BELKIN Vision, the Israel-based medical device company committed to bringing an accessible first-line glaucoma laser treatment to market, announced today that it has been awarded CE Mark under Medical Device Regulation (MDR) from its notified body DEKRA, making it the first automated, non-contact glaucoma laser treatment available within Europe.
BELKIN’s sight-saving technology could revolutionize first-line glaucoma care for the more than 100 million people who have glaucoma and ocular hypertension worldwide. The treatment is the first and only contactless laser for glaucoma – a true game-changing innovation. BELKIN will begin controlled roll-out of the Eagle laser in Europe in the second half of 2022.
Professor Sir Peng Tee Khaw, of Moorfields Eye Hospital and UCL, London, and member of the BELKIN Scientific Advisory Board commented: “The health economic impact of DSLT technology is potentially significant and is anticipated to allow for greater access to high-quality, contactless glaucoma treatment across Europe. Current treatment options are more complex and DSLT can change the first-line glaucoma treatment paradigm improving patient quality of life, while at the same time improving access and allowing us to contribute to lower healthcare costs for both patients and health systems.”
Historically, conventional laser treatment is manual, involving contact with the eye and is accessible mainly to a limited number of glaucoma specialists trained in laser technology who generally see advanced stage patients. BELKIN’s DSLT technology is automated and therefore reduces the need for specialized training, thus allowing access to all ophthalmologists. The timing for the introduction of this technology is ideal as the UK National Institute for Healthcare Excellence (NICE) has recently recommended laser treatment as a first-line treatment for newly diagnosed glaucoma patients, following similar guidelines by the European Glaucoma Society (EGS).
BELKIN Vision was recently selected to receive $20M (€17.5M) of blended financing in grants and equity from the European Innovation Council Accelerator (EIC). This financing will support the company in the execution of its European commercialisation.
CEO, Daria Lemann Blumenthal added, “We anticipate that our unique DSLT technology will become the new standard of first-line glaucoma care. Receiving CE mark under MDR is a pivotal moment for our company, as being able to offer BELKIN Vision’s Eagle in Europe, will transform the way glaucoma is treated. We look forward to accelerating our collaboration with doctors and health systems across Europe.”
Source: Company Press Release
