Control Bionics (ASX:CBL) Lands Medicare Billing Code for OMNI Device and Launches NeuroStrip in Three Markets

Aditi Sarkar

29 October 2026 01:31 PM AEDT

Control Bionics (ASX:CBL) Lands Medicare Billing Code for OMNI Device and Launches NeuroStrip in Three Markets

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Highlights

Control Bionics secured a Medicare PDAC code for its NextLevel OMNI device on 27 August 2026, with first US shipments and revenue in September.
NeuroStrip received FDA and UK MHRA registration in August 2026 and CE marking after quarter-end, with four paying customers and 30 live trials across 80 organisations.
The company completed a A$9.75 million capital raising and repaid a $400,000 Phoenix Development Fund loan, and says it is funded through FY27 without a further raise.
FY27 revenue growth of 50% on FY26 was reaffirmed, weighted to the second half, with the assistive communication business expected to achieve monthly profitability in the first half.

A reimbursement code, three market launches and a capital base to see the year through — Control Bionics (ASX:CBL) used its September quarter to clear a string of commercial hurdles simultaneously. The NextLevel OMNI device is now billable under Medicare in the United States, NeuroStrip is registered across the US, UK and Europe, and the company says it is funded through FY27 without another capital raise. The quarter's momentum builds on a deliberate strategy of opening multiple channels at once — reimbursement, new products and new geographies — rather than relying on a single market.

Medicare Code Opens the OMNI Market

The NextLevel OMNI device secured a Medicare PDAC billing code on 27 August 2026, with first US shipments and revenue recorded in September. CBL expects higher OMNI volumes from October onwards as the reimbursement pathway becomes available to more US providers. PRC-Saltillo trained nine more consultants for NeuroNode during the quarter, and Tobii Dynavox extended its NeuroNode rollout into additional US states. A NeuroNode distribution agreement with Tobii Dynavox GmbH in Germany was launched on 23 September, opening a third international market for the product.

The company reports that unaudited revenue grew each month of the quarter and was ahead of the June quarter, with the improving trend described as driven by the US assistive communication business. No aggregate quarterly revenue figure was disclosed.

NeuroStrip Launches Across Three Regions

NeuroStrip was registered with the US FDA and UK MHRA in August 2026 and received CE marking in Europe after quarter-end, opening the EU market. A TGA application for Australian registration is pending. At 30 September 2026, approximately 80 organisations were engaged, approximately 30 were in live trials and four were paying customers. The device recorded 282 customer sessions during the quarter across 28 organisations — an early-stage commercial footprint that provides a foundation for conversion.

The US launch of a NeuroStrip prehabilitation programme is planned for November 2026, with first cohort conversion outcomes expected in the December quarter. The path from trials to paying customers is a key watchpoint for the FY27 revenue target.

Capital Position and FY27 Targets

Tranche 2 of the A$9.75 million raising, comprising 96.7 million shares including director participation, was approved at the general meeting on 6 August 2026 and settled on 11 August. The company repaid a $400,000 Phoenix Development Fund loan on the same date, removing a near-term obligation.

Closing cash was $5.79 million. Operating outflow was $2.75 million for the quarter, though the company notes about $800,000 of those payments are not expected to recur in FY27. An R&D tax refund of $440,531 received in early October is not captured in the quarter-end figure, providing a post-quarter cash boost.

The company reaffirmed FY27 revenue growth of 50% on FY26, weighted to the second half, with its assistive communication business expected to achieve monthly profitability in the first half. Australian NDIS approval timeframes remain extended, though August was the strongest month for approvals in twelve months. These are management forecasts dependent on regulatory, reimbursement and customer outcomes, not guaranteed results.

Next Milestones

Upcoming items include Apple brain-computer interface support via an upgraded NeuroNode app in the second quarter of FY27, the NeuroStrip prehabilitation US launch in November, first cohort conversion data in the December quarter and a pending TGA decision for Australian registration.

Related-party payments were $242,199 for the quarter, including a $97,500 short-term incentive for the chief executive. The source document notes a likely typographical inconsistency, describing the Phoenix loan repayment as $0.04 million in one place where the underlying loan amount indicates $0.4 million.

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