# May Health: Clinical-Stage Medical Device Company
High-Level Overview
May Health is a clinical-stage medical device company developing Ovarian Rebalancing™, an investigational treatment designed to restore ovulation in people with polycystic ovary syndrome (PCOS).[2][4] The company addresses a significant unmet need in women's reproductive health by offering a novel, hormone-free approach to PCOS-related infertility that can be administered in an outpatient setting.[4]
May Health serves women living with PCOS who struggle with infertility caused by the condition. The company's core mission centers on providing safe, straightforward treatment options for activating natural ovulation through targeted ovarian ablation, which aims to lower androgen production.[2][4] With €10 million in Series A funding and a subsequent $25 million Series B round, the company is advancing its pivotal REBALANCE clinical study to validate safety and efficacy for FDA approval in the US and CE Mark approval in Europe.[2][3]
Origin Story
May Health was founded in 2017 by Sofinnova Partners' medtech acceleration team, MD Start, emerging from the firm's in-house accelerator focused on catalyzing innovative medical device technology from conception to clinic.[2] The company's origins trace back to an earlier entity called Ziva Medical, which integrated into the Paris-based accelerator MD Start, subsequently becoming Ablacare SAS before being renamed May Health SAS and May Health Inc.[1]
The founding team comprises seasoned MedTech entrepreneurs with deep experience in product development, validation, and launch.[1] Leadership includes Colby Holthouse (Chief Executive Officer), Hugh E. Magen (Chief Technical Officer), and clinical and regulatory experts including Ross W. McQuivey, MD (Chief Medical Advisor) and Rich Ferrick (Vice President, Quality Assurance/Regulatory Affairs).[1] The company is headquartered in Paris, France.[2]
Core Differentiators
- Novel Treatment Mechanism: Ovarian Rebalancing™ uses targeted ovarian ablation to lower androgen production and restore natural ovulation—a one-time, hormone-free approach distinct from traditional hormonal therapies.[2][4]
- Outpatient Convenience: The treatment can be administered in an outpatient setting, improving accessibility and patient experience compared to more invasive or complex alternatives.[4]
- Strong Investor Backing: Founded and supported by Sofinnova Partners' MD Start accelerator, the company has attracted co-leadership from Bpifrance and Trill Impact in its Series B round, alongside participation from founding investor Sofinnova Partners, Avestria Ventures, and Kidron Capital Assets LP.[3]
- Experienced Leadership: The team combines serial medtech and women's health entrepreneurs with extensive operational experience in product development, validation, and clinical launch.[2]
- Regulatory Progress: The company has completed feasibility studies, received FDA approval for its pivotal trial, and is actively enrolling participants in the REBALANCE Study.[2][3]
Role in the Broader Tech Landscape
May Health operates within the women's health and reproductive medicine sector, addressing a historically underserved market segment. PCOS affects a significant portion of women of reproductive age, yet treatment options remain limited and often rely on hormonal interventions with variable efficacy.[4] The company's emergence reflects a broader trend of venture capital and impact investors prioritizing women's health innovation, with firms like Trill Impact and Bpifrance increasingly backing medtech solutions targeting endocrine and fertility disorders.
The timing is particularly significant as regulatory pathways for medical devices treating PCOS have become clearer, and patient advocacy around reproductive health has intensified. May Health's approach—combining clinical rigor with a focus on non-hormonal, convenient treatment—positions it to influence how the medical community approaches PCOS management and potentially reshape treatment standards in Europe and North America.
Quick Take & Future Outlook
May Health stands at a critical inflection point. With $25 million in Series B funding and an active pivotal trial underway, the company is positioned to generate clinical evidence that could support regulatory submissions within the next 2-3 years.[3] Success in the REBALANCE Study would validate Ovarian Rebalancing™ as a viable alternative to existing PCOS treatments, potentially opening significant market opportunities in both the US and EU.
The company's trajectory will depend on clinical trial outcomes, regulatory approval timelines, and market adoption among gynecologists and reproductive endocrinologists. If successful, May Health could establish a new standard of care for PCOS-related infertility, while also demonstrating the viability of the MD Start accelerator model for building high-impact medtech companies from inception through commercialization.
