Madorra announces publication of positive 12-week and 12-month Pilot 1 Randomized Controlled Trial Results

Madorra's first product is a home-use, handheld device designed for the treatment of moderate to severe vulvovaginal atrophy, a condition affecting millions of postmenopausal women in the US

• Madorra's proprietary therapeutic ultrasound device could offer a new, nonhormonal treatment option for post-menopausal women with vaginal atrophy
• Published Today in Menopause, the Journal of the North American Menopause Society (NAMS)
• The company believes that this preliminary data support continued evaluation of home-use ultrasound as a potentially new, nonhormonal treatment for vaginal dryness
• Madorra is also designated as a Breakthrough Device by the FDA for the treatment of moderate to severe vulvovaginal atrophy

PORTLAND, Ore., Feb. 9, 2023 /PRNewswire/ -- Madorra announces publication of positive Pilot 1 randomized controlled trial results for the company's non-invasive, home-use device for women experiencing moderate to severe vulvovaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).

Positive Pilot 1 Clinical Study Results

The Company's Pilot 1 clinical study evaluated the safety and effectiveness of therapeutic ultrasound for treatment of vaginal dryness in postmenopausal women with VVA. A combination of clinician assessments and a validated patient-reported outcomes (PRO) assessment were utilized in the study to evaluate the treatment's effectiveness. Twenty-one (21) participants in the study were randomized (1:1) to double-blind ultrasound treatment or sham device for 12 weeks. The primary effectiveness endpoint was change from baseline to week 12 on the Vaginal Assessment Scale (including questions about dryness, soreness, irritation, and dyspareunia—pain with sex), a validated PRO for VVA. A secondary effectiveness endpoint was scoring of the clinician-reported Vaginal Health Index (including assessments of vaginal elasticity, fluid, pH, mucosa, and moisture). After 12 weeks, participants received open-label ultrasound treatment to 1 year. 

At week 12, women showed a statistically significant reduction in symptoms as measured by the Vaginal Assessment Scale with ultrasound treatment versus sham. Participants also demonstrated a statistically significant improvement in their vaginal tissue health, as measured by their clinicians on the Vaginal Health Index.

Improvement in effectiveness endpoints was also seen at 1 year compared with baseline. The device also had an excellent safety profile. In this study, Madorra's home-use ultrasound was safe and effective for treating vaginal dryness after 12 weeks and effectiveness was maintained to 1 year. Madorra's therapeutic ultrasound device could offer a new, nonhormonal treatment option for postmenopausal women with vulvovaginal atrophy.

The study report can be found in Menopause, the Journal of the North American Menopause Society (NAMS). 

"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," said Dr. Mindy Goldman, Chair of Madorra's Scientific Advisory Board and Clinical Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences at UCSF. "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."

"We are thrilled to have achieved these exciting results in our first randomized controlled pilot trial of the Madorra device," said CEO, Holly Rockweiler. "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."

Upcoming Pilot 2 Clinical Study Results Presentation

In addition, the company has recently completed a second randomized controlled trial, Pilot 2. The results of Pilot 2 have been invited for oral presentation at the annual scientific meeting of the International Society for the Study of Women's Sexual Health (ISSWSH). These results will be presented in March by Dr. Goldman. 

Recognition of both the Pilot 1 and Pilot 2 data by the premier societies for the care and study of menopause and women's sexual health validate the Company's important and breakthrough work.

Menopause Is a Burgeoning Market Affecting Millions of Women

There has been a clear and growing trend to both discuss and address the needs of post-menopausal women, an undertaking which is gathering momentum in the mainstream. 

A recent New York Times article has drawn much needed attention to the many and often misunderstood symptoms of menopause and the lack of new, innovative, and nonhormonal treatment options. 

Madorra was founded to change the paradigm for treating vaginal dryness by providing a nonhormonal, noninvasive solution to VVA. VVA affects 43 million women in the US^.1,2, yet only 7% of this population today are using the gold standard treatment of hormone therapy.³ Approximately 9.5 million women in this population are either unable to use hormone therapy (such as breast cancer survivors who are contraindicated from using hormones) or have outright failed hormone therapy.^4,5,6 This subsegment of the broader VVA market represents a $13 billion opportunity.

About VVA

VVA is a condition that results from a decrease in the body's estrogen levels. Symptoms of VVA can include vaginal dryness, soreness, irritation, and pain with sex. The condition may be widely underdiagnosed and undertreated.⁷ Symptoms generally do not improve without treatment, which today usually involves lubricants or hormonal therapies, according to the NAMS 2020 position paper on the evidence-based guidelines for treatment of VVA.⁸ VVA, like most conditions, ranges from mild to severe. Women with moderate to severe VVA can experience significantly debilitating symptoms such as depression, anxiety, pain with activities of daily living, recurrent urinary tract infections, and reduced quality of life. 

VVA often impacts intimate relationships, as intercourse can often be painful.

Many women do not discuss their VVA symptoms with their healthcare providers despite being concerned about their symptoms, according to research about women's awareness of VVA. Most women are not familiar with or are unsatisfied with available treatments.⁸

About Madorra

Madorra Inc. is a privately held medical device company based in Portland, Oregon, focused on enhancing quality of life for women by providing them with new treatment paradigms for menopause.

Madorra spun out of the Stanford Byers Center for Biodesign Fellowship Program in 2014. The company was incubated at Stanford StartX, Fogarty Innovation, and the Oregon Bioscience Incubator. 

The company's Series A was led by OneVentures, an Australian healthcare and technology venture capital fund, with co-investors Portfolia, Avestria, Berkeley Catalyst Fund, Joyance, Stargazer Ventures, Elevate Capital, Astia Angels, and Golden Seeds. The company has also been funded through Small Business Innovation Research (SBIR) grants from the National Institutes of Health and the National Science Foundation.

Madorra was granted a Breakthrough Device Designation for Treatment of Moderate to Severe Vulvovaginal Atrophy by the US FDA in 2021. The Company's lead product is a non-invasive, nonhormonal, home-use device that holds the potential to change the treatment of VVA.  

Caution

The Madorra Device is currently under clinical investigation. It is not commercially available anywhere in the world and does not have marketing authorization.

Media Contacts

In United States:
Holly Rockweiler
CEO at Madorra
+1 314-239-3059
[email protected]

Beverly Huss
Executive Chair at Madorra
+1 415-602-2862
[email protected]

References:

¹ US Census Data, 2019
² Gass M, Menopause, 2011
³ IMS Health Plan Claims Apr 2008 - Mar 2011
⁴ Trinkaus M, The Oncologist, 2008
⁵ breastcancer.org
⁶ Krychman M, The Journal of Sexual Medicine, 2017
⁷ Nappi R, Gynecological Endocrinology, 2016
⁸ NAMS 2020 GSP Position Statement Editorial Panel, Menopause, 2020
⁹ Kingsberg S, Journal of Sexual Medicine, 2013

SOURCE Madorra Inc