Healthcare Industry News:  cataract 

Devices Ophthalmology FDA

 News Release - April 11, 2006

Ellex Receives FDA 510(k) Clearance for Industry's First Solid-State Red/Green Photocoagulator

ADELAIDE, Australia--(HSMN NewsFeed)--April 11, 2006--Ellex Medical Lasers Ltd. (ASX:ELX ), a world leading designer and manufacturer of laser systems for the ophthalmic industry, announced today that it has received 510(k) clearance for the Integre Duo, the world's first solid-state red and green photocoagulator. The Integre Duo utilizes a patent-pending, dual-wavelength laser cavity enabling ophthalmologists to better treat challenging retinal conditions, often caused by age or diabetes.

Peter Falzon, Ellex' CEO, commented "We have responded to our customers desire to integrate the clinical utility and performance of the existing ion argon-krypton lasers in a solid-state laser. The Integre Duo provides the benefits of both: simultaneous true red and green wavelength selection in a compact solid-state design."

The Integre Duo was presented to the ophthalmic community in March at the ASCRS meeting in San Francisco, CA, and compliments Ellex' comprehensive line of lasers for cataract, glaucoma and retina treatments and is expected to contribute to the growing revenue base of Ellex branded systems.

The Integre Duo has already been approved for sale in Japan where the first customer units will be installed in April. Ellex expects the first customer units to arrive in the US market in July. Today, two thirds of the company's revenue is derived from new products released in the past three years as a result of recent investments in product development and distribution solely focused on ophthalmology.

About Ellex

Ellex Medical Lasers Ltd. (ASX:ELX ) designs, manufactures and markets a complete line of lasers used by ophthalmologists to preserve vision and treat eye diseases. With more than 10,000 systems delivered to the market, Ellex has evolved since 1985 from a manufacturing company of primarily OEM products, to direct marketing of its own branded products through subsidiaries in the United States and Japan and a network of distribution partners in more than 50 countries. Ellex maintains a strong emphasis on intellectual property and research into new and better treatments to manage and treat the leading causes of blindness.

For additional information about Ellex and its products, please visit

Source: Ellex Medical Lasers

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