BioTime announced the submission of a design dossier application for CE Mark approval to market Renevia® in Europe. BioTime anticipates CE Mark approval in the second half of 2018.
“Submission of the CE Mark application establishes an important milestone for BioTime and we are delighted with the achievements made in the clinical performance of Renevia, as demonstrated in the pivotal trial,” said Adi Mohanty, Co-Chief Executive Officer of BioTime. “We look forward to approval in the EU and, provided appropriate clinical data support, expanding the label into other indications and geographies, including the U.S.”
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, we believe we 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.
