Nova Eye Medical (ASX: EYE) has made its first commercial sale of iTrack™ Advance in South Korea, completed during the first week of November 2026. The sale follows regulatory clearance and approval of device pricing in the country.
Sales will be made through an established and experienced ophthalmic distribution partner. They are expected to add to the company’s revenue growth in FY27.
Regulatory and pricing path cleared
The launch followed a sequence of South Korean approvals and the first sale:
- Regulatory clearance from the Ministry of Food and Drug Safety (MFDS) in mid-2025.
- Approval of device pricing arrangements from the Health Insurance Review and Assessment Service (HIRA), under South Korea’s National Health Insurance system, in September 2026.
- First commercial sale in the first week of November 2026.
According to the company, the pricing approval cleared the way for the launch of iTrack™ Advance in South Korea.
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South Korea market opportunity
Nova Eye said South Korea is expected to be a strong market for iTrack™ Advance, citing the following reasons:
- A relatively high level of GDP and economic development, with advanced health care facilities and trained ophthalmologists.
- Meaningful adoption of interventional glaucoma, led by glaucoma specialists.
- National Health Insurance Service data indicate surgeons performed approximately 690,000 cataract surgeries in 2025, which suggests there may be more than 100,000 patients each year presenting for cataract surgery who also have glaucoma. The estimate draws on the Marketscope Glaucoma Surgical Devices Report August 2026, which found approximately 15% of patients presenting for cataract surgery have concurrent glaucoma.
- iTrack™ Advance can also be performed as a standalone glaucoma procedure, which adds to the addressable market. HIRA data show approximately 1.2 million people were treated for glaucoma (both pharmaceutical and surgical treatment) in South Korea in 2023.
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