BioTime studies cosmetic use of Premvia in clinical trial

US-based biotechnology firm BioTime has announced that a clinical trial evaluating the cosmetic applications of Premvia for facial volume deficit has successfully treated its first patient.

Premvia secured 510(k) clearance from the US Food and Drug Administration (FDA) for wound management to treat tunnelling wounds, pressure ulcers, venous ulcers, and podiatric wounds.

In a new investigator-led, single-arm trial, Premvia is being studied as a carrier for stromal vascular fraction cells (SVF) to treat age-related skin volume loss.

SVF cells are formulated using a lipoaspirate at the point-of-care. They are reported to comprise fat tissue progenitors.

The clinical trial will assess the safety and performance of Premvia in ten non-HIV subjects, with a primary endpoint of mean change in volume of each side of the face from baseline to six months after treatment.

In addition, the trial will monitor hemi-facial volume change at one, two, three, and 12 months from baseline as the secondary endpoints.

Trial investigator and plastic surgeon Dr Joel Aronowitz said: “Premvia has the potential to address the limitations that we see with autologous fat transfer.

“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.”

The firm intends to file an application for CE mark of Premvia in Europe by the end of this year, with plans for commercial launch during next year.