9:06AM BioTime reports results of clinical safety trial of Renevia; appears safe and well tolerated with no serious unexpected adverse events observed during the trial period; manufacturing and biocompatibility information Submitted in a Device Master File to FDA (BTX) 3.76 :
Examinations of the subjects during the trial period have shown that Renevia was well tolerated by all subjects with no serious adverse events or subject withdrawals. The Renevia-01 safety study was completed on November 4, 2013 and a four week follow-up procedure evaluating the trial subjects has been completed.
The protocol for a pivotal clinical study (Renevia-02) is under development and submission to Spanish regulatory authorities is planned for the first quarter of 2014. This latter clinical study is intended to document the efficacy of Renevia as a delivery matrix for adipose cells to restore normal skin contours in patients where the subcutaneous adipose tissue has been lost to lipoatrophy, specifically HIV-related facial lipoatrophy. Lipoatrophy is a localized loss of fat beneath the skin and is often a consequence of the normal aging process, but lipoatrophy can also be associated with trauma, surgery, and specific diseases. For example, lipoatrophy is a frequent disorder experienced by HIV patients being treated with antiviral drugs. According to published estimates, at least several hundred thousand patients in Europe, and a similar number in the U.S., are affected by lipoatrophy and related conditions such as lipodystrophy.
BioTime's plans to proceed with the Renevia-02 pivotal clinical trial subject to obtaining required regulatory and institutional approvals.
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