Aesthetic Technologies Forum In Brief
This article was originally published in The Gray Sheet
Executive Summary
Isolagen wrinkle treatment: Isolagen estimates FDA approval for its autologous cellular "self-therapy" by summer 2005, Vaughan Cliff, VP and medical director, told attendees at the Feb. 9 Aesthetic Technologies Forum in Washington, D.C. Starting with a 3 mm x 7.5 mm patch of biopsied skin from behind the ear, the treatment cultures fibroblasts, which are reinserted into the patient's dermis, regenerating collagen and tissue. Burn and acne applications also are under consideration. The ten-site, double-blind, 152-patient, Phase III wrinkle trial began in August under an investigational new drug application and will include four-month follow-up. Data analysis is due in March, with a marketing submission expected in November or December...