Bloomer Tech

According to the World Health Organization, 70% of healthcare workers HCW globally are women. During any outbreak they will be at the forefront, fighting disease. Today, female HCW have the highest rate of COVID-19 infections. With over 20 years of clinical evidence on sex-differences and COVID-19 female survivors having higher levels of antibodies compared to their male counterparts, our solution is to use remote patient monitoring tailored to each unique physiology. Our patented medical-grade sensing technology is invisibly embedded in a woman’s bra making early detection and treating disease effortless for the patient and enabling remote patient-specific disease management and prevention to be shared with doctors and public health efforts. At scale, this cost-effective, easy to wear, accessible platform to monitor progression of the same virus on women of different age, race and baseline health will enable bigger datasets to aid in understanding women’s health using non-traditional and non-invasive pathways.

Throughout history, the trend has been for diverse populations to face the hardest challenges when it comes to outbreaks and hard to understand health issues, from preventive to emergency care. With worse experiences and catastrophic care expenditures, rates of recovery and death are higher in minorities, and COVID-19 is no exception.  Since clinical trial participants for most medical devices and drugs that exist today have been primarily, white men, only 1 in every 4 clinical trial participants are female, it is not surprising that 8 out of 10 drugs that the FDA pulled out of the market posed more threat to women.  Pharmacokinetics and pharmacodynamics of drugs can be influenced by menstrual cycle phases, hormonal fluctuations, use of oral contraceptives and hormonal therapy, and life events such as pregnancy and lactation. When a pandemic or outbreak occurs the R&D community often fails to recognize women, 50% of the population, for solution development. To find effective treatments and preventative interventions, obtaining female-specific medical-grade data can accelerate progress and have a profound effect during crises. COVID-19 female survivors have developed higher levels of antibodies. Cardiac safety is most critical to monitor, especially since heart ailments present differently in men and women.

Our solution looks and feels like an everyday bra, making monitoring and treating disease effortless and easy for women and care providers. Our patented medical-grade sensing technology uses novel materials to make soft electronics and sensors seamless in the fabric. Our product helps patients feel comfortable instead of sick with high-fidelity data of medical-grade devices that includes: a full multi-lead electrocardiogram, temperature, activity and position. Women also have a portal to data insights via a mobile app that will allow them to participate in more effective, remote care coordination with their health care provider. On the clinician side, we provide the current standard of reporting with comprehensive findings for patient-specific disease management and prevention. Our product is an ideal tool to gain insights on the progression of disease with minimal disruption to their lives. Designed to 1) increase patient compliance (comfortable and without requiring an expert to place the medical device) 2) increase diagnostic yield specific to female physiologies 3)incentivize women to participate in self-care practices and improve their disease detection, drug reaction and advance data-driven clinical decision-making 4) Build quick-vast valuable datasets for research data collection to develop novel biomarkers, treatments, detection algorithms, etc

The ecosystem of Bloomer Tech consists of Women’s Health programs within hospitals, Women’s patient non-profit organizations, heart disease in women awareness and patient groups that are affected by disparities and advancing research in women’s health. Our venture initially focuses on paid pilots for investigational data services 

We work with hospitals Women's Heart Programs and with patient advocate groups such as the American Heart Association Go Red for Women. We co-designed workshops, studies and interviews to understand the needs of women who have survived cardiac episodes. We also held feasibility studies for them to test the bra device. Understanding both: the doctor's interest for activity logs/patient diary and the patients lack of adherence to certain devices and medication, we automated this by providing the information they both need in summarized reports. With our technology and data service, women can be diagnosed efficiently and target their disease with treatment specific to them, their data and their lifestyles.

In the absence of any vaccine or medical treatment during infectious disease emergencies, remote monitoring minimizes spreading of the disease and collects valuable data to beat the pandemic. Early on, monitoring female healthcare workers may reduce impact infection on health care systems since worldwide more women are in the frontline. As the spread progresses our solution can help and collect data from all women, especially those most vulnerable and with comorbidities and generate a fast-track for detection and treatment testing. 

A human-centered design approach was used to design our remote patient monitor. We are the first to combine apparel and medical-grade technology into a seamless, intimate remote monitor specific for a woman and that is powered by proprietary algorithms specific to female physiology. Other remote monitors currently in the market have low diagnositc yield for women, they especially obtain a lot of noise in the signal due to breast tissue. Incorporating female-centered design to tackle this huge problem is our core. Current medical devices in the market are really uncomfortable, especially for women and have constraints with their data usage. Handhelds and wristbands are not continuous monitors and need the user to trigger a recording, thus to feel a symptom. Our device is continuous and has asymptomatic triggering too. Doctors have applauded our efforts by sharing with us that they often have to bargain with female patients to use a traditional remote monitor and lack of adherence is a huge problem. Our design increases adherence to 100% as women already wear a bra, everyday. And it also collects female-specific data that none of the other remote monitoring devices take into account.

With our solution, remote crisis management can be augmented through real-world evidence data, enabling access to healthcare services to those who otherwise would take longer time to diagnose or reducing emergencies through a preventative approach. Through our sensor data new features could be enabled such as automated medication-adherence tracking, medication delivery, first responders due to emergency detection. 

Alicia focused her thesis at MIT on Sex-specific computationally-generated biomarkers for risk-stratification post acute coronary syndromes. When she noticed that most clinical trial datasets are missing women (significantly less than men in the datasets) and the progress made by many cardiologists in the field of understanding female physiology showed years of evidence demonstrating sex-differences proprietary algorithms for continuous disease detection, progression and risk stratification were developed. Along with Monica (expert in sensors) and Aceil(user experience and designer), whose family's had been personally affected by heart disease, they developed what is now Bloomer Tech's patented technology (US10456080B2) that consists of washable, flexible soft electronics and textile, medical-grade sensors that integrate seamlessly into garments, such as the woman's bra to collect physiological data. Therefore our core technology is Advanced Fabrics Technology and AI.

We had MIT IRB approved, early feasibility studies in patients with different bra sizes.

Very old prototype video: https://youtu.be/-3rKThrzHog

- MIT Tech Review: This Bra Could Save Lives https://www.technologyreview.com/2018/06/27/240494/this-bra-could-save-lives/

- We had the opportunity to present our work to Apple CEO Tim Cook:  https://www-eecs-mit-edu.ezproxyberklee.flo.org/news-events/announcements/mit-students-present-their-work-apple-ceo-tim-cook

Our current app version and latest bra design prepared for regulatory approval has yet to be launched publicly. We'd be excited to share it live with Solve.

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For hundreds of years, women have been underrepresented in clinical studies. By collecting data we can build better tools, designed specifically to a population that is currently limited to designs that are not centered around them. By making an everyday bra this health data tool, low cost, our platform can build the biggest dataset on women's health that can enable breakthrough's in the field. Just like cardiovascular research has especially improved for male population we can now also advance this field for the female population and tailor medicine to each unique physiology. Around the world, if people are born on height they have larger sized hearts, women still wear a bra, everyday. So we can change the missing data by including it in their care routine in a seamless, non-invasive way.

Bloomer Tech incorporated in 2017, and our CEO graduated from MIT in 2018 where they served over 200 women in development studies. Bloomer Tech is still in piloting phase of the company and has not reached commercialization yet. However, we expect to serve at least 500 women through our next pilot studies with our hospital partners prior to locking device iterations for FDA submission. 

Once we get FDA cleared, our first year we aim to steady grow towards 6,500 per month (1/3 of avg incoming female cardiac patients in 1 hospital pre-covid), in 3 years reach 48,000 monthly patients and in 5 years, go internationally and reach 250,000 monthly patients, which is around 3M women annually. 

We are in line with sustainable development goals #3 and #5. We have three social impact goals in the next year; (1) Scaling manufacturing and testing  53 sizes to fit diverse body types to collect valuable, diverse data (2) To reliably detect cardiac abnormalities with higher diagnostic yield for women than current devices >85%. This aligns with sustainable development goal #3 to therefore eliminate undiagnosed, undetected heart disease in women and improve outcomes, promoting good health and well-being. (3) To launch paid pilots. This aligns with sustainable development goal #5 for gender equality, so that we build datasets to accelerate progress in women's health . After paid pilot studies iterate and improve device reliability. We can go through the regulatory process to afterwards scale through prescriptions-based model.

Partnerships: we aim to work with women's heart centers across the country and patient groups to enable tech-enabled care. Once we have a CPT code As health financing options we can more easily scale.

- A first barrier that currently exists is that the women's health market is widely recognized as reproductive health and breast cancer. This limits the awareness of the huge impact and financial projections for this large unmet needs to have more data on women's physiology. 

- Women not knowing their correct bra size, limited use of smartphones (elderly or other subgroup)

- Hospital partners could be wary due to logistical challenges and integration due to remote care practices. 

- Once we become a regulated medical device it will be a barrier that limits constant improvement to bring to market the best tools for patients since device will be locked.

- For the first barrier on women's health market, we recently joined http://womens.health a coalition that puts femtech as all issues in womens health. We are validating and demonstrating the economic benefits of early detection and disease prevention through joint efforts and will demonstrate through pilots the economic savings and we would also highlight recognition of the correlations between cardiovascular monitoring and the fact that the U.S has the worst rate of maternal deaths in developed nations and the major contribution, common cause is due to cardiovascular disease, the field of cardio-pregnancy has emerged and can benefit from our solution and another non-obvious correlation is that women that survive breast cancer or any cancer face increased risk of heart disease, cardio-oncology is another field

- We are sending bra sizing kits first to ensure that her bra device fits properly and comfortably. The app is mostly for self-care but the monitor will generate the reports to send for the doctor so the experience will be simple for mobile app limited use

- For hospital partners, Bloomer Tech will instill confidence through the bra device detailed design and constant communication to improve device functionality and show how it works easily for their remote care. We will provide assurance that the team has thought through the logistics too

- We will continue to perform pilot studies for new innovation and once tools that impact people's lives are developed we will submit new features to the FDA and get it cleared as well

We have 5 full-time, 3 contractors at Bloomer Tech. We have the technology, data science, product and apparel design, marketing, regulatory and operations background to propel towards commercialization. 

We are personally triggered to solve this unacceptable problem that has affected women in our families and friends. Our team's core expertise is designing and testing semiconductors, intelligent sensors, medical devices, product design, bra design and stretchable and soft electronics. We have been leading teams across the US, Asia and LATAM. 2 of our founders have previously founded for profit and non profit organizations still growing today. Our other founder has implemented services and experiences used by hundreds of thousands of users globally. We have surrounded ourselves with the nation's best cardiologists at leading women's heart programs, highest growing volunteer patient organizations as well as C-level executives from the largest medical device companies.  Our seed round's lead investor Material Impact, our partner has 30+ years operator/executive bringing medical devices to market, other investors include One Brave Idea, fund led by cardiologist and Vice-Chair of Scientific Innovation at Brigham and Women's Hospital, Dr. Calum McRae and Boston Scientific Founder, John Abele. Founders met at MIT and completed theses on Sex-specific biomarkers at the MIT Computational Biophysics Group and on forecasting behavioral science at the MIT Collective Intelligence Center. Founders have completed MIT delta v accelerator, Project Entrepreneur incubator and the team is part of MassChallenge Boston and AXA Femtech rising stars. Founders have won 7 pitch competitions for BloomerTech.

We collaborate with several organizations to move forward raising awarenes and taking action. Therefore we collaborate with a number of organizations, at MIT, we collaborate with MIT Legatum who provide emerging market network, growth and entrepreneurship support, MIT Global Co-creation Lab at MIT IMES (Intitute for Medical Engineering Sciences) who provide access to other womens health partners and hospitals in Florida and MIT Clinical Research Center to perform pilot studies. We are also working with Major Hospitals in the Boston Area, we are piloting the solution and using their capital and resources. Legal documents are in process and awaiting their permission for public announcements. 

Pre-FDA: with investigational data services (IDS) using IRB approvals within hospitals (making around 100k per pilot)

Post-FDA: Our IDS platform expands to pharma for cardiac safety trials (making around $3M-$5M per trial) and reimbursement strategy starts with
software subscription and reports per month. 72% profit margin

Mixed Model: Organizational Support Model & 

Via a combination of grants, paid pilots and a seed round that enables us to reach fulfill a regulatory process which is when our scalability occurs and  our revenue streams increase significantly enabling our path to financial sustainability. 

Solve can provide visibility and a global impact network to facilitate breaking barriers for advancing women's health with technologyAs mentioned before, one of the barriers is that 90% of efforts in women's health go towards reproductive health and preventing AI bias in healthcare in different fields were data is limited is highly important to bring at the forefront for the benefit of health equity.

Joining and collaborating with people and organizations in the social impact community is highly important to us. Solve would provide the opportunity for mentorship on building a social impact-driven company with leadership and financial stability. Meeting previous Solve alumni will be inspiring and learning how they faced challenges as well. 

Solve has a worldwide impact network that we hope to tap into, to reach different regions, countries and women around the globe. It would be a huge opportunity to meet other Solvers that we can push our social impact and entrepreneurship goals together and share the experience of going through Solve.

Last week, IBM, Amazon and Microsoft removed their facial recognition algorithms used in police surveillance from the market. The reason: Algorithmic biases that where creating racial injustices. 

Missing data in datasets will create similar algorithmic biases in healthcare and a divide that could be dangerous and life-threatning instead of life-saving with digital health tools. 

Our female-specific models perform 2x better than mixed-sex models with ¼ of comparable, combined training data for detecting female ailments. These were designed to avoid algorithmic bias (AI Bias) using cardiovascular monitoring. As we collect more data our models will improve. We aim to generate female-specific computational biomarkers that enable breakthroughs for women's health. The female-specific data we are collecting are prognostic of long-term outcomes. Through physiological and lifestyle data acquisition via their everyday bra. Feature extraction that enriches the models are used in data from both pre-menopausal and post-menopausal women. Novel biomarkers like screening for elevated potassium levels without requiring any blood (hyperkalemia) have already been achieved with similar methods.  To improve disease diagnosis and identify onset of complex disease, we use computational methods for identifying potential biomarkers, and also shows its potential for the identification of warning signals.

The power of this approach is that these biomarkers are continuously collected in real time with no apparent change in the patients’ experience or any additional cost of care. This could lead to treatments, understanding each person's unique physiology and ultimately improve quality and extend the lives of female patients.

If selected for this prize, we would utilize it by 1)We will enrich the lives of more women by scaling our manufacturing batch in commercial production, and impact more women through our pilots 2) Execution and operational expenditures throughout the clinical trial of the first medical device for women using emerging technologies such as advanced fabrics and AI developed and led by multicultural female engineers from MIT with support by world-class renowned female cardiologists.