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Problem Tech Solves
Tech Brief
By 2025 there will be 1.12 billion women in menopause globally.Women who will suffer from hot flashes, sleep disturbances, stress and anxiety. In the U.S. alone, over 2 million women are entering menopause each yer and will suffer with debilitating symptoms for up to 10 years. The traditional medical provider approach to menopausal treatment has included hormonal replacement therapy as well as sleep, anxiety and depression medications, most of which women reject due to risks and side effects. The most impactful and prevalent menopausal symptoms a woman experiences are hot flashes, increased anxiety, and sleep disturbances. While each of these symptoms is deleterious in their own right, when combined, the menopausal woman experiences a downward spiral that mimics the traditional pain cycle. Insomnia begets anxiety which then gives rise to more intense hot flashes. Essentially, a woman’s sympathetic nervous system is in a constant state of overdrive. Embr Labs uses temperature as a unique neural pathway to the brain to balance the autonomic nervous system (ANS). The Embr Wave® low power wearable device delivers dynamic cooling (or warming) sensations to the user’s skin, targeting a specific receptor in the skin responsible for communicating with the nervous system’s innate response to temperature, ultimately dampening down the symptoms of an out-of-balance ANS. It is the combination of our wearable temperature haptic and the companion mobile app that empowers our customers to harness the therapeutic power of temperature.
Tech Differentiators
Embr Labs is unique in that we are the first company to harness temperature in a haptic therapy. This is a difficult technical issue to solve, as evidenced by the lack of competition. Most wearables on the market only measure and track data or biometrics, but Embr Labs actually delivers instant relief from symptoms at the touch of a button. Our superpowers are our patent-protected thermal waveforms . Embr Labs “owns” the application of dynamic thermal stimulation (known as waveforms) via its utility patent: (Patent No. 10,182,937) and has international filings in the EU and Japan. This utility patent protects the dynamic stimulation of temperature sensitive nerve endings in the skin and also enables the development of miniaturized, low-power thermal systems. Embr has been through two Freedom to Operate analyses on its IP: one of which was conducted by a global pharmaceutical company. Based on our core patent, other companies are not able to deliver thermal stimulation that is as effective, personalized, miniaturized, or low power. Embr Labs has built a robust portfolio of patent families that cover the 360° architecture of our digital thermal technology. Embr Labs has filed 10 patent families which are currently made up of 2 granted utility patents, 15 granted design patents and 24 pending patent filings
Validation
Clinical studies that generate evidenced-based consumer claims are a core part of Embr’s strategy to to use clinical data to differentiate the consumer product. Published studies: Evaluating the comfort of thermally dynamic wearable devices https://www.sciencedirect.com/science/article/abs/pii/S0360132319306535 Thermal Comfort Intervention for Hot Flash Related Insomnia Symptoms in Perimenopausal and Postmenopausal- Aged Women: An Exploratory Study https://pubmed.ncbi.nlm.nih.gov/31801384/ 2021 Completed Studies: Embr Thermal Device for Hot Flash Management in Prostate Cancer https://clinicaltrials.gov/ct2/show/NCT04892914?term=Embr+Labs&draw=2&rank=1 This manuscript is currently being authored. However,interim data was presented at American Society for Clinical Oncology in June 2022, Current data: statistically significant reduction in hot flash interference, sleep disturbance and daytime fatigue. There were also improvements in subjective ratings of hot flash frequency, duration, interference with daily life/sleep, bothersomeness and control (all p<0.01). The majority (69%) of participants reported that the device was effective at helping them manage hot flashes. Walgreens Boots Consumer Study of Embr Thermal Device for Hot Flash Management in Natural Menopause Sleep Quality: 112% improvement in sleep satisfaction, 36% reduction in trouble falling asleep, 30% reduction in trouble staying asleep, 40% reduction in daytime sleepiness Hot Flashes: 48% reduction in bothersomeness, 46% reduction in interference with daily activities, 221% increase in control over interference in daily activities, 50% reduction in bothersomeness in night time hot flashes, 49% reduction in interference with sleep, 474% control over interference from night sweats Ongoing and Newly Approved Studies: Embr Wave for the Reduction of Hot Flashes in Women with a History of Breast Cancer https://clinicaltrials.gov/ct2/show/NCT05086705?term=Embr+Labs&draw=2&rank=2 This study is ongoing at Mayo-OSU.
