New Non-Invasive Treatment Significantly Reduces Excessive Underarm Sweating and Significantly Improves Quality of Life – Including Reducing the Negative Impact of Excessive Sweating on Daily Activities – After a Single In-Office Treatment
FDA Clearance Based on Data from Randomized, Double-Blind, Multicenter Pivotal SAHARA Study Demonstrating Brella is Effective and Well Tolerated
Brella-Treated Participants Maintained Sweat Reduction for Three Months and Longer in Some
NASHVILLE, TN, April 13, 2023 – 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.2
“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 low3 and 80% of consumers are seeking new treatments to manage excessive underarm sweat.4 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.”