RELIANT FRAXEL SR LASER RECEIVES ADDITIONAL FDA CLEARANCES; KEY MILESTONE DEMONSTRATES CLINICAL BENEFITS TO PHYSICIANS AND PATIENTS
SAN DIEGO—(BUSINESS WIRE)—July 13, 2004 The Reliant FRAXEL(TM) SR laser has now gained additional 510(k) clearances to treat pigmented lesions (including age spots, sun spots and skin discoloration) at any location on the body and periorbital (around the eye) wrinkles, joining the clearance obtained in 2003 for dermatological conditions requiring the coagulation of soft tissue.
As of July 1, 2004, the Reliant FRAXEL(TM) SR laser has FDA 510(k) clearance for:
—Dermatological procedures requiring the coagulation of soft tissue.
—Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia.
—Treatment of periorbital wrinkles.
Reliant FRAXEL(TM) Laser Treatment is a breakthrough technology based on a new science of "fractional" skin repair. By treating a fraction of the skin's surface at a time, FRAXEL(TM) Laser Treatment provides the positive results of traditional skin resurfacing without the down time and risks. The first FRAXEL(TM) laser installations across the U.S. are scheduled for the fourth quarter of 2004, with widespread treatment available by January 2005.
The FDA clearances are based upon the clinical study of 30 patients with skin types I-III. These patients showed improvement in periorbital wrinkles and linear shrinkage in tissue as early as one week post-treatment. Minimal swelling and redness were the only side effects reported, and these resolved within 1-2 days. Treatment was well tolerated with minimal pain scores, largely due to spared tissue that remains between microthermal treatment zones.
"These three FDA clearances are based on two of six studies planned for completion in 2004," said Len DeBenedictis, Reliant President and Chief Technology Officer. "Patients, investigators and prominent, expert dermatologists agreed that there were compelling improvements in wrinkles, texture and discoloration after FRAXEL(TM) treatment, which is a powerful endorsement of the versatility and functionality of this new science and technology."
Reliant Technologies is positioned for growth and poised to become a new market leader in aesthetic laser medicine, surgery and biomedical technologies. Reliant is dedicated to fulfilling the promise of laser medicine by creating breakthrough systems focused on FRAXEL(TM) Laser Treatment. Reliant employs 50 professionals in two primary locations, San Diego and Palo Alto, California. For more information, visit www.reliant-tech.com.Download Press Release ••