Madorra Inc., a medical device company developing innovative solutions for menopause-related conditions, announced the enrollment of the first patient in its pivotal clinical trial, The WAVES Study, evaluating the Madorra Therapy System for the treatment of moderate to severe vulvovaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM). The pivotal trial represents a significant milestone for Madorra following the FDA’s grant of Breakthrough Device Designation.
Device and Trial Design
The Madorra Therapy System is an investigational, non-invasive, home-use, handheld device that applies therapeutic ultrasound waves and is being evaluated for its ability to improve vaginal lubrication to alleviate VVA symptoms. The WAVES study is being conducted at clinical sites in the United States. According to Dr. James Simon, principal investigator of the WAVES study and Clinical Professor of OB-GYN at George Washington University, “Suffering with vaginal dryness and sexual pain is completely unnecessary. With the Madorra therapy, women may be able to treat these symptoms at home using this non-hormonal device.”
Clinical Impact and Preliminary Findings
VVA affects at least half of all post-menopausal women and breast cancer survivors, many of whom report substantial reductions in quality of life. Women with moderate to severe VVA can experience significantly debilitating symptoms including depression, anxiety, pain with activities of daily living, and recurrent urinary tract infections. Preliminary data from the company’s 2023 randomized, controlled study demonstrated that participants using the Madorra Therapy System for 12 weeks experienced improvements in the physician-assessed Vaginal Health Index and reductions in self-assessed symptoms compared to those using a sham device. Participant adherence to the therapy regimen was notably high at 80% at 12 weeks, and a majority of women who used the device experienced symptom relief and wanted to continue using it after the trial concluded. Holly Rockweiler, MS, co-founder and CEO of Madorra, stated: “Enrolling our first patient in the WAVES study marks a transformative moment for Madorra and for the millions of women suffering from VVA. This trial brings us one step closer to providing women with a novel, non-invasive, non-hormonal treatment option they can use in the comfort of their own homes.”
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://menafn.com/1110901033/Madorra-Enrolls-First-Patient-In-Pivotal-Trial-For-Treatment-Of-Moderate-To-Severe-Vulvovaginal-Atrophy-The-WAVES-Study