Candesant Biomedical Receives FDA Clearance of Brella™¹, the First and Only 3-Minute SweatControl Patch™, to Significantly Reduce Primary Axillary Hyperhidrosis (Excessive Underarm Sweating)

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, 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.²

Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9159151-candesant-biomedical-receives-fda-clearance-of-brella/

"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."

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.^5,6

"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.

About Hyperhidrosis or Excessive Sweating
Approximately 5% of Americans (15.3 million) report having hyperhidrosis,⁷ which is excessive sweating not related to heat or exercise. Many hyperhidrosis experts believe these numbers are an underestimation because the condition is underreported and underdiagnosed.⁷ Indeed, data show most adults with hyperhidrosis have never spoken to a healthcare provider about it. Further, only 18% are actually diagnosed, meaning the vast majority of the population (82%) remains undiagnosed.⁷ Additionally, the International Hyperhidrosis Society (IHHS) estimates one in three U.S. adults (85.2 million ^8,9) are bothered by their excessive underarm sweating.⁸ Among consumers seeking aesthetic treatments, a recent survey by the American Society for Dermatologic Surgery (ASDS) found 58% stated they are most bothered by excessive sweating.¹⁰

About the Pivotal SAHARA Study
FDA clearance of Brella is supported by the results of SAHARA, a randomized, double-blind, sham-controlled, multicenter pivotal study which enrolled 110 adult subjects with primary axillary hyperhidrosis (or excessive underarm sweating).¹¹ 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.¹² 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 study achieved its primary and secondary endpoints – for example, significantly reducing sweat production and improving quality of life – and was well tolerated, with no serious or severe adverse events reported at any time by any study participant. Results from the pivotal study were described in a late-breaking oral presentation at the American Academy of Dermatology annual meeting, on March 18, 2023 in New Orleans, LA,¹¹ and will be submitted to a peer-reviewed dermatology publication.

About Candesant Biomedical
Candesant Biomedical is a private medical device company focused on the development and commercialization of non-invasive treatments for hyperhidrosis or excessive sweating. The company's first FDA-cleared product – the Brella SweatControl Patch for the reduction of excessive underarm sweating in adults with primary axillary hyperhidrosis – uses Candesant's novel, patented TAT (targeted alkali thermolysis) technology. The company is also exploring future potential indications, including facial hyperhidrosis, palmar hyperhidrosis, and plantar hyperhidrosis. To learn more about Candesant, visit https://candesant.com.

"Candesant" and the Candesant logo are registered trademarks of Candesant Biomedical. "Brella™", the Brella logo, and "SweatControl Patch™" are trademarks of Candesant Biomedical.

Media Contact
Suzanne Haber
TogoRun
917-531-6953
[email protected]

References

1. Brella is the Trade Name for the N-SWEAT Patch Technology
2. For complete prescribing information, see device instructions for use.
3. Glaser DA, Hebert A, Pieretti L, Pariser D. Understanding Patient Experience With Hyperhidrosis: A National Survey of 1,985 Patients. J Drugs Dermatol. 2018;17(4):392-396.
4. Data on file, Candesant Biomedical
5. Kaufman J, Green JB, Cazzaniga A, Canty DJ, Tims E, Waugh J. A Pilot Study of the Safety and Effectiveness of a Novel Device in Subjects With Axillary Hyperhidrosis. Dermatol Surg. 2022;48(11):1220-1225. doi:10.1097/DSS.0000000000003598
6. Waugh JM, Elkins C, Rhee H, inventors. Candesant Biomedical, Inc., assignee. Medical devices for generating heat and methods of treatment using same. U.S. Patent 2021;11:425.
7. Doolittle J, Walker P, Mills T, et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 308, 743–749 (2016). https://doi.org/10.1007/s00403-016-1697-9.
8. International Hyperhidrosis Society. IHHS sweat survey reveals many are suffering in silence. Sweat Solutions. September-October 2008: 1-4.
9. Ogunwole SU, Rabe MA, Roberts AW, Caplan Z. Population Under Age 18 Declined Last Decade. August 12, 2021. Available: https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html#:~:text=In%202020%2C%20the%20U.S.%20Census,from%20234.6%20million%20in%202010. Accessed Mar 7, 2023.
10. American Society for Dermatologic Surgery (ASDS). 2021 Consumer Survey on Cosmetic Dermatologic Procedures. Press Release, June 20, 2022. Available: https://www.asds.net/skin-experts/news-room/press-releases/dermatologists-are-the-leading-influencer-for-cosmetic-procedures-and-skin-care-decisions. Accessed Feb 10, 2023.
11. Glaser DA, Green L, Kaminer M, Smith S, Pariser D. Outcomes from the SAHARA Clinical Study on the TAT Patch for Excessive Axillary Sweating or Primary Axillary Hyperhidrosis. Late-breaking oral presentation at: American Academy of Dermatology annual meeting; March 17-21 (presented March 18, 10:10 am CT), 2023; New Orleans, Louisiana.
12. Solish N, Bertucci V, Dansereau A, et al. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007;33(8):908-923. Doi:10.1111/j.1524-4725.2007.33192.x

SOURCE Candesant Biomedical