Madorra has developed a non-invasive, home-use therapeutic ultrasound device that can potentially treat vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA). This condition affects millions of women in the US and is a component of genitourinary syndrome of menopause (GSM).
Madorra’s Pilot 1 clinical study, which was published in Menopause, the Journal of the North American Menopause Society (NAMS), showed that after 12 weeks of using the ultrasound device, women experienced a statistically significant reduction in symptoms as measured by the Vaginal Assessment Scale with ultrasound treatment versus sham. Additionally, women demonstrated a statistically significant improvement in their vaginal tissue health as measured by the clinician-reported Vaginal Health Index. The effectiveness was maintained up to a year, and the device had an excellent safety profile. Madorra’s Pilot 2 clinical trial results will be presented at the annual scientific meeting of the International Society for the Study of Women’s Sexual Health (ISSWSH) in March.
Madorra CEO Holly Rockweiler shares: “We are thrilled to have achieved these exciting results in our first randomized controlled pilot trial of the Madorra device. The recognition of our research by the North American Menopause society in their esteemed journal further underscores the potential impact of our device as well as the importance of developing alternative solutions for treating VVA.”
Dr. Mindy Goldman, Chair of Madorra’s Scientific Advisory Board and Clinical Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences at UCSF adds: “There are so many menopausal women that suffer from symptoms related to vaginal dryness and although we know that vaginal hormones can help alleviate these symptoms, many women either choose not to use hormones or have medical conditions where it may not be recommended. To have other effective options is important. These results with the Madorra device are very exciting as women found the device easy to use, were compliant with therapy, and found good success in treating their symptoms.”
The FDA has designated Madorra’s ultrasound device as a Breakthrough Device for treating moderate to severe vulvovaginal atrophy.