Candesant Biomedical, a medical device company focused on non-invasive treatments for hyperhidrosis, announced that its patented technology, Brella, has been granted FDA clearance as the first and only 3-Minute SweatControl Patch for reducing excessive underarm sweating in adults with primary axillary hyperhidrosis.
Hyperhidrosis, or excessive sweating not related to heat or exercise, affects approximately 5% of Americans, and is believed to be underreported and underdiagnosed. This condition curtails activities, stains clothes, causes frustration and embarrassment, undermines confidence, and has been inadequately treated for far too long.
Brella is a sodium sheet with an adhesive overlay, a single-use disposable patch that healthcare providers apply to the patient’s underarm for up to three minutes. Its mechanism of action 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 fast, non-invasive, needle-free, aluminum-free, and affordable, with results lasting three to four months. The patch provides a new in-office approach to sweat control that is simple and fast to administer, with no needles or downtime, and fits easily into a patient’s in-office treatment regimen.
FDA clearance of Brella is based on the data from the randomized, double-blind, multicenter pivotal SAHARA study, which enrolled 110 adult subjects with primary axillary hyperhidrosis. Study participants had baseline Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4, indicating their sweating frequently or always interferes with their daily activities. The participants underwent bilateral treatment with Brella or a sham patch for up to three minutes for each underarm, and were evaluated weekly for 12 weeks post-treatment, with responders followed for up to 24 weeks post-treatment.
The results of the SAHARA study demonstrated that Brella is effective and well-tolerated, with treated participants maintaining sweat reduction for three months and longer in some cases. The study achieved its primary and secondary endpoints, including significantly reducing sweat production and improving the quality of life for those affected by excessive sweating.
“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.”
“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 in the late summer of 2023 through the Candesant Brella Early Experience Program.