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ALAMEDA, Calif.--(BUSINESS WIRE)--BioTime, Inc. (NYSE American: BTX), a backward date analytic biotechnology aggregation focused on developing and commercializing articles acclamation degenerative diseases, today appear that an investigator-led analytic balloon has auspiciously advised its aboriginal accommodating in a abstraction of Premvia™ as a carrier for stromal vascular atom beef (SVF) for the analysis of age-related aggregate accident in the face. This is the aboriginal analytic balloon to abstraction Premvia™ in a absolutely corrective application. Premvia™, which has 510(k) approval in the U.S. for anguish management, is accepted to book for CE Mark in Europe beneath the name Renevia® for the analysis of facial lipoatrophy in HIV patients afterwards this year.
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The cold of this investigator-led abstraction is to appraise the assurance and achievement of Premvia™ as a carrier for autologous SVF in non-HIV patients. SVF beef are believed to accommodate fat tissue progenitors, and are able at the point of affliction from a lipoaspirate. This single-arm abstraction is advised to appraise 10 capacity who anniversary accept a analysis of Premvia™ and SVF. The study’s primary endpoint is beggarly change in aggregate of anniversary ancillary of the face from baseline six months column treatment, with accessory endpoints actuality hemi-facial aggregate change at one, two, three and 12 months from baseline.
“I am encouraged by the after-effects apparent in the EU cardinal study. Premvia has the abeyant to abode the limitations that we see with autologous fat transfer,” said Dr. Joel A. Aronowitz, a arch Beverly Hills-based artificial surgeon who is administering the study. “My patients charge added options, and I am aflame that Premvia may enhance fat alteration and could advice accommodate continued lasting, accustomed attractive facial accession with college aggregate retention.”
HIV-associated lipoatrophy is a astringent anatomy of lipoatrophy characterized by the dissection accident of anatomy fat from beneath the skin. In an EU cardinal analytic trial, Renevia® met its primary endpoint, and advised patients retained about 100% of crude aggregate at six months, based on 3-D aggregate altitude of the built-in area. In accession to affair the primary endpoint, BioTime appear that advised patients retained an boilerplate 70% of the crude aggregate at 12 months and 64% at 18 months. While alone a baby cardinal of patients accept been empiric through 18 months, the after-effects appropriately far are auspicious and the abiding achievement exceeded administration expectations. All Renevia® transplants were apparent to be able-bodied acceptable and there were no device-related austere adverse contest acclaimed during this trial.
The abstracts in the balloon has encouraged BioTime to accomplish affairs to seek added break for Renevia®, such as corrective facial aesthetics. BioTime expects to book the CE mark appliance by the end of this year with accessible approval and barrage abutting year.
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About Renevia®
Renevia® is an investigational medical accessory that is actuality developed as an another for accomplished adipose tissue alteration (fat grafting) procedures. Renevia’s® hydrogel polymer arrangement provides the requisite amino acerbic sequences for adipose stromal vascular corpuscle adapter and may abutment proliferation, localization and adipogenic differentiation. Renevia® is allotment of the HyStem® hydrogel ancestors of proprietary injectable matrices, which are advised to facilitate the adaptation and advance of crude cells.
Premvia™Important Information
Approved Uses
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Premvia™ is adumbrated for the administration of wounds including: partial-thickness, full-thickness, tunneling wounds, burden ulcers, venous ulcers, diabetic ulcers, abiding vascular ulcers, donor bark affix sites, post-Moh’s surgery, post-laser surgery, podiatric wounds, anguish dehiscence, abrasions, lacerations, added amount burns, bark tears, and clarification wounds.
Contraindications
Important Assurance Information
About BioTime, Inc.
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BioTime is a backward date analytic biotechnology aggregation focused on developing and commercializing articles acclamation degenerative diseases. The Company’s accepted analytic programs are targeting three primary sectors, aesthetics, ophthalmology and corpuscle and biologic delivery. Its analytic programs are based on two belvedere technologies: pluripotent cells, which can become any blazon of corpuscle in the animal body, and cell/drug delivery. Renevia®, a corpuscle commitment product, met its primary endpoint in an EU cardinal analytic balloon for the analysis of facial lipoatrophy in HIV patients beforehand this year. Submission for approval of Renevia® in the EU is accepted afterwards this year, with accessible approval and bartering barrage in 2018. OpRegen®, a retinal colorant epithelium displace therapy, is in a Phase I/IIa multicenter balloon for the analysis of dry age-related macular degeneration, the arch account of amaurosis in developing countries. BioTime additionally has cogent disinterestedness backing in two about traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE American: OCX), and one clandestine company, AgeX Therapeutics, Inc.
BioTime common banal is traded on the NYSE American and TASE beneath the attribute BTX. For added information, amuse visit www.biotimeinc.com or affix with the aggregation on Twitter, LinkedIn, Facebook, YouTube, and Google .
To accept advancing BioTime accumulated communications, amuse bang on the afterward articulation to accompany the Company’s email active list: http://news.biotimeinc.com.
Forward-Looking Statements
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Certain statements independent in this absolution are “forward-looking statements” aural the acceptation of the Clandestine Securities Litigation Reform Act of 1995. Statements pertaining to artefact technology, analytic development, authoritative approval timelines, the success of abeyant corrective applications and abeyant opportunities for BioTime, Inc. and its subsidiaries, forth with added statements about the approaching expectations, beliefs, goals, plans, or affairs bidding by administration aggregate advanced statements. Any statements that are not actual actuality including, but not bound to statements that accommodate words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should additionally be advised advanced statements. Advanced statements absorb risks and uncertainties, including, afterwards limitation, risks inherent in the development and/or commercialization of abeyant products, ambiguity in the after-effects of analytic trials or authoritative approvals, charge and adeptness to access approaching capital, and aliment of bookish acreage rights. Actual after-effects may alter materially from the after-effects advancing in these advanced statements and as such should be evaluated calm with the abounding uncertainties that affect the business of BioTime, Inc. and its subsidiaries, decidedly those mentioned in the cautionary statements begin in added detail in the “Risk Factors” area of its Annual Reports on Anatomy 10-K and Quarterly Reports on Anatomy 10-Q filed with the SEC (copies of which may be acquired at www.sec.gov). Subsequent contest and developments may account these advanced statements to change. BioTime accurately disclaims any obligation or ambition to amend or alter these advanced statements as a aftereffect of afflicted contest or affairs that action afterwards the date of this release, except as appropriate by applicative law.
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