Candesant® Biomedical Announces Publication of Pilot Study Data on a Novel, Non-invasive Medical Device for the Reduction of Axillary Hyperhidrosis

Study Published in Dermatologic Surgery Shows Three-Minute TAT Patch Treatment is Well Tolerated and Maintains Reduced Sweating for up to Six Weeks or Longer

SAN FRANCISCO, Nov. 29, 2022 /PRNewswire/ -- Candesant Biomedical ("Candesant"), a clinical-stage company focused on the development of non-invasive treatments for primary hyperhidrosis (excessive sweating), today announced the publication of a pilot study showing that its investigational "TAT" (targeted alkali thermolysis) patch was well tolerated and reduced underarm sweating in patients with axillary hyperhidrosis. The report, "A Pilot Study of the Safety and Effectiveness of a Novel Device in Subjects with Axillary Hyperhidrosis," was published in the November print issue of the journal Dermatologic Surgery¹.

Nearly 15 million Americans are impacted by hyperhidrosis or excessive sweating somewhere on their body, and approximately half experience their sweating under the arms. Many hyperhidrosis experts believe these numbers are an underestimation.^2,3,4 The International Hyperhidrosis Society estimates that up to 1 in 3 people are bothered by excessive underarm sweating, but many remain undiagnosed and untreated.⁵

"People with hyperhidrosis need a modern solution that is non-invasive, safe, effective, and easy," said Joely Kaufman, MD, Director of Skin Associates of South Florida, and the lead author of the study. "I am encouraged by these findings and look forward to the results of upcoming pivotal clinical trials."

"We are pleased with the results of this pilot study, which is the first published clinical trial data on our patented TAT patch technology, supporting the TAT patch's potential as an important treatment option for people with excessive underarm sweating," said Niquette Hunt, Founder and CEO of Candesant Biomedical. "Our team remains focused on providing people suffering from hyperhidrosis with a modern "SweatTech" approach to potentially reduce their excessive sweat and improve their quality of life."

Study and Findings
The study included 16 adults with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4, indicating hyperhidrosis. The study participants were treated with the TAT patch or a sham patch for up to three minutes and evaluated weekly for six weeks post-treatment. The primary effectiveness measure was improved HDSS at Week 4.

Key findings from the study include:

• For the primary efficacy measure, 83% of TAT-treated subjects – but no sham-treated subjects – reported improved HDSS scores of 1 or 2, indicating mild or moderate hyperhidrosis (p=0.0032). The percentages at Week 6 were 86% vs. 14% (p=0.0094), respectively.
• At Week 4, 67% of TAT-treated subjects had a 2-point improvement in HDSS scores vs. 0% of sham-treated subjects (p=0.0123). The percentages at Week 6 were 71% vs. 14% (p=0.0376), respectively.
• Overall, 66.7% of TAT-treated subjects experienced a 50% or greater reduction in the actual amount of sweat produced (gravimetric sweat production or GSP) compared to 14.3% of sham-treated subjects.

Quality of life (QoL) was assessed as an exploratory endpoint and scored from 0 to 4, with 4 being extremely bothered or impacted and 0 being not bothered or impacted at all. At Week 4, the differences between the two groups in these QoL measures were statistically significant (p=0.0005 and p=0.0135, respectively). By Week 6, the levels of bother and impact on daily activities were notably less in the TAT-treated group vs. the sham-treated group: 0.71 vs. 3.29 and 1.14 vs. 3.43, respectively.

The TAT patch was well tolerated, with only one transient moderate adverse event reported which resolved without sequelae.

Candesant's Modern SweatTech™ Treatment Approach
Candesant is the developing the TAT patch with the goal of providing a treatment option for patients that is quick, effective, and affordable with a favorable safety profile. This novel, innovative, non-invasive solution is designed to reduce excessive sweating – focused first on primary axillary hyperhidrosis (excessive underarm sweating). The TAT patch is single-use and disposable. It uses alkali metal that creates thermal energy when it interacts with underarm sweat, microtargeting sweat glands and temporarily inactivating them to reduce sweating. The TAT patch is applied by a healthcare professional for up to three minutes per underarm. It is designed to be simple, fast, with no downtime, and should fit easily into patients' quarterly in-office treatment regimens. The investigational TAT patch is currently undergoing review by the U.S. Food and Drug Administration.

To find out more about how Candesant is working to modernize excessive sweat control, visit https://candesant.com.

About Candesant Biomedical
Candesant Biomedical is a clinical stage company focused on the development of non-invasive treatments for hyperhidrosis or excessive sweating. Candesant is developing a product utilizing its patented targeted alkali thermolysis (TAT) technology, with the lead indication for primary axillary hyperhidrosis, with future potential indications including facial hyperhidrosis, palmar hyperhidrosis, and plantar hyperhidrosis. To learn more about Candesant, visit https://candesant.com.

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References

¹ 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
² 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.
³ McConaghy JR, Fosselman D. Hyperhidrosis: Management Options. Am Fam Physician. 2018 Jun 1;97(11):729-734.
⁴ American Academy of Dermatology. Hyperhidrosis: Who Gets and Causes. Available at https://www.aad.org/public/diseases/a-z/hyperhidrosis-causes. Accessed September 20, 2022.
⁵ International Hyperhidrosis Society. IHHS sweat survey reveals many are suffering in silence. Sweat Solutions. September-October 2008: 1-12.

SOURCE Candesant Biomedical, Inc.