Nova Eye Medical secures FDA clearance for iTrack Advance to treat glaucoma

Nova Eye Medical is celebrating after being given US FDA clearance for its updated surgical device to treat glaucoma, which is forecast to significantly expand its market in the US.

The US Food and Drug Administration (FDA) has provided 510(k) clearance for the Nova Eye Medical (ASX:EYE) new generation canaloplasty device for canal-based glaucoma surgery, the iTrack Advance, for sale to surgeons in the USA to treat glaucoma.

EYE said the original iTrack was the pioneering canaloplasty device that first established canal surgery for glaucoma and to date ~120,000 surgeries have been performed by surgeons worldwide with outstanding clinical efficacy and safety profile.

The trademarked clinically proven iTrack microcatheter is the only product that is indicated for canal surgery to treat glaucoma with viscodilation alone, a leading cause of blindness in the developed world, with viscodilation alone.

iTrack Advance is the latest addition to the iTrack family. It is a high precision hand-held delivery system that places the iTrack microcatheter into the main drainage canal of the eye for injection of viscoelastic fluid (canaloplasty) to clear blockages causing elevated eye pressure (glaucoma).

Increase to EYE’s market of US surgeons

With FDA 510(k) clearance secured, EYE said it can immediately start marketing and sales of iTrack Advance to US ophthalmologists for the treatment of glaucoma.

The original iTrack is principally used by glaucoma surgeons whereas the new iTrack Advance, with the extended feature set, is expected to also appeal to cataract surgeons and comprehensive surgeons, for use in a combination procedure alongside cataract surgery.

EYE’s 12-month revenue for its glaucoma surgical devices was A$15.2 million and is forecast to grow significantly following iTrack Advance’s US clearance, which will broaden the company’s US customer base by a factor of ~50.

Clinical Professor James P. Luton MD Endowed Chair in Ophthalmology at the Dean McGee Eye Institute Mahmoud A. Khaimi said iTrack Advance will make the canaloplasty procedure much more accessible to the broader market of cataract and anterior segment surgeons.

“I’ve been given the great opportunity and honour to pair hand in hand with Nova Eye to develop the iTrack Advance,” he said.

“We’ve taken the original iTrack device and incorporated it into an ergonomic handpiece that allows surgeons to easily advance and retract the microcatheter through the canal.”

He said the new design has streamlined the canaloplasty procedure and made it efficient and very ergonomic for the surgeon.

“I am confident that surgeons will adopt this device into their treatment algorithm, either as an adjunct to cataract surgery or as a standalone procedure,” he said.

Well-positioned for market growth

EYE managing director Tom Spurling said currently its existing iTrack product is used by about 200 glaucoma surgeons in the US but there are about 1200 glaucoma specialists in total, and on top of that nearly 10,000 cataract and anterior segment surgeons.

Spurling said cataract surgery is the world’s most common surgery and 20% of people who have cataracts have glaucoma.

“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,” he said.

A full product launch is planned for the American Society of Cataract and Refractive Surgery (ASCRS) annual conference scheduled for May 5-8, 2023 in San Diego.

This article was developed in collaboration with Nova Eye Medical, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.