Madorra Enrolls First Patient in Pivotal Trial for Treatment of Moderate to Severe Vulvovaginal Atrophy: The WAVES Study

Breakthrough Device-Designated Therapy System Takes Important Step Toward Market Authorization

PORTLAND, OR, UNITED STATES, March 24, 2026 /EINPresswire.com/ -- Madorra Inc., a medical device company developing innovative solutions for menopause-related conditions, today announced the enrollment of the first patient in its pivotal clinical trial, The Pivotal IDE Study of the Madorra Therapy System in Women with A Diagnosis of Vulvovaginal Atrophy to Evaluate Effectiveness and Safety (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.

"Enrolling our first patient in the WAVES study marks a transformative moment for Madorra and for the millions of women suffering from VVA," said Holly Rockweiler, MS, co-founder and CEO of Madorra. "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."

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.

“Suffering with vaginal dryness and sexual pain is completely unnecessary,” Dr. James Simon, PI of the WAVES study, Clinical Professor of OB-GYN at George Washington University, and Medical Director and Founder of IntimMedicine Specialists in Washington DC, highlighted regarding the excitement of this trial. “With the Madorra therapy, women may be able to treat these symptoms at home using this non-hormonal device.”

Dr. Dr. Jeffrey Baker, MD, co-PI of the WAVES study, Principal Investigator at Clinical Research Prime, and OB-GYN and Integrative and Functional Medicine physician at the Healing Sanctuary in Idaho Falls, ID commented, “Unfortunately, many women suffering from vaginal atrophy in menopause experience more pain and discomfort with sexual activity because of the dryness menopause brings to the vaginal environment. This therapy is being investigated for its potential to restore elasticity and moisture for those unable or unwilling to use hormonal therapy."

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.

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. Despite these impacts, many women are unfamiliar with or are unsatisfied with available treatments.

The WAVES study is evaluating the safety and effectiveness of the Madorra Therapy System for treating moderate to severe VVA.

About Madorra
Madorra, a medical device company based in Portland, Oregon, aims to empower people to live fuller, healthier lives by providing them with new treatment paradigms for menopause. Launched as a spin-out of the Stanford University Biodesign Fellowship Program, Madorra's lead product is a non-invasive, non-hormonal, home-use device that holds the potential to change the treatment of vulvovaginal atrophy. For more information, visit www.madorra.com.

Holly Rockweiler
Madorra Inc.
holly@madorra.com
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