BioTime Announces First Patient in U.S. Clinical Trial Treated for Facial Volume Deficit

BioTime reported that an investigator-led clinical trial has successfully treated its first patient in a study of Premvia as a carrier for stromal vascular fraction cells (SVF) for the treatment of age-related volume loss in the face. This is the first clinical trial to study Premvia in a purely cosmetic application. Premvia, which has 510(k) clearance in the U.S. for wound management, is expected to file for CE Mark in Europe under the name Renevia for the treatment of facial lipoatrophy in HIV patients later this year.

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. Joel A. Aronowitz, a leading Beverly Hills-based plastic surgeon who is conducting the study. “My patients need additional options, and I am excited that Premvia may enhance fat transfer and could help provide long lasting, natural looking facial augmentation with higher volume retention.”

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, BioTime announced that treated patients retained an average 70% of the transplanted volume at 12 months and 64% at 18 months. While only a small number of patients have been observed through 18 months, the results thus far are encouraging and the long-term performance exceeded management expectations. All Renevia transplants were shown to be well tolerated and there were no device-related serious adverse events noted during this trial.

The data in the trial has encouraged BioTime to make plans to seek additional indications for Renevia, such as cosmetic facial aesthetics. BioTime expects to file the CE mark application by the end of this year with possible approval and launch next year.