Madorra, a medical device company spun out of the Stanford Biodesign Fellowship Program, has enrolled the first patient in its pivotal clinical trial (the WAVES Study) evaluating the Madorra Therapy System for moderate to severe vulvovaginal atrophy (VVA) – a milestone following the FDA’s grant of Breakthrough Device Designation.
The Madorra Therapy System is a non-invasive, non-hormonal, home-use handheld device that applies therapeutic ultrasound waves to improve vaginal lubrication and alleviate VVA symptoms. It’s being developed for the at least 50% of post-menopausal women and breast cancer survivors who experience VVA, many of whom report substantial quality-of-life impacts including pain with daily activities, recurrent UTIs, depression, and anxiety.
“Enrolling our first patient in the WAVES study marks a transformative moment for Madorra and for the millions of women suffering from VVA,” said co-founder and CEO Holly Rockweiler. “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.”
“Suffering with vaginal dryness and sexual pain is completely unnecessary,” said Dr. James Simon, principal investigator of the WAVES study and clinical professor of OB-GYN at George Washington University. “With the Madorra therapy, women may be able to treat these symptoms at home using this non-hormonal device.”
Preliminary data from a 2023 randomized, controlled study showed participants using the device for 12 weeks experienced improvements in physician-assessed Vaginal Health Index scores and reductions in self-assessed symptoms compared to a sham device. Adherence was notably high at 80% at 12 weeks, and a majority of women who used the device wanted to continue after the trial concluded – a strong signal for a home-use device in a category where treatment drop-off is a persistent challenge.
The WAVES study is being conducted at clinical sites across the U.S. and is designed to support FDA marketing authorization.
