Nova Eye Medical (ASX:EYE) has confirmed that the U.S. Food and Drug Administration (FDA) has cleared the company’s iTrack Advance device in the U.S.
The company reports that iTrack Advance is its newest generation canaloplasty device for canal-based glaucoma surgery. Additionally, the FDA-approved device will now appeal to a substantially ‘larger new’ market.
Commenting on the FDA clearance, Nova Eye Medical Managing Director, Tom Spurling said: “Having pioneered canaloplasty technology with the original iTrack device, Nova Eye is now well positioned to materially penetrate the expanding canal surgery market with iTrack Advance.”
“With this new design, we have streamlined the canaloplasty procedure and made it efficient and very ergonomic for the surgeon”
Dean McGee Eye Institute, University of Oklahoma Managing Director Endowed Chair in Opthalmology and Clinical Professor, James P. Lutton said: “We’ve taken the original iTrack device and incorporated it into an ergonomic handpiece that allows surgeons to easily advance and retract the mircrocatheter through the canal.
With this new design, we have streamlined the canaloplasty procedure and made it efficient and very ergonomic for the surgeon.”
iTrack is a pioneering canaloplasty device that first established canal surgery for glaucoma. To date, 120,000 surgeries have been performed by surgeons across the world, with an ‘outstanding’ clinical efficacy and safety profile.
Nova reports the iTrack Advance is the latest addition to the iTrack collections. The company states it is a ‘high precision’ hand-held delivery system, which clear blockages that cause elevated eye pressure.
The company reports that now the FDA clearance is secured, Nova Eye can immediately begin marketing and sales of iTrack Advance to the U.S. Additionally, a full product launch is planned for the American Society of Cataract and Refractive Surgery (ASCRS) annual conference scheduled for 5 to 8 May 2023 in San Diego.
Nova Medical is a medical technology company that develops, manufactures, and sells a portfolio of proprietary ophthalmic treatment technologies and devices. The company’s sales headquarters are based in Fremont, California, alongside manufacturing facilities in Fremont and Dunedin, New Zealand.