Ophthalmos receives FDA clearance for revolutionary lens free Ophthalmoscope, The Optyse

Released on = June 6, 2006, 1:45 am

Press Release Author = Ophthalmos

Industry = Pharmaceuticals

Press Release Summary = Cambridge/ UK-based Ophthalmos Limited, has received Food
and Drug Administration (FDA) 510(k) clearance to market its OptyseTM Lens Free
Ophthalmoscope in the United States of America.

Press Release Body = Cambridge/ UK-based Ophthalmos Limited, specialists in the
design, development and marketing of medical devices for use in ophthalmoscopy, has
received Food and Drug Administration (FDA) 510(k) clearance to market its OptyseTM
Lens Free Ophthalmoscope in the United States of America.

The OptyseTM is a relatively low cost easy to use direct ophthalmoscope designed to
be used by a range of healthcare workers and medical students. Direct
ophthalmoscopy is an effective, non invasive technique enabling medical
practitioners to view the back of the eye for evidence of abnormalities indicative
of serious medical conditions including hypertension, diabetes, cerebral malaria and
early signs of brain tumours, as well as eye conditions such as glaucoma and
cataracts that can lead to loss of sight or even blindness.

Unique in its simplicity, the lens free technology eliminates the need to calibrate
the ophthalmoscope prior to use, providing an immediate and clear view of the
retina. Ease of use is further enhanced by the patented technology that minimises
glare from the light source and the lens free viewing hole that eliminates
interference that could otherwise result from dust or scratches on lenses.

"As the OptyseT is pen-sized it is easy for practitioners to carry on their person
so they can incorporate direct ophthalmoscopy into their routine work" commented the
inventor, Roger Armour. "This is especially true for general practitioners, nurses,
paramedics, medical students and those professionals working in the field or in
remote locations".
Laura Garcia, CEO of Ophthalmos commented: "Receiving our first marketing clearance
by the USA FDA is a major milestone for the company. We are excited by the market
opportunities in the United States and the ability to broaden our work with
charitable agencies based both within the States and abroad to help achieve the
VISION 2020 goal of eliminating unnecessary blindness by 2020."
Laura continued: "We are in discussions with potential distribution partners, but
are pleased that we may now begin to sell to healthcare workers in the United
States."

- ends -
Notes to editors

About Ophthalmos
Ophthalmos Limited designs, manufactures and markets medical devices for use in
ophthalmoscopy, promoting the use of eye health in general medical practice through
the provision of revolutionary products. Roger Armour's Lens Free Technology was
the overall winner and winner of Best Innovation to Improve Global Healthcare at the
Medical Futures Innovation Awards 2003, was a finalist in the 2006 Saatchi and
Saatchi Awards Ceremony for World Changing Product, and received the prestigious
Edward De Bono Award for Lateral Thinking (2006).

For further information please contact Laura J Garcia, CEO on +44 (0) 1799 532 777
or email laura.garcia@ophthalmos.co.uk.

External PR Agency: Black Pig
Account Manager: Anna Plant
Telephone: +44 (0) 1763 222 333 Email: anna.plant@blackpig.co.uk


Web Site = http://www.ophthalmos.co.uk

Contact Details = Anna Plant
47 Upper King Street
Royston
Hertfordshire
UK
SG8 9AZ
44(0)1763222333
44(0)1763222000
anna.plant@blackpig.co.uk

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