ASX Health Quarterly Wrap: Control Bionics makes 15pc sales revenue jump
The June results are particularly pertinent as the last quarter of the financial year in Australia, providing an overview of the full year for many companies.
Control Bionics (ASX:CBL)
Control Bionics delivered a record year, with unaudited sales revenue rising 15% to more than $6 million and total revenue exceeding $7m in FY25. The company also reported an 8% lift in cash receipts, reaching $5.7m.
During the quarter Control Bionics officially launched its NeuroNode Only sales model in the US following issuance of US Medicare reimbursement code E2513 under the Healthcare Common Procedure Coding System (HCPCS), locking in a rate of US$4300 (A$6600) per device.
NeuroNode is a wearable, watch-like, wireless non-invasive electromyography (EMG) or spatial sensor device to assist people with physical disabilities perform everyday functions. Notably, this includes sufferers of cerebral palsy or motor neurone disease.
Control Bionics said the US HCPCS reimbursement code laid the foundation for continued growth in the US, its largest addressable market. Discussions with multiple potential distribution partners in the US are well advanced.
Control Bionics' Neuro Elite Athletics program NeuroBounce continues to gain commercial traction, diversifying its EMG technology into the sports performance market.
Control Bionics has launched NeuroBounce in Australia with all five athletes in the initial four-week program improving their vertical jump height, with one recording an increase of 14 centimetres.
Meanwhile, the company's NeuroNode device continues to gain traction in global markets. Following adoption within the UK's National Health Service (NHS), Control Bionics is now in active partnership discussions in both Europe and the US as it builds out its distribution-only strategy.
In its NeuroStrip product line, Control Bionics has begun collecting EMG-labelled data from athletes and rehabilitation facilities with its development team now assessing opportunities to incorporate AI solutions to automate elements of the system.
NeuroStrip hardware is now in use in both Australia and the US, with clinical evaluations underway across several areas.
With growing international interest, expanding product lines, and a clear focus on commercialisation, Control Bionics said it had entered FY26 with strong momentum and multiple catalysts for further growth.
Alterity Therapeutics (ASX:ATH)
CEO and managing director Dr David Stamler said US Food and Drug Administration (FDA) fast track designation for ATH434 in multiple system atrophy (MSA) was the highlight of the recent quarter that also featured additional positive clinical data from its Phase 2 double-blind trial.
"Receiving fast track designation alongside the orphan drug designation we have already received underscores the promise of this potentially disease-modifying therapy to address the urgent needs of individuals with MSA," he said.
"In addition, we presented additional efficacy data from the ATH434-201 double-blind trial at prominent medical meetings, including slowing of disease progression on the Unified MSA Rating Scale or UMSARS, improvement in key symptoms of MSA, and preserved activity in the outpatient setting."
Following quarter end Alterity this week announced positive results from its ATH434-202 open-label phase II clinical trial, in which ATH434 demonstrated a clinical benefit on the UMSARS and global assessments of neurological symptoms.
Neuroimaging biomarkers showed target engagement and slowed brain atrophy in a manner consistent with the double-blind study findings with ATH434 continuing to demonstrate a favourable safety profile.
"These data reinforce our confidence in the MSA program as we prepare for interactions with the US FDA," Stamler said.
Alterity's cash position on June 30 was $40.66m, with operating cash outflows for the quarter of $2.35m.
Neurotech International (ASX:NTI)
Positive human PK study results for NTI164 released in June following preclinical toxicology results in May
Data from Rett Syndrome program presented at the International Rett syndrome Foundation (IRSF) Annual Scientific Meeting
Neurotech initiated formal engagement with US FDA in preparation for lodging an investigational new drug (IND) application in FY26
Neurotech's June quarter was marked by important clinical progress, growing international recognition, and further regulatory engagement for its lead investigational therapy NTI164, a proprietary CBDA-rich cannabinoid formulation being developed for paediatric neurological and inflammatory brain disorders.
The company completed its first-in-human pharmacokinetic (PK) study. Conducted in healthy adult volunteers, the study confirmed that NTI164 is rapidly and predictably absorbed, with CBDA reaching peak plasma levels within 2–4 hours and emerging as the dominant circulating cannabinoid.
Neurotech said the results validated NTI164's systemic stability, safety, and potential suitability for paediatric use.
The PK study builds on preclinical toxicology results released in May, which demonstrated excellent tolerability in rats and dogs under GLP conditions.
Neurotech also presented data from its Rett syndrome program at the International Rett Syndrome Foundation (IRSF) Annual Scientific Meeting in Boston.
Following the quarter, Neurotech announced that results from its phase I/II open-label clinical trial in Rett syndrome had been published in the Journal of Paediatrics and Child Health, a peer-reviewed scientific journal.
Neurotech continued to progress its dual regulatory pathway strategy in Australia and the US during the quarter. In Australia, the company is moving toward potential product registration with the therapeutic Goods Administration (TGA) and is exploring expedited approval options to support timely market entry.
The company has initiated formal engagement with the FDA in preparation for lodging an investigational new drug (IND) application in FY26.
In June, Neurotech appointed leading US clinician Dr Bonni Goldstein as chief medical advisor USA, who has more than 25 years of clinical experience, including 17 years specialising in cannabinoid-based medicine.
Goldstein is internationally recognised as a pioneer in paediatric cannabinoid therapy and brings key expertise as NTI164 progresses its development pathway.
Also in June, CEO Dr Anthony Filippis attended the BIO International Convention in Boston as Neurotech continues to elevate its global profile and explore partnering and funding opportunities.
Neurotech placed its wholly owned subsidiaries AAT Medical Ltd and AAT Research Ltd, responsible for the Mente neurofeedback device, into voluntary liquidation. The move reflects the company's focus on advancing NTI164.
Operating cash outflows for the quarter were $2.6m, primarily driven by R&D expenditure supporting its FDA IND and TGA submissions, as well as clinical trial extension costs.
Neurotech ended the period with $3m in cash and expects reduced outflows in Q1 FY26. A ~$3m R&D tax refund is anticipated in Q1 or early Q2 FY26 to further bolster cash reserves.
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