Hyivy Health

Hyivy Health creates an intelligent and holistic pelvic rehabilitation device for the 1 in 3 women worldwide who will experience a pelvic health complication in their lifetime. After childbirth, over 35% of women experience urinary incontinence and over 20% experience severe pelvic floor injury, which leads them to have symptoms that impair their physical and mental function, impacts their relationships and directly decreases their quality of life. Our device is the first on the market to provide real time information from multiple sensors and mechanical functions to help keep track of progress, adapt treatment plans and provide more effective, customized and comfortable rehab experiences. Our clinical goal for our users is to help increase tissue elasticity by 46%, increase comfort by 90% and decrease pain by 60%. This allows women to return to safe and comfortable intimate activity quicker and increases their overall quality of life.

Over $100.5M is spent in Canada treating pelvic pain disorders and the national demand for women's health care is forecast to grow by 6% by 2020 with women’s health creating an economic burden of over $500B on the health care system. In the US, over $258M is spent on ambulatory services for pelvic pain and there are over 1.2M new patient visits for pelvic health each year. This representing a 35% increase in demand for pelvic health clinics and treatments in the US. In addition to postpartum health, there are over 2.2M women yearly worldwide diagnosed with pelvic based cancers including colorectal, bladder and gynecological cancers, 25M women passing through menopause each year, 116M women with PCOS worldwide and 176M women with endometriosis worldwide. These women represent just a portion of the 1 in 3 women who experience pelvic health issues globally. Their day to day lives include experiencing symptoms such as vaginal atrophy, dryness and stenosis, inflammation, pain, bleeding, bladder and bowel incontinence, changes in sensation, loss of sex drive, mental stress and inability to participate in intimate activity. These symptoms are often debilitating, embarrassing and prevent women from being able to enjoy work, home and family life.

HyIvy Health creates a connected, modular, medical grade pelvic rehabilitation device for pelvic floor recovery that can be used from the comfort of the patient’s home. We created a vaginal wand that includes electrical and mechanical functions as well as a mobile application for showcasing data, educational videos and tracking progress. The device collects before and after treatment data, benchmarks this data against medical data from their session and educates the patient on the proper technique to perform treatment. The data collected can then be examined by the doctors to assess the clinical progress made by the patient during their rehabilitation and make adaptive changes to their treatment plans based on the outcomes. The device is modular so that a user can create a custom package of therapeutic add on modules that are specific to their own treatment regimen. The goal of the device is to allow the user to facilitate their own pelvic floor therapy that is consistent, safe, reliable, does not require frequent therapist and doctor visits and allows the user to see their progress made over sessions. 

Hyivy Health is the first device which provides the proper education, knowledge and tools to help a patient better understand their pelvic floor function, showcase their progress and provide treatment at a speed and comfort level which allows the user to remain in control. With better education, privacy during a rehabilitation session due to the device’s remote nature, and customizable add ons to the device, patients can have rehabilitation that is specific to their needs, keeps track of their progress and empowers them to perform their own treatment. This reduces the shame and embarrassment often accompanied by seeking treatment for pelvic health complications while also helps avoid invasive examinations and therapy which can often be painful and traumatic. On a functional level, we are the only device on the market that is custom to a women's specific treatment needs, tracks data for more effective treatment plans and is proven to increase vaginal elasticity by 46%, increase comfort by 90% and decrease pain by 60%.

Our team has realized that this industry does not know the basics about gynecological health, let alone baseline information on the population who are experiencing pelvic health complications. While developing our product and user testing, we have came up with a medical approach, which is starting to be adopted in Canada, to better treat gynecological health for women. We have created the 5 vital signs of the pelvic floor to not only gather baseline data on gynecological information that has never been developed before, but also to provide a guide for the creation better products and treatment options for women.

The Hyivy Health device was created using the feedback from a number of different women who have experienced challenges with their pelvic health; from gender reassignment surgeries for trans women to chronic pain issues with vulvodynia. Our goal was to create the first holistic device that treats, monitors and prevents a number of different symptoms from occurring that are often interconnected. This is how we came up with our medical approach to make sure our device was able to serve all 5 vital signs a women experiences when dealing with pelvic health complications. These vital signs include healthy tissues, sensation (pain to pleasure), muscle control and response, incontinence (bowel and bladder) and lubrication (infection to fertility). On top of Hyivy being the only device to serve all 5 symptom areas of the pelvic floor, we are also the only company tracking data in all 5 vital sign areas. By tracking data, we can start to have a better understanding of the pelvic floor, how to treat it effectively and truly understand what treatment is best for certain diagnosis. With this data, our goal is to start to bring standardization to the medical industry around gynecological health as well as better treatment options from the current standard of care with dilations, kegel's and pelvic floor therapists for every women's diagnosis.

Hyivy Health creates a modular, connected vaginal wand that has electrical and mechanical functions to help women treat and monitor pelvic health symptoms from the comfort of their own home. Our users work directly with their doctor to set up a treatment plan on the device, which can include using the device up to 3-5 times a week for 10 to 15 minutes. After customizing the device with tech modules built for their specific treatment plan, the patient would walk through a number of different training and educational videos on how the treatment should be administered and the outcomes they should expect through the mobile application. The patient goes through a before and after session check in on their symptoms and inserts the device for treatment. The device will provide an optimal treatment of auto dilation using air chambers and force sensors, hot and cold contrast therapy, self lubrication monitored by humidity sensors, imaging for reduction in injury, vibration for muscle relaxation and other functions dependant on their attached modules. By collecting this data from multiple sensors, the user and their doctors and therapists will get a holistic picture of the state of their pelvic floor and administer the rehabilitation accordingly. After each treatment, the data from their sessions and their progress reports can be remotely shared with their doctors and reviewed for adaptive changes to the treatment regimen if needed. As the patient continues on with their treatment and watches more educational videos, their progress is gamified for rewards. 

Although this technology does not exist in its holistic form, there are a number of ways women currently address each of their functions individually. The standard of care for the majority of women experiencing pelvic health issues includes static manual dilators and pelvic floor therapy. Pelvic Floor Therapy is used to massage out tense muscles, break down scar tissue and improve incontinence. It is proven to improve urinary incontinence by 74% and improve pelvic pain by 59%. Unfortunately, it is extremely expensive, often needs up to 5-12 months before seeing results and has a high patient fall off rate. Our goal is to work with pelvic floor therapists to provide the same type of data they would normally get with using their hands while keeping their patients on track with their treatment. Dilators are the other standard of care used by doctors and have mild success with 55% of patients reporting comfortable sexual intercourse after the use of the therapy. The problem with dilators is that 62% of women still report vaginal stenosis after using the therapy, which is connected to the 87% of women feeling like they had a lack of education on how to use them properly and 76% reporting a lack of motivation due to the pain and discomfort they feel. This pain is connected to the static sizes that do not conform to a women's specific needs and anatomy.

Sources: 

http://urology.stanford.edu/content/dam/sm/urology/JJimages/publications/Pelvic-floor-physical-therapy-in-the-treatment-of-pelvic-floor-dysfunction-in-women.pdf

https://www.ncbi.nlm.nih.gov/pubmed/24725693

https://search-proquest-com.ezproxyberklee.flo.org/docview/220765072?pq-origsite=gscholar

https://ascopubs.org/doi/full/10.1200/jco.2005.05.101

https://www-sciencedirect-com.ezproxyberklee.flo.org/science/article/abs/pii/S1083318817302656

Hyivy Health was developed by Rachel Bartholomew after her diagnosis of cervical cancer at age 29. Using her own experience and listening to groups of over 10,000 women on online Gynecological Cancer Support Groups, she found that the number one issue these women were dealing with was their after care in pelvic health after treatment. Through secondary research, Rachel found out that many of these symptoms and complications were similar among many diseases and women's health changes and as she started radiation, she used her time at the hospital to pitch the solution to doctors in the cancer ward who gave her the clinical validation to start building a solution to solve these problems.

As we built our team and started to scope out the technology, we realized that a lot of the baseline data on basic female gynecological health was missing. This forced our company to take a step back and start user testing with a small group of women representing each area of pelvic health complications to gather our own baseline data. When gathering this primary data, our team discovered that many of the solutions and research studies in pelvic health have been isolated and siloed into groups focused on treating and understanding one symptom or function. This has caused products and treatment plans to be developed that do not encompass the larger picture of what is happening in the pelvic floor. Through this knowledge, we created a medical approach called the "5 vital signs of the pelvic floor" in which we base all of our research and product development around. We wanted to make sure to holistically look at the pelvic floor as an entire entity that creates the network complex symptoms women deal with.

The theory of change for our device is to keep our women safe and comfortable at home while empowering the patient with knowledge and education to allow them to have a better understanding of their pelvic health with quality and trustworthy data. This will drastically improve their quality of life while reducing the strain and demand on the health care system.

We are currently user testing and gathering baseline threshold data with a handful of trans women in New York City, 3 gynecological cancer patients, 2 post-partum patients and 2 endometriosis patients. This testing is being done in tightly controlled environments so that our team can gather the missing medical research on the population dealing with the pelvic health complications we need for optimizing our electrical and mechanical functions. We have over 150 patients signed up for alpha/beta user testing which we are planning to begin in 4-6 months. During our pre-sale in 2021, our goal is to pre-sell 250 units before releasing the product to the general public. 

With over 24% of women in the US and 10% of the Canadian population experiencing pelvic health complications, this means that there is an immediate need for pelvic health rehabilitation and treatments from over 43M women. If we are able to achieve even a 1% penetration in North America within the next 5 years after our pre-sale selling direct to consumer, this is over half a million women’s lives we can change with our product.

All of our main product development is scheduled to be completed at the end of Summer 2020, with alpha and beta testing starting Fall 2020 and Manufacturing and Pre-Sale activities happening Winter/Spring 2021. Our plan is to go to market within North America direct to consumer using our thought leadership, early testing, user traction and support from the medical communities in Canada and the US. Meanwhile, we have already been building up a network within UK and France, Japan and Australia to start exploring the different medical markets and consumer perceptions in each market. Our goal, once our product is released, is to start working with entities we have already connected with like Medilink in the UK, Fermata in Japan and The University of Queensland in Australia to connect to medical researchers and consumers interested in purchasing for global expansion. We also will also start exploring FDA, Health Canada and NHS regulatory approval in Fall 2021 to Winter 2022. The goal with regulatory clearance is to have our device used worldwide but also offered as a standard of care by doctors, used in therapists offices and used as the main source of treatment by gynecologists. This medical market helps us scale both in device sales as well as data collection since gynecologists see an average 50-100 patients a week and each pelvic floor therapist provides access to hundreds of patients in their client base.  

1. We need to build a robust team around many different areas to make sure our business runs smoothly. These areas include regulatory and quality management, manufacturing, advanced electrical and mechanical engineering, medical research, human studies, marketing, HR, financial, business strategy and product development. This is not only financially taxing for the business but requires a lot of collaboration and team management.

2. We have a couple, well established competitors in the pelvic health space that have the funding and patent profile built to compete against us as well as the track record having a product already on the market.

3. The third major business risk is making sure to balance our costs so that we do not create an expensive product that pushes us to charge a higher price and pushes us out of the consumer market, forcing us to go through the costly medical regulatory approval right away.

4. Lastly, there is concern with the consumer mentalities around sexual health products. These are products that are often stigmatized and make people uncomfortable, making them a harder sell. This has been noted from a number of partners we have connected with who have stated that large markets, such as Asia, are harder to gain traction in.

From a technical and clinical perspective, safety of the customer is our number one priority and we need to make sure that we follow strict guidelines around data compliance for storing and securing data of our users. 

It is important for us to build a strong patent portfolio, continue our “medical first approach” in the development of our product and take extra time to understand and educate our customers on the proper use and the impact of our device from a medical perspective. This will not only help with competitive pressures but also help with a reduction in error and ensure safety when using our product. Marketing tactics will need to be well thought out with mentorship from our business board of advisors who have gone through similar go to market strategies and handling consumer perceptions. We have access to world class universities in Canada and the US and their knowledge base, expertise, and equipment for research and testing will help us build a reliable, safe and innovative product. Our team has past start up experience that can help us navigate the grant and investor fund raising activities and has performed years’ worth of engineering, research and product design. We are supported by strong business incubators across Canada and the US who will provide us access to the right business and medical advisors and will integrate us into medical communities. We have partnered with the Privacy Commissioners Office in Canada to mitigate the risk of data and information flow between patient and doctor while also putting in place proper protocol, knowledge base and guidance tools for patients to properly conduct the treatments from home using our device.

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1. Rachel Bartholomew, CEO and Founder
2. Kamyar Rouindej, Technical Lead and Co-Founder
3. Bryce Bonneville, Legal Counsel
4. Sandy Zakaria, Medical Research lead
5. Sarah DiPietro, Medical Strategy Lead
6. Julianna Downes, Biomedical Engineer - Electrical
7. Madeleine MacKinnon, Biomedical Engineer - Mechanical
8. Lois Lin, Medical Product Manager
9. Rama Krishna, Software and Embedded Systems Lead
10. Michael Katz, Electrical Engineer Consultant
11. Amir Pahlevanpour, Industrial Designer
12. Michael Vilenkin, Mechanical Design Consultant 
13. Fatin Sakar, Research Manager 
14. Boxun Li, User Interface & Graphics Designer
15. Manthan Pawar, Medical Robotics Lead
16. Hannah Duraid, Global Distribution and Marketing
17. Claire Rosario, User Experience Lead

Our team is highly experienced and well educated in the areas of entrepreneurship, technology and product creation. Our founder has lived the horrors of this problem directly after her diagnosis with Cervical Cancer and wants to solve this problem not only for herself, but all of the women she encounters whose life has been impacted. For 6 of our team members, this is their second Startup they have worked on from the beginning of its conception.  Our team has accomplished exits, global expansion and the delivery of high-tech solutions with their previous companies. Our engineering team have all worked with creating medical devices in the past and medical team all has extensive research experience in the biomedical and medical science fields. 11 of our staff members have also achieved master’s and PhD level educations in their relative fields. 

We are backed by a board of medical advisors made up of 10 reputable, respected and talented medical professionals in their fields. We have 2 Gynecologists, a pain specialist, a Medical Doctor, a Gerontologist, a Pelvic Floor Therapist, a Radiologist, a Sex Therapist, a  Gyne-Oncologist, a Urologist and a Health Sciences Researcher helping us navigate the design, patient perspective, medical applications and use cases of the device in the medical field. 

In combination of our medical advisory board, large number of business advisors and well-established team, we have the proper access to knowledge, research, patient perspectives, market access and business strategies to make a successful global product.

We are partnered with the following institutions and individuals:

• Hamilton Health Sciences has partnered with us to help deploy our medical approach as a quality improvement project for pelvic health clinics.
• Mohawk College has partnered with us on a research project around the technical needs of our solution including the development of sensor technology, use of medical grade materials, creating mechanical elements and manufacturability.
• Our medical advisor and gynecologist, Dr. Julie Moore, has offered up a partnership for clinical trials and testing using her patient-base.
• Privacy Commissioners Office of Canada is working with us to help navigate patient information compliance and lobby the government for opening up barriers to sharing patient data across networks.
• We are apart of a number of business accelerators in North America including Communitech, NYDesigns, The Forge, Rhyze Ventures, VentureLab, Synapse Life Sciences for business and technical advisory. 
• We have partnerships with Autodesk and Solidworks for software support to develop our technology, designs and simulations.

We are also in the process of working on the following partnerships:

• ENQCOR 5G & IBM to build a secure and compliant medical network between gynecologists and pelvic floor therapists to their patients on the 5G network.
• Google Fit to start exploring how to integrate our 5 vital signs of the pelvic floor into a baseline for monitoring women's health using Google's products

We operate with multiple revenue streams direct to consumer through a one time charge for different packaged versions of the product, one time charge for any additional add-on modules the user wants to add to the device, a monthly reoccurring subscription model for lubrication packs, which are custom to the device, and selling anonymized data from the device for medical research.  We sell the base device (built for menopausal women) for $350 with a pack of 12 lubrication pods custom for the device and a charger. Our gynecological level (built for post partum women) product package is sold for $400 and our cancer/gender reassignment level product package is sold for $450. We charge $20 for a monthly subscription to the lubrication pods and are exploring selling our additional add on modules for $50-100. We reach a 58-62% margin on our materials and supply chain costs and our reoccurring revenue from the lubrication pod packs represent 30% of our overall revenue. 

We will first run a pre-sale through our website or Kickstarter with a product release online to the novelty market directly through our webstore. Once established, we plan to scale our distribution through selling to other online retailers and North America wide storefronts. We want to use our revenues to help fund regulatory approval needed to sell to the health care market to doctors and therapists, where we will be putting together a medical sales team to sell to doctors and therapists as well as insurance companies for reimbursement.

To get our product through the R&D phase of user testing and medical research, we will need approximately $300,000, in which we have already secured $130,000. We are guaranteed to close the other $170,000 needed within the next 2 months. For beta testing, ramping up our pre-sale and  first manufacturing run, we need to raise $550,000 from a combination of a lead angel investor and partnerships with research institutions. With our current projection plan of a presale of 250 units in 2021, we will be able to gain traction of $100,000 in revenue. We plan to have another manufacturing run of 1000 units shortly after our presale with a full product launch in the fall of 2021, which rounds our revenue potential up to $235,000 at the end of the year, including the $100K made from the presale and the sale of an additional 500 units (device only) after product launch. Our goal for 2022 will be to ramp up our marketing efforts and tackle the North American market with the sale of 3500 units and over 20,000 lubrication pods. This puts our revenue projections at $1.6M in 2022 with the ability to be cash flow positive by 2023 using a conservative projection approach. Based on current projections, our MOM revenue growth is 15%. In 2022, we will be looking to raise a significant Series A round of $5M to gain regulatory approval to sell into the B2B medical and insurance markets.

Hyivy Health is applying to Solve to help create partnerships, access to resources and personnel on the front lines of driving gynecological care for women worldwide. Our goal is to help improve gynecological care for all women, including women dealing with pelvic health challenges from post-partum complications. The Solve challenge will provide us direct access to the regulatory support we need, help us get access to world class medical research in the fields of women's health to help us with testing our device and creating correlations with the data we are collecting on the pelvic floor.

Another reason why we are applying to Solve is because of the access to global partners, companies, entrepreneurs and researchers who are active in physical locations we would not normally have access too. We want to work with these partners to understand consumer challenges, perceptions and health care system stresses around the world and in the most remote areas. 

We would use the $10,000 in funding to further our research in how to build our device to work in these remote areas for women who may not have access to basic health care needs. We want to understand how their health care systems work, what they lack and how we can fill a gap for gynecological needs. We would also use this grant to build up a minority population for user testing to better understand the reason for higher maternal complication rates within low income and minority populations by testing and gathering data.

Business model - We are looking for mentorship and guidance from companies and individuals who have been successful going to market direct to consumer and the pivoting to also provide a similar device to the medical market. 

Product distribution - We would like to connect with companies who have options and access to networks where we can test the device, not only on a variety of different minority backgrounds and medical conditions, but also different markets set up with their own health care and consumer challenges.

Regulatory - We are looking to connect with regulatory and government entities on their own countries specific requirements for bringing medical devices to market ,while also exploring how they are pushing remote & digital care after COVID 19.

Marketing - We would like to connect with researchers and companies on how they navigated consumer perspectives and how they built trust around their health products.

There are a number of different organizations within the Solve network we would like introductions to potential partnerships including:

WEEMA international, Women Deliver and technical companies like Cisco, who are applying health care in remote communities globally where there is a lack the access to basic health care treatments. They have navigated the area of women's health, understand the needs and have deployed clinical care to these areas. They know the challenges, limitations and understand these women and their day to day struggles, specifically with their health.

MIT is a leader in both technology development and health care. With our complex product and the lack of knowledge in the area of gynecological health, we would like to partner with faculty working in the areas of gynecological health, digital health and data analysis, such as the Data and Feminism Lab, to help us navigate our development through our engineering challenges and help make correlations between the data we collect.

There are also a number of individual Solvers we would like to connect with including DoctHers and Sexperto who can help us understand the global sexual and women's health needs in their respected locations. Also, companies like E-heza and Neopenda, who have explored and developed complex technologies for women's health needs.

Our device is one of the first to collect data that can be used by doctors to provide remote gynecological care. We want to empower doctors by gathering data every time they perform a rehab treatment using our device so that they have a better understanding of the type of treatment that is best suited for each of their individual patients. This customized and individualized care helps doctors not only have regular screening over their patients consistently, but also helps them create more effective treatment plans and outcomes. With our medical approach providing a holistic view of the entire pelvic floor in combination with a device that can collect data on the 5 vital signs of the pelvic floor, doctors can finally provide care that is not separated into its isolated buckets focused on pain or incontinence, but actually treat and monitor all of the symptoms experienced in the pelvic floor as a whole. This allows doctors to have a better knowledge of what treatment options are needed, understand and predict the further needs of their patients and will improve the treatment outcomes of their patients.