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Company Press Release
SOURCE: Palomar Medical Technologies
Palomar Is First Laser Company to Receive FDA Clearance For 'Permanent Hair Reduction'
LEXINGTON, Mass., July 22 /PRNewswire/ -- Palomar Medical Technologies, Inc. (Nasdaq: PMTI - news), the technology leader in laser hair removal, today announced that it is the first laser company to receive clearance from the United States Food and Drug Administration (FDA) to market a hair removal laser for ''permanent hair reduction.'' The FDA clearance is granted specifically for the company's EpiLaser(R) system.
''The achievement of 'permanent hair reduction' sets us apart from all other competitive laser technologies currently on the market,'' said Louis P. (Dan) Valente, chairman and chief executive officer of Palomar. ''We believe this FDA clearance will dramatically increase consumer interest in Palomar's laser technology, and propel us to an even greater market share in this growing multi-billion dollar worldwide market.''
Valente added, ''As the trailblazer in innovative laser hair removal, Palomar reinforces its position as the research and development leader in the cosmetic laser industry. This clearance adds to the list of distinctions in our field that include receiving the first FDA clearance for a high-powered ruby laser (EpiLaser) and also obtaining the first FDA clearance for a high- powered pulse diode laser. Most importantly, these technology accomplishments are now beginning to positively impact top- and bottom-line financial results.''
The clearance allows Palomar to claim ''permanent hair reduction'' of treated hairs. To support its hair reduction claim, the company submitted results from clinical studies conducted at Massachusetts General Hospital (MGH) during the past five years. Palomar is the exclusive worldwide licensee of MGH's laser hair removal technology. Palomar's laser hair removal products are distributed exclusively by Coherent, Inc. (Nasdaq: COHR - news).
''Safe Harbor'' Statement Under the Private Securities Litigation Reform Act With the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties, including but not limited to, statements relating to financial results, consumer interest and market share that may individually or mutually impact the matters herein, and cause actual results, events and performance to differ materially. These risk factors include, but are not limited to, the company's dependence on a limited number of products and on the successful development and introduction of second-generation products that will generate improved gross margins, product demand and market acceptance, the effect of economic conditions, the impact of competitive products and pricing, governmental regulations, technological difficulties and/or other factors outside the control of the company, which are detailed from time to time in the company's SEC reports, including the report on Form 10-K for the year ended December 31, 1997. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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For more information about Palomar, visit our home page at palmed.com |