SAN LUIS OBISPO, California – June 5, 2007 – FzioMed Inc. today announced that the company’s Laresse® dermal filler has received regulatory approval in Australia from the Therapeutic Goods Administration (TGA). The TGA is the government agency responsible for regulating drugs and medical devices in Australia.
Facial wrinkles, fine lines and creases are the result of a loss of collagen and elastin, the skin’s natural support structure. Injectable dermal fillers temporarily restore the skin’s internal structure, filling in lines and wrinkles to non-surgically erase the signs of aging.
Laresse is a novel dermal filler launched in Europe last year by FzioMed. Unlike conventional hyaluronic acid (HA) and collagen fillers, Laresse is made from non-bacterial, non-animal sources and is free of cross-linking chemicals. Laresse’s ultra-smooth texture results in a very natural look and feel.
“Australia is an important market and our first expansion of Laresse outside of Europe,” said John Krelle, FzioMed President and Chief Executive Officer. “Laresse has taken the science of dermal fillers to a new level, and we are proud to offer this new advancement to Australian patients and physicians.”
Laresse Dermal Filler is an ultra-smooth, non-permanent, non-HA gel composed of pure, absorbable medical polymers. Laresse is the first non-permanent filler without many of the drawbacks of HA and collagen fillers. No other filler offers the same features as Laresse: non-permanent wrinkle correction, non-animal and non-bacterial components, easy injection through a very fine needle, improved comfort, and smooth texture and feel. Laresse is now available in the European Union and Australia.
FzioMed is a privately held medical company developing and commercializing absorbable biomaterials based on the company’s patented science. FzioMed’s polymer technology has uses in a variety of specialties including orthopedics, spine, gynecology, general surgery and aesthetic surgery. FzioMed products include Oxiplex/SP, the leading adhesion barrier for spine surgery currently marketed outside of the U.S., Oxiplex/AP adhesion barrier for gynecologic and general surgery, and Laresse dermal filler. FzioMed products are for investigational use only in the U.S.
FzioMed®, Oxiplex® and Laresse® are registered trademarks of FzioMed, Inc.