Rosenman Portfolio, Candesant Biomedical’s Brella™ technology, is the first of its kind to receive FDA clearance

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Candesant Biomedical’s Brella™ technology is the first of its kind to receive FDA clearance based on data from their study with 110 adults who experience excessive underarm sweating. Brella is a pioneering 3-minute sweat control patch designed to alleviate excessive underarm sweating and improve the quality of life of individuals day-to-day. Beginning this year, Brella will be available in select markets as the latest innovation in sweat control.
From the press release:

NASHVILLE, Tenn., April 13, 2023 /PRNewswire/ — Candesant Biomedical (“Candesant”), a private medical device company focused on the development and commercialization of non-invasive treatments for hyperhidrosis or excessive sweating not always related to heat or exercise, today announced the U.S. Food and Drug Administration (FDA) granted a de novo request for Brella™, the first and only 3-Minute SweatControl Patch™ for the reduction of excessive underarm sweating in adults with primary axillary hyperhidrosis. Brella uses Candesant’s novel, patented TAT (targeted alkali thermolysis) technology. The Brella 3-Minute SweatControl Patch provides a new in-office approach to sweat control that is fast, non-invasive, needle-free, aluminum-free, and affordable, with results lasting three to four months.

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,” said Niquette Hunt, Founder and CEO of Candesant. “Satisfaction with current treatments is low 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.”

About the Brella SweatControl Patch
Consisting of a sodium sheet with an adhesive overlay, the Brella SweatControl Patch is a single-use disposable patch applied to a patient’s underarm by a healthcare provider for up to three minutes. Its mechanism of action utilizes Candesant’s patented TAT technology, which is based on the scientific principle that heat is generated when sodium comes in contact with water in sweat. The thermal energy created by the sodium sheet is precisely localized, microtargeting sweat glands to significantly reduce sweat production. The Brella SweatControl Patch is the first clinical application to harness and target this well-established property of sodium and is the only patented medical device based on it.

“Patients with excessive underarm sweating struggle with treatment options that can be tedious, uncomfortable, and even ineffective,” said Dee Anna Glaser, MD, a leading dermatologist, expert in excessive sweating, and founding board member of the International Hyperhidrosis Society. “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.”

Brella will be available in select U.S. markets beginning late summer of 2023 through the Candesant Brella Early Experience Program, which will include healthcare providers with aesthetic practices focused on providing their patients with the latest innovations in sweat control and will be launched nationally following the Brella Early Experience Program.

To find out more about Brella, including when and where it will be available in the United States, visit Candesant Biomedical.