May Health, a medical device company focused on PCOS-related infertility, has raised €10 million ($11.7 million) to drive completion of its pivotal U.S. clinical trial and prepare for European market launch of its Anavi System – a one-time, office-based procedure designed to restore ovulation in women with PCOS who don’t respond to, are contraindicated for, or decline first-line therapies.
The round included existing investors Sofinnova Partners, Trill Impact, and Bpifrance, with new investor Nexpring Health, a global assisted reproductive technologies (ART) solutions company. The Nexpring participation signals strategic alignment with the fertility industry’s clinical infrastructure.
PCOS affects 10-13% of women worldwide and is the most common endocrine condition among reproductive-age women and a leading cause of female infertility. Women with PCOS-related infertility often struggle to conceive because they are unable to ovulate consistently or at all – and current treatment pathways can be limited for those who don’t respond to first-line ovulation induction.
The Anavi System received CE Mark certification under EU MDR in October 2025, and May Health is now advancing its REBALANCE pivotal IDE trial in the U.S. across more than 15 fertility centers. The study is a prospective, multicenter, randomized controlled trial evaluating safety and effectiveness in eligible women ages 18-40 who have been diagnosed with PCOS-related infertility, and is designed to support FDA marketing authorization.
“For too long, women with PCOS-related infertility have needed more options to support their family-building journey,” said CEO Colby Holtshouse. “With the continued support of our existing investors, we are making significant progress enrolling the REBALANCE trial and preparing to bring the Anavi System to market in Europe and the United States. We are pleased to welcome Nexpring Health to the syndicate, and we celebrate the strong mission alignment between our organizations.”
“May Health is addressing a critical gap in modern infertility care,” said Antoine Papiernik, chairman and managing partner of Sofinnova Partners. “By targeting the underlying drivers of PCOS-related infertility, the company is reshaping the treatment paradigm for millions of women worldwide.”
May Health is a French company with U.S. headquarters in Menlo Park, California, originally founded as Ziva Medical and developed through the Paris-based accelerator MD Start.
