Breakthrough Medical Device Gives Hope for Blindness-Related Diseases

Microcurrent Neuromodulation, 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, Minnesota, USA, 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 www.onemedplace.com, click here: ScyFIX Video

The procedure is safe, non-invasive and painless and no side effects or adverse reactions have been observed.


 
     

ScyFIX uses targeted micro-current energy to address the Dry form of Macular Degeneration (AMD) and Retinitis Pigmentosa (RP). ScyFIX has completed two human Pilot clinical trials for RP and AMD that demonstrated safety, stability and improvements in visual acuity, fields, contrast sensitivity and quality of life. Some patients are now using mobile phones, reading newspapers, seeing faces of family members and threading needles; none of these day-to-day activities were possible for these patients before using the ScyFIX.