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Lumenis Announces that the ALLEGRETTO WAVE Excimer Laser Receives FDA Clearance
First refractive laser to be granted concurrent approvals for myopia and hyperopia in the United States
YOKNEAM, Israel
October 21, 2003
Lumenis™ Ltd. (Nasdaq: LUME) announced today that their strategic partner WaveLight Laser Technologie AG of Erlangen, Germany received marketing clearance for the ALLEGRETTO WAVE™ Excimer Laser which provides treatment of myopia (nearsightedness) and hyperopia (farsightedness) from the United States Food and Drug Administration ("FDA"). The ALLEGRETTO WAVE is the first refractive laser to receive clearance for both indications with treatment ranges for myopia of up to -12 diopters and with astigmatism of up to -6 diopters. The approval for hyperopia was granted for up to +6 diopters and with astigmatism of up to +5 diopters, not exceeding a mean spherical equivalent of +6 diopters.
"Lumenis is pleased to extend its 30-year track record of pioneering groundbreaking laser systems to the ophthalmic industry by delivering the next generation of refractive technology to the U.S. market," said Avner Raz, President and Chief Executive Officer of Lumenis. "The excellent performance and results demonstrated in FDA clinical studies we attribute to the laser's unique ablation profile, which has the capability to achieve unparalleled clinical results in standard LASIK procedures. We believe that the ALLEGRETTO WAVE system will set a new benchmark for standard LASIK treatment in the United States and meets our goal of providing physicians with the highest quality laser products in the marketplace."
"The FDA approval for the ALLEGRETTO WAVE is the most important milestone that we have reached this year and one of the most important ones in our overall company history. The entire team at WaveLight has devoted tremendous time and effort to make this happen," stated Max Reindl, Founder and Chief Executive Officer of WaveLight Laser Technologie AG, in an earlier press release.
Lumenis will be the exclusive sales agent in the U.S. responsible for all sales, marketing and field service efforts required to support the ALLEGRETTO WAVE in the U.S. market, in accordance with an exclusive representative agreement with WaveLight Laser Technologie AG. Discussions are continuing regarding licensing arrangements covering the sale of the ALLEGRETTO WAVE in the United States
The existing partnership between Lumenis and WaveLight Laser Technologie AG has successfully captured significant market share of global refractive sales outside the U.S. over the last two years. FDA clearance will allow ophthalmologists to access the German-engineered laser for the first time in the United States, the world's largest refractive surgery market.
Clinical studies evaluated by the FDA involved treating over 800 eyes with myopia and 290 eyes with hyperopia for refractive vision correction with the ALLEGRETTO WAVE at 11 U.S. clinical sites. The laser will be officially launched at this year's annual American Academy of Ophthalmology (AAO) meeting, the largest professional conference for ophthalmologists and medical doctors for eye treatments, in Anaheim, California next month.
About WaveLight Laser Technologie AG
WaveLight Laser Technologie AG, noted since January 2003 in the Prime Standard of the German Stock Exchange, develops, produces and distributes laser systems in the field of ophthalmology, aesthetic and urology as well as industrial processing. The innovative and technologically advanced laser systems in conjunction with a broad network of distribution channels and partners are the foundation of the market success of WaveLight. Just five years after entering the market in 1996, WaveLight managed to achieve a positive business result. In the fiscal year 2002/2003 WaveLight reached revenues of 47.8 Million Euros and an EBIT of 4.4. Million Euros.
Further information about WaveLight can be found at www.wavelight-laser.com
About Lumenis
Lumenis develops, manufactures, and markets state-of-the-art proprietary laser and intense pulsed light devices. Its systems are used in a variety of aesthetic, ophthalmic, surgical and dental applications, including skin treatments, hair removal, non-invasive treatment of vascular lesions and pigmented lesions, acne, psoriasis, ENT, gynecology, urinary lithotripsy, benign prostatic hyperplasia, open angle glaucoma, diabetic retinopathy, secondary cataracts, age-related macular degeneration, vision correction, neurosurgery, dentistry and veterinary. For more information about the Company and its products log on to www.lumenis.com
The statements in this press release that are not historical facts are forward-looking statements which are subject to risks and uncertainties. The Company's actual results could differ materially from those anticipated in the forward looking statements based on a variety of factors, including, among others: uncertainties with respect to market acceptance of the Company's products, obtaining regulatory approvals for new products or for the sale of existing products in new markets and enforcement of intellectual property rights; risks associated with competition and competitive pricing pressures, economic conditions generally, the Company's international operations and the Company's ability to integrate its operations with those of acquired businesses; the outcome of the Securities and Exchange Commission investigation and several securities class action lawsuits to which the Company is subject; uncertainties relating to the Company's continuing liquidity; and other risks detailed from time to time in the reports filed by Lumenis with the SEC, including its annual report on Form 10-K and quarterly reports on Form 10-Q.
Contacts:
Kevin Morano
CFO
212-515-4187
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