Candesant Biomedical (Candesant) has received de novo approval from the US Food and Drug Administration (FDA) for its three-minute SweatControl Patch, Brella.
Brella is designed to treat adults with primary axillary hyperhidrosis, a condition that causes excessive sweating of the underarms.
Claimed to be the first three-minute sweat control patch, Brella offers a new in-office approach to sweat control that is fast and non-invasive.
The needle-free, aluminium-free Brella SweatControl patch delivers results that can last for three to four months.
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 low and 80% of consumers are seeking new treatments to manage excessive underarm sweat.”
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The approval is based on results from a randomised, double-blind, multicentre pivotal study named SAHARA. The study, which involved 110 adult patients, showed the efficacy and tolerance of Brella.
A healthcare provider placed the single-use disposable patch on the patient’s underarm for three minutes. The patch features a sodium sheet with an adhesive overlay and utilises the company’s targeted alkali thermolysis technology.
The sodium sheet generates localised thermal energy to micro-target sweat glands to significantly cut down sweat production.
Brella will be launched in select US markets in the second half of this year via the Candesant Brella Early Experience Programme, in which the product will then be made available across the country.
International Hyperhidrosis Society founding board member Dee Anna Glaser said: “I’m excited to offer my patients the Brella SweatControl Patch because the data is impressive and shows Brella has the potential to set a new standard of care that is simple and fast to administer, with no needles or downtime and fits easily into a patient’s in-office treatment regimen.”