May Health revealed that is Anavi system to treat polycystic ovary syndrome (PCOS)-related infertility has received CE mark clearance.

PCOS impacts about 10-13% of women worldwide. It’s the most common endocrine condition affecting reproductive-age women and the leading cause of female infertility. Women with PCOS-related infertility can struggle to become pregnant because they cannot 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.

First-line pharmacologic therapies are an option to induce ovulation, but they don’t work for all patients. For women who don’t respond to first-line treatments, care pathways usually progress to more expensive and invasive options like laparoscopic ovarian surgery or in vitro fertilization (IVF), but many families discontinue fertility treatments rather than proceed with these steps.

May Health’s one-time, office-based procedure is intended to restore natural ovulation in women with PCOS-related infertility who don’t respond to, are contraindicated for, or decline first-line medications. The company’s 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 to re-initiate ovulatory cycles, providing an alternative for women who aren’t ready, willing, or able to advance to IVF.

Data supporting CE mark of Anavi system

CE mark certification was supported by safety and feasibility data from the U.S. and European ULTRA clinical studies. 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.

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 represents a significant achievement and an important step toward expanding options for women affected by this challenging condition,” said Colby Holtshouse, president and CEO 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.”

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