Hyivy | Kisaco Research

Founder Journey

with CEO & Founder Rachel Bartholomew

Starting with any relevant education, walk me through the twists and turns of your career to date? How did one opportunity lead to the next + what was the key takeaway/ experience in each role + how did this lead you to where you are now? 

I’ve been involved with the startup community for over 15 years with extensive experience in small businesses, venture capital, innovation labs and ecosystem partnerships. I’ve been proud to be an entrepreneurial advisor to over 250 formation stage businesses and have also taught as a professor in entrepreneurship for quantum computing. 

My first business was one I got the idea for when I was completing my Master of Business Entrepreneurship and Technology at the University of Waterloo. I have a passion for cars, and from that passion and seeing an opportunity in the market, I founded an automotive ecommerce software which I brought to an exit. As a first-time founder I learned a lot of lessons on the ground and went on to work as an Innovation Manager at a large Canadian Financial Institution and helped restart Laurier University’s incubator program. 

Then I received a cervical cancer diagnosis in 2019. During the time of my treatment, I learned how my medical interventions would have a profound effect on my pelvic health with extensive scarring, narrowing and the potential for lifelong pain. I took to online support groups and learned how many other conditions like endometriosis, vaginismus, menopause, post-partum, and more are leaving patients with a decreased quality of life, and the clinicians who treat them to with little or no clinical data or tools to effectively treat them.  

With my varied experiences as a founder and entrepreneur I was in a unique position to tackle an issue that has hit epidemic proportions. 

What was the pivotal moment that put you on your current founder path? 

Cancer. I know that’s not the typical path for a founder or innovator, but when we think about innovation and drive, it often comes from a great necessity. This became a driving force for me, and I was put on a path where not only was I facing a personal pivotal point. As a founder, innovator and entrepreneur at heart, I was called to action. 

I was able to take my experiences as a founder, advisor, and analyst to pragmatically approach the first questions and challenges in creating a medical device company. I grounded myself in the lessons learned about the importance of leveraging your network, reaching out to experts in the industry, building the right team, and what it means to build a startup from the ground up. 

I infused my personal journey and connections to take a patient-centered approach. You could say my first market research exercise was interrogating my radiologist while I was getting my radiation treatment. Shortly after, I was called to my oncologist's office about this, and honestly thought I was going to get some bad news about how my treatment was going, but instead they wanted to speak to me about getting involved with the project! 

That was over 4 years ago, and now Hyivy Health has a full-time team of 10 experienced award-winning engineering, medical, quality, and marketing professionals. We have our main office in Kitchener-Waterloo in Ontario, Canada, with subsidiaries in Chicago and the UK.  

Can you provide a summary of the technology/ area of innovation and its potential application? Have there been any pivot points in the company’s lifetime and what triggered these? 

1-in-3 women experience pelvic health issues at any age with over 51 associated conditions. Chronic pelvic pain is pain that lasts for more than six months in the pelvic area.  Many patients suffering from chronic pelvic pain are the result of chronic, non-curable conditions. 99% of people with chronic pelvic pain are women, and have a too tight, or hypertonic pelvic floor.  

The current standard of care is a cylindrical-like device invented almost 100 years ago designed to stretch and lengthen the muscles of the pelvic floor. In theory this makes sense, however, very little innovation has been applied to this approach with patients universally hating these devices with an abysmal adherence rate.  

Clinicians like OBGYNs, UROGYNs, and Pelvic PTs are left with insufficient diagnostic or treatment tools, and limited evidence-based solutions. They’re seeing a continued influx of patients with chronic pelvic pain with a 35% increase in year-over-year demand and are seeing up to 1 year long waiting lists, and the demand simply isn’t keeping pace with supply. 

The current standard of care is a direct-to-consumer model leaving patients feeling directionless in their care with doctors having few tangible insights. 

This was a turning point for Hyivy, because we realized we needed to create a solution that wasn’t just going to sit in a drawer and have no way of connecting with the medical community. I made the decision to create a class II medical device, patient app, and clinicians' software. This was a hard decision because I knew the road would be longer, need more funding and resources, and would require navigation of the regulatory pathway, but it will pay off in the long run. 

Hyivy Health’s pelvic health rehabilitation system for patients and the clinicians who treat them. This system includes Floora™ vaginal dilator for at-home use, our patient app, and clinician software. 

Floora™ is a class II medical device designed to provide auto-dilation, thermal therapy, and is equipped with multiple sensors providing the patient with an elevated standard for therapy as well as providing the first ever objective data set for chronic pelvic pain patients.  

The patient app empowers patients to set their schedules, access education and resources, chart progress, set goals, record their outcomes, and connect remotely with their clinician. The clinician software lets doctors curate unique and personalized therapy plans, compare analytics across large databases, prevent, predict, and treat conditions, track and monitor high risk populations, connect with their patients through telehealth, and efficiently record reimbursement information. 

What stage are you at? 

We’re currently at the clinical stage with a variety of clinical trials in process. We’re also in preparation for commercialization first in the US . We’re currently closing a seed round and are heading for a Series A round in 2025.  

Discuss the biggest challenges of getting to this point? With the benefit of hindsight, what would you have done differently if anything? 

I think I can speak for any startup founder that challenges are always present! As a FemTech founder who started a company centered on women’s health, the biggest challenge has been the lack of awareness about how critical the need for innovation is.  

Because there’s so much stigma, shame, dismissal, and lack of data around women’s health and bodies, it can feel like an uphill battle just to communicate the basic facts around what you’re trying to achieve. It can still be a challenge when pitching to a crowd who may not have had direct experience with what you’re talking about, so they think, “well I’ve never heard of this, so it can’t be that bad!”  

But this is changing, and with the groundswell women’s health innovation I’m doing everything I can to support and amplify why FemTech is so critical at this moment in time.  

Would I do anything differently? Sure, there are a few examples I can think of where I can get a case of the “woulda, shoulda, couldas” but like with anything in life, I’ve tried to take things in stride and learn lessons as they come.

 

How have you approached funding? 

Our main focus has always been non-dilutive funding in a variety of forms to get support for our clinical trials, early-stage R&D, with rounds of dilutive investor funding for medical devices and derisking over time to get the product to market.  

What has been the greatest source of help/ guidance along the way? 

I’ve been fortunate to be surrounded by a wide array of folks in my network who have given me support and shared their wealth of knowledge and experience.  

Velocity and MIX in the Kitchener-Waterloo region have given us resources and space to build our company. Mentors and advisors with an array of expertise from medical, business modeling, and regulatory. The Zambon Group has been a key partner in providing capital and resources, backed by a dedication to women’s health innovation and their mission to help people not just be alive, but truly live. 

I’ve also found connecting with other FemTech and MedTech companies extremely helpful and sharing information, resources, and lessons learned.  

Best advice you’d pass on to other founders? 

Trust your gut. As a founder there can sometimes be a cacophony of voices sometimes pulling you in opposite directions. This can be especially true for female founders who can be over mentored and underfunded.  

Sometimes you can feel “lost in the sauce” when it comes to growing a startup. I suggest finding a way to reconnect with why you started your mission in the first place. For me, it’s the thousands of women who have come forward to share their stories with us at Hyivy. It helps to ground me in why I started this company and highlights what I am not willing to sacrifice to find success. 

What do you think are broadly the biggest needs and opportunities in the Women’s Health Market? 

Funding and research. I feel like anyone in the FemTech or Women’s Health Industry understands the historical factors contributing to a lack of understanding, interest, basic knowledge and urgency around health issues that impact women, girls, non-binary, and trans women.  

The irony about this need is women are responsible for 80% of all healthcare spending for themselves and their families and given the absence of effective solutions and treatments are often early adopters and savvy consumers. 

The need becomes the opportunity in this case. Investors, governments, and researchers all have the lucrative chance to align themselves with this opportunity, and take advantage of the research, clinical trials, R&D, and regulatory pathways required to develop impactful and meaningful solutions. 

FemTech is a global movement which intersects with women’s health and we’re seeing a boom in the number of founders working on a new generation of women’s health innovation. The opportunity to shine a spotlight, provide resources, and connect founders was part of the reason I founded FemTech Canada to join the plethora of other global organizations advancing the narrative around women’s health needs.  

 

What’s going to have the single biggest impact on change in your area of the market? 

Data. The gender data gap expands across all sectors of women’s health from reproductive and sexual health to the brain and heart. Women have been excluded from clinical research with an “ideal” male body standing in as the default, and there is a lot of work to do to bridge this gap.  

A major driver for us at Hyivy is to collect the first ever objective and subjective data set on the pelvic floor. What will the data show us? We aren’t going in with assumptions, and it’s the most exciting part of our project.  

Closing the gender data gap stands to usher in effective innovation, policy, and economic growth of the likes we’ve never seen before.  

What do the next two years have in store for you? 

Bringing Hyivy Health’s pelvic rehabilitation system into the hands of patients and clinicians is our next big milestone. We’re working on getting our regulatory approvals in conjunction with reimbursement through various payers and continuing to expand our clinical research with world renowned researchers and clinicians across the US, Canada, the UK, and Europe.  

I’ll also be continuing my work in FemTech and women’s health with various initiatives supporting FemTech founders through FemTech Canada, as well as the recently launched FemTech Across Borders (FAB) where organizations from all over the world are collaborating on how to advance progress in women’s health.  

On a personal level, this year I’ve been officially discharged as a cancer patient with my final scans just last week. Hyivy Health has been my mission over my years being in treatment, and now that I’ll be on the other side I feel more energized than ever to ensure that women can live healthier, happier lives. 

 


Hyivy’s vision is to provide lifetime value to women, globally; and their mission is to support and care for women who are on a journey to a better quality of life, one pelvic floor at a time. To raise the bar on pelvic health and improve the standard of care for patients and clinicians.

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