May Health has received CE Mark certification for its Anavi System, a device designed to restore ovulation in women with PCOS-related infertility who do not respond to first-line therapies. The approval enables commercialization in the European Union, with rollout planned on a country-by-country basis.
PCOS affects approximately 10-13% of women worldwide and is the most common endocrine condition in reproductive-age women. It is also a leading cause of female infertility. For women who do not respond to first-line ovulation induction medications, treatment options typically progress to laparoscopic ovarian surgery or IVF, though many families discontinue fertility treatment rather than proceed with these steps.
The Anavi System delivers targeted radiofrequency energy to ablate a small fraction of ovarian tissue, translating a laparoscopic procedure into an ultrasound-guided, office-based option. The procedure is performed once and does not involve hormonal therapy.
“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 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 was supported by data from the ULTRA clinical studies. In preliminary results presented at the ESHRE Annual Meeting in 2025, 77% of evaluable patients (20 of 26) reported ovulation at 12 months. The studies showed a 46% cumulative pregnancy rate at 12 months, including 10 spontaneous pregnancies and six live births at the time of reporting. The most common procedure-related 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 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.”
May Health is currently conducting the REBALANCE study in the United States, a pivotal IDE trial to support FDA submission. The company, originally founded as Ziva Medical in France, is backed by Sofinnova Partners, BPIfrance, and Trill Impact, and has U.S. headquarters in Menlo Park, California.
