Born from its founder’s own experience with cervical cancer, FemTech startup Hyivy Health has secured $1.1 million in pre-seed funding to improve womens’ pelvic health.
Threshold Impact, Beresford Ventures, Equation Angels, Zambon Research Venture, The51, OCI, iGan, and Velocity all participated in the oversubscribed round, along with a number of individual angel investors. The round closed in December.
“Through my cervical cancer diagnosis and recovery, I quickly learned the hard way that women have to navigate, and are often neglected by, a broken pelvic health system.”
Hyivy Health is developing the first smart, holistic pelvic health rehabilitation product for the one in three women who will develop pelvic health complications in their lifetime.
Hyivy claims its pelvic health system is the first fully ergonomic, remote monitoring device collecting multiple data sets and connecting patients to their clinicians and pelvic floor therapists virtually.
The startup has ambitious plans for its new capital. Hyivy Health plans to use the funds to help with manufacturing of its device, safety testing, certification, and to move through regulatory approvals with the FDA and Health Canada.
It plans to complete an upcoming clinical trial in May 2022 with McMaster University to further explore the device’s use for pelvic pain with endometriosis patients and tracking chronic pelvic pain.
The startup is also setting up a clinical trial with Grand River Cancer Centre in Kitchener in which the device will be used for rectal as well as gynecological cancer patients, helping them with post-radiation treatments. Rachel Bartholomew, Hyivy’s founder and CEO, said she hopes that trial will begin in the summer of 2022.
As well, Hyivy Health intends to launch the first private, anonymous online pelvic health community where women can have a safe space to ask their pelvic health questions and can connect with Hyivy-accredited clinicians.
Hyivy Health’s rehabilitation system aims to provide a prescribed protocol from Hyivy accredited-clinicians for patients to use at home. It features auto-dilation, hot and cold contrast therapies, and self-lubrication.
The startup claims it is the first technology to connect clinicians with patients as well as the first to collect both objective and subjective data about the pelvic floor. Patients will also have access to a Hyivy app where they can track their progress, and have on-demand virtual sessions with their therapist.
Batholomew founded Hyivy Health while she fought and recovered from cervical cancer. She created the startup after she witnessed the lack of holistic pelvic healthcare for herself and the thousands of women she connected with through online support groups.
“Through my cervical cancer diagnosis and recovery, I quickly learned the hard way that women have to navigate, and are often neglected by, a broken pelvic health system that has failed millions of women for decades,” said Bartholomew.
“I started this company because I believe women deserve better,” she said.
In a blog post on the startup’s website, Bartholomew recalled the problems she experienced.
“From surgery for endometriosis, pelvic floor therapy sessions treating my PTSD for Bartholin’s gland issue, to a cervical cancer diagnosis at 28 years old, I have faced the realities of early menopause, long lasting damage to my bladder and pelvic floor, and the ways this has impacted my ability to be intimate for rest of my life,” she wrote.
She recounted how she created Hyivy Health while on bed rest after her hysterectomy and lymphadenectomy in 2019. Batholomew remembered turning to a community of over 10,000 women who shared their stories, support, and tips about after care which got her through what she calls her darkest days. “These women inspired me to get inquisitive about pelvic floor rehabilitation,” she wrote.
“Because we believe women deserve better, we made the decision to create a medical device rather than a direct-to-consumer device knowing it will be a more complex and costly process,” Bartholomew said. “We’re passionate about taking women’s health care to the next level in a space that has seen little-to-no innovation in nearly 100 years.”
Headquartered in Kitchener-Waterloo, Hyivy has seven full-time employees and five part-time. Before this pre-seed round, the company received some $700,000 in funding from federal and provincial governments.
“Since its participation in the fourth edition of our Open Accelerator program in 2020, the potential of this innovative start-up has always been clear,” said Elena Zambon, president of Zambon Research Venture and Open Accelerator Ideator within Zcube, and one of HyIvy Health’s investors.
Hyivy Health also took part in L-Spark’s new medical technology accelerator program, launched in 2020 in partnership with Telus, BlackBerry, Solace, and the Canadian Internet Registration Authority.
At Communitech’s Winter 2020 Fierce Founders Bootcamp, the startup took second place in the pitch contest, taking home $25,000.
The International Trade Administration in the United States notes Canada has the eighth largest medical device market in the world, and pegs its value at $10.7 billion CAD. The Canadian government reports that in 2019 medical device exports to the United States were worth $3 billion CAD or 70 percent of Canada’s total medical device exports.
Back in Kitchener, Hyivy can’t take on customers until it receives full regulatory approval for its device. In the meantime, Hyivy is working with potential customers and focus groups to get feedback as they prepare for the launch of the device.
Bartholomew conceded that the regulatory process is challenging, but that doesn’t sway her from pursuing approval.
“Regulatory is always a scary process,” she said. “But we realized how significant the lack of research was in this space, and as we were doing product development and we saw these gaps, we were like, ‘somebody’s got to just pull up their socks and just do this, and get the true core data that we need both from clinical trials and efficacy on what actually works and what doesn’t.’”