIa multicenter clinical trial
for the treatment of dry age-related macular degeneration, the leading
cause of blindness in the developed world. There have been no unexpected
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 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
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To receive ongoing BioTime corporate communications, please click on the
following link to join the Company’s email alert list: http://news.biotime.com.
Certain statements contained in this release are “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Any statements that are not historical fact
including, but not limited to statements that contain words such as
“will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”
should also be considered forward-looking statements. Forward-looking
statements involve risks and uncertainties. Actual results may differ
materially from the results anticipated in these forward-looking
statements and as such should be evaluated together with the many
uncertainties that affect the business of BioTime, Inc. and its
subsidiaries, particularly those mentioned in the cautionary statements
found in more detail in the “Risk Factors” section of BioTime’s Annual
Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with
the SEC (copies of which may be obtained at www.sec.gov).
Subsequent events and developments may cause these forward-looking
statements to change. BioTime specifically disclaims any obligation or
intention to update or revise these forward-looking statements as a
result of changed events or circumstances that occur after the date of
this release, except as required by applicable law.
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Source: BioTime, Inc.
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