Control Bionics (ASX: CBL) has entered an exclusive US joint venture with NextLevel Assistive Technology for iOS-based speech-generating devices, a move that capitalises on the growing US AAC market.
The partnership focuses on the manufacturing and distribution of iOS-based speech-generating devices, specifically the UnoTouch Omni and Active models.
The arrangement is designed to be capital-light for Control Bionics. NextLevel Assistive Technology will fund all tooling and manufacturing costs.
For its part, Control Bionics will act as the FDA Manufacturer of Record and manage distribution channels.
Leveraging US AAC Market Potential
The joint venture targets initial annual volumes of 1,000–1,500 devices within the US addressable iOS Speech Generating Device (SGD) market.
The US market for speech-generating devices is substantial, with an estimated 55,000–65,000 units sold each year.
This market is estimated to be worth USD 100–150 million annually.
A significant trend in this market is the dominance of tablet-based SGDs, which account for 60–70% of all new prescriptions.
Control Bionics' role as the FDA Manufacturer of Record is pivotal for navigating US regulatory requirements.
The joint venture structure has been established with positive working capital dynamics, aiming to generate a fixed per-device contribution margin.
Expanding US Footprint
This new joint venture builds upon Control Bionics' ongoing efforts to expand its US footprint.
In January 2026, the company secured a distribution agreement with PRC-Saltillo for its NeuroNode device.
This was preceded by a six-month pilot program with Tobii Dynavox, also in January 2026, to evaluate a distribution partnership in northwestern US.
These strategic partnerships aim to increase the availability of Control Bionics' devices and leverage established distribution channels in the US.
The company also acquired full ownership of Neuro Elite Athletics in December 2025, integrating its NeuroBounce program with the NeuroStrip EMG platform to target growth in performance markets across the US and Australia.
Annual Performance and Funding
For the financial year 2025, Control Bionics reported record revenue of AUD 6.14 million.
Despite this growth, the company posted a net loss of AUD 6.11 million.
Cash reserves at year-end were AUD 0.59 million. To support its operations and growth initiatives, Control Bionics has continued to rely on capital raises and loans.
The company announced a rights issue in August 2025, aiming to raise up to AUD 2.06 million.
Outlook and Risks
The exclusive US joint venture with NextLevel Assistive Technology represents a capital-light expansion into a significant market, building on existing US distribution efforts.
However, successful execution hinges on converting preliminary agreements into sales and managing the company's ongoing funding needs, which remain a key investor concern.
