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Norwood Abbey Receives FDA 510k Clearance for Centurion SES Epi-LASIK Enhancement.


MELBOURNE, Australia -- Norwood Abbey Limited (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
: NABYY)(OTC: NABYF)(ASX ASX

See: Australian Stock Exchange
: NAL) today announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted 510(k) marketing clearance for the Company's new 9.0mm version of the suction ring utilized in its Centurion SES(TM) Epikeratome with EpiEdge(TM) for Epi-LASIK.

Surgeons will be able to choose the ring most suitable for the size of the eye, reducing the chance of involvement of epithelial stem cells at the limbus limbus /lim·bus/ (lim´bus) pl. lim´bi   [L.] an edge, fringe, or border.

corneal limbus  the edge of the cornea where it joins the sclera.
 (the junction of the cornea and sclera sclera: see eye. ). This is of particular importance in patients of Asian background. The suction ring will continue to be available in its current 10.0mm size.

Unlike conventional LASIK LASIK laser-assisted in-situ keratomileusis.

LA·SIK
n.
Eye surgery in which the surface of the cornea is reshaped using a laser, performed to correct certain refractive disorders such as myopia.
, in which a sharp blade is used to make a stromal Stromal
A type of tissue that is associated with the support of an organ.

Mentioned in: Wilms' Tumor
 flap in the cornea, the Epikeratome employs a non-sharp plastic separator to gently lift a hinged sheet of intact epithelium from the cornea. The suction ring secures the Epikeratome to the eye during the Epi-LASIK procedure and allows the cornea to protrude through it.

"Epi-LASIK is a huge step forward in refractive surgery; this will change the way we perform refractive surgery today," explained Marguerite McDonald, M.D., F.A.C.S., professor of ophthalmology at Tulane University. "My patients are relieved when I tell them their laser surgery can be done without using a cutting blade. I feel the risk/benefit ratio gives Epi-LASIK advantages over LASIK."

Professor Ioannis G. Pallikaris, M.D., Ph.D., President of the University of Crete The University was established in 1973 and started functioning in the academic year 1977-78. As a higher education institution, it is a legal person of public law, i.e. it operates under the supervision of the State. The seat of the University is in Rethymnon.  and inventor of Epi-LASIK, commented, "The refractive community has already enthusiastically accepted Epi-LASIK and I believe Norwood can really enhance its progress. I feel their presence will be a gain for refractive surgery."

Norwood's bladeless Epi-LASIK technology provides the benefits of LASIK but is designed to reduce trauma to the eye and the risk of LASIK-induced dry eye, facilitating faster recovery and less postoperative pain. Patients for whom LASIK is not advised -- such as those with thin corneas or dry eye -- or who have had concerns about potential LASIK side effects are strong candidates for Epi-LASIK.

To find out more about the company, visit www.norwoodabbey.com.

About Norwood Abbey

Norwood Abbey is a publicly listed medical technology company based in Melbourne, Australia and traded on both the Australian and the NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
 stock exchanges. Norwood Abbey specializes in developing and commercializing innovative projects and technologies that address significant unmet needs in the medical industry. The Company has two business segments: Norwood Devices (EyeCare and Drug Delivery) and Norwood Immunology.

Norwood's Drug Delivery technology platforms can be applied to a range of potential applications, from pain management and metabolic diseases to vaccinations. Norwood Immunology is aimed at boosting the immune system of patients, enabling them to fight infection and better cope with treatments where the immune system is compromised. This technology has application in almost all diseases affecting the immune system, including cancer, viral infections and autoimmune disorders.
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Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Nov 4, 2004
Words:483
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