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Lumenis Announces FDA Clearance for Laser Contact Bone Removal
OpusDuoTM Er:YAG is First Laser System Cleared for Contact Thermal Mechanical Ablation of Bone
Yokneam, Israel
January 03, 2005
Lumenis® Ltd. LUME.PK, and OpusDent™ Ltd., its dental laser division, announced the FDA clearance of the OpusDuo™ Er:YAG laser system for contact bone removal during oral surgical and periodontal procedures. This represents the first ever FDA clearance for contact cutting of bone tissue in dentistry and is based on the precise and safe Thermal Mechanical Ablation (TMA) of bone utilizing the company’s proprietary contact sapphire tip.
“Lumenis is pleased to extend its 39-year track record of pioneering groundbreaking laser systems with novel applications,” said Avner Raz, President and Chief Executive Officer of Lumenis, the parent company of OpusDent. “We believe this clearance paves the way for dental professionals to achieve unparalleled clinical results by staying in contact with calcified bony tissue. Contact bone removal using our OpusDuoTM laser system sets a new benchmark for oral and periodontal surgery in the US and provides dentists and oral surgeons the most effective laser systems on the market.”
Lumenis reviewed this new application with over 100 US and international dental professionals at the December Symphony of Light Laser Education Symposium in Las Vegas, NV. Dr. Eric Bornstein of Natick, MA, who assisted Lumenis with the FDA application, said, “FDA clearance for the ‘contact cutting’ of bone is one of the most significant milestones ever reached in the dental laser field. This will allow practitioners using the OpusDuoTM to actually feel the laser hand-piece make contact with the bony tissues being ablated, instead of the previous method, of having to point and shoot in a surgical field.”
About Symphony of Light
The Symphony of Light Laser Education Symposium, sponsored by OpusDent and held monthly in cities across the US, introduces dental practitioners to the benefits of laser dentistry and expands their skills with new techniques and procedures. In classroom and hands-on wet labs combined with prominent faculty and staff ensure that attendees gain a comprehensive knowledge of laser dentistry from basic physics to the interaction of specific laser energy on various tissue types. A Standard Proficiency Certification segment recognized by the Academy of Laser Dentistry is included within the two-day program. In addition, all participants receive 12 continuing education credits recognized by the American Dental Association and Academy of General Dentistry. For more information on the Symphony of Light program and future seminar dates and locations, call 408-764-3813 or visit www.symphony-of-light.com.
About Lumenis
Lumenis is a global developer, manufacturer and seller of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications. The Company offers a wide range of products along with extensive product support systems including training, education and service. Lumenis invests heavily in research and development to maintain and enhance its leading industry position. The Company holds numerous patents worldwide on its technologies. For more information about Lumenis and its products, log onto www.lumenis.com.
The statements in this press release that are not historical facts are forward-looking statements 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. These include, 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, general economic conditions, the Company's international operations, 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.
Contact:
Lauri Hanover, CFO
1-866-232-6803
+972-4-959-9273
http://www.lumenis.com/wt/home
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