LSCP FDA Approval
Monday March 13, 8:11 am Eastern Time
Company Press Release
Laserscope Receives FDA Clearance to Market New
Lyra Laser System for Hair Removal
First Laser Designed for Full Range of Skin Types
SAN JOSE, Calif.--(BW HealthWire)--March 13, 2000--Laserscope (Nasdaq:LSCP - news) today announced that it has
received written clearance from the U.S. Food and Drug Administration to market its innovative Lyra(TM) Laser System for
hair removal on patients with the full range of skin tones from Fitzpatrick Types I-VI. The system was cleared in late August
1999 for various dermatological applications including the treatment of vascular lesions, including leg veins.
Compact and portable, the Lyra Laser System is the first system designed to remove hair from darker skin types as well as
light, making it the most versatile product available. In contrast, systems based upon less advanced technologies are best suited
to patients with light skin tones and dark hair only. To the Company's best knowledge, the Lyra is the only laser currently FDA
approved for treatment of the full range of Fitzpatrick skin types.
``Lyra reflects Laserscope's ongoing commitment to introduce innovative, state-of-the-art, competitively-priced devices to
enable physicians to grow their practices by expanding treatment capabilities to more diverse patient populations,' said Eric
Reuter, Laserscope President and CEO. ``We have been successful in placing the new system into the leg vein treatment
market and this important additional clearance will help us penetrate another sizable market thereby expanding the overall utility
of the system.'
Industry sources estimate the potential worldwide market for hair removal lasers to be $600 million to $700 million over the
next three years. The leg vein treatment market is also significant. Unsightly spider veins on the legs, for example, occur in 30 to
40 percent of women and 5 to 15 percent of men in the United States.
``The Lyra and Lyra XP combine the longest available wavelength (1064nm) ever used for hair and leg vessel removal and
Laserscope's proprietary Extended Duration Pulse (EDP) technology. This advanced approach allows physicians to vary the
laser's pulse duration from 10 msec to 100 msec to match precisely the thermal relaxation time of hair follicles and vascular
structures. The principal benefit of the long wavelength is its relative safety for darker skin patients who could not be previously
treated with lasers for cosmetic procedures.'
``Lyra's optimized wavelength and full pulse width regime, coupled with high treatment speeds make it a truly state-of-the-art
product at a very affordable price,' added Reuter.
Speed and consistency of treatment are further assured with Lyra's integrated SmartScan Plus(TM) scanning device.
Microprocessor-controlled, SmartScan Plus delivers rapid, precise bursts of laser light in user selectable doses and patterns.
Homogeneous dosimetry is critical for accomplishing ``reproducible' results and reducing the risk of overtreatment or tissue
damage.
Physicians involved with Lyra's clinical trials are enthusiastic about the new product:
``The long-pulsed Nd:YAG wavelength of the new Lyra laser enables deeper follicular penetration while inducing minimal
epidermal damage,' said Christopher Zachary, M.D., San Francisco.
``My work with the long wavelength approach indicates quite remarkable clearance after just a single treatment,' added David
J. Goldberg, M.D., Pascack Valley Hospital, New Jersey. ``The combination of the long wavelength with Laserscope's EDP
technology is a significant advantage, particularly for removing hair from darker skin types.'
Oscar Hevia, M.D., who has been involved in the clinical trials in Miami, commented, ``A long-pulsed Nd:YAG laser that can
penetrate more extensively into vessels is a breakthrough in the non-surgical treatment of deep blue, purple and large red vein
lesions. I have found that the clearing and healing results, while minimizing skin discoloration, have improved from previous laser
systems.'
To diminish patient discomfort, Lyra's cooling module minimizes heat exposure to the epidermis and the surrounding tissue
before, during, and after exposure. Its cooling module uses an active, dynamic contact cooling process, which is rapidly gaining
acceptance as the safest and most repeatable way of protecting the epidermis during hair removal and vascular lesion treatment.
The complete system is backed by Laserscope's exclusive 99% Uptime Guarantee (available in the USA only.)
Laserscope also said today that it is sponsoring a clinical study at a major U.S. military facility using Lyra(TM) to treat
pseudofolliculitis barbae and expects to announce preliminary results in the near future.
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 on 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 contain forward-looking statements that
involve risks and uncertainties, including the development and growth of new markets and treatments such as laser hair removal,
pseudofolliculitis barbae, and vascular lesion treatment, results from clinical trials, the timing of regulatory approvals outside the
U.S., the impact of competitive products and technologies, physician and consumer acceptance and demand for the medical
procedures targeted by the Company, general economic conditions in the U.S. and abroad, and 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
Laserscope's most recent forms 10K and 10Q are available upon request from itss Investor Relations Department.
Contact:
Laserscope
Eric Reuter, 408/943-0636 (President & CEO)
Dennis LaLumandiere, 408/943-0636 (CFO)
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Laserscope Inc (NasdaqNM:LSCP - news)
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