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Aussie firm reveals next-gen MIGS device in pipeline

Adelaide ophthalmic device manufacturer Nova Eye Medical is developing a next generation iTrack glaucoma surgical system to reduce operating times. It is also progressing towards a pivotal US study for its 2RT laser therapy for intermediate AMD that could fulfil a distinct gap in a multi-billion-dollar market.

The latest developments announced by the ASX-listed firm, formerly known as Ellex Medical Lasers, were revealed in its full-year financial results to 30 June when it reported net profit after tax of $35.7 million, and a debt-free position with $26 million in cash.

After offloading its laser and ultrasound business to French firm Lumibird Group for $100 million in June, Nova Eye is mainly focussed on the consumable glaucoma surgical device market with its iTrack minimally invasive glaucoma surgery (MIGS)  technique and the Molteno glaucoma drainage device, the latter of which was acquired on 31 July.

According to Nova Eye, the COVID-19 pandemic impacted iTrack global unit sales, which were down 24% to 11,774 units versus the same period last year, and revenues which fell 19% to $11.6 million.

iTrack revenues fell 19% to $11.6 million during the past year.

However, Nova Eye revealed that during the past year it has been developing a next generation iTrack system, aimed at significantly reducing surgical times and ease of use for surgeons. This will enable the company to tap into a broader base of physicians.

“The mode of action of iTrack, as well as its design, is such that it provides significant scope to introduce additional clinical indications. It also provides a platform for future product development. Our advanced R&D team is focused on developing our technology pipeline well into the future,” Mr Victor Previn, executive chairman of Nova Eye Medical said.

It is planning for regulatory and commercial initiatives later in the 2021 financial year in the post COVID-19 market recovery.

Approval in the US for 2RT therapy could open up a multi-billion-dollar market for the company.

For its 2RT retinal rejuvenation therapy, Nova Eye reported “solid progress via formal engagement” with the US Food and Drug Administration to obtain approval for a pivotal study on US patients.

If successful, it could lead to regulatory clearance for the treatment of patients with intermediate age-related macular degeneration (iAMD), via an Investigational Device Exemption (IDE).

“A therapy that delays AMD disease progression will address a very large unmet clinical need currently estimated at US$5.1 billion (AU$6.9 b) annually. It is intended to seek an investment partner to fund the study with Nova Eye Medical retaining a significant equity stake,” the company stated.

Financial results

Nova Eye’s net profit after tax of $35.7 million was driven by a $55.8 million gain on the sale of the capital equipment business to Lumibird, which was completed on 30 June.

Despite revenue declines for iTrack and 2RT, earnings before interest, taxes, depreciation and amortisation (EBITDA) loss improved by 16% from $6.9 million to $5.8 million due to cost management measures.

On a pro-forma basis, after adjusting for the capital return and dividend payment to shareholders of $61 million, and tax payable of $8.1 million, the company will retain $26.5 million in cash, with no debt.

Previn said: “The 2020 financial year presented both significant opportunities for Nova Eye, with completion of the capital equipment business to Lumibird and subsequent return to shareholders, but also presented sales challenges due to the impact of COVID-19 on surgical procedures in the US and Europe.”

He added: “While the business successfully took steps to reduce operating expenditures during the year and there is some early evidence that sales may be returning to pre-pandemic levels, the long-term opportunity for our suite of consumable surgical devices in the burgeoning glaucoma market remains very strong.”

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