Document text
Principal Investigator: Holly Rockweiler
Organization: MADORRA, INC.
Fiscal Year: 2024
Award: $1,514,498
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
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.
Terms: <Abstinence><Address><Adjuvant><Adopted><Affect><Amentia><Anatomic Sites><Anatomic structures><Anatomy><Apoplexy><Atrophic><Atrophy><Blinded><Blood flow><Body Tissues><Brain Vascular Accident><Breast Cancer survivor><Cancer Treatment><Cerebral Stroke><Cerebrovascular Apoplexy><Cerebrovascular Stroke><Client satisfaction><Clinical><Clinical Trials><Comparative Study><Control Groups><Coronary Disease><Coronary heart disease><Coupling><Data><Dementia><Devices><Double-Blind Method><Double-Blind Study><Double-Blinded><Double-Masked Method><Double-Masked Study><Dryness><Dyspareunia><Endocrine Therapy><Ensure><Estrogens><Evaluation><Exercise><Exhibits><Failure><Feasibility Studies><Feedback><Funding><Goals><Health><High Risk Woman><High-Risk Cancer><Home><Hormonal Therapy><Iatrogenic Cancer><Incidence><Leanness><Learning><Left><Libido><Lubricants><Lubrication><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Measures><Medical Device><Mental Depression><NIH><National Institutes of Health><Pain><Painful><Participant><Pathway interactions><Patient Satisfaction><Patients><Perimenopausal><Perimenopause><Phase><Physiologic><Physiological><Post-Menopause><Post-menopausal Period><Postmenopausal Period><Postmenopause><Prevalence><Production><QOL><Quality of life><Randomized><Recurrent Malignant Neoplasm><Recurrent Malignant Tumor><Reporting><Risk><SBIR><Safety><Serious Adverse Event><Severe Adverse Event><Severities><Small Business Innovation Research><Small Business Innovation Research Grant><Stroke><Survivors><Symptoms><System><Technology><Temperature><Therapeutic><Therapeutic Effect><Therapeutic Estrogen><Therapeutic Uses><Therapy Related Malignant Neoplasm><Therapy Related Malignant Tumor><Therapy-Associated Cancers><Therapy-Related Cancer><Thinness><Time><Tissues><Treatment-Associated Cancer><Treatment-Related Cancer><Ultrasonic><Ultrasonic Therapy><Ultrasonics><United States National Institutes of Health><Update><Vagina><Vasodilatation><Vasodilation><Vasorelaxation><Visual><Woman><after menopause><anti-cancer therapy><arm><at-risk females><at-risk women><atherosclerotic heart disease><brain attack><cancer recurrence><cancer therapy><cancer-directed therapy><cerebral vascular accident><cerebrovascular accident><clinical effect><commercialization><coronary disorder><depression><design><designing><dry vagina><efficacious therapy><efficacious treatment><efficacy study><female treatment><females at high risk><following menopause><high risk females><homes><hormone therapy><improved><indexing><menopause transition><novel><open label><open label study><past menopause><pathway><peri-menopausal><peri-menopause><placebo group><post-menopausal><postmenopausal><postmenopausal status><prevent><preventing><primary end point><primary endpoint><prototype><randomisation><randomization><randomly assigned><response><safety study><serious adverse experience><serious adverse reaction><sex><sex drive><sexual drive><sexually active><sham group><sham-controlled study><side effect><standard of care><stroked><strokes><success><therapy adherence><therapy compliance><transition to menopause><transitional menopause><treat females><treat women><treatment adherence><treatment among females><treatment among women><treatment compliance><treatment in females><treatment in women><ultrasound><ultrasound energy><ultrasound therapy><usability><vagina dryness><vaginal dryness><venous thromboembolism><women at high risk><women's treatment>