Healthcare Industry News:  macular edema 

Devices Ophthalmology Regulatory

 News Release - September 9, 2006

OptiMedica Receives ISO Certification and CE Mark for the PASCAL(R) Photocoagulator

Approvals Clear Path for International Shipments

SANTA CLARA, Calif. & CANNES, France--(HSMN NewsFeed)--Sept. 9, 2006--OptiMedica® Corp., a leading developer of ophthalmic therapeutic devices, today announced it has received ISO 13485 certification and the Pascal Photocoagulator has received CE Mark approval. Launched in the US earlier this year, the Pascal Photocoagulator is now available for sale internationally. The Pascal Photocoagulator was previewed this past week at the "New Therapies in Retinal Diseases" International Congress in Rome and will be on display at the Cannes Retina Festival 2006 (24th Annual Meeting of the American society of Retinal Specialists) in France starting today.

"With CE Approval and ISO's quality certification, we are pleased to provide ophthalmologists in many of the world's leading markets with the Pascal Photocoagulator," said Jean-Robert "JR" Strele, Vice President of International Business for OptiMedica. "These approvals have come at just the right time for us, as we are exhibiting Pascal at two prestigious retina conferences this month as well as the American Academy of Ophthalmology in November."

The first Pascal systems placed outside the US will be at key practices in Japan and Europe. OptiMedica will immediately begin working with leading international ophthalmologists to establish a new standard of care in the treatment of retinal diseases.

"Throughout the past year, US physicians have been presenting spectacular case studies and clinical data for treating retinal diseases, such as diabetic retinopathy and diabetic macular edema, with the Pascal Photocoagulator," said Dr. Paulo Stanga, Associate Head of Division, The Royal Eye Hospital, Manchester, UK. "We are looking forward to becoming one of the first international sites to acquire the Pascal system, as retinal diseases are the leading cause of blindness in the UK."

OptiMedica can be visited at exhibit number 210 at the Cannes Retina Festival in France from September 9 - 13.

About OptiMedica

OptiMedica Corp. develops and markets medical devices that treat ophthalmic disorders such as diabetic retinopathy, age-related macular degeneration, retinal vascular occlusive disease and retinal tears and detachments. OptiMedica holds the exclusive license to the PASCAL® (PAttern SCAn Laser) method of photocoagulation and its associated technologies, which are FDA approved to treat a variety of retinal conditions. OptiMedica was founded in 2004 in Santa Clara, Calif. and is funded by Kleiner, Perkins, Caufield & Byers and Alloy Ventures. For more information, please visit

Source: OptiMedica

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