Medicare Billing Code Secured for NextLevel Speech Devices

Key points

• Medicare PDAC coding verification granted for UnoTouch Omni range
• Devices assigned HCPS code E2510, highest allowable among Medicare's SGD base codes
• Non-binding Letter of Intent in place with a US launch customer for up to 1,000 devices

Full summary

Control Bionics Limited (ASX: CBL) has received Healthcare Common Procedure Coding System (HCPCS) coding verification for its UnoTouch Omni range of Apple iOS-based speech generating devices (SGDs) from the US Pricing, Data Analysis and Coding (PDAC) Contractor. This verification allows the devices to be funded through the US reimbursement system, clearing the way for US sales to commence. The devices have been assigned the HCPCS code E2510, the highest allowable among Medicare's speech generating device base codes, with a fee schedule allowable of up to US$9,645.69 per device. Control Bionics has also secured a non-binding Letter of Intent with a US launch customer for up to 1,000 devices in the first 12 months, with a US$100,000 advance payment received.

Guidance

First revenue targeted for September 2026

Outlook

Control Bionics plans to support its launch customer's rollout plans, with potential for further market share growth.