BIOLASE Receives FDA Clearance for Orthopedic and Podiatric WaterLase iPlus
First Non-Dental Clearance for the Flagship WaterLase iPlus
(firmenpresse) - IRVINE, CA -- (Marketwired) -- 05/08/13 -- BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, announced today that the U.S. Food and Drug Administration (the "FDA") has cleared the WaterLase® iPlus® all-tissue laser for use as a surgical instrument for soft-tissue procedures in orthopedic and podiatric surgery.
"We are extremely pleased to receive this first non-dental WaterLase clearance related specifically to our revolutionary iPlus," said Federico Pignatelli, Chairman and Chief Executive Officer. "This clearance gives us the ability to leverage our flagship iPlus and its related consumables business in the orthopedic and podiatric markets, each with tremendous potential. Just the top ten orthopedic surgical soft-tissue procedures, for example, offer a $2.6 billion market opportunity for our WaterLase technology."
The iPlus has been specifically cleared for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including soft and cartilaginous tissue in small and large joints.
Amado Carino, MD, Global Clinical Affairs Manager, said, "During the past several years, the use of lasers in orthopedic surgery has become more accepted as a less invasive alternative to conventional surgery and it has become clear that modern lasers will play a significant role in the treatment of musculoskeletal injuries. Procedures can include debridement of both healthy and diseased tissue, soft tissue release, tendon transfer, incision, excision, coagulation and hemostasis, and nerve and vascular repair, both in the upper and lower extremities of the human body. These types of soft-tissue procedures are generally performed in an out-patient setting and with its revolutionary Er,Cr:YSGG laser technology, the WaterLase iPlus will provide an innovative and relevant alternative to orthopedic and podiatric surgeons."
About BIOLASE, Inc.
BIOLASE, Inc. is a biomedical company that develops, manufactures, and markets lasers in dentistry and medicine and also markets and distributes dental ; products that are focused on technologies that advance the practice of dentistry and . The Company's laser products incorporate over 340 patented and patent-pending technologies designed to provide biologically clinically superior performance with less pain and faster recovery times. Its imaging products provide cutting-edge technology at competitive prices to deliver the best results for dentists and patients. BIOLASE's principal are dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications, and a full line of dental imaging equipment. BIOLASE has sold more than 22,500 lasers.
Other products under development address ophthalmology and other medical and consumer markets.
For updates and information on WaterLase® and laser dentistry, find BIOLASE online at , Facebook at , Twitter at , Pinterest at , Linkedin at , Instagram at and YouTube at .
BIOLASE®, WaterLase®, and iPlus® are registered trademarks of BIOLASE, Inc.
For further information, please contact:
Michael Porter
Porter, LeVay & Rose, Inc.
212-564-4700
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Datum: 08.05.2013 - 07:00 Uhr
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