BUSINESS WIRE
MINNEAPOLIS--(BUSINESS WIRE)--A new treatment that has been shown to delay and potentially reverse
blindness received CE Mark approval in the European Union. The
first-of-its-kind therapy, developed by ScyFIX, uses microcurrent
neuromodulation to help prevent vision loss and even restore sight for
patients with low-vision blindness-related diseases. This is the
first-ever device therapy approval for Retinitis Pigmentosa (RP), a
degenerative disease where peripheral vision is lost that can lead to
total blindness. Additional approvals for the treatment of other
blindness-related diseases are expected soon.
The new ScyFIX 700 therapy is immediately available for purchase with a
prescription from an eye care professional in all countries that
recognize CE Mark.
The ScyFIX 700 works by administering a tiny current of electricity that
stimulates the body’s own healing capabilities. ScyFIX, based in
Minneapolis, Minn., has developed the technology over the past seven
years.
“The approval of this breakthrough therapy gives hope to the millions of
people suffering from low-vision, blindness-causing diseases who have
had no therapy options until now,” said Thomas W. Harold, founder of
ScyFIX and inventor of the ScyFIX 700. “Patients now report seeing faces
of their family members, using mobile phones, reading newspapers and
performing day-to-day tasks, which was not possible for them prior to
use of the ScyFIX therapy.”
RP affects more than 2 million people worldwide. Since it is
degenerative, the condition will only worsen and can lead to total
blindness. But in the study, the visual field – the actual amount the
eyes can see – was either expanded or remained stable in 85 percent of
patients and actually improved in 63 percent. The ScyFIX 700 was also
shown to improve the clarity of vision.
Patients can receive the ScyFIX 700 from their ophthalmologist, who will
instruct them on the appropriate in-home use.
“ScyFIX will continue to pursue successive regulatory approvals around
the world, including the FDA in the United States,” said Dr. Darrell
DeMello, president of ScyFIX. “This will allow the ScyFIX
neuromodulation technology to be used to slow the progression of
symptoms for people with devastating blindness-related diseases.”
Additionally, clinical results show promise for the ScyFIX 700 to treat
other blindness-related diseases, including Age-Related Macular
Degeneration (ARMD). This condition affects more than an estimated 50
million people worldwide and has two forms: wet and dry. Wet ARMD occurs
in only 10 percent of cases, while the other 90 percent are what is
known as Dry ARMD. Once approved, the ScyFIX 700 would be the first
approved therapy to treat Dry ARMD.
A video describing the ScyFIX 700 system is available at http://www.onemedplace.com/database/list/cid/9896/.
More information is also available on www.scyfix.org.
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