Canada clears BioLight’s IOPtiMate system
The Canadian Medical Devices Bureau has approved BioLight Life Sciences Investments’ (OTCQX:BLGTY; TASE:BOLT) IOPtiMate system for the treatment of glaucoma, 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 that provides a safer and more precise alternative to the complex and risky glaucoma surgeries that are currently available.
With a Canadian license now in place, BioLight plans to initiate commercial activity in Canada through a local distributer.
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.
“The IOPtiMate 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,” CEO, Suzana Nahum Zilberberg, said in a statement.
BioLight is primarily marketing the IOPtiMate system to leading physicians and medical centers in Asia and Europe, which has resulted in first sales in Hong Kong, Poland, Hungary, Romania, Peru and Portugal, with distribution agreements under negotiation in additional countries.
The company recently signed a joint-financing agreement 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 with the FDA.