Clinical Trials in Process for Age-Related Macular Degeneration Treatment

    BRIGHTON, Mich., Oct. 24 /PRNewswire/ -- Acuity Medical is planning for
the recruitment of clinical sites in the United States for their pivotal pre-
market clinical (PMA) trial for TheraMac(TM), a medical 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.
Currently there is no effective treatment for dry AMD.
    TheraMac(TM) has already successfully completed a proof of concept FDA
trial which 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.
TheraMac(TM) has also been the subject of an open label study on 404 patients
and it received CE Marking in Europe in 2002.
    "Our history with the FDA has been very positive," says Tom McColley,
President of Acuity Medical. "This important stage of our development will
allow our treatment guidelines and protocols to be further defined and
hopefully bring a safe, effective treatment to an increasing population that
suffers from the devastating effects of AMD."
    TheraMac(TM) produces minute amounts of electrical biocurrent that is
delivered to the retina through a probe that touches 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.
    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."
    Acuity is in discussion with several groups regarding next stage funding
for the PMA clinical trial through to commercialization.
    Acuity Medical, located in Brighton, Michigan, is a therapeutic technology
company that is developing treatments for all aspects of macular disease. For
more information, contact Tom McColley at (810) 229-5828 or at
tom.mccolley@acuitymedical.com.

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