The goal of this Fast-Track SBIR is to demonstrate the safety and efficacy of a therapeutic-ultrasound-based medical device to treat the symptoms of vaginal dryness for breast cancer survivors and postmenopausal women. Today's best treatments for vaginal dryness all involve the use of hormones; yet, hormonal treatments are contraindicated for the 1.4 million breast cancer survivors suffering from vaginal dryness (due to the risk of cancer recurrence). Further, millions of postmenopausal women avoid hormone use because of the long-term risks and unpleasant side effects. Madorra has developed a medical device that uses therapeutic ultrasound to revitalize vaginal lubrication, abating symptoms of vaginal dryness completely without the need for hormone therapy. Preliminary research conducted by the Madorra team has indicated the promise of vaginally applied therapeutic ultrasound to treat vaginal dryness when used daily in the home by women suffering from vaginal dryness. However, the modified off-the-shelf ultrasound devices used in those studies were cumbersome and posed significant usability challenges for the study participants. Women in the study complained about the user interface, challenges in programming the correct ultrasound dose, difficulty positioning and holding the device during therapy, and the burdens of cleaning the device after each use. Accordingly, an ultrasound device that can effectively deliver desired ultrasound directly to vaginal tissue while being easily used (and hence readily adopted by end users) is required. Madorra has developed such a device based on this user feedback, but it has not yet been tested clinically. This Fast-Track SBIR proposal would support the first clinical use of the Madorra device. Phase I encompasses a small, single-arm, Pilot Study of the Madorra device, and Phase II comprises a larger randomized, sham-controlled Pivotal Study. The Pilot Study (Specific Aims 1-3) will be used to gather initial clinical use experience data on the Madorra device, including: safety, proof of physiologic response, validation for ease of use, and preliminary efficacy. The Pivotal Study (Specific Aims 4-6) will collect statistically significant safety and efficacy data demonstrating the Madorra device's ability to treat vaginal dryness in comparison to a sham device. These data will be submitted to the FDA in support of device approval and will serve to irrevocably establish the clinical efficacy of the Madorra device. Once FDA approved, the Madorra device will be commercialized and will allow millions of breast cancer survivors and postmenopausal women to regain their sexual wellness and improve their quality of life.
This research contributes to the fundamental knowledge about women's sexual health and further demonstrates a new treatment paradigm for relieving the symptoms of vaginal dryness. This new treatment option will enhance the health and quality of life of millions of women suffering from decreased sexual wellness due to vaginal dryness. The Madorra treatment paradigm will specifically provide relief for breast cancer survivors and other postmenopausal women who are contraindicated from using today's gold standard, hormone-based treatments.