Aussie MedTech company Nova Eye Medical (ASX: EYE) has kicked off the new year with good news for investors, recording an impressive $7.6 million in sales in the US for its glaucoma surgical devices during the six months concluding on December 31, 2023 (unaudited). 

This represents a remarkable 65% growth compared to the previous corresponding period (PCP).

What’s more, this follows the many challenges Nova Eye faced in the final months of 2023 as USA sales revenue in November and December took a hit due to uncertainties surrounding Medicare reimbursement for Nova Eye Medical’s iTrack™ portfolio. 

The cloud of doubt stemmed from local coverage determinations (LCDs) proposed by five Medicare Administrative Contractors (MACs). The situation led to a temporary setback, with the US saying that Medicare, its national Healthcare policy, will no longer cover glaucoma surgeries. This was later withdrawn, bringing relief and affirmed continued reimbursement coverage for the iTrack™ portfolio.

The Company also faced a potential setback with the LCDs proposing restrictions or denials of coverage for several procedures, including canaloplasty. Despite this hurdle, Nova Eye Medical Limited managed to achieve significant market penetration in the USA since May 2023.

Nova Eye Medical Limited is a medical technology company specialising in the development, manufacturing, and sale of proprietary ophthalmic treatment technologies and devices. Among its globally used technologies is iTrack’s minimally invasive glaucoma surgery (MIGS), a surgical device designed to restore the eye’s natural outflow pathway. This solution aims to lower intraocular pressure and reduce patient reliance on anti-glaucoma medications for mild to moderate glaucoma, thus transforming into a potential cure for some forms of blindness.

The pivotal factor driving Nova Eye Medical’s robust performance during the H1 FY24 period was the widespread adoption of its new iTrack™ Advance. Launched in the USA in May 2023, the iTrack™ Advance received positive acclaim from both new and existing ophthalmologist customers. The steady rise in demand for this innovative surgical device contributed significantly to the overall sales growth.

Looking forward, the withdrawal of the proposed reimbursement changes by the MACs is expected to pave the way for accelerated sales growth in the second half of FY24. The Company anticipates releasing unaudited global sales results for the period ending December 31, 2023, during the week commencing February 5, 2024.

In the first four months of FY24, Nova Eye Medical witnessed a remarkable global sales growth (excluding China) of 39%, surpassing the $5.9 million mark. Despite initial challenges, the Company has managed to cushion the blow.

Besides achieving its American dream, Nova Eye has secured several important registrations in key strategic markets outside of the USA during the period. For instance, registrations for iTrack Advance in China and South Korea are underway.

It is also seeking commercialisation opportunities for 2RT, its drug addressing AMD, an intermediate stage disease causing blindness in over 50 million people globally.