Candesant gets FDA approval for disposable sweat control patch-Brella
14 Apr 2023
Clinical ResultDrug Approval
Brella is a single-use disposable patch, developed using the company’s patented targeted alkali thermolysis (TAT) technology, to reduce excessive underarm sweating in adults with primary axillary hyperhidrosis
Brella SweatControl Patch. (Credit: PRNewswire/Candesant Biomedical)
Candesant Biomedical, a medical device company focused on hyperhidrosis (excessive sweating), has received the US Food and Drug Administration (FDA) approval for its Brella SweatControl Patch.
Brella is a single-use disposable patch, applied to a patient’s underarm for up to three minutes, to reduce excessive underarm sweating in adults with primary axillary hyperhidrosis.
Candesant has developed its three-minute SweatControl Patch using its novel, patented targeted alkali thermolysis (TAT) technology.
The company’s patented TAT technology is based on the scientific principle of heat generation when sodium comes in contact with water.
Brella SweatControl Patch contains a sodium sheet with an adhesive overlay, where heat is generated when water in the sweat touches the sodium sheet.
The generated thermal energy is localised to precisely target the sweat glands to significantly reduce sweat production.
Brella provides a new, rapid, non-invasive, needle-free, aluminium-free, and low-cost in-office approach to sweat control with results lasting three to four months.
It is the first clinical application to utilise the well-established property of sodium and is the only patented medical device based on this principle, said the medical device company.
Candesant founder and CEO Niquette Hunt said: “FDA clearance of Brella represents a significant advance for millions of people dealing with the physical, emotional, financial, and aesthetic impact of hyperhidrosis, or sweating beyond what’s needed to keep the body cool.
“Satisfaction with current treatments is low3 and 80% of consumers are seeking new treatments to manage excessive underarm sweat.
“Brella provides a new option for a common condition that curtails activities, stains clothes, causes frustration and embarrassment, undermines confidence, and has been inadequately treated for far too long.”
The US FDA approval of Brella is based on the results of SAHARA, a randomised, double-blind, sham-controlled, multicentre clinical study in 110 adults with primary axillary hyperhidrosis.
In the study, the participants were given bilateral treatment with Brella or a sham patch for up to three minutes for each underarm, and were evaluated weekly for weeks 12 after treatment.
The study achieved its primary and secondary endpoints, and Brella was well tolerated with no serious or severe adverse events reported, said the medical device company.
Candesant intends to commercialise Brella SweatControl Patch in select US markets, starting in late summer of 2023, through its Brella Early Experience Programme.
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