|BioTime Announces First Patient in U.S. Clinical Trial Treated for Facial Volume Deficit|
The objective of this investigator-led study is to evaluate the safety and performance of Premvia™ as a carrier for autologous SVF in non-HIV patients. SVF cells are believed to contain fat tissue progenitors, and are prepared at the point of care from a lipoaspirate. This single-arm study is designed to evaluate 10 subjects who each receive a treatment of Premvia™ and SVF. The study’s primary endpoint is mean change in volume of each side of the face from baseline six months post treatment, with secondary endpoints being hemi-facial volume change at one, two, three and 12 months from baseline.
“I am encouraged by the results seen in the EU pivotal study. Premvia
has the potential to address the limitations that we see with autologous
fat transfer,” said Dr.
HIV-associated lipoatrophy is a severe form of lipoatrophy characterized
by the pathological loss of body fat from under the skin. In an EU
pivotal clinical trial, Renevia® met its primary endpoint,
and treated patients retained approximately 100% of transplanted volume
at six months, based on 3-D volume measurement of the implanted area. In
addition to meeting the primary endpoint,
The data in the trial has encouraged
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 transplanted cells.
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.
Important Safety Information
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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. Statements pertaining to product technology,
clinical development, regulatory approval timelines, the success of
potential cosmetic applications and potential opportunities for