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TGA approves Control Bionic’s autonomous wheelchair for commercial sales after NDIS delays

So you’ve seen self-driving cars and drones, now gear up for an autonomous wheelchair that dispels the need for joysticks. In wheelchair users, atrophying muscles can make it challenging to use the joystick properly, thus losing control of their wheelchair. That’s where digitising the experience further helps. 

Medical device company Control Bionics (ASX: CBL)’s autonomous wheelchair module, DROVE, gives a wheelchair user greater independence. The device has been officially included as a Class 1 Medical Device in the Australian Register of Therapeutic Goods. This milestone follows almost 12 months of extensive internal and external testing. 

With this inclusion, Control Bionics can now kick off commercial sales for the DROVE module in Australia. The official launch of DROVE will take place in the coming weeks.

CEO Jeremy Steele said, “This is a fantastic confirmation of the quality of our DROVE solution. I am delighted for our team, who have worked for years to design, test and get this device registered. I am even more excited to be able to provide independence to Australians currently living with conditions that impact their ability to control their own wheelchair.”

Control Bionics assists patients whose communication ability is compromised by conditions such as Motor Neurone Disease (MND) and Amyotrophic Lateral Sclerosis (ALS). Its core patented NeuroNode technology is a wireless, wearable device that detects minute signals sent from the brain to any skeletal muscle, capturing EMG (Electromyography) output. This enables speech, email and texting. It recently expanded its offering to include mobility solutions with the launch of DROVE.

DROVE is designed and manufactured in Australia to provide powered wheelchair users with independence and ease of use within their own homes. This advanced module integrates with existing wheelchair systems, enabling users to navigate their environment autonomously and safely.

Users can select various access methods to select pre-defined destinations on its system. This removes the need for the acute and many joystick movements typically required to navigate tight corridors and doorways in a home. The system memorises the route and navigates it independently.  

DROVE has an advanced camera system that creates a virtual railway within the home, always staying within the carefully curated railway path. The twelve obstacle detection sensors on the ground level detect obstacles in the path. 

Steele added, “Work is also progressing well on a similar approval in the US with the FDA, supported by a grant from the ALS Association received earlier this year. We are encouraged by the revenue growth opportunity DROVE provides Control Bionics.”

In Q3 FY24, the Company received the first $299.9k from the ALS Association in the US to support the launch of DROVE in the US market. It spent $500,000 in R&D for the quarter, accelerating the development of DROVE and the NeuroStrip.

During the quarter, Control Bionics struggled to get things off the ground in Australia due to the significant delays by the NDIS (National Disability Insurance Scheme) in approving submissions for Assistive Technology. 

As per the Company, this frustrated many clients and suppliers in the industry, including CBL. The Australian team has about $0.6m of submissions with the NDIS awaiting approval, and a similar amount is due to be submitted to the NDIS in the coming months. However, with the TGA approval, things appear to have picked up pace.

Alinda Gupta

Alinda is a Business Reporter for The Sentiment

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