Laserscope Announces FDA Clearance Received for the Non-Invasive Treatment of Wrinkles

Indication further strengthens Lyra as premier non-invasive aesthetic laser technology

San Jose, Calif. (July 16, 2002) -- Laserscope (Nasdaq: LSCP), a leader in design, manufacture, sales and service on a worldwide basis of an advanced line of medical laser systems and related energy delivery devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared its LyraTM Surgical Laser System for the non-invasive treatment of wrinkles. This clearance enhances the Lyra's market competitiveness by adding the fifth major indication for the system. The Lyra is currently cleared and used in the market for permanent hair reduction in all skin types and tones, the treatment of pseudo-folliculitis (shaving bumps), and the treatment of vascular lesions and leg veins.

"We are very pleased to have received clearance from the FDA for this exciting and important additional indication for our Lyra laser," commented Eric Reuter, Laserscope President and CEO. "The American Society for Aesthetic and Plastic Surgery (ASAPS) recently announced that aesthetic procedures had increased 48% over the past year and over 300% in the past five years despite the fluctuating economy. This indicates that the market for procedures and products that address the process of aging remain strong. The market for treatment of aging skin is a very large component of this aesthetic segment and is growing as the baby boomers look for ways to look and feel younger. In the recent past, other laser technologies have been used in "skin resurfacing" procedures to treat facial wrinkles. Though usually effective, these procedures carried a significant risk of scarring and disfigurement along with substantial recovery times. Patients would typically have to endure significant trauma to the tissue during the procedure and several weeks of post-operative recovery time before they could return to work or other important functions. The Lyra's combination of its safe 1064 nanometer wavelength, proprietary pulsing characteristics, and patented epidermal cooling system are clinically shown to reduce wrinkles and improve the tone of the skin by non-invasively stimulating new collagen production. This makes it possible for patients to return to an active lifestyle immediately."

Dr. Steve Dayan, clinical assistant professor in the Department of Otolaryngology and Division of Facial Plastic Surgery, University of Illinois in Chicago said, "The type of response we've been hearing from patients is that they feel like their skin is lifted. There is a decrease in pore size, their skin feels tighter, and there is a reduction in fine lines and wrinkles." Dr. Dayan has used the Lyra for nearly two years and contributed clinical data for the FDA submission.
- more -

 

Continued Reuter, "We have additionally found that when the Lyra is used in combination with our AuraTM Surgical Laser System, the results the patients see are even more immediate and very gratifying since the Aura works to remove facial telangiectasias, rosacea, pigmented lesions, melasma, and other skin color defects. This combination treatment is extremely popular with patients because the effects are noticeable and immediate and there is virtually no recovery time. It is popular with physicians because it adds yet another potentially large revenue generating procedure with the same product(s)."

Dr. Christine Lee is director of the East Bay Laser and Skin Care Center in Walnut Creek, California and is a pioneer of this unique combination treatment using the Laserscope Lyra and Aura lasers for the procedure that is becoming known industry-wide as "skin rejuvenation". Dr. Lee said, "By combining visible light (of the Aura) and infrared light (of the Lyra) we take care of noticeable coloration defects and also provide the skin toning, tightening, and textural improvement that patients are seeking. Non-invasive techniques for skin rejuvenation are being quickly established as a new standard in the treatment of mild wrinkles and overall skin toning. All patients showed improvement after the treatment. It helps collagen tighten and tone, reducing sagging."

"In our first quarter 2002 earnings release and conference call we indicated that we had submitted our clinical data to the FDA for this marketing clearance and that we were expecting clearance shortly," said Reuter. "Now that we have received clearance, we believe that this additional indication will significantly increase the attractiveness of our Lyra relative to other competing technologies and will make it possible for us to market and take full advantage of the "skin rejuvenation" procedure consistent with our previously discussed plans for our aesthetics business."

About Laserscope

Laserscope designs, manufactures, sells and services on a worldwide basis an advanced line of medical laser systems and related energy delivery devices for the office, outpatient surgical center, and hospital markets. More information about Laserscope can be found on the Company's Web Site at www.laserscope.com.

Except for historical information presented, the matters discussed in this announcement may contain forward-looking statements that involve risks and uncertainties. These risks are detailed from time to time in the Company's public disclosure filings with the U.S. Securities and Exchange Commission (SEC). Copies of Laserscope's most recent forms 10K and 10Q are available upon request from its Investor Relations Department.