Nova Eye Medical Secures Key Approval to Expand Glaucoma Device Sales in China
Nova Eye Medical has gained regulatory approval for its iTrack Advance glaucoma device in China, setting the stage for significant market expansion and sales growth from late fiscal 2026.
- NMPA approval granted for iTrack Advance in China
- Established Chinese partner to accelerate market entry
- China’s glaucoma patient population over three times larger than the US
- Sales growth anticipated from late FY26
- iTrack Advance offers improved surgical efficiency over original device
Regulatory Milestone Opens Chinese Market
Nova Eye Medical Limited (ASX, EYE) has achieved a pivotal regulatory milestone with the National Medical Products Administration (NMPA) approving its iTrack Advance device for sale in China. This approval is a critical step in the company’s global expansion strategy, enabling access to one of the world’s largest glaucoma markets.
Leveraging Established Partnerships
The company will leverage its existing, experienced channel partner in China to expedite market access and manage sales efforts. This partnership is expected to smooth the path for the iTrack Advance, which builds on the success of the original iTrack device already generating US$1.2 million in revenue in China for the year ended June 2025.
Market Potential and Competitive Edge
China’s glaucoma patient population dwarfs that of the United States, with approximately 24.3 million affected compared to 7.5 million in the US. Diagnosed cases in China are also more than double those in the US, and diagnosis rates are expected to rise. The iTrack Advance device offers significant improvements in surgical efficiency, which is anticipated to attract a broader base of Chinese surgeons and drive long-term sales growth.
Strategic Timing Amid Market Shifts
Managing Director Tom Spurling highlighted that the approval coincides with a paradigm shift in China towards interventional glaucoma treatments, mirroring trends seen in the US. This shift could accelerate adoption of Nova Eye’s technologies, positioning the company well to capitalize on evolving clinical practices.
Looking Ahead
Pre-launch initiatives with the Chinese partner are set to begin immediately, with sales growth expected from late fiscal year 2026 onwards. While the timing and scale of market penetration remain to be seen, this approval marks a significant validation of Nova Eye’s product and strategy in a critical global market.
Bottom Line?
With regulatory approval in hand, Nova Eye Medical is poised to tap into China’s vast glaucoma market, but the real test will be how quickly surgeons adopt the new device.
Questions in the middle?
- How rapidly will Chinese surgeons adopt the iTrack Advance compared to the original device?
- What competitive pressures exist in China’s glaucoma surgical device market?
- How will Nova Eye’s sales partner execute the market entry strategy to maximize growth?
