Fibrocell Science ($FCSC) has won FDA approval to market a new competitor to Botox which uses a sample of a person's cells to create an individualized therapy to smooth out the wrinkles-often called smile lines-that gather above a person's mouth. The company plans to harvest small quantities of tissue from patients and then isolate fibroblasts that will be used to generate a personalized cell treatment that can smooth skin. The treatment will be sold as laViv.
"The concept of using a patient's own collagen-making cells is a revolutionary way to help treat nasolabial fold wrinkles and help restore a fresh appearance," said Dr. Robert A. Weiss, a clinical associate professor at Johns Hopkins School of Medicine and an investigator for the laViv clinical trials. "Since this is a biological process that works over time, laViv is able to provide gradual and natural-looking results."
To fulfill a post marketing requirement of the FDA's, the company will set up a registry of about 2,700 patients to further evaluate the dermal filler's safety. Investigators recruited more than 400 patients to participate in two late-stage studies. Fibrocell's shares were up about 7 percent this morning.
- here's the Fibrocell release