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Nova’s Glaucoma surgical device iTrack Advance has its eyes set on FDA approval

Over 100 million people worldwide suffer from glaucoma—a cocktail of eye infections resulting in blindness. Though glaucoma has no cure, some treatments can aid vision loss, slowing down its progression or intensity. One such treatment is MedTech company Nova Eye Medical’s (ASX: EYE) glaucoma surgical devices, which witnessed sales revenue of $5.66 million between July and October 2022, exceeding the forecasted value of $5.02 million.

The growing global aging population and the prevalence of eye infections have boosted Nova’s business. So much so that it witnessed a 38% top-line sales growth compared with the prior comparative period (PCP). The underlying sales growth was 27% compared with the PCP.

Nova Eye Medical CEO, Tom Spurling, detailed, “The glaucoma surgical devices market continues to be a burgeoning market. Our results for the first four months of the fiscal year show the early signs of success and support our strategy to invest in the market. Of the global market for glaucoma surgical devices, however, the USA accounts for the vast majority of the global market for glaucoma surgical devices at US$469 million ($692 million). The planned market introduction of the iTrack ™ Advance in the USA is expected to significantly improve the growth trajectory of our business.”

Its report revealed that its impressive sales performance was primarily thanks to the commercial launch of its new iTrack Advance canaloplasty device to customers in Europe and Canada. Canaloplasty is a new, non-perforating surgery that is used to treat glaucoma. Through devices like the iTrack Advance, surgeons use the microcatheter to create small incisions in your eye that are then used to navigate the canal within.

Nova’s iTrack Advance combines a microcatheter with an ergonomic, easy-to-use handheld injector for all ophthalmic surgery and specialist settings. It covers mild to intense glaucoma, providing different treatment options for all. In fact, the Company believes that its latest iteration will appeal to cataract and glaucoma surgeons, thus expanding its total addressable market by ten times.

Nova is all smiles about its initial launch program for the new iTrack Advance canaloplasty device in markets in Europe and Canada. However, the sales growth for the remainder of the 2023 fiscal year will be largely contingent on the timing of marketing clearance of the iTrack ™ Advance in the USA. In June 2022, the Company lodged a 510(k) submission for the device and expects to receive clearance from the Food and Drug Administration (FDA) before the end of the 2022 calendar year. Through its USA launch, the Company expects to shoot up its profits.

In FY22, its sales revenue was down 3% on the prior period, following a strong rebound during the six months to 30 June 2022, when sales grew 10%, compared with sales in the six months to 31 December 2021.

Besides iTrack, the Company is also focusing on its other solutions, like 2RT, from its AlphaRET division. 2RT is a proprietary nanosecond laser therapy to treat age-related macular degeneration in its intermediate stage, and its trials are set to start soon.

Ultimately, one thing is for sure. Nova is working hard to ensure that its solutions catch peoples’ eye—both literally and figuratively.

Alinda Gupta

Alinda is a Business Reporter for The Sentiment

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