Nova Eye Medical Limited advised that it has received feedback from the US Food & Drug Administration (FDA) in relation to its 510(k) submission for marketing clearance of the Company's new iTrackTM Advance canaloplasty device in the USA. Nova Eye Medical advises that, with the receipt of the feedback from the FDA, it does not expect to receive marketing clearance prior to December 31, 2022, as previously stated. The Company will continue to actively engage with the FDA in support of a marketing clearance.

On November 16, 2022 the Company reported strong sales performance for the four months ended October 21, 2022, with sales revenue of USD 3.82 million, which materially exceeded the forecast guidance of USD 3.4 million. This growth was driven by the launch of the iTrackTM Advance in markets outside of the USA, as well as rebound sales of the Company's iTrackTM in the USA. The iTrackTM Advance has been designed based on the success of the original iTrackTM.

Both the original iTrackTM and the iTrackTM Advance are manufactured by Nova Eye Medical in its state-of-the art manufacturing facility in the USA. The original iTrackTM was cleared by the FDA in 2008 and has been used in nearly 120,000 canaloplasty procedures globally. It is currently the only device in the USA with an indication for canaloplasty.

The iTrackTM Advance leverages the same design and function of the original iTrackTM but is designed for improved surgical efficiency. A key feature of the iTrackTM Advance is an ergonomic handpiece, which enhances the advancement/withdrawal of the microcatheter through Schlemm's canal (part of the eye's drainage channel) and eliminates the need for forceps, as compared to the original iTrackTM. Based on the enhanced ease-of-use and ergonomic design, the iTrackTM Advance is expected to drive increased surgeon uptake of the canaloplasty procedure.

A description of the opportunity in the USA is attached to this release. Positive surgeon feedback from early clinical use in Germany, the UK, Italy, Canada and Australia further supports the global market opportunity for the iTrackTM Advance.