Key Highlights

  • Control Bionics has received US Medicare PDAC coding verification for two UnoTouch Omni speech generating device models
  • The devices have been assigned HCPCS code E2510, carrying a fee schedule allowable of up to US$9,645.69 per device
  • A non-binding Letter of Intent is in place with a US launch customer for up to 1,000 devices over the first 12 months, alongside a US$100,000 advance payment already received
  • The company has targeted first US Revenue from the UnoTouch Omni range for September 2026

Control Bionics Limited (ASX:CBL) has announced that its US subsidiary, Control Bionics Inc., has received Healthcare Common Procedure Coding System (HCPCS) coding verification from the Pricing, Data Analysis and Coding (PDAC) Contractor for its UnoTouch Omni range of Apple iOS-based speech generating devices. The devices are commercialised under the company's exclusive licence agreement with NextLevel Assistive Technology, announced on 26 February 2026.

Since 1 June 2016, only products for which the PDAC Contractor has issued written coding verification and which appear on the Product Classification List may be billed to Medicare under HCPCS code E2510. Without that verification, claims submitted under the code are denied as incorrectly coded. Coding verification therefore removes the final regulatory obstacle to selling the devices into the US market and allows Control Bionics' distribution partners to submit claims through their existing Medicare, Medicaid and private payer billing workflows.

Reimbursement Value and Market Sizing

The UnoTouch Omni devices have been assigned code E2510, which the company describes as the highest allowable among Medicare's speech generating device base codes and the broadest and highest-value code in the device family, reflecting devices capable of multiple message-construction and multiple access methods. Under the 2026 Medicare Durable Medical Equipment, Prosthetics, Orthotics and Supplies fee schedule, the code carries a national allowable of up to US$9,645.69 for a new device purchase. Control Bionics clarified that this allowable amount is payable to the accredited durable medical equipment supplier that dispenses the device, and is not the company's own revenue per unit; under its licence arrangement with NextLevel, Control Bionics instead sells to distribution partners on wholesale terms and receives a fixed per-device contribution margin, with NextLevel funding device tooling and manufacturing.

The company estimates annual US speech generating device volumes at approximately 55,000 to 65,000 units, with tablet-based devices representing 60 to 70% of new prescriptions, equating to an iOS-based Market Segment estimated at US$100 million to US$150 million annually. Control Bionics' initially contemplated volumes of 1,000 to 1,500 devices per annum represent a small proportion of that addressable market.

Launch Customer Commitment and Route to Market

Control Bionics disclosed that a non-binding Letter of Intent is in place with a US launch customer for up to 1,000 devices over the first 12 months, alongside a US$100,000 advance payment already received. The company confirmed it will not pursue a direct-to-consumer or retail model for the UnoTouch Omni range, instead supplying devices wholesale to its established US distribution partners, which hold the payer contracts, accreditation and clinical service infrastructure required to dispense funded devices at scale. This approach is intended to require no incremental Capital Investment or Manufacturing risk from Control Bionics.

Conclusion

With Medicare coding verification now secured, Control Bionics has cleared the final regulatory prerequisite standing between the UnoTouch Omni range and the US reimbursement system, positioning the company to commence first device sales through its distribution network in September 2026. The wholesale-only route to market, combined with the existing launch customer commitment, is intended to allow the company to pursue sales growth in the assistive communication market without directly bearing manufacturing or retail distribution costs.