Hyivy Health's Smart Dilator Aims to Measure the Unseen in Pelvic Pain

For patients navigating the long road of pelvic rehabilitation, progress is often measured in silence. The standard tools,simple plastic dilators, pain scales, and intermittent clinic visits,leave clinicians with little more than subjective reports to gauge recovery from conditions like post-cancer radiation, endometriosis, or chronic pelvic pain. Hyivy Health, a Canadian medical device startup, is betting that the path to better outcomes runs through objective, at-home data.

Founded by Rachel Bartholomew after her own experience with cervical cancer, Hyivy has built a connected pelvic-health system called Floora. It combines a smart vaginal dilator with precision control, integrated sensors, and heat therapy, paired with companion software for patients and their care teams [RBCx, November 2023]. The company’s seed round, led by Zcube,Zambon Research Venture and closed in September 2024, brought its total disclosed funding to approximately $3.1 million [Femtech Insider, September 2024]. The core proposition is to turn a traditionally opaque and isolated therapy into a measurable, remotely monitored treatment protocol.

From personal experience to clinical protocol

Rachel Bartholomew’s path to founding Hyivy was not through a traditional medical or engineering track, but through lived experience. Following her cervical-cancer diagnosis and treatment, she encountered firsthand the gaps in supportive care for pelvic health, a domain she says affects one in three women in their lifetime [Hyivy]. Her professional background in the Canadian startup ecosystem, spanning venture capital and innovation labs, provided the network to begin building a solution [Hyivy]. This founder-market fit, rooted in patient need, has been a cornerstone of the company’s narrative and investor appeal. The cap table reflects a mix of specialized healthtech and impact-focused funds, including Threshold Impact, The51, and Women’s Equity Lab [BetaKit, January 2022][Femtech Insider, September 2024].

The data-driven wedge in pelvic rehab

Hyivy’s product strategy targets a specific wedge in a broad market. While the company cites a potential addressable population of hundreds of millions with pelvic floor dysfunction, its initial focus is on prescribed rehabilitation for complex, often iatrogenic conditions [Women of Wearables]. The system is designed to give clinicians something they largely lack: quantifiable biomarkers of treatment adherence and physiological response.

• Remote monitoring. Clinicians can prescribe personalized dilation and heat therapy protocols through the software and monitor patient usage and progress remotely, aiming to replace guesswork with data [SOSV].
• Objective biomarkers. The integrated sensors in the Floora device are intended to collect data on factors like tissue compliance and patient tolerance, moving beyond subjective pain scores [SOSV].
• Clinical integration. The model is clinician-prescribed, positioning the system as a tool for hospitals, gynecologists, and pelvic-floor physical therapists, rather than a direct-to-consumer wellness product [RBCx, November 2023].

The company reports a waitlist of over 300 hospitals, gynecology practices, and physical therapy clinics, though it has not publicly named commercial contracts [SOSV, January 2026]. Early deployment has occurred through research partnerships with institutions like Women’s College Hospital and McMaster University [The Honest Talk].

Building evidence through clinical trials

For a device making health claims, regulatory and clinical validation is non-optional. Hyivy has moved deliberately on this front, embedding its technology within academic research frameworks. The company has conducted two clinical trials assessing Floora for post-cancer and endometriosis patients, and it is set to launch another at the Grand River Cancer Centre [Future Fem Health][Ontario Institute for Cancer Research].

Two registered trials are particularly telling of the intended use cases:

Endometriosis-Associated Pain (NCT05643131) | 1 | trial
Interstitial Cystitis/Bladder Pain (NCT07038512) | 1 | trial

The first, listed on ClinicalTrials.gov, is assessing changes in self-reported pelvic pain following use of the Hyivy device in people with endometriosis-associated chronic pelvic pain. The second, noted by CenterWatch in June 2025, is evaluating Floora for managing interstitial cystitis and high-tone pelvic floor dysfunction [CenterWatch, June 2025]. These studies represent critical steps toward generating the peer-reviewed data Pulse Raman looks for, which will be essential for convincing payers and expanding clinical adoption.

The commercialization hurdle

The most credible near-term risk for Hyivy is the transition from clinical research and a waitlist to sustained commercial deployment, particularly in the lucrative but complex U.S. market. The company’s 2024 seed round was framed as a step toward U.S. commercialization, with an anticipated Series A to follow [KISACORE, May 2024]. Success will require navigating reimbursement pathways, demonstrating durable clinical utility beyond early studies, and scaling manufacturing and support for a hardware-plus-software system. Furthermore, while the waitlist number is a positive traction signal, it remains a pre-revenue metric until converted into paying customers.

The competitive landscape includes consumer-focused brands like Elvie in pelvic floor strengthening and other femtech players, but Hyivy’s focus on clinician-prescribed rehabilitation for specific medical conditions carves a distinct, if narrower, path. The company’s answer likely hinges on the data its system can generate. Early, non-peer-reviewed signals are promising; the company states data sets are showing results for treating pelvic pain across over 51 associated conditions [The Honest Talk]. Turning those signals into published outcomes will be the key to its next chapter.

A new standard for a neglected need

The patient population here is vast and historically underserved: individuals managing chronic pelvic pain, recovering from pelvic cancers or surgeries, or living with conditions like endometriosis. For them, the current standard of care is often fragmented and passive. It typically involves a one-time prescription for basic dilators, infrequent physical therapy appointments limited by insurance and geography, and a reliance on patient diaries to track pain and function. This model leaves significant gaps in support, feedback, and objective measurement of healing.

Hyivy’s bet is that a connected device can close those gaps, offering not just a tool but a continuous feedback loop between patient and provider. The next twelve months will be defined by the results of its ongoing clinical trials and its ability to convert its substantial clinician waitlist into a commercial footprint. For a field where progress has long been felt but rarely seen, Hyivy is trying to make the invisible measurable.

Sources

1. [BetaKit, January 2022] Hyivy Health secures $1.1 million in pre-seed funding to ease women’s pelvic health problems | https://betakit.com/hyivy-health-secures-1-1-million-in-pre-seed-funding-to-ease-womens-pelvic-health-problems/
2. [Femtech Insider, September 2024] Hyivy Health Secures $2M Seed to Unlock New Model for Treating Pelvic Pain | https://femtechinsider.com/hyivy-seed-round/
3. [RBCx, November 2023] Hyivy: Rachel Bartholomew’s femtech startup | https://www.rbcx.com/ideas/profiles/how-femtech-startup-hyivy-is-bringing-pelvic-rehabilitation-therapy-into-the-digital-age/
4. [SOSV, January 2026] QA: Hyivy - Reclaiming Pelvic Health | https://sosv.com/qa-hyivy-reclaiming-pelvic-health/
5. [Hyivy] Hyivy Health | https://hyivy.com/
6. [Cortex Design, April 2021] HyIvy Health Founder Rachel Bartholomew’s FemTech Journey | https://cortex-design.com/blog/interview-hyivy-health-founder-rachel-bartholomew-on-her-femtech-journey/
7. [KISACORE, May 2024] Founder Journey Profiles: Hyivy | https://www.kisacoresearch.com/founder-journey-profiles/hyivy
8. [Women of Wearables] Hyivy Health profile | Source not linked in snippets
9. [The Honest Talk] Hyivy Health partnership and data claims | Source not linked in snippets
10. [Future Fem Health] Hyivy clinical trials | Source not linked in snippets
11. [Ontario Institute for Cancer Research] Hyivy trial at Grand River Cancer Centre | Source not linked in snippets
12. [ClinicalTrials.gov] Trial NCT05643131 | https://clinicaltrials.gov/study/NCT05643131
13. [CenterWatch, June 2025] Trial NCT07038512 noted | Source not linked in snippets