# Madorra Inc.

> Madorra is a Portland medical-device company developing an investigational, at-home therapeutic-ultrasound system for moderate to severe vulvovaginal atrophy, a menopause-related condition that can cause dryness, irritation and painful sex. Its nonhormonal, noninvasive approach is designed first for postmenopausal people and breast cancer survivors who cannot or prefer not to use estrogen. Founded out of the Stanford Biodesign program, the company has FDA Breakthrough Device designation, published pilot data and began enrolling its U.S. pivotal WAVES study in March 2026.

- **Founded:** 2014
- **Headquarters:** Portland, United States
- **Founders:** Holly Rockweiler (Co-Founder and CEO), Ryan Krone (Co-Founder)
- **Team size:** Public sources vary: LinkedIn lists 2-10 employees, SBIR lists 6, and supplied company data lists 18.
- **Products:** Madorra Therapy System, WAVES Study
- **Notable:** Received FDA Breakthrough Device designation in 2021 for moderate to severe vulvovaginal atrophy., Published randomized, sham-controlled Pilot 1 results in the journal Menopause in 2023., Reported symptom and clinician-rated tissue-health improvements in per-protocol pilot analyses, maintained versus baseline at one year, with no serious adverse events.

## Products & services

- **Madorra Therapy System** — An investigational, prescription, handheld home-use medical device that applies therapeutic ultrasound at the vaginal introitus to increase blood flow and lubrication and improve tissue health in moderate to severe vulvovaginal atrophy.
- **WAVES Study** — A U.S. pivotal IDE study evaluating the safety and effectiveness of the Madorra Therapy System in women diagnosed with moderate to severe vulvovaginal atrophy.

## Achievements

- Received FDA Breakthrough Device designation in 2021 for moderate to severe vulvovaginal atrophy.
- Published randomized, sham-controlled Pilot 1 results in the journal Menopause in 2023.
- Reported symptom and clinician-rated tissue-health improvements in per-protocol pilot analyses, maintained versus baseline at one year, with no serious adverse events.
- Received five SBIR/STTR awards totaling $5,199,828 according to SBIR.gov.
- Won the 2021 FemAging Project fast-pitch grand prize.
- Enrolled the first patient in the pivotal U.S. WAVES study in March 2026.

## Latest updates

- **2026-03** — Madorra announced enrollment of the first patient in the U.S. pivotal IDE WAVES study for moderate to severe vulvovaginal atrophy.
- **2024** — The company received a $2 million NIH Phase II award to update the Therapy System and conduct an efficacy and safety study.
- **2023-02** — Randomized Pilot 1 findings were published in Menopause, including 12-week and one-year observations.
- **2021-09** — The FDA granted Breakthrough Device designation for treatment of moderate to severe vulvovaginal atrophy.

## Links

- Website: https://www.madorra.com/
- LinkedIn: https://www.linkedin.com/company/madorra-inc-
- Twitter/X: https://twitter.com/MadorraMedical
- Facebook: https://www.facebook.com/MadorraHealth

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Profile page: https://yespress.io/madorra-inc
Published by YesPress — https://yespress.io
Last updated: 2026-08-18