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Acuity Medical Macular Degeneration Device Shows Positive Results In FDA Trial Proving Safety And Efficacy


10/19/2005 5:13:20 PM

BRIGHTON, Mich., Oct. 11 /PRNewswire/ -- Acuity Medical has successfully completed a proof of concept FDA-compliant trial of its TheraMac(TM) device for the treatment of dry age-related macular degeneration (AMD). AMD is the leading cause of legal blindness effecting more than 50 million people worldwide. The trial showed that in two weeks 26% of the eyes treated had improved vision by 10 letters or more, the equivalent of two lines on the eye chart. There were zero serious adverse events.

TheraMac(TM) produces minute amounts of electrical biocurrent that is delivered to the retina through a probe touching the skin around the eye. The biocurrent facilitates increases in membrane permeability, improves cellular functionality and stimulates cellular repair. The total time for treating one eye is approximately 15 minutes.

Macular degeneration, which is caused by the deterioration of the central portion of the retina, is diagnosed as either dry or wet. TheraMac(TM) is for use with the dry non-bleeding form, which makes up 90% of the cases. Currently there is no approved treatment for dry AMD.

According to Robert Gale Martin, M.D., Principal Investigator for Acuity Medical's TheraMac(TM), "The initial results were extremely encouraging. The clinical impression was that TheraMac(TM) dramatically improved patients who had eyes with dry age-related macular degeneration. I feel that it's imperative that double blind cross-over scientific studies be carried out to confirm these initial clinical impressions."

Prior to the FDA trial, an open label study was conducted on 404 patients. After one week of treatments, 85% of the eyes treated improved one or more lines on the Snellen eye chart, 68% improved two or more lines and 48% improved three or more lines.

There were zero serious adverse events. In 2002, TheraMac(TM) received CE Marking in Europe.

Acuity Medical, located in Brighton, Michigan, is a therapeutic technology company that is developing treatments for all aspects of macular diseases. For more information, contact Tom McColley at (810) 229-5828 or at tom.mccolley@acuitymedical.com.

Acuity Medical

CONTACT: Thomas A. McColley of Acuity Medical, Inc., +1-810-229-5828



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