- Enrollment completed in first safety study of Renevia™ for
dermatological applications -
- Two weeks following administration, Renevia™ appears safe
and well tolerated with no serious unexpected adverse events observed to
The ten healthy volunteers each received one subcutaneous injection of Renevia™ without cells. The primary objective of the trial is to determine the safety, tolerability, and acceptance of Renevia™without cells as determined by monitoring subjects for any post-treatment reactions. Examinations of the subjects after they received Renevia™ injections have shown that Renevia™ was well-tolerated by all subjects with no serious adverse events or subject withdrawals. A final check of the enrolled subjects for adverse events will be made four weeks after the injection.
The Renevia™ safety study was initiated on
Subsequent clinical studies are planned 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, beginning with HIV related facial lipoatrophy. Lipoatrophy is a localized loss of fat beneath the skin. Lipoatrophy is often a consequence of the normal aging process where the loss of fat in the cheeks or the back of the hands contributes to an aged appearance, but lipoatrophy can also be associated with trauma, surgery, and diseases, and is frequently suffered by HIV patients being treated with anti-viral drugs. According to published estimates, at least several hundred thousand patients in