Strong growth boosts Control Bionics’ US revenue in H1 FY25

• Control Bionics reports US revenue for H1 FY25 should exceed prior corresponding period by more than 15%
• The company is moving to diversify revenue beyond augmentative and assistive communication
• It anticipates positive EBITDA for December – typically its strongest month

Special Report: Assistive technology medical device company Control Bionics Limited has provided a positive trading update for H1 FY25, driven by robust trading in the US during the second quarter of the fiscal year.

Control Bionics Limited (ASX:CBL) said it anticipates its US revenue for H1 FY25 will exceed the prior corresponding period by more than 15% with revenue in H2 CY24 likely to be almost 30% higher than H1 CY24.

Control Bionics has attributed the growth to increased demand for its solutions, the benefit of a US Medicare reimbursement code in the US for its flagship device NeuroNode and growing market penetration.

NeuroNode is a wearable wireless, non-invasive electromyography (EMG) or spatial sensor device to assist cognitive people with physical disabilities – notably sufferers of cerebral palsy or motor neuron disease – to perform everyday functions.

The device was approved by the US Food and Drug Administration (FDA) in 2020.

Earlier this month the company announced NeuroNode was attributed the US Medicare reimbursement code E2513 under the Healthcare Common Procedure Coding System (HCPCS), locking in a rate of US$4300 (A$6600) per device.

The company said sales have also been boosted by a significant new customer – a US university – which made the first of what it expects will be meaningful orders for its US subsidiary.

Control Bionics noted it expects to generate positive EBITDA for December in the US – typically its strongest month in the American market.

Australian revenue trends encouraging despite NDIS challenges

Control Bionics said National Disability Insurance Scheme (NDIS) approvals remain inconsistent and well outside service guarantee timelines.

The company noted it currently has almost $1.2 million either with the NDIS for approval, or shortly with it for approval, with the Australian government promising to resolve processing issues by early 2025.

Despite these challenges, Control Bionics said Australian revenue trends were encouraging, with revenue in H2 CY24 expected to grow over 20% compared to the first half.

“This growth underscores the resilience of our sales efforts and client engagement strategies,” the company said.

Driving DROVE progress in Australia and US

Control Bionics is also driving forward growth plans for its autonomous wheelchair DROVE.

Four demonstration sites are now operational across Australia for DROVE, which the company said enables users to navigate around their house independently, without the need for a joystick, mouse or keyboard.

The sites provide potential clients and clinicians with hands-on opportunities to experience the capabilities of DROVE in real-world settings.

Control Bionics has also inked its first distribution partnership with Motion Specialities in Queensland for DROVE, which it said marks a significant milestone in expanding its reach and customer accessibility.

The company said initial NDIS funding applications for DROVE are progressing, laying the groundwork for further commercialisation.

In the US, Control Bionics is finalising a partnership with Cleveland Metro Health as its clinical trial partner for FDA approval for the autonomous wheelchair.

The company emphasised that the partnership represents a critical step in advancing DROVE towards regulatory milestones and market readiness and noted it remains on target to submit an FDA application by mid-2025.

Diversifying revenue streams

Control Bionics is continuing to evolve its growth strategy and is moving to diversify its revenue into areas outside of augmentative and assistive communication.

The company is also looking to trim costs in the US with an annualised benefit of ~$700,000, and is forecasting to see the full benefit of these reductions in H2 FY25.

Control Bionics is currently commercialising its most recent advancement in its technology, the NeuroStrip.

The wearable, miniaturised EMG device provides CBL with the opportunity to enter new markets such as health diagnostics, sports performance and rehabilitation.

The company this week announced it had entered two strategic agreements with industry leaders to expand the presence of NeuroStrip into the high-growth US sports performance and Japanese neurological rehabilitation markets.

This article was developed in collaboration with Control Bionics, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.