Bio Light's IOPtiMate System Receives Regulatory Approval in Canada
PR Newswire Bio Light Israeli Life Sciences Investments Ltd.
TEL AVIV, Israel, December 21, 2015 /PRNewswire/ --
Bio Light Israeli Life Sciences Investments Ltd. (TASE: BOLT, OTCQX: BLGTY) ("Bio Light" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, announced today that its IOPtiMate™ system for the treatment of glaucoma has been approved by the Canadian Medical Devices Bureau, allowing the Company to commercialize the surgical system in Canada.
The IOPtiMate™ surgical system enables a non-penetrating, CO2 laser-assisted procedure known as CLASS (CO2 Laser-Assisted Sclerotomy Surgery) to reduce elevated intraocular pressure. CLASS is an automated, easy to perform procedure which requires only a short learning curve and provides a safer and more precise alternative to the complex and risky glaucoma surgeries that are currently available.
Bio Light is primarily marketing the IOPtiMate[TM] system to leading physicians and medical centers in Asia and Europe, which has resulted in first sales of the system in Hong Kong, Poland, Hungary, Romania, Peru and Portugal, with distribution agreements under negotiation in additional countries. The Company also recently signed a joint-financing agreement in November 2015 with two Asia-based venture capital firms to further support the global commercialization of the IOPtiMate™ system, as well as to initiate a regulatory approval pathway process for it with the U.S. Food and Drug Administration. With a Canadian license now in place, Bio Light plans to initiate commercial activity in Canada through a local distributer.
"According to CNIB, glaucoma is the second leading cause of vision loss for seniors in Canada, and more than 250,000 Canadians suffer from chronic open-angle glaucoma, the most common form of the disease," explained Biolight's Chief Executive Officer, Suzana Nahum Zilberberg. "The IOPtiMate[TM] system represents a true breakthrough for people who are afflicted by this terrible disease, and we are thrilled to secure the necessary approval to drive the adoption and commercialization of this innovative surgical solution in Canada."