May Health receives CE Mark for its radiofrequency infertility device

May Health said its Anavi System has received CE Mark certification under the European Union’s Medical Device Regulation, a milestone that allows the device to be marketed in EU countries, according to the company. The system is intended to help women with PCOS-related infertility who do not respond to standard drug therapies.

PCOS affects an estimated 10% to 13% of women worldwide and is the most common endocrine disorder affecting women of reproductive age, according to the company. It is also one of the leading causes of female infertility, often because affected women “are unable to ovulate consistently or at all.”

“Approximately 80% of women with PCOS have oligo-anovulatory infertility, a condition characterized by lack of ovulation,” said Saad Amer, lead investigator of the ULTRA EU study and a professor at the University of Nottingham. “Moreover, 20–30% of those women do not respond to first-line ovulation induction therapies.”

Current treatment pathways typically begin with medications to induce ovulation. For patients who do not respond, options often escalate to laparoscopic ovarian surgery or in vitro fertilization, which are more invasive, costly and emotionally demanding. Many patients discontinue fertility treatment before reaching those steps.

May Health said its system offers a new alternative: a one-time, ultrasound-guided procedure performed in a physician’s office. The device delivers targeted radiofrequency energy to a small portion of ovarian tissue with the goal of restoring ovulatory cycles.

“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,” Amer said, adding that it can be “efficiently incorporated into the care pathway for appropriate PCOS women.”

The CE Mark was supported by safety and feasibility data from the ULTRA clinical studies conducted in Europe and the United States. In a preliminary analysis presented at the European Society of Human Reproduction and Embryology annual meeting in 2025, 77% of women evaluable at 12 months reported ovulation. At the same time point, researchers observed a cumulative pregnancy rate of 46%, including spontaneous pregnancies and pregnancies achieved with assisted reproductive technologies. The most commonly reported adverse events were 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 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.”

The company said it plans to roll out the system across Europe on a country-by-country basis and is also conducting a pivotal U.S. study to support a future submission to the Food and Drug Administration.

Advances in infertility treatment for PCOS

The CE Mark decision comes amid broader advances in the treatment of infertility associated with polycystic ovary syndrome, a condition that has long posed clinical challenges due to its hormonal complexity and variability among patients.

Historically, treatment for PCOS-related infertility has focused on pharmacologic ovulation induction using oral or injectable hormones. While effective for many patients, these therapies can fail in a substantial subset of women or cause side effects that limit long-term use. As a result, researchers and clinicians have increasingly sought alternatives that address ovarian dysfunction more directly while reducing reliance on systemic hormones.

One area of progress has been the refinement of minimally invasive procedures aimed at restoring ovulation. Techniques that were once limited to surgical settings are being adapted for outpatient care, leveraging advances in imaging, energy delivery and procedural guidance. These approaches aim to lower cost, reduce recovery time and improve patient acceptance compared with traditional surgery.

There has also been growing interest in personalizing fertility care for women with PCOS. Clinicians are using improved diagnostic tools to better classify PCOS subtypes, allowing treatments to be tailored based on hormonal profiles, metabolic status and reproductive goals. This shift reflects a broader move away from one-size-fits-all treatment algorithms toward more individualized care pathways.

In parallel, research into the underlying biology of PCOS has expanded, shedding light on the role of ovarian signaling, androgen production and metabolic dysfunction in disrupting ovulation. These insights are informing the development of therapies that seek to reset ovarian function rather than simply override it with medications.

For patients, these advances could translate into earlier intervention options that sit between first-line drug therapy and assisted reproductive technologies such as IVF. By offering less invasive alternatives that preserve natural ovulation, clinicians hope to keep more patients engaged in fertility care and reduce the physical, emotional and financial burden associated with prolonged treatment journeys.

Together, these trends signal a gradual but meaningful evolution in how PCOS-related infertility is managed, with a growing emphasis on accessibility, patient-centered care and long-term reproductive health.