May Health’s Anavi™ System enables a one-time, office-based procedure intended to restore ovulation in women with PCOS-related infertility who do not respond to first-line therapies

May Health, a medical device company dedicated to helping women living with polycystic ovary syndrome (PCOS), today announced that its novel technology to treat PCOS-related infertility, the Anavi™ System, has received CE Mark certification. The CE Mark, granted under the European Union’s Medical Device Regulation (EU MDR) 2017/745, is a significant regulatory milestone that enables commercialization in the European Union.

PCOS affects approximately 10% to 13% of women worldwide and is the most common endocrine condition impacting reproductive-age women, as well as a leading cause of female infertility.^1,2 Women with PCOS-related infertility often struggle to become pregnant because they are unable to ovulate consistently or at all. This lack of ovulation in PCOS is linked to dysregulation of androgen production and other hormonal signals within the ovary.³ First-line pharmacologic therapies are current options to induce ovulation, but they do not work for all patients. For women who do not respond to first-line treatments, care pathways typically progress to more expensive and invasive options such as laparoscopic ovarian surgery or in vitro fertilization (IVF), but many families discontinue fertility treatments rather than proceed with these steps.

May Health introduces a new option: a treatment offered as a one-time, office-based procedure intended to restore natural ovulation in women with PCOS-related infertility who do not respond to, are contraindicated for, or decline first-line medications. Building on the established success of laparoscopic ovarian surgery to restore ovulation,⁴ this approach translates a laparoscopic procedure into a more accessible, ultrasound-guided in-office option. The Anavi System delivers targeted radiofrequency (RF) energy to ablate a small fraction of ovarian tissue with the aim of re-initiating ovulatory cycles, offering an alternative for women who are not ready, willing, or able to advance to IVF.

“Approximately 80% of women with PCOS have oligo-anovulatory infertility, a condition characterized by lack of ovulation. Moreover, 20–30% of those women do not respond to first-line ovulation induction therapies,” said Dr. Saad Amer, lead investigator of the ULTRA EU study, expert in PCOS, endometriosis, and infertility, and professor at the University of Nottingham. “The Anavi System provides a compelling treatment option that restores ovulation in women with PCOS without the use of any hormonal therapy, and as a single, in-office procedure that can be efficiently incorporated into the care pathway for appropriate PCOS women.”

CE Mark certification for the Anavi System was supported by safety and feasibility data from the ULTRA clinical studies conducted in Europe and the United States. Participants were women with PCOS who were anovulatory or oligo-ovulatory and had failed to respond to first-line pharmacologic treatments, or who were contraindicated for or declined such treatment. A preliminary analysis from the ULTRA studies presented at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting in 2025 demonstrated:

• In 26 of 32 women evaluable at 12 months, 77% (20/26) reported ovulation, with 13 women experiencing spontaneous ovulation and seven women ovulating after first-line medications were resumed.
• At 12 months, a 46% (12/26) cumulative pregnancy rate was observed, including 10 spontaneous pregnancies (seven with and three without the restart of first-line medication) and two pregnancies with assisted reproductive technology (one intrauterine insemination (IUI), one IVF), resulting in six live births at the time of reporting.
• The most common procedure-related adverse events were reported as mild and included vaginal bleeding, pain, and headache.

The CE Mark permits commercialization of the Anavi System in the European Union, with rollout planned on a country-by-country basis.

In addition, May Health is currently conducting the REBALANCE study in the United States, a pivotal Investigational Device Exemption (IDE) trial designed to support submission to the U.S. Food and Drug Administration (FDA) for marketing authorization.

“The CE Mark represents a significant achievement and an important step toward expanding options for women affected by this challenging condition,” said Colby Holtshouse, President and Chief Executive Officer of May Health. “We are encouraged by these clinical results, which reinforce the potential of this approach to restore ovulation without systemic hormones through a single in-office procedure. We look forward to making the Anavi System available to women across Europe who are struggling with the difficult challenge of PCOS-related infertility.”

About the REBALANCE Study

The REBALANCE Study (NCT06206746) is an ongoing prospective, multicenter, randomized controlled trial evaluating the safety and effectiveness of May Health’s technology for restoring ovulation in eligible women with polycystic ovary syndrome (PCOS)-related infertility. The study is currently recruiting women ages 18–40 who have been diagnosed with PCOS and who have failed, are contraindicated for, or decline first-line ovulation-induction therapies. More than 15 fertility centers across the United States are enrolling participants. Learn more at www.mayhealth.com/rebalance-study.

About May Health and the Anavi™ System

May Health is a medical device company dedicated to expanding treatment options for women living with polycystic ovary syndrome (PCOS). The company is led by a team of experienced medtech and women’s health entrepreneurs and executives with deep expertise in product development, clinical validation, regulatory strategy, and commercialization. Founded as Ziva Medical, May Health evolved through the Paris-based accelerator, MD Start, and previously operated as Ablacare before becoming May Health. A French company with U.S. headquarters in Menlo Park, California, May Health is proud to have Sofinnova Partners, BPIfrance, and Trill Impact as lead investors. For more information, visit www.mayhealth.com and follow us on LinkedIn.

References:

1. Teede, H., et al. (2023). Recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Human Reproduction, 38(9), 1655–1679. https://doi.org/10.1093/humrep/dead156.
2. Legro RS, Kunselman AR, Brzyski RG, et al. (2012). The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: Rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome. Contemporary Clinical Trials. 33(3):470-481. https://doi.org/10.1016/j.cct.2011.12.005.
3. Wang, K., Li, Y., & Chen, Y. (2023). Androgen excess: a hallmark of polycystic ovary syndrome. Frontiers in Endocrinology, 14, Article 1273542. https://doi.org/10.3389/fendo.2023.1273542.
4. Farquhar, C. M., Williamson, K., Gudex, G., Johnson, N. P., Garland, J., & Sadler, L. (2002). A randomized controlled trial laparoscopic ovarian diathermy versus gonadotropin therapy for women with clomiphene citrate–resistant polycystic ovary syndrome. Fertility and Sterility, 78(2), 404–411. https://doi.org/10.1016/S0015-0282(02)03225-9.

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