Control Bionics’s shares surge after TGA approval
Control Bionics (ASX:CBL) surged by 51% this morning after announcing a TGA approval for its DROVE autonomous wheelchair module.
DROVE has now been officially classified as a Class 1 Medical Device in the Australian Register of Therapeutic Goods.
This achievement follows rigorous testing over nearly a year, and the inclusion in the register now allows Control Bionics to commence commercial sales of the DROVE module in Australia.
The company anticipates the official launch of DROVE in the coming weeks.
DROVE, designed and manufactured in Australia, represents a global first in its category.
The technology aims to empower users of powered wheelchairs with unparalleled independence and ease of use within their homes. The module seamlessly integrates with existing wheelchair systems, enabling autonomous and safe navigation in various environments.
CEO Jeremy Steele commented: “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.”
Work is now 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,” Steele said.
Botanix Pharma granted US FDA approval
Meanwhile, Botanix Pharma (ASX:BOT) said the US FDA has granted approval for its Sofdra (sofpironium) gel, 12.45%.
Sofdra is now the first and only chemical entity approved specifically to treat primary axillary hyperhidrosis, commonly known as excessive underarm sweating, in both adults and children aged 9 years and older.
This FDA approval addresses a significant medical need, as approximately 10 million people in the US suffer from primary axillary hyperhidrosis, yet effective treatment options have been limited.
The approval of Sofdra was supported by compelling data from two pivotal Phase 3 studies involving 701 patients with primary axillary hyperhidrosis.
Botanix now plans to roll out its patient experience program starting in Q3 of this year, with the expectation of generating initial revenue from Sofdra in early Q4.
Sofdra’s approval signifies a breakthrough in dermatological care.
“We are very excited to provide a new option for the 10 million patients with primary axillary hyperhidrosis in the United States,” said Botanix’s CEO, Vince Ippolito.
“As the first and only new chemical entity, Sofdra represents a new therapeutic approach for dermatologists to treat patients with this disabling medical condition.”
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