Business & Finance
Business and Finance
Business and Finance
Thu, July 14, 2011
Wed, July 13, 2011 Annidis Corporation receives FDA 510(k) clearance for its RHA2020-U Multi-spectral Digital Ophthalmoscope
OTTAWA, July 13, 2011 /CNW/ - Annidis Corporation (TSXV: RHA) announced today that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance allowing Annidis Corporation to commence the marketing and sales of the RHA2020-U multi-spectral digital ophthalmoscope in the United States. Access to the US market opens up significant opportunities for the Company.
The Annidis RHA2020-U instrument is intended to non-invasively capture images of the fundus of the eye which can be used by ophthalmologists and optometrists to assist them in the early diagnosis and observation of eye diseases. There are more than 40,000 Optometrists and 20,000 Ophthalmologists in North America who are potential users of this leading edge technology. The approved instrument is based on multispectral fundus imaging and provides visualization of deep retinal features and choroidal vessels creating a practical tool to non-invasively aid in early detection and monitoring of eye diseases.
"FDA approval represents a major achievement for the Company that reflects a significant amount of effort and dedication from our team. We are excited about the opportunity for the RHA2020-U instrument in the large and growing US marketplace. The Annidis technology will provide a significant new tool to support the tremendous efforts by ophthalmologists and optometrists in eye disease management and prevention" said Gerald Slemko, CEO of Annidis.
"Annidis developed technology is a major advancement in retinal health management and a significant tool for assisting eye care professionals in the diagnosis and monitoring of sight-threatening eye diseases", says Dr. Brian Leonard, Annidis Chief Medical Officer.
About Eye Disease:
Significant vision loss due to retinal based eye diseases including Age Related Macular Degeneration (AMD), Diabetic Retinopathy (DR) and Glaucoma is been driven by an aging demographic and the increasing prevalence of diabetes. In countries where the population continues to work into their late 60s and live into their mid to late 80s, people consistently identify vision as their most important sense, allowing them to read, drive, recognize faces and be a fully productive member of society.
Publications by the Canadian National Institute of Blind, the National Eye Institute and other respected North American institutions indicate that there are more than 25 million diabetics in US and 0.5 million in Canada. The occurrence of sight threatening retinopathy among diabetics is 8% in US and 6.4% in Canada. In addition there are more than 2 million people with AMD in the US alone. The annual cost of blindness in the US is estimated to be $80 billion and $16 billion in Canada. Vision loss in general is not reversible in most cases and early diagnosis is critical to managing eye disease.
About Annidis Health Systems Corporation:
Annidis was founded in 2007 and is dedicated to researching and developing instrumentation to assist in the early detection and monitoring of diseases of the eye. The RHA2020-U is the result of a multiyear research and development effort by the Annidis team in collaboration with leading eye care professionals and researchers in Canada including the Ottawa Eye Institute, Toronto Western Hospital, the School of Optometry in Montreal and numerous optometric clinics in Ontario.
In June, 2011, Annidis became a publicly traded Canadian company on TSX-V and trades under the symbol RHA.
Disclaimer
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For more information about Annidis Corporation or on the RHA2020-U Multi-spectral digital ophthalmoscope, please visit [ www.annidis.com ] or call Nick Ribaric, President (613) 596-1800 ext. 2020.
