AcuFocus Receives Approval from Health Canada for KAMRA Inlay
IRVINE, Calif.–(BUSINESS WIRE)–AcuFocus, Inc. (www.AcuFocus.com), maker of an innovative corneal inlay revolutionizing the treatment of near vision loss (presbyopia), today announced that it received approval from Health Canada to market and sell the KAMRA™ inlay within Canada. They announced further that they have received a certificate of free sale, which will now open up additional markets such as Argentina, Russian Federation, Venezuela, Peru, Mexico, India and Colombia. The KAMRA inlay is a unique treatment option that uses small aperture optics to restore near and intermediate vision.
Presbyopia is a naturally frustrating condition affecting millions of people over 40, resulting in the loss of near vision. It is caused by changes that occur within the proteins of the eye’s natural lens, making the lens gradually thicker and less elastic over time. With less flexibility, the eye has a harder time focusing up close. As a result, presbyopes become dependent upon reading glasses for most everyday near tasks.
“Presbyopia currently affects approximately 40% of Canadians, representing nearly 14 million people, and that number is expected to increase over time,” said Dr. Gordon Balazsi, Clinique Laservue, Montreal, Quebec. “Patients have been searching for a reliable solution that allows them to read their mobile devices or check their wristwatches without dependence on reading glasses, now with the approval of the KAMRA inlay, our patients have a real solution,” shared Dr. Marc Mullie, Clinique Laservue, Montreal, Quebec.
“The unique small aperture design of this inlay is a proven approach for extending depth of focus, with years of research and data behind it,” said Dr. Jeff Machat, Crystal Clear Vision, Toronto. “It is the only option where patients experience improvements in both near and intermediate vision as well as maintenance of distance vision. I am especially enthusiastic about the opportunity to provide the KAMRA inlay in conjunction with LASIK for a complete solution for my patients over 40 that are struggling with loss of reading vision.”
“The outcomes and safety profile of the procedure have been excellent, accounting for why so many ophthalmologists around the world have personally undergone the procedure to enhance their own reading ability,” said Dr. Raymond Stein, Bochner Eye Institute in Toronto. In addition to offering KAMRA Vision in their own practices, Drs. Balazsi, Mullie and Machat, recently had the inlay implanted in their own eyes, bringing the total number of Ophthalmologists enjoying the benefits of KAMRA Vision to nine worldwide.
“We have been following AcuFocus eagerly for a few years now with great anticipation. We are very excited to be part of the most significant new refractive procedure since the advent of LASIK,” said Jay Herman, President, Sigmacon Medical, distributor for the AcuFocus KAMRA™ inlay in Canada.
“We are excited to bring the KAMRA inlay to surgeons in Canada so they can offer a sound solution to their presbyopic patients,” said Ed Peterson, AcuFocus President and Chief Executive Officer. “We are striving to make the KAMRA inlay available to presbyopes around the world, with our CE Mark, certificate of free sale and now approval from Health Canada brings, we are one step closer to achieving that goal.”
To date, the KAMRA inlay has been implanted in more than 15,000 patients and is now available in over 40 countries worldwide. The inlay has received CE mark and is available in select markets across Europe, Asia-Pacific, Middle East and South America. The company anticipates submitting for FDA approval for distribution in the United States in Q4 of this year.
AcuFocus Inc., a privately held company located in Irvine, California, developed the KAMRA inlay for the treatment of near vision loss (presbyopia). The KAMRA inlay is an intra-corneal inlay designed to create a small aperture effect, allowing the eye to see near and intermediate objects more clearly while maintaining distance vision. By applying the “depth-of-focus” principle commonly used in photography, the KAMRA inlay controls light transmission, allowing only central rays to reach the retina through a fixed 1.6mm aperture. More than 15,000 KAMRA inlays have been implanted and it is available for sale in over 40 countries worldwide. The AcuFocus KAMRA inlay is a 2012 Medical Design Excellence Awards® Finalist. For more information about the KAMRA inlay from AcuFocus visit www.AcuFocus.com. KAMRA® is a trademark of AcuFocus, Inc.
Sigmacon is a Canadian distributor of new and emerging healthcare technologies, with over 30 years of experience in the Ophthalmic industry. Sigmacon also provides diagnostic equipment, light therapy systems and surgical lasers for dermatology, otolaryngology, gynecology, neurosurgery and urology.
Jay Herman, President, Toll-Free: 1-800-898-7455 (x353)