SAN JOSE, Calif.--(BW HealthWire)--March 5, 1997--Laserscope (NASDAQ:LSCP) today announced that it has received clearance from the U.S. Food and Drug Administration to market its ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece with the Pulsar CO2 Laser System for laser skin resurfacing, laser resurfacing, laserbrasion, the treatment of wrinkles and warts, and scar revision.
"These new marketing clearances," said Robert V. McCormick, Laserscope president and chief executive officer, "move Laserscope into a unique position in the dermatology and aesthetic surgery marketplaces."
"To the best of our knowledge," he said, "Laserscope is the first and only company whose product portfolio has received specific FDA clearance for skin resurfacing and the treatment of surface leg veins. This makes Laserscope a virtual one-stop shop for physicians performing aesthetic and cosmetic laser procedures."
"The company has made steady inroads into the aesthetic marketplace over the past 18 months," said McCormick.
"The Aura Laser System, which was introduced in late 1995, we believe is now the industry's leading product for treating surface leg veins, a very simple, quick procedure with wide consumer appeal. The new clearances just granted by the FDA should now provide us with additional marketing leverage in the application of our CO2 technology to laser skin resurfacing and the treatment of wrinkles, equally popular aesthetic procedures."
Laserscope's Pulsar CO2 Laser System is the name given to the Paragon Laser System obtained in the company's acquisition of Heraeus Surgical Inc. in August 1996.
FDA clearances for the ParaScan and the CBH-1 products with the Pulsar CO2 Laser System include all soft tissue indications previously obtained by Heraeus Surgical. Additional indications now FDA-cleared include laser skin resurfacing; laser resurfacing; laserbrasion; the treatment of wrinkles/rhytides; solar/actinic elastosis; keratoses; lentigos; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.
Laserscope designs, manufactures, sells and services an advanced line of medical laser systems and related energy delivery devices for the office, outpatient surgical center and hospital markets. In addition, Laserscope's Ascent Medical Systems(TM)(AMS) group provides innovative, custom equipment solutions for surgical and patient care.
Laserscope's AMS family of products includes O.R. and treatment room lights, ceiling-mounted equipment organizers, video systems, operating room tables and centralized smoke evacuation systems.
Except for the historical information presented, the matters discussed in this announcement contain forward-looking statements that involve risk and uncertainties, including the timely development and market acceptance of new products and procedures, the impact of competitive products and technologies, as well as other risks detailed from time-to-time in the company's public disclosure filings with the U.S. Securities and Exchange Commission (SEC).
Copies of the most recent Forms 10K and 10Q are available from Laserscope's Investor Relations Department.
CONTACT: Laserscope, San Jose
Richard Wood, 408/943-0636 (IR/Media)
Dennis LaLumandiere, 408/943-0636 (Financial)
or
Halsted Communications
John Lockhart, 800/600-7111 ext. 224
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