MADORRA INC. — Department of Health and Human Services SBIR Phase I: 102

Description

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 womenTodayandapos s best treatments for vaginal dryness all involve the use of hormonesyethormonal treatments are contraindicated for themillion breast cancer survivors suffering from vaginal drynessdue to the risk of cancer recurrenceFurthermillions of postmenopausal women avoid hormone use because of the long term risks and unpleasant side effectsMadorra has developed a medical device that uses therapeutic ultrasound to revitalize vaginal lubricationabating symptoms of vaginal dryness completely without the need for hormone therapyPreliminary 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 drynessHoweverthe modified off the shelf ultrasound devices used in those studies were cumbersome and posed significant usability challenges for the study participantsWomen in the study complained about the user interfacechallenges in programming the correct ultrasound dosedifficulty positioning and holding the device during therapyand the burdens of cleaning the device after each useAccordinglyan ultrasound device that can effectively deliver desired ultrasound directly to vaginal tissue while being easily usedand hence readily adopted by end usersis requiredMadorra has developed such a device based on this user feedbackbut it has not yet been tested clinicallyThis Fast Track SBIR proposal would support the first clinical use of the Madorra devicePhase I encompasses a smallsingle armPilot Study of the Madorra deviceand Phase II comprises a larger randomizedsham controlled Pivotal StudyThe Pilot StudySpecific Aimswill be used to gather initial clinical use experience data on the Madorra deviceincludingsafetyproof of physiologic responsevalidation for ease of useand preliminary efficacyThe Pivotal StudySpecific Aimswill collect statistically significant safety and efficacy data demonstrating the Madorra deviceandapos s ability to treat vaginal dryness in comparison to a sham deviceThese data will be submitted to the FDA in support of device approval and will serve to irrevocably establish the clinical efficacy of the Madorra deviceOnce FDA approvedthe 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 womenandapos s sexual health and further demonstrates a new treatment paradigm for relieving the symptoms of vaginal drynessThis new treatment option will enhance the health and quality of life of millions of women suffering from decreased sexual wellness due to vaginal drynessThe Madorra treatment paradigm will specifically provide relief for breast cancer survivors and other postmenopausal women who are contraindicated from using todayandapos s gold standardhormone based treatments