Healthcare Industry News:  Glaucoma 

Devices Ophthalmology Regulatory

 News Release - June 12, 2006

Lumenis Receives SFDA Approval to Sell Selecta(R) II in China

China's Ophthalmologists and Large Rural Population of Glaucoma Patients to Benefit from Lumenis' SLT Advanced Glaucoma Therapy System

YOKNEAM, Israel, June 12 (HSMN NewsFeed) -- Lumenis® Ltd., a global developer, manufacturer and seller of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications, announced today the company has received approval from China's medical device regulating authority (SFDA) to sell Selecta®(1) II in China.

China's Glaucoma Challenge

While China represents approximately 20% of the world's total population, experts postulate that the single largest ethnicity with Glaucoma will be Chinese by the year 2010(2). Worldwide, there will be over 60 million people with Glaucoma, which will continue to be the second leading cause of preventable blindness. Patients with this devastating disease will continue to increase to nearly 80 million by 2020.

Currently, 80% of the visually impaired in China live in rural areas, while 70% of the country's 24,000 ophthalmologists work in urban hospitals. This makes Glaucoma drug compliance monitoring extraordinarily difficult. With Lumenis' Selecta II Selective Laser Trabeculoplasty (SLT) technology, doctors in China will now be able to treat their Glaucoma patients with "a drop of light" -- and secure 100% therapeutic compliance.

Avner Raz, Lumenis' President and Chief Executive Officer, noted, "Lumenis continues to lead the medical technology industry by making available to growing markets across the globe the most recent advances in technology worldwide. While the use of SLT has increased rapidly since Lumens' family of Selecta laser systems gained FDA clearance, we continue to identify and pursue untapped markets for our technologies. Our entrance into China with the Selecta II and SLT signifies a major milestone in this effort."

Dr. Ding Lin, MD, PhD, Director of Aier Eye Hospital Group in Changsha China, one of China's largest private hospitals, said, "The problem of Glaucoma in China is a staggering one. As a clinician treating Glaucoma, I can say the challenge of patient compliance to a pharmaceutical treatment paradigm is complex. In China, as in many other countries, patient compliance to these drops is dismal. We in China welcome SLT as part of the Glaucoma management tools."

SLT - Selective Laser Trabeculoplasty

SLT works by using a specific wavelength to irradiate and target only the melanin-containing cells in the trabecular meshwork. Because of the specific wavelength of light generated, as well as the power and duration of the exposure, SLT selectively targets pigmented cells in the trabecular meshwork and causes no discernable damage to adjacent tissue. Researchers have found treated and untreated tissue to be nearly indistinguishable. When treated with SLT, a primarily biologic response is induced in the trabecular meshwork which involves the release of cytokines that trigger macrophage recruitment and other changes, leading to a reduction in intraocular pressure (IOP).

The Lumenis Selecta II provides physicians the perfect vehicle to perform SLT. Since its introduction in 2001, this novel therapy has demonstrated to clinicians the ability to reduce IOP associated with Glaucoma - versus the need for on-going and repeated medication for therapy - and directly addresses patient compliance concerns.

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.

1. Selecta is a registered trademark in the U.S. and elsewhere, however this mark is not registered in China.

2. British Journal of Ophthalmology 2001; 85:1277-1282


Source: Lumenis

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