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I just send an email to the CEO of ScyFIX, Thomas Harold to find out why he needs the approval of the FDA to sell his product since Dr. Kondrot seems to be able to sell his unit freely without the FDA approval or is it? They have offices in Belgium, INdia, Middle East and here in the U.S. I also asked him to email me any information he may have regarding his Micro Current technology. The product is sold outside the U.S. and will find out if I can get one. I also told him about this blog and suggested that he'll be part of it. Corporate information, USA: ScyFIX is developing sight-saving technologies for people suffering from degenerative eye diseases for which there are currently no cures or therapies. ScyFIX offers the only patented micro-current neuromodulation/stimulation device for the treatment of macular degeneration, Stargardt's disease, retinitis pigmentosa and other degenerative eye diseases. |
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| Products / Services |
| The ScyFIX 700 micro current neuromodulation/stimulation device facilitates increased brightness, decreased fogginess, improved visual acuity, enhanced color perception and reduction of blind spots. Micro-current stimulation has also been proven to expand the visual fields of individuals diagnosed with retinitis pigmentosa. The ISO 13485 medical directive certification was recieved in February, 2009. |
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| Technology / Differentiation |
| Research suggests that the ScyFIX electrical neuromodulation/stimulation device approximates the level of electrical activity present in a healthy eye, stimulating recovery in diseased or dormant cells. Electrical stimulation is known to release retinal neuroprotective factors protecting against photoreceptor cell death, raise ATP synthesis (needed for energy metabolism, membrane viability and waste management), improve microvascular circulation, and improve nerve conduction and velocity. Studies have shown that micro-current stimulation can improve vision for 85% of patients suffering from macular degeneration, 83% of those suffering from Stargardt's disease, and 66% of those suffering from retinitis pigmentosa. |
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| Market / Customers |
| Macular degeneration (MD) is a major cause of eyesight deterioration in older age groups, affecting millions of people. It is estimated that 5% of the world's population will develop a form of MD. Currently there are no FDA approved treatments for Dry AMD or retinitis pigmentosa. The untreated U.S. market for Dry AMD includes over 7 million people; the aging of the baby boomer generation will lead to an estimated 50% increase in the prevalence of age-related degenerative eye diseases by 2020. Penetration of 5% into the large American market would yield $3.2 billion in associated revenues. |
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| Competitors / Substitutes / Alternatives |
| Other than the ScyFIX 700, there are no device treatments or cures for Retinitis Pigmentosa and Dry Macular Degeneration |
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| Strategy |
| Build distribution outside the US in Europe, Asia, South America and Canada during the balance of 2009 and 2010; while awaiting US FDA approval |
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| Funding |
| Owners and private individuals |
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| Status |
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The ScyFIX 700 is approved for use in Europe, and the regulatory requirements for Canada have been met as well. ScyFix anticipates receiving FDA approval for the use of micro-current neuromodulation/stimulation to treat dry macular degeneration and retinitis pigmentosa sometime between the third quarter of 2009, and Q1 2010.
You can listen to the video at http://www.onemedplace.com/database/list/cid/9896/ |
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