Data from Pharmawand - Curated by EPG Health - Date added 14 March 2018
BioTime, Inc., a clinical-stage biotechnology company focused on addressing degenerative diseases, announced the submission of a design dossier application for CE Mark approval to market Renevia in Europe for treatment of facial lipoatrophy in HIV patients. BioTime anticipates CE Mark approval in the second half of 2018. Renevia is known as Premvia in the US.
The CE Mark application was based on Renevia successfully meeting its primary endpoint with treated patients retaining approximately 100% of transplanted volume at six months. In addition to strong product performance at 6 months, treated patients retained an average 70% of the transplanted volume at 12 months and 64% at 18 months. All Renevia transplants were shown to be generally well tolerated and there were no device-related serious adverse events noted during this trial. BioTime views the European pivotal trial in HIV-associated lipoatrophy as an entryway into a larger market opportunity, like cosmetic facial aesthetics.
Currently, the cosmetics facial aesthetics market is estimated to be over 5 billion dollars and growing at or near double digits. Exploration of Renevia's performance (known as Premvia in the U.S.) into the broader facial aesthetics market has already begun with an investigator-led trial in the U.S. This ongoing facial aesthetics trial is being conducted by Dr. Joel A. Aronowitz, who is a leading Beverly Hills plastic surgeon. In combination with the U.S. investigator-led trial, BioTime believes it can build upon the European trial data with additional appropriate clinical evidence to expand the potential utility of Renevia and enter other geographies, including the U.S.
Comment: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.