Control Bionics Gets TGA Approval For Autonomous Wheelchair Module

Control Bionics Ltd (ASX:CBL) has announced that its autonomous wheelchair module, DROVE, has been officially included as a Class 1 Medical Device in the Australian Register of Therapeutic Goods.

This significant milestone follows almost 12 months of testing, ensuring the safety and effectiveness of the mobility solution.

DROVE is an autonomous wheelchair module that allows powered wheelchair users to operate their wheelchairs independently in their own homes.

Next steps

With the inclusion in the register, Control Bionics can now commence commercial sales of the DROVE module in Australia.

Control Bionics said that the official launch of DROVE will take place in the coming weeks.

Revenue growth opportunity

Control Bionics CEO Jeremy Steele said: “This is a fantastic confirmation of the quality of our DROVE solution.

“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.”

Funding for growth

Last month, Control Bionics secured firm commitments to raise A$1.04 million via the issue of shares at A$0.043 each.

Read: Control Bionics Bags A$1.04M To Expand Assistive Technology Solutions

The placement was strongly supported by new investors and existing shareholders.

This new funding will assist the company in achieving its global growth strategy with a focus through FY25 as follows:

  • Grow each of the 3 operating businesses (US, Australia, Japan) such that the selling operations in each market are EBITDA positive.
  • Build NeuroNode (patented wireless wearable device) business globally.
  • Deliver first commercial sales of DROVE autonomous wheelchair controller.
  • Identify and execute on opportunities to more rapidly scale Control Bionics.
  • Commercialise the NeuroStrip and associated app.


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