Hyperhidrosis

Candesant Biomedical Announces $35M in Series B Financing to Advance Commercialization of Brella™, the First and Only FDA-cleared 3-Minute SweatControl Patch™

Retrieved on: 
Tuesday, June 6, 2023
Learning, Senior, Hyperhidrosis, Polaris Partners, Patient, Perspiration, KCK, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

The financing was led by KCK MedTech, a venture capital firm specializing in medical technologies, along with other investors including Polaris Partners, Astia Fund, and Correlation Ventures.

Key Points: 
  • The financing was led by KCK MedTech, a venture capital firm specializing in medical technologies, along with other investors including Polaris Partners, Astia Fund, and Correlation Ventures.
  • "We are proud to secure this financing supporting the ongoing commercialization efforts of Brella and its national launch in 2024," said Niquette Hunt, Founder and CEO of Candesant.
  • "We are pleased to be supporting Candesant Biomedical as they prepare to launch this exciting new product, Brella."
  • Providers interested in participating in the Brella Early Experience Program or learning more about launch details can visit Candesant Biomedical.

FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

Retrieved on: 
Monday, May 22, 2023
Blood pressure, Priority review, Restless, Goose, Nasal cavity, Emergency, Drug overdose, Hyperhidrosis, Diarrhea, Hypotension, Anxiety, Fever, Yawn, Weakness, Appetite, Shivering, Tachycardia, Pain, Vomiting, Nose, Death, Dizziness, Chronic pain, Erythema, Patient, Throat irritation, Hypoventilation, Perspiration, Nausea, Sneeze, Drug, Diagnosis, Nervous, FDA, Headache, Nasal congestion, Tremor, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Irritability, Food, Safety, Fatigue, Pharmaceutical industry, Medical device

SILVER SPRING, Md., May 22, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.

Key Points: 
  • This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.
  • "The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products," said FDA Commissioner Robert M. Califf, M.D.
  • "On the heels of the FDA's recent approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders."
  • If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation and low blood pressure (i.e., hypotension).

Aquavit Receives FDA Clearance for Two INDs to Initiate Clinical Trials With Its Botulinum Toxin

Retrieved on: 
Saturday, April 29, 2023
Hyperhidrosis, Safety, Efficacy, AB toxin, Research, History, Botulinum toxin, Patient, Perspiration, FDA, IND, Pharmaceutical industry, Aquavit, MD

NEW YORK, April 29, 2023 /PRNewswire/ -- Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has received FDA clearance to initiate clinical trials for DTX-023 and DTX-024, following its submission of Investigational New Drug Applications.

Key Points: 
  • NEW YORK, April 29, 2023 /PRNewswire/ -- Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has received FDA clearance to initiate clinical trials for DTX-023 and DTX-024, following its submission of Investigational New Drug Applications.
  • Aquavit will begin its Phase II/Phase III trials for DTX-023 (aqubotulinumtoxinA) and DTX-024 (aqubotulinumtoxinA with intradermal microinjector) under the study protocol titled S.W.E.A.T.
  • Aquavit is the first company in history to pursue an FDA approval for intradermal injection of botulinum toxin for the treatment of palmar hyperhidrosis.
  • Aquavit is currently on the forefront of botulinum toxin application development and currently has a third IND approval pending before the FDA and will continue to expand its role in the industry.

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)

Retrieved on: 
Thursday, April 13, 2023
Well, Exercise, Hyperhidrosis, TAT, De novo, Embarrassment, Frustration, Perspiration, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Medical device, Pharmaceutical industry

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

Key Points: 
  • FDA Clearance Based on Data from Randomized, Double-Blind, Multicenter Pivotal SAHARA Study Demonstrating Brella is Effective and Well Tolerated
    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-rec...
    "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."

Aquavit Files Additional IND for DTX-024, a New Botulinum Toxin With Microchannel Technology™ for Palmar Hyperhidrosis

Retrieved on: 
Saturday, March 18, 2023
Neurotoxin, BA, Drug development, Columbia University Vagelos College of Physicians and Surgeons, University, Hyperhidrosis, Allergan, MBA, Uniform Securities Agent State Law Exam, Doctor of Philosophy, Aquavit, Harvard Medical School, Dermatology, Investment, Patient, Physician, Ophthalmology, FINRA, Axial, Drug discovery, Knowledge, Health, FDA, IND, Clostridium botulinum, Neurology, University of Oxford, Pharmaceutical industry, Management, MD

NEW YORK, March 18, 2023 /PRNewswire/ -- Aquavit Holdings has submitted to FDA an IND for its DTX-024, for the treatment of palmar hyperhidrosis using its patented microchannel technology™.

Key Points: 
  • NEW YORK, March 18, 2023 /PRNewswire/ -- Aquavit Holdings has submitted to FDA an IND for its DTX-024, for the treatment of palmar hyperhidrosis using its patented microchannel technology™.
  • Alongside Aquavit's biosimilar program for its botulinum toxin, this will be the first in the world, indicated for palmar hyperhidrosis, approved by FDA.
  • Aquavit has been investing in proprietary delivery technologies and related intellectual property for botulinum toxin.
  • This is a strategic move that puts them ahead of the curve in the fast-growing multi-billion-dollar botulinum toxin market.

Aquavit Files Two IND's For Its Botulinum Toxin With FDA

Retrieved on: 
Friday, March 17, 2023
AB toxin, Neurotoxin, Roa, Hyperhidrosis, Toxicity, Botulinum toxin, Physician, AAD, Knowledge, FDA, IND, Clostridium botulinum, Pharmaceutical industry, Canning, Dermatology, Aquavit

NEW YORK, March 17, 2023 /PRNewswire/ -- Aquavit Holdings, the exclusive licensee of Huons Global's Botulinum Toxin in the USA and Canada, will officially unveil the Aquatox™ program at the Annual American Academy of Dermatology - 2023, the world's largest dermatology conference scheduled from March 17-21, 2023, in New Orleans, LA.

Key Points: 
  • According to The Aesthetic Society and the Global Market Insights, botulinum toxin has been the #1 non-surgical aesthetic procedure since 1999 and is still growing rapidly with only 4 companies with approved botulinum toxin in the US.
  • With a projected CAGR of 7-9%, the global botulinum toxin market in 2026 is expected to be $8.9B.
  • For several years, Aquavit has been investing in its proprietary delivery technologies and related intellectual property for botulinum toxin.
  • We plan to introduce the most innovative botulinum toxin products, uplift and modernize the treatment paradigm" said Sobin Chang, CEO of Aquavit.

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

Retrieved on: 
Tuesday, November 29, 2022
Hyperhidrosis, SAN, User experience, Perspiration, Food, Safety, Week, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Quality of life, Exocrine gland, MD, HDSS, Skin, TAT, GSP, Effectiveness, Medical device, Wool, Pharmaceutical industry, Silviculture

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.

Key Points: 
  • The study included 16 adults with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4, indicating hyperhidrosis.
  • This novel, innovative, non-invasive solution is designed to reduce excessive sweating focused first on primary axillary hyperhidrosis (excessive underarm sweating).
  • 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.

Sensus Healthcare Reports Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 3, 2022
ROI, System, Company, Growth, Sale, GAAP, Finasteride, GLOBE, Tropical Storm Ian, Method, Conference, EBITDA, Vision, Tax, COVID-19, Nasdaq, Marketing, Income, EPS, Attention, Research, Adjustment, Conference call, Toxin (comics), TDI, Epidermis, Hyperhidrosis, SRT, Dermatology, Advertising, Depreciation, Patient, Pain, Medical imaging, Video game, Security (finance), Pharmaceutical industry, Bookkeeping

BOCA RATON, Fla., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces financial results for the three and nine months ended September 30, 2022.

Key Points: 
  • Revenues for the third quarter of 2022 were $9.0 million, compared with $5.5 million for the third quarter of 2021.
  • Cost of sales for the third quarter of 2022 was $3.1 million, compared with $2.3 million for the prior-year quarter.
  • Selling and marketing expense for the third quarter of 2022 was $1.8 million, compared with $1.2 million for the third quarter of 2021.
  • Adjusted EBITDA for the third quarter of 2022 was $2.3 million, compared with $0.5 million for the third quarter of 2021.

Breaking the Stigma of Excessive Sweating During Hyperhidrosis Awareness Month

Retrieved on: 
Tuesday, November 1, 2022
Population, Efficiency, Social stigma, Research, Finger, View, Health care, Swelling, Friends, CME, Skin, Clothing, Hyperhidrosis, CEO, Perspiration, Jaw, Family, Psoriasis, Oil, Shame, Embarrassment, Patient, Multimedia, Cyst, Hypertrichosis, Itchy, Pimple, Awareness, Dizziness, Earwax, Risk, Physician, Bacteria, Continuing medical education, Bleeding, Education, Hearing loss, Ear canal, Diagnosis, Blog, Pain, Acne, News, YouTube, Itch, Anxiety, Eyelash, Social media, Irritation, Quality of life, Depression, Pharmaceutical industry, Medical device, Cosmetics, Dentistry, Online shopping, IHH (Turkish NGO)

CENTER VALLEY, Pa., Nov. 1, 2022 /PRNewswire/ -- Today marks the beginning of Hyperhidrosis Awareness Month and the International Hyperhidrosis Society (IHhS) is committed to raising awareness of this medical condition that affects 365 million people worldwide, of which 27% of adults go undiagnosed. In the United States alone, more than 15 million Americans have hyperhidrosis (approximately 5% of the population), but many of those dealing with the condition fail to recognize it as a medical issue and only 51% discuss it with their physicians.

Key Points: 
  • While sweating is a normal, necessary part of human function, hyperhidrosis sufferers experience excessive and uncontrollable perspiration that interferes with daily functioning, negatively impacting their quality of life.
  • "Our organization's goal is to is educate sufferers, provide support and show them they don't have to live with excessive sweating as hyperhidrosis can be effectively treated."
  • This November during Hyperhidrosis Awareness Month, the IHhS is especially committed to spreading the word about hyperhidrosis to help destigmatize, educate and effectively treat the condition.
  • Attendees will learn best practices in hyperhidrosis diagnosis and management as well as the latest research related to excessive sweating.

The Best You® Acquires Bay Street Salon and Spa

Retrieved on: 
Tuesday, October 18, 2022
Surgery, Health, Oncology, Physician, PRP, Hyperhidrosis, Skin care, Ontario Health Insurance Plan, Dermatology, Family, Fat removal procedures, TBY, Partnership, Knowledge, You Wanted the Best, You Got the Best!!, Breast augmentation, Friends, Acquisition, Onychomycosis, Pedicure, Blepharoplasty, Leadership, Platelet-rich plasma, Hair removal, Bay Street, OHIP, Mesotherapy, Acne, Ownership, Skin cancer, United Counties of Prescott and Russell, Beauty salon, General store, National Capital Region (Canada), Embrun

The Best You (TBY), a long-standing group of medical aesthetic clinics in Ontario, today announced that it has completed the acquisition of the Bay Street Salon and Spa in Embrun, Ontario (Bay Street).

Key Points: 
  • The Best You (TBY), a long-standing group of medical aesthetic clinics in Ontario, today announced that it has completed the acquisition of the Bay Street Salon and Spa in Embrun, Ontario (Bay Street).
  • The Bay Street Salon and Spa, located 20 minutes from the outskirts of Ottawa, complements TBYs current offerings.
  • Bay Street is a family-owned and operated salon and spa, offering massage therapy, hair styling services as well as laser treatments for acne, onychomycosis and wart removal, vascular treatments, laser hair removal, and CoolSculpting.
  • With the addition of Bay Street Salon and Spa to its portfolio of companies, TBY will expand its service offerings across the Greater Ottawa area and continue to provide excellent client service based on the knowledge, expertise, and leadership of the team at Bay Street.