BioTime Announces the Start of an Investigator Initiated Study of Premvia™ Designed and Conducted by Dr. Gordon H. Sasaki
Aug. 02, 2018
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 contributions include:
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 fat only.
Premvia ™ Important Information
Approved UsesPremvia ™ 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.
ContraindicationsPremvia ™ 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 derivatives. Premvia ™ is not indicated for use in third degree burns.
Important Safety InformationComplications 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 Renevia ®
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 connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
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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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David Nakasone, 510-871-4188
KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA MIDDLE EAST ISRAEL
INDUSTRY KEYWORD: STEM CELLS HEALTH BIOTECHNOLOGY PHARMACEUTICAL GENERAL HEALTH
SOURCE: BioTime, Inc.
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PUB: 08/02/2018 07:00 AM/DISC: 08/02/2018 07:01 AM