The Centers for Medicare & Medicaid Services has approved a new Healthcare Common Procedure Coding System code for the NeuroNode, patent technology by Control Bionics (ASX: CBL). 

This approval, effective from 1 October 2024, introduces a reimbursement rate of US$4,300 for the NeuroNode, a significant enhancement from the previous reimbursement conditions.

Control Bionics is a medical device company dedicated to helping patients with compromised communication abilities due to illnesses like Motor Neurone Disease and Amyotrophic Lateral Sclerosis enabling them to communicate verbally or via text and social media.

The newly established HCPCS Level II code, E2513, labelled “Accessory for speech generating device, electromyographic sensor,” recognises the advanced functionality of NeuroNode as a cutting-edge augmentative and alternative communication device. Unlike conventional input devices such as joysticks and buttons, the NeuroNode utilises electromyographic signals and 3D spatial movements to provide precise control over speech generating devices. This new code not only improves the reimbursement process but also facilitates easier claim processing and broader patient access to this transformative technology.

This strategic approval represents a substantial opportunity for Control Bionics. It aligns with the Company’s previously outlined ‘NeuroNode Only’ strategy, which focuses on expanding the US market through a wholesale distribution model. The approval is anticipated to boost the company’s operations in the US and drive significant growth. 

Historically, if this code had been in effect from 1 July 2023, it could have contributed an additional USD $400k  in revenue for FY24, with all proceeds potentially flowing directly to EBITDA. Moreover, this development is expected to enhance sales through existing sales channels, as well as create an addressable market worth approximately USD $30 million for ALS and Cerebral Palsy patients alone.

The NeuroNode is a Class I medical device designed to offer non-invasive, EMG-mediated communication and control for individuals with severe motor and speech impairments, including those with Amyotrophic Lateral Sclerosis, cerebral palsy, spinal muscular atrophy, and certain traumatic brain injuries. By detecting subtle EMG signals or 3D spatial movements, NeuroNode enables users to issue precise commands to their AAC devices, providing a vital communication solution for those unable to use traditional input methods.

The Medicare benefit categorises NeuroNode under the Durable Medical Equipment benefit, with the Medicare Fixed fee for this device set at US$4,299.75. This change represents a significant improvement over the previous general ‘Accessories’ code, which resulted in reduced margins and less favourable reimbursement conditions.

As Control Bionics moves forward, the Company will initiate negotiations with private insurers to include the NeuroNode as an in-network device, with reference to the new HCPCS code. The process of securing these agreements may be lengthy due to the complexities of the US healthcare system. However, the introduction of the new HCPCS code marks a pivotal moment in Control Bionics’ efforts to enhance accessibility and expand its market presence.

Jeremy Steele, CEO of Control Bionics, commented, “The new HCPCS code for NeuroNode is a significant milestone, not just for Control Bionics but for the countless individuals who rely on our technology to communicate and regain control of their lives. This recognition will greatly enhance accessibility, making it easier for patients to obtain the necessary support and devices through their insurance provider.

“This new code validates the groundbreaking innovation behind NeuroNode and positions Control Bionics for accelerated growth. It will expand our market reach and drive our mission to enhance communication and independence for those with severe disabilities.”

For the June 2024 quarter, CBL reported $968k in cash receipts. This contributed to a negative operating cash flow of $1.3 million bringing the 12-month year-to-date operating cash outflow to $4.1 million. 

As of June 30, 2024, the Company had $1.06 million in cash on hand.