ASX Quarterly Health Wrap: Who is making progress for FDA approval?

EBR Systems’ quarterly update says it’s on track to deliver the final PMA application module to the US FDA in Q3 for its WiSE cardiac technology.

EBR will submit final module for key FDA approval in Q3. Pic: Getty Images

• EBR on track to submit final module for PMA application for WiSE in Q3 FY24

• Neurotech delivered several key trial results in Q4 FY24, while undertaking $10m cap raise

• Aroa reports strong H1 FY25 results and forecasts being cashflow positive in H2 FY25

It’s the quarterly season again as the ASX market announcements page becomes increasingly flooded with update lodgements.

To save you the trouble of trudging through it all, we’ve wrapped up highlights from some of the reports in the ASX health sector that caught our eye.

EBR Systems (ASX:EBR)

Cardiac company EBR has released its Q2 2024 update and says regulatory activities are progressing to schedule for its WiSE Cardiac Resynchronization Therapy (CRT) system technology.

EBR is on track to submit the final module of its pre-market approval (PMA) application to the US FDA in Q3 2024 for WiSE, which uses proprietary wireless methods to provide pacing stimulation directly inside the heart’s left ventricle.

The size of a cooked grain of rice, the system has been granted US FDA breakthrough device designation with four out of five modules for the PMA submitted.

During the quarter, EBR appointed Erik Strandberg as chief commercial officer, bringing extensive commercial cardiovascular leadership experience to drive EBR’s US commercialisation strategy.

The company says commercial readiness activities are underway, including fostering relationships with key US clinical sites in preparation for FDA approval targeted in Q1 2025.

“We continued to make important progress toward our final PMA submission in Q3 2024, underpinned by our positive engagement with the FDA,” president and CEO John McCutcheon says.

“During the quarter we welcomed Erik, whose track record in driving growth in the medical device industry will push us towards fully realising the commercial potential of WiSE in the US.

“Our WiSE-CRT System continues to receive significant attention at key industry conferences, providing the opportunity to showcase our technology to peers and the scientific community.”

EBR holds cash and short-term investments of US$54.1m (~$81.11m) as of June 30, 2024.

Neurotech (ASX:NTI)

Q4 FY24 was all about trial results for the clinical-stage biotech focused predominantly on paediatric neurological disorders.

April 17 was a big day for the company which announced two trials had successfully met their primary endpoints along with a $10m placement for the issue of 100m new fully paid ordinary shares to institutional, professional, and sophisticated Australian and overseas investors. The placement was completed on April 24.

NTI reported positive top-line Phase 1/2 Rett Syndrome clinical trial results with its NTI164 being the first broad-spectrum cannabinoid drug therapy to show a statistically significant clinical improvement in Rett Syndrome patients.

The trial reached its primary endpoint with results indicating a statistically significant improvement in Clinical Global Impression (CGI) scores, a key measure of clinical symptoms associated with Rett Syndrome, compared to baseline measures.

The CGI scale is a tool used by clinicians to assess the overall state of an individual, commonly used in clinical trials for neuropsychiatric disorders.

NTI also reported its Phase 2/3 NTIASD2 trial targeting children diagnosed with Autism Spectrum Disorder (ASD) successfully met its primary endpoint and key secondary endpoints.

Head of the paediatric neurology unit at Monash Medical Centre and the chief investigator of the NTIASD2 trial Professor Michael Fahey says the trial which compared NTI164 to placebo over eight weeks of daily treatment demonstrated statistically significant and clinically meaningful improvements in severity of illness and adaptive behaviours without any significant side effects.

In June, NTI announced the 11 patients in Phase 1/2 trial in ASD (NTIASD1) had cross over two years of daily oral treatments with no serious reportable adverse events. NTI says importantly no patient had dropped out due to safety or reversal in their clinical improvements.

NTI also reported further data from its ongoing open-label Phase 1/2 trial of its drug, NTI164 in children diagnosed with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS).

Involving all 15 patients who started the trial, results showed further significant improvements in illness severity (38% improvement compared to baseline) and reductions in anxiety and depression levels (45% improvement compared to baseline).

During the quarter NTI announced it had signed a binding term sheet with leading contract research organisation Fenix Innovation Group. Fenix will work with NTI on the development of NTI164 for neurological disorders.

NTI also announced the appointment of Robert Maxwell Johnston as a non-executive director, who has an extensive career in global healthcare including 11 years as president and CEO of Johnson and Johnson Pacific.

The company will divest or wind-down operations of its wholly owned subsidiaries AAT Medical ad AAT Research, which manage its neurofeedback device Mente.

NTI says the decision to do so was difficult, having regard to small number of children using the device to date with the company taking the strategic decision to focus its resources and capital on NTI164.

NTI Closed the quarter with cash and cash equivalents of $11.6m, up from $4.2m in Q3 FY24, which it says will enable the company to deliver on future clinical and regulatory initiatives.

Aroa Biosurgery (ASX:ARX)

Wound care company ARX has reported strong quarterly results with net operating cash outflow of NZ$3.6m for Q1 FY25 but forecasting to be cashflow positive in H2 FY25.

ARX says net cash outflows from operations were NZ$3.6m for Q1 FY25, reflecting the typical post-financial year payments and the planned operating loss for the quarter.

The company says outflows are also due to large clinical expenses associated with the Symphony RCT, an 18-month multi-center study assessing Symphony’s efficacy in treating diabetic foot ulcers.

The majority of expenses from the study are expected to be cleared by H1 FY25 with enrolment completed.

ARX has indicated H2 FY25 is expected to be operating cashflow positive with FY25 normalised EBITDA profit guidance maintained at NZ$2-6m.

ARX has reconfirmed FY25 revenue guidance of NZ$80-87m, representing 21-32% constant currency growth on FY24.

The company US commercial operations continues to build, delivering 11% quarter-on-quarter growth in Myriad active accounts to 242 and a 17.5% quarterly increase in average sales by representatives who have been with ARX for a year or less.

Ex-US sales also performed strongly regulatory approval received to sell Myriad Matrix in Taiwan and Endoform and Myriad Matrix now available in Switzerland.

Distributors have been appointed to sell the Endoform and Myriad family of products in Chile and South Africa.

ARX’s MASTRR study has been extended to 15 sites and 800 patients from its previous target of 10 sites and 300 patients.

The MASTRR study evaluates use of its Myriad Matrix and Myriad Morcell products in a wide range of surgical specialties and procedures.

ARX says its will leverage data from the 300 enrolments completed to date to publish study
results based on sub-group analysis of specific procedures from ~Q2 FY25.

ARX had a cash balance of NZ$23.9m as at June 30, 2024.

At Stockhead, we tell it like it is. While EBR Systems, Neurotech International and Aroa Biosurgery are Stockhead advertisers, the companies did not sponsor this article.

Originally published as ASX Quarterly Health Wrap: Who is making progress for FDA approval?