Candesant Biomedical Announces Late-Breaking Oral Presentation of Pivotal Clinical Trial Data for its Investigational Patch to Reduce Excessive Underarm Sweating

2023-03-09

临床研究

NASHVILLE, Tenn., March 9, 2023 /PRNewswire/ -- Candesant Biomedical ("Candesant"), a private medical device company focused on the development of non-invasive treatments for hyperhidrosis or excessive sweating, today announced the acceptance of its pivotal SAHARA clinical trial data for its investigational targeted alkali thermolysis (TAT) Patch in a late-breaking oral presentation at the 2023 annual meeting of the American Academy of Dermatology (AAD), on March 18, 2023 in New Orleans, LA. Details of the presentation are as follows: Title: Outcomes from the SAHARA Clinical Study on the TAT Patch for Excessive Axillary Sweating or Primary Axillary Hyperhidrosis Session: Late-Breaking Research Session 1 (S025) Date/Time: Saturday, March 18, at 10:10 am CT Location: New Orleans Ernest E. Morial Convention Center Theater B The oral presentation will be given by Dr. David Pariser, Eastern Virginia Medical School and Virginia Clinical Research, Inc., and one of the Investigators for the SAHARA trial. "We are delighted our SAHARA pivotal trial data was selected as a late-breaking oral presentation at this year's AAD meeting," said Niquette Hunt, Founder and CEO of Candesant. "Excessive underarm sweating impacts millions of people physically, emotionally, and aesthetically. If FDA cleared, our investigational Patch will provide an important treatment option for patients seeking a non-invasive approach for control of primary axillary hyperhidrosis." About Candesant's Investigational Patch Currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of primary axillary hyperhidrosis or excessive underarm sweating, Candesant's investigational non-invasive Patch is applied to the underarm by a health care provider during an in-office treatment. The Patch is activated when the water in sweat contacts the Patch's sodium sheet. The sodium in the Patch creates precisely localized thermal energy, microtargeting sweat glands and reducing excessive underarm sweat production. The Patch stays on for up to three minutes on each underarm, is single-use, and disposed of after the treatment. About Hyperhidrosis or Excessive Sweating Approximately 4.8% of Americans (15.3 million) report having hyperhidrosis, and about two-thirds of them (~10 million) experience sweating under the arms, the most frequently reported site.1 However, many hyperhidrosis experts believe these numbers are an underestimation because the condition is underreported and underdiagnosed1. In fact, the International Hyperhidrosis Society (IHHS) estimates one in three U.S. adults (85.2 million2,3) have excessive underarm sweating.4 About Candesant Biomedical Candesant Biomedical is a private medical device company focused on the development of non-invasive treatments for hyperhidrosis or excessive sweating. Candesant's investigational Patch is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of primary axillary hyperhidrosis or excessive underarm sweating. The Patch utilizes Candesant's patented SweatTech "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 . 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). . International Hyperhidrosis Society. IHHS sweat survey reveals many are suffering in silence. Sweat Solutions. September-October 2008: 1-4. Ogunwole SU, Rabe MA, Roberts AW, Caplan Z. Population Under Age 18 Declined Last Decade. August 12, 2021. Available: Accessed Mar 7, 2023. International Hyperhidrosis Society. IHHS sweat survey reveals many are suffering in silence. Sweat Solutions. September-October 2008: 1-4.

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