At-home, ultrasonic device for treatment of vulvovaginal atrophy

Abstract Decreases in endogenous estrogen production during and after menopause or cancer treatment is associated with decreased lubrication and thinning of the vaginal tissue, making it sensitive, friable, and inelastic. Vulvovaginal Atrophy (VVA) leads to pain during sex, which contributes to lower libido, abstinence, strained relationships, and often depression. VVA affects up to 90% of all peri- and postmenopausal women, which represents up to 44.6M women in the US alone. By 2025, VVA is predicted to impact between 369-990M postmenopausal women worldwide. VVA not only causes pain during sex, but it can also make it uncomfortable to sit, stand, exercise, or urinate, significantly affecting quality of life whether women are sexually active or not. Nearly 75% of breast cancer survivors (BCS)—1.4M women in the U.S.—receive adjuvant estrogen-suppressing treatments to prevent cancer recurrence. These treatments exacerbate VVA, resulting in poor therapy compliance and thereby placing these women at high risk for cancer recurrence. Hormone therapy (HT), the most efficacious treatment for VVA, is associated with a higher risk of cancer, and therefore absolutely contraindicated for BCS. Over-the-counter (OTC) lubricants and moisturizers are disdained by users as messy, temporary, and simply not effective enough for the severity of symptoms endured. There is a critical need for an affordable, non-hormonal, and readily adoptable treatment for women with VVA. Madorra Inc. has developed a novel, non-hormonal, non-invasive medical device to answer these concerns and treat VVA. The Madorra Therapy System was developed in response to a well-vetted unmet clinical need for postmenopausal women and BCS on estrogen-suppressing treatments. The Madorra Therapy System is the first technology to use therapeutic ultrasound to treat VVA, enabling a safe, effective at-home treatment option. Madorra’s device uses therapeutic ultrasound to support vaginal health by increasing vasodilation and blood flow to the vagina, resulting in increased lubrication in the near term, and improvements in tissue health with continual therapy. The Madorra solution leverages the physiologic mechanisms of the body’s own lubrication pathway and ultrasound’s ability to increase blood flow to treat VVA without the side-effects and risks associated with HT. Madorra proposes the following Specific Aims for this SBIR Direct-to-Phase II project: 1) Update design of the Madorra Therapy System to improve operational settings for enhanced, reliable ultrasound therapy based on feedback from prior clinical trials and 2) Conduct a Madorra device efficacy and safety study demonstrating positive clinical effect and no Serious Adverse Events (SAEs). The project framework aligns with FDA requirements for clearance, which have been defined through discussions with the FDA. Accomplishment of these aims will prove the safety and efficacy of the Madorra device and establish its usability among the primary target adopters: BCS and women suffering from severe VVA.