Hyivy Health
A pelvic-health rehabilitation system combining a smart vaginal dilator with a patient app and clinician software.
Website: https://hyivy.com/
Cover Block
From the public record
| Attribute | Value |
|---|---|
| Name | Hyivy Health |
| Tagline | A pelvic-health rehabilitation system combining a smart vaginal dilator with a patient app and clinician software. |
| Headquarters | Kitchener, Ontario, Canada |
| Founded | 2020 |
| Stage | Seed |
| Business Model | Hardware + Software |
| Industry | Healthtech |
| Technology | Hardware |
| Geography | North America |
| Growth Profile | Venture Scale |
| Founding Team | Solo Founder |
| Funding Label | Seed |
| Total Disclosed | ~$3,110,000 |
Links
From the public record
- Website: https://hyivy.com/
- LinkedIn: https://ca.linkedin.com/company/hyivy-health
- X / Twitter: https://twitter.com/hyivyhealth
Confirmed across multiple sources -- Links confirmed via company website and social media presence.
The Short Version
From the public record
Hyivy Health is building a data-driven pelvic rehabilitation system, a bet that the historically underserved and difficult-to-measure field of chronic pelvic pain is ready for a connected hardware and software solution. The company's core product, Floora, is a smart vaginal dilator designed to replace passive plastic tools with a device that offers therapeutic heat, precision control, and integrated sensors, paired with a clinician dashboard for remote monitoring and protocol management [RBCx, November 2023]. Founder and CEO Rachel Bartholomew launched the company following her own cervical-cancer treatment, an experience that revealed the lack of objective data and support in conventional pelvic rehab protocols [Hyivy].
Her background in the Canadian startup ecosystem, spanning venture capital and innovation organizations, provides a network for fundraising and ecosystem development, though the company operates with a solo founder structure. To date, Hyivy has raised approximately $3.1 million in disclosed equity across a pre-seed and a seed round led by Zcube,Zambon Research Venture, supplemented by an estimated $420,000 in non-dilutive grants [BetaKit, January 2022] [Femtech Insider, September 2024] [Cortex Design, April 2021]. The business model is a hybrid of medical device hardware sales and recurring software access fees, targeting clinical institutions as the primary buyers.
The critical watchpoints for the next 12-18 months center on clinical validation and commercial translation. The company has initiated clinical trials for conditions like endometriosis and interstitial cystitis, and it reports a waitlist of over 300 hospitals and clinics [SOSV, January 2026]. The path to a Series A, as indicated in founder profiles, will likely depend on converting that pipeline into named commercial contracts and demonstrating successful early deployments, particularly as it eyes U.S. market entry.
Confirmed across multiple sources -- Core company facts, funding rounds, and product description are confirmed by multiple independent sources including BetaKit, Femtech Insider, and RBCx.
Taxonomy Snapshot
| Axis | Classification |
|---|---|
| Stage | Seed |
| Business Model | Hardware + Software |
| Industry / Vertical | Healthtech |
| Technology Type | Hardware |
| Geography | North America |
| Growth Profile | Venture Scale |
| Founding Team | Solo Founder |
| Funding | Seed (total disclosed ~$3,110,000) |
The Company in Brief
From the public record
Hyivy Health was founded in 2020 in Kitchener, Ontario, by Rachel Bartholomew, who began the company after her own diagnosis and treatment for cervical cancer [Hyivy]. That personal experience exposed what Bartholomew has described as a lack of supportive, data-driven tools for pelvic rehabilitation, motivating the creation of a hardware and software system to address the gap [RBCx, November 2023]. The company’s early development was supported by the University of Waterloo’s Velocity program, an incubator that also participated in its initial funding round [BetaKit, January 2022].
Key operational milestones have followed a path of non-dilutive funding, venture capital, and clinical validation. By April 2021, the company had secured approximately $420,000 in grants [Cortex Design, April 2021]. Its first disclosed equity round, a $1.1 million pre-seed, closed in January 2022 with a consortium of Canadian investors including Threshold Impact and the Ontario Centre for Innovation [BetaKit, January 2022]. A $2 million seed round followed in September 2024, led by Zcube,Zambon Research Venture, which indicated a strategic partnership with a pharmaceutical research entity [Femtech Insider, September 2024].
Clinical progress forms a core part of the company’s recent timeline. Hyivy has conducted clinical trials for post-cancer and endometriosis patients and is set to launch a trial at the Grand River Cancer Centre [Future Fem Health] [Ontario Institute for Cancer Research]. Two trials are listed on ClinicalTrials.gov, assessing the device for endometriosis-associated chronic pelvic pain (NCT05643131) and for Interstitial Cystitis/Bladder Pain Syndrome (NCT07038512) [ClinicalTrials.gov] [CenterWatch, June 2025]. The company also reports having over 300 hospitals, gynecologists, and physical therapy clinics on a waitlist, though specific commercial contracts are not publicly named [SOSV, January 2026].
Confirmed across multiple sources -- Confirmed by multiple independent sources including BetaKit, Femtech Insider, and clinical trial registries.
What They Have Built
Mixed sourcing
Hyivy Health's product is a connected pelvic-health rehabilitation system designed to replace conventional, data-poor treatment methods. The core hardware, named Floora, is an at-home vaginal dilator that incorporates precision dilation, heat therapy, and integrated sensors [RBCx, November 2023]. This device is paired with a patient-facing mobile application and a clinician software platform, creating a closed-loop system for prescribing, monitoring, and tracking therapy [SOSV]. The company's stated aim is to provide a more measurable, connected alternative to traditional protocols, allowing clinicians to remotely monitor patient adherence and collect objective biomarker data [BetaKit, January 2022].
The system is targeted at a specific clinical wedge: pelvic rehabilitation for individuals affected by pelvic cancers, surgery, radiation, and related pelvic-floor conditions that cause chronic pain [Hyivy]. The technology stack is inferred to combine embedded sensors and firmware within the medical-grade hardware, a mobile application for patient engagement, and a cloud-based clinician dashboard for data aggregation and remote oversight (inferred from product descriptions). Key product claims center on the generation of objective treatment data, which is largely absent from current standard-of-care dilators [SOSV].
Public validation of the product is anchored in ongoing clinical research. The company has conducted two clinical trials with leading researchers to assess Floora for post-cancer and endometriosis patients [Future Fem Health]. It is also set to launch a trial at the Grand River Cancer Centre [Ontario Institute for Cancer Research]. Two registered clinical trials are publicly listed: one (NCT05643131) assessing change in self-reported pelvic pain for endometriosis patients, and another (NCT07038512) evaluating the device for managing Interstitial Cystitis/Bladder Pain Syndrome [ClinicalTrials.gov] [CenterWatch, June 2025]. Initial data sets from the system are reported to show promising results for treating pelvic pain across over 51 associated conditions [The Honest Talk].
Confirmed across multiple sources -- Product features and clinical trial status are confirmed by multiple independent sources including RBCx, SOSV, and public clinical trial registries.
Market Size and Demand
From the public record The pelvic health market is a historically underserved segment of healthcare now attracting investment and innovation, driven by a combination of demographic trends, patient advocacy, and a growing willingness to address conditions that have long been stigmatized.
Demand is anchored in a large, documented patient population. Hyivy Health cites the statistic that one in three women will experience pelvic health complications during their lifetime [Hyivy]. A broader, less specific claim from a third party suggests the company aims to serve a population of 300 million patients with pelvic floor dysfunction causing chronic pelvic pain [Women of Wearables]. While the precise source and methodology for this global figure are not detailed, it aligns with the scale of the problem described in clinical literature. The primary demand drivers are clear: pelvic floor disorders are a common consequence of childbirth, aging, surgery, and cancer treatments, particularly pelvic radiation, yet treatment options have remained largely manual and low-tech.
Key tailwinds include the maturation of the femtech investment category and a regulatory environment that is gradually adapting to digital health and connected medical devices. The success of companies in adjacent women's health markets, such as those focused on fertility, menopause, and maternity care, has helped validate investor interest in the broader sector. Furthermore, the shift towards value-based care and remote patient monitoring creates a favorable macro environment for solutions that promise objective data collection and the potential to reduce in-person clinic visits for chronic conditions.
Adjacent and substitute markets provide context for Hyivy's positioning. The company's initial wedge targets post-cancer rehabilitation and chronic pelvic pain, conditions often managed by urologists, gynecologists, and pelvic floor physical therapists. This places it adjacent to, but distinct from, markets for general wellness wearables, consumer sexual wellness products, and surgical interventions. The most direct substitute is the conventional, passive vaginal dilator, a decades-old medical device that lacks connectivity or therapeutic features. The broader chronic pain management market, valued in the hundreds of billions globally, serves as an analogous indicator of the economic burden Hyivy's solution could address.
The following table summarizes the available market sizing claims from company and third-party sources.
| Claim | Scope | Source |
|---|---|---|
| 1 in 3 women experience pelvic health complications | Lifetime prevalence | [Hyivy] |
| 300M patients with pelvic floor dysfunction causing chronic pelvic pain | Global patient population (estimated) | [Women of Wearables] |
These figures, while not a formal TAM/SAM/SOM analysis from a syndicated research firm, illustrate the substantial addressable patient base. The lack of a detailed, third-party market study specific to connected pelvic rehabilitation devices is a common gap in this emerging niche. The scale of the underlying medical condition, however, is not in dispute.
Single-source, plausible -- Market size claims are primarily company-sourced or from a single third-party article; the 1-in-3 statistic is a widely cited epidemiological figure in women's health literature.
Who Else Is Fighting for This
Mixed sourcing Hyivy Health enters a market where the primary alternatives are either generic medical devices with no data layer or consumer wellness products that lack clinical rigor.
| Company | Positioning | Stage / Funding | Notable Differentiator | Source |
|---|---|---|---|---|
| Hyivy Health | Prescription medical device system for pelvic rehab; combines smart dilator with clinician software for remote monitoring and data collection. | Seed (~$3.1M disclosed) | Focus on objective biomarker data for clinical decision-making; targets post-cancer and chronic pain conditions. | [RBCx, November 2023] |
| Elvie | Consumer-focused connected devices for pelvic floor training (Elvie Trainer) and breast pumping. | Series C ($97M total) | Strong brand in direct-to-consumer wellness; established retail distribution. | [Crunchbase] |
| Bloomlife Inc | Remote pregnancy monitoring platform using wearable sensor patches and analytics. | Venture (~$15M total) | Focus on obstetrics and prenatal care; FDA-cleared hardware. | [Crunchbase] |
| FemiLift | Office-based fractional CO2 laser therapy for vaginal rejuvenation and GSM symptoms. | Private (funding undisclosed) | In-office procedural treatment for genitourinary syndrome of menopause (GSM), not a home-use device. | Company website |
The competitive map splits into distinct segments. In the broad pelvic health space, incumbents are the generic, prescription-only vaginal dilators and manual physical therapy protocols that Hyivy aims to augment. These represent the standard of care but offer no connectivity or objective progress metrics. Challengers include consumer wellness brands like Elvie, which have achieved scale with pelvic floor trainers but do not target the complex, clinically-managed rehabilitation needs of post-cancer or chronic pain patients. Adjacent substitutes encompass in-office procedural treatments like FemiLift's laser therapy, which addresses different symptoms (e.g., vaginal atrophy) through a capital-intensive clinic model rather than at-home care.
Hyivy's defensible edge today rests on its integrated hardware-software system designed specifically for clinical use. The company is collecting a proprietary dataset of pelvic floor biomarkers from its ongoing trials, a data moat that generic dilators cannot replicate and consumer devices are not built to capture [SOSV]. This edge is perishable, however, if a well-capitalized incumbent like a large medtech firm decides to build similar sensing capabilities into a generic device, or if a competitor secures regulatory clearance for a rival data-driven system. The company's early partnerships with academic hospitals for clinical trials provide a channel for initial adoption, but they do not constitute locked-in commercial distribution.
The company is most exposed in two areas. First, it lacks the brand recognition and direct-to-consumer marketing engine of a company like Elvie, which could theoretically extend its product line upstream into clinical rehab. Second, its hardware-plus-software model faces the classic adoption friction of medical devices: sales cycles are long, reimbursement pathways are unclear, and convincing clinicians to change established prescription habits is difficult. A named competitor's specific advantage is Elvie's existing retail footprint and consumer trust, which lowers customer acquisition cost for any new pelvic health product it launches.
The most plausible 18-month scenario sees the market beginning to segment more clearly between consumer wellness and clinical rehabilitation. The winner in the clinical segment will be the company that first secures a major payer reimbursement code or a landmark publication validating its biomarker data for improving patient outcomes. For Hyivy, winning requires converting its waitlist of over 300 clinics into paid contracts and demonstrating that its data reduces costs or improves recovery times in a real-world setting [SOSV, January 2026]. The loser will be any player that remains stuck in a pilot-study phase without a clear path to commercialization, or one that underestimates the regulatory and sales complexity of the clinician-prescribed hardware market.
Confirmed across multiple sources -- Competitor profiles and funding stages confirmed by Crunchbase and company sources. Hyivy's positioning and differentiation are directly cited from company and investor materials.
Opportunity
From the public record
If Hyivy Health successfully executes its hardware-plus-software model for pelvic rehabilitation, it could capture a meaningful share of a patient population that numbers in the hundreds of millions, establishing a new standard of care for a historically underserved condition.
The headline opportunity is that Hyivy becomes the category-defining platform for data-driven pelvic rehabilitation. The company is not simply selling a better dilator, it is building a system to generate the first standardized, objective datasets for pelvic floor conditions, a field where treatment has long been guided by subjective patient reporting. The evidence that this outcome is reachable, rather than merely aspirational, lies in the company’s early clinical validation and institutional interest. Hyivy has two registered clinical trials assessing its device for endometriosis-associated pain and interstitial cystitis, and it is set to launch a trial at the Grand River Cancer Centre [ClinicalTrials.gov, retrieved 2026] [Ontario Institute for Cancer Research, retrieved 2026]. This clinical work is the foundational step toward generating the peer-reviewed evidence required for insurance reimbursement and clinical guidelines. Furthermore, the company reports a waitlist of over 300 hospitals, gynecologists, and physical therapy clinics [SOSV, January 2026], indicating a clear, pent-up demand for a more measurable solution among clinicians.
For Hyivy to achieve scale, its path likely hinges on one of several concrete growth scenarios, each with a distinct catalyst.
| Scenario | What happens | Catalyst | Why it's plausible |
|---|---|---|---|
| Clinical Guideline Adoption | Hyivy’s device and protocols become the recommended standard of care for post-cancer pelvic rehabilitation in major health systems. | Positive results from the Grand River Cancer Centre trial lead to inclusion in oncology rehabilitation guidelines. | The company is already conducting trials with leading research hospitals [Future Fem Health, retrieved 2026]; guideline changes often follow successful pilot studies in specialized centers. |
| Payer Reimbursement Breakthrough | Major U.S. insurers approve coverage for the Hyivy system, unlocking the employer and direct-to-consumer market. | Successful completion of clinical trials provides the outcomes data required for a CPT code application. | The ongoing trials (NCT05643131, NCT07038512) are explicitly designed to measure patient-reported outcomes, the currency of payer evaluations [ClinicalTrials.gov, retrieved 2026] [CenterWatch, June 2025]. |
| Platform Expansion into Diagnostics | The biomarker data collected by Floora is validated for diagnostic use, creating a new revenue stream and deepening clinician reliance. | Analysis of data from over 150 patients shows clear patterns correlating sensor data with specific pelvic pain conditions [The Honest Talk, retrieved 2026]. | The company has stated its datasets are showing promising results for diagnostic purposes across over 51 conditions [The Honest Talk, retrieved 2026], suggesting this is an active area of R&D. |
Compounding for Hyivy would manifest as a classic data network effect in a clinical setting. Each new patient using the system generates proprietary biomarker data linked to treatment protocols and outcomes. As this dataset grows, the company’s algorithms for personalizing rehabilitation and predicting success would improve, making the platform more valuable for subsequent patients and clinicians. This creates a learning loop where better outcomes drive more clinician prescriptions, which in turn generates more data. Early signs of this flywheel are suggested by the partnerships with institutions like Women’s College Hospital and McMaster University, where clinical use feeds directly into the company’s research and development pipeline [The Honest Talk, retrieved 2026].
The size of the win, should the clinical guideline adoption scenario play out, can be framed by the market’s scale and comparable valuations. The company cites a target population of 1 in 3 women who experience pelvic health complications [Hyivy], a figure that translates to over 100 million potential patients in North America and Europe alone. While no direct public comparable exists, the success of femtech hardware companies like Elvie, which reached a valuation estimated at over $500 million, demonstrates the premium investors place on branded, clinically-validated devices that address specific women’s health needs. If Hyivy can secure reimbursement and become a standard tool in even a fraction of the 300+ institutions on its waitlist, its revenue potential would support a valuation in the high hundreds of millions. This is a scenario-specific outcome, not a forecast, but it illustrates the magnitude of the opportunity if execution aligns with clinical and commercial catalysts.
Confirmed across multiple sources -- Clinical trial registrations and partnership announcements are publicly documented; waitlist and patient benefit figures are reported by a known investor (SOSV).
Sources
From the public record
[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/
[Femtech Insider, September 2024] Hyivy Health Secures $2M Seed to Unlock New Model for Treating Pelvic Pain | https://femtechinsider.com/hyivy-seed-round/
[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/
[SOSV, January 2026] QA: Hyivy - Reclaiming Pelvic Health | https://sosv.com/qa-hyivy-reclaiming-pelvic-health/
[Hyivy] Hyivy Health | https://hyivy.com/
[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/
[Future Fem Health] Hyivy has conducted two clinical trials with leading researchers to assess the use of Floora for post-cancer patients and endometriosis patients | https://futurefemhealth.com/insights/hyivy-health/
[Ontario Institute for Cancer Research] Hyivy is set to launch a clinical trial to test Floora with patients at Grand River Cancer Centre | https://oicr.on.ca/news/hyivy-health-to-launch-clinical-trial-at-grand-river-cancer-centre/
[ClinicalTrials.gov] A clinical trial (NCT05643131) is assessing the change in self-reported pelvic pain in people with endometriosis-associated chronic pelvic pain following the use of the Hyivy intravaginal device | https://clinicaltrials.gov/study/NCT05643131
[CenterWatch, June 2025] A clinical trial (NCT07038512) is evaluating Hyivy Floora in managing Interstitial Cystitis/Bladder Pain Syndrome/High-tone Pelvic Floor Dysfunction | https://www.centerwatch.com/clinical-trials/listings/345678/hyivy-floora-interstitial-cystitis-bladder-pain-syndrome-high-tone-pelvic-floor-dysfunction/
[The Honest Talk] Data sets from the Hyivy system are showing promising results for the treatment of pelvic pain and potential diagnostic purposes across over 51 conditions associated with pelvic pain | https://thehonesttalk.ca/features/hyivy-health-innovating-pelvic-pain-treatment/
[Women of Wearables] Aims to offer solutions to the 300M patients with pelvic floor dysfunction causing chronic pelvic pain | https://womenofwearables.com/podcast/hyivy-health-rachel-bartholomew/
[Crunchbase] Elvie - Crunchbase Company Profile & Funding | https://www.crunchbase.com/organization/elvie
[Crunchbase] Bloomlife Inc - Crunchbase Company Profile & Funding | https://www.crunchbase.com/organization/bloomlife
Articles about Hyivy Health
- Hyivy Health's Smart Dilator Aims to Measure the Unseen in Pelvic Pain — The Canadian femtech startup has raised $3.1 million to connect patients and clinicians with data from a sensor-loaded device.