France-based May Health has secured a European CE mark for its Anavi system to address infertility in women with polycystic ovary syndrome (PCOS).
The system is positioned as a one-time treatment for women with PCOS-related infertility who have not responded to or declined first-line medications. Anavi uses targeted radiofrequency (RF) energy to ablate a small fraction of ovarian tissue with the aim of re-initiating ovulatory cycles in those with PCOS.
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Women with PCOS-related infertility often struggle to become pregnant because they are unable to ovulate consistently or at all. Estimated to impact between 10% and 13% of the global population, the lack of ovulation in individuals with PCOS is linked to dysregulation of androgen production and other hormonal signals within the ovary.
May Health’s CE mark was supported by data from its ULTRA feasibility study (NCT03760926). Data from the study were first presented at the 2025 European Society of Human Reproduction and Embryology (ESHRE) annual meeting. The results demonstrated that in 26 of 32 women evaluable at 12 months, 77% reported ovulation, with 13 women experiencing spontaneous ovulation and seven women ovulating after first-line medications were resumed.
At 12 months, a 46% cumulative pregnancy rate was observed, including ten spontaneous pregnancies and two pregnancies with assisted reproductive technology, resulting in six live births at the data cut-off.
Procedure-related adverse events (AE), including vaginal bleeding, pain, and headaches, were reported as mild and no serious AEs were recorded.
May Health’s CEO Colby Holtshouse commented: “The CE mark represents a significant achievement and an important step toward expanding options for women affected by this challenging condition.
“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.”
With the CE mark, May Health said that Anavi’s EU rollout would be planned on a country-by-country basis. Meanwhile, the company is conducting the REBALANCE study (NCT06206746) in the US, a pivotal investigational device exemption (IDE) trial intended to support a marketing authorisation with the US Food and Drug Administration.
