ASX Quarterly Medtech Wrap: Strong growth, fresh capital and key milestones

• Control Bionics reports strong growth with cash receipts up $1.68 million
• PainChek achieves key milestones with its digital pain assessment device 
• Optiscan undertake ~$18 million placement during Q1 FY26 to progress product development

ASX-listed medtech companies have been rolling out their latest quarterly results, showing solid progress across key areas for the start of FY26.

From achieving regulatory milestones to advancing clinical programs and bolstering their balance sheets, Australia’s medtech innovators are poised for growth in the year ahead.
 

Control Bionics (ASX:CBL)

• Cash receipts of $1.68 million, up 24% with revenue up ~10% on previous corresponding period
• US and global distribution of NeuroNode progresses during quarter with decision expected before end of CY25
• US reimbursement for NeuroNode now covers 70% of the population, supporting FY26 sales growth

Control Bionics reported a start to FY26 with cash receipts for Q1 totalling $1.68 million, up 24% on the previous corresponding period (pcp) and marking the second highest quarter on record.

Group revenue grew ~10% in Q1 FY26 as the company progressed multiple options for the US and global distribution of its flagship NeuroNode device during the quarter with final decisions expected before the end of 2025.

NeuroNode is a wearable, watch-like, wireless non-invasive electromyography (EMG) and spatial sensor device to assist cognitive people with physical disabilities perform everyday functions.

The company said reimbursement for NeuroNode is now available in US states covering more than 70% of the population, providing a strong foundation for continued sales growth in FY26.

The company is encouraged by the growing application of its technology and take up of its miniaturised EMG device NeuroStrip.

Weighing less than a piece of paper, the wearable NeuroStrip measures physiological data such as unintentional muscle movements and expands the company’s market from disabilities to the sports science, occupational health and rehabilitation sectors.

Control  Bionics said multiple groups in sports performance and rehabilitation, in both the US and Australia, are currently using—or will soon be using—NeuroStrip technology.

NeuroStrip device and consumables will start in December 2025 quarter to support increasing demand.

The company raised ~$1.5m via a rights issue during the quarter. In October it was announced a further $600,000 was raised from a placement of the shortfall. An R&D tax refund of ~$480,000 for its spend in FY25,  further strengthens the company’s cash position.

PainChek (ASX:PCK)

• Post-quarter PainChek receives US FDA approval for its pain assessment device for people living with dementia in long-term care
• Sales of the PainChek Infant App have started in Australia, targeting a global $15 billion annual market
• PainChek establishes a Canadian headquarters in Edmonton Metropolitan Region of Canada

Post-quarter in October PainChek became the first and only regulated medical device in the US to assess pain in people living with moderate to severe dementia in long-term care.

The company announced on October 8 PainChek Adult had received US Food and Drug Administration (FDA) De Novo (new device) classification opening the door to the $175m annual US long-term care market.

The company has potential to reach $582m annual opportunity across home care and hospital sectors through the 510(k) clearance route.

Within days of FDA clearance, PainChek secured its first US commercial deal with a New Jersey-based long-term care facility, marking the start of its US rollout.

A growing pipeline of US sales opportunities has been further qualified, supported by engagement with sales and marketing consultants at a key conference in Las Vegas.

PainChek now has 115,770 contracted licences across more than 1,900 aged care facilities in Australia, New Zealand and the UK generating an ARR of $5.6m once fully implemented,  up 15.4% on the prior year and 4.4% on Q4 FY25.

Of these, 71,751 licences are implemented, producing ARR of $3.5m a 16% increase on the prior year with customer retention remaining strong at more than 85%.

Sales of the PainChek Infant App have started in Australia, targeting a global $15 billion annual market. A new head of growth Sasha Grant has been appointed to drive this segment.

During the quarter the company announced successful completion of the Scottish Care Inspectorate pilot and the InterSystems integration and implementation pilot at Edinburgh Royal Infirmary.

It also launched its North American headquarters in Edmonton Metropolitan Region of Canada.

Cumulative PainChek pain assessments have reached 14.6 million, up 97% on the previous year.

Cash reserves stood at $6.3 million at the end of Q1 FY26 with customer receipts of $1m and unaudited revenue of $849,000 for the quarter.

Optiscan (ASX:OIL)

• Optiscan undertakes ~$18 million capital raise during quarter to progress next development phase
• Company images its first patient for breast cancer study at the Royal Melbourne Hospital, using InVue and Inform devices
• Veterinary device InSpecta also advancing, with first imaging invivo and ex vivo sets in dogs

Optiscan successfully raised ~$18m during Q1 FY26 through a fully underwritten pro-rata renounceable entitlement offer, supported by substantial shareholder Peters Investments.

Optiscan has pioneered the world’s first miniaturised confocal microscope that allows doctors, pathologists and veterinarians to see living tissue at sub-cellular resolution in real-time with funds raised primarily supporting clinical and regulatory activities for its three devices including  InVue, InForm, and InSpecta.

During the quarter, the company marked a key operational milestone by imaging its first patient for the breast cancer study at the Royal Melbourne Hospital, using its InVue and InForm devices.

Regulatory documentation, testing, and certification for these devices are continuing, in preparation for rollout in US-based clinical studies.

Optiscan’s veterinary device, InSpecta is also advancing both clinically and commercially, with the company focused on scaling adoption in the veterinary sector.

The Optiscan team conducted an onsite visit at the Arizona Animal Hospital and completed the first InSpecta in vivo an ex vivo imaging sets in dogs.

Financially, the company reported cash receipts from customers of $139,000 for the quarter, up on the previous two quarters.

The company is looking to strengthen its clinical evidence as it prepares for FDA regulatory submission over the coming 12 months.

“The first quarter of Optiscan’s FY26 has been eventful, both from a financial and operational perspective, ” CEO and managing director Dr Camile Farah said.

EMvision Medical Devices (ASX:EMV)

• Recruitment gains momentum for pivotal trial of EMVision’s first device emu to rapidly detect and differentiate types of strokes
• Progress made on second device First Responder to detect strokes and traumatic brain injury 
• Company raises $12 million, receiving strong support from new and existing institutional and sophisticated investors

Recruitment gained momentum during the quarter for the EMVisions pivotal (validation) trial for its first device emu – a portable brain scanner designed to rapidly detect and differentiate types of stroke at the bedside.

Running alongside the pivotal trial is the Continuous Innovation Study, aimed at delivering valuable insights for ongoing AI algorithm training and additional feature development.

Progress is also being made on EMVision’s second product First Responder, a portable device to detect strokes and traumatic brain injury First Responder.

Ethics approvals were secured for First Responder for both the Royal Flying Doctor Service (RFDS) Aeromedical Study and the Mobile Stroke Unit (MSU) Workflow and Data Collection Study in Melbourne, with the MSU study now underway.

The company was awarded a $3m Cooperative Research Centres Projects (CRC-P) non-dilutive grant to evaluate the impact of an expedited stroke care model enabled by a telehealth-integrated emu device in regional hospitals.

Financially, the company successfully raised $12 million via a placement, receiving strong support from  new and existing institutional and sophisticated investors.

The business remains well-funded, with cash reserves of $18.35m as at 30 September 2025. In addition, an oversubscribed $2 m share purchase plan closed post quarter.

A further $7.4m in non-dilutive funding is available under current grant programs while the company is finalising its FY25 R&D tax incentive rebate.

At Stockhead, we tell it as it is. While Control Bionics, PainChek, Optiscan and EMVision Medical Devices are Stockhead advertisers, the companies did not sponsor this article.