May Health
May Health is a clinical-stage medical device company dedicated to developing innovative treatments for Polycystic Ovary Syndrome (PCOS) and infertility related to PCOS. They are currently in the clinical trial stage for their investigational treatment, Ovarian Rebalancing™, which aims to restore ovulation through a minimally invasive outpatient procedure. The company is committed to safety, efficacy, and regulatory approval in the US and Europe, with a focus on modern, convenient treatment options for women with PCOS.
Industries
Nr. of Employees
small (1-50)
Patents
Products
Transvaginal radiofrequency ovarian ablation system
Investigational medical device system that delivers radiofrequency energy via a transvaginal needle/catheter under ultrasound guidance to selectively heat ovarian tissue with the objective of lowering androgen production and restoring ovulation in patients with PCOS-related anovulatory infertility.
Transvaginal radiofrequency ovarian ablation system
Investigational medical device system that delivers radiofrequency energy via a transvaginal needle/catheter under ultrasound guidance to selectively heat ovarian tissue with the objective of lowering androgen production and restoring ovulation in patients with PCOS-related anovulatory infertility.
Services
End-to-end conduct of feasibility and pivotal clinical studies for an investigational transvaginal ovarian ablation system, including site coordination, patient screening, procedure delivery at investigational sites, follow-up visits, and data collection.
End-to-end conduct of feasibility and pivotal clinical studies for an investigational transvaginal ovarian ablation system, including site coordination, patient screening, procedure delivery at investigational sites, follow-up visits, and data collection.
Expertise Areas
- Clinical trial management for investigational devices
- Minimally invasive gynecologic procedures
- Medical device development and validation
- Regulatory compliance for medical devices (FDA and CE pathways)
Key Technologies
- Transvaginal ultrasound guidance
- Radiofrequency energy ablation
- Temperature-controlled RF generators
- Echogenic needle visualization
News & Updates
Announcement of leadership appointment on March 10, 2025.
Funding news announced on May 13, 2024, to support development of their innovative therapy.
Update on June 26, 2023, about study data and FDA approval for pivotal trial.
News from December 20, 2022, about treatment completion in a U.S. study.
Announcement on September 9, 2022, about leadership team enhancement.
Announcement of leadership appointment on March 10, 2025.
Funding news announced on May 13, 2024, to support development of their innovative therapy.
Update on June 26, 2023, about study data and FDA approval for pivotal trial.
News from December 20, 2022, about treatment completion in a U.S. study.
Announcement on September 9, 2022, about leadership team enhancement.