Nova Eye gets reprieve after US Medicare reimbursement delayed until 2024. Picture Getty
Health & Biotech
Nova Eye Medical (ASX:EYE) jumped 15% this morning after advising that the final draft of the local coverage determination (LCD), issued by the US National Government Services (NGS), has been deferred from December 23 to March 23, 2024.
The NGS administers insurance reimbursement claims of healthcare facilities in the states of New York, Connecticut, Rhode Island, Massachusetts, Vermont, New Hampshire, Maine, Minnesota, Illinois, and Wisconsin.
NGS said the the deferral is to “allow more time to make decisions regarding comments received”.
A fortnight ago, EYE reported that four additional Medicare Administrative Contractors (MACs) have proposed LCD changes on Medicare reimbursement of minimally invasive glaucoma surgery (MIGS) procedures in the US.
This would have hit Nova Eye particularly hard, as “approximately 40% of the company’s global revenues are derived from health care facilities located in the 38 states covered by these four MACs,” according to an ASX announcement from the company.
“Today’s deferral by NGS is therefore a positive outcome for the near-term sales of the Nova’s iTrack portfolio of canaloplasty devices, which have been performing strongly since the USA launch of iTrack Advance in May.”
Reimbursement coverage of canaloplasty surgeries by NGS beyond March 23, 2024 will now depend on whether the proposed LCD is implemented.
Dimerix (ASX:DXB) surged 12% this morning after saying that the Investigational New Drug (IND) application for DMX-200 has been approved by the National Medical Products Administration (NMPA), the Chinese regulatory agency.
The approval will allow Dimerix to commence recruitment for its ACTION3 Phase 3 study of DMX-200 on focal segmental glomerulosclerosis (FSGS) kidney disease patients in China.
Importantly, the IND approval confirms that no further manufacturing, nonclinical or clinical (bridging) studies are required prior to recruitment of Chinese patients. The open IND will also likely further support partnering discussions in the region.
Dimerix says the full study will enrol 286 patients with FSGS globally, including some in mainland China.
Positive data from the ACTION3 study may support a future marketing authorisation application for DMX-200 (or Qytovra in some territories) in China.
“FSGS remains an area of high unmet medical need with no approved therapies for this indication. We look forward to reporting the outcome of the study’s first analysis in March 2024,” said Dr David Fuller, Dimerix chief medical officer.
Microba Life Sciences (ASX:MAP) announced that Stage 1 activity screening for the company’s autoimmune disease program has been completed on schedule together with partner Ginkgo Bioworks (NYSE: DNA).
The Stage 1 activity screening analysed 1,821 strains selected through Microba’s data driven drug discovery platform, with 62% of strains demonstrating significant immuno-modulatory activity, and a further 18% significantly impacting the inflammasome.
From this work, 36 strains have now progressed into Stage 2 functional screening for expected completion in Q4 FY24 to enable lead candidate selection.
“This milestone for our auto-immune disease program is a critical step as we move toward selecting potential lead candidates for future development,” said Professor Trent Munro, SVP of Therapeutics at Microba.
“Our partnership with Ginkgo has allowed us to interrogate complex biology with a speed and throughput which would not be otherwise possible.”
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