May Health raises $25M to address PCOS-related infertility

The company has developed Ovarian Rebalancing, a one-time, in-office procedure to induce ovulation

Polycystic ovary syndrome (PCOS) is a lifelong endocrine disorder that affects 10% of women around the world, and can cause excess body hair, weight gain, acne or oily skin, and baldness or thinning hair. It's also the leading cause of female infertility.

Currently, however, there are no treatments available today to address the underlying causes of PCOS, or PCOS-related infertility: first-line ovulation induction medications aren't effective for all women, typically leaving IVF as the only remaining treatment option. Yet, IVF is both inaccessible and expensive, at over $18,000 per cycle, causing 70% of women to go into debt to afford it. Another treatment option for PCOS-related infertility is ovarian drilling, an invasive procedure that requires doctors to cut through the abdomen to access the ovaries.

May Health, a clinical-stage medical device company dedicated to helping those living with PCOS, which announced a $25 million Series B financing round on Monday, has come up with a less invasive, and less costly treatment called Ovarian Rebalancing, a one-time, in-office procedure intended to allow for minimal downtime from normal activities.

The procedure is designed to induce ovulation through the targeted ablation of ovarian tissue using radiofrequency energy, leveraging trans-vaginal ultrasound guidance to access the ovary. This is the same technique employed during the egg retrieval procedure performed as part of the IVF process.

"Women living with PCOS deserve more options and there is an unmet need for more affordable, more accessible and less burdensome fertility treatments," Anne Morrissey, CEO of May Health, told VatorNews.

"With this, we developed Ovarian Rebalancing, a modern approach to PCOS and PCOS-related infertility with the potential to restore ovulation in a straightforward one-time office procedure."

Currently, May Health is in the clinical trial stage where it's following FDA and EU regulations to validate the overall safety and effectiveness of its treatment. To date, the company has enrolled 32 patients in feasibility studies in the U.S. and Europe, with what Morrissey calls "encouraging early outcomes for inducing ovulation and achieving pregnancy.

The new funding round was co-led by Bpifrance and Trill Impact, with participation from founding investor Sofinnova Partners, as well as Avestria Ventures and Kidron Capital Assets LP. It brings May Health's total funding to $32 million. 

The company plans to use the funding will to support its growth and to advance its Ovarian Rebalancing therapy through its REBALANCE Study, a prospective, multi-center, randomized pivotal study designed to evaluate ovarian ablation with Ovarian Rebalancing in women aged 18 to 40 who have been diagnosed with PCOS and are resistant to, or are contraindicated to, or decline first-line ovulation induction treatments. More than 15 fertility centers across the U.S. will participate in the clinical trial.

The study will allow May Health to evaluate its potential to address PCOS-related infertility, so it can understand the effectiveness of Ovarian Rebalancing for restoring ovulation in women with PCOS who are looking to become pregnant. The results will, in turn, help inform an FDA submission for marketing authorization.

In conjunction with the financing, May Health also added two new members to its board of directors: Nina Rawal, co-head and partner at Trill Impact Ventures Advisory, and Jean-Francois Morin, investment director at Bpifrance.

"Nina Rawal holds a M.S. in biomedicine and a Ph.D in molecular neurobiology. Her extensive healthcare background and VC experience will serve May Health as we look to raise more funding and advance Ovarian Rebalancing," Morrissey said.

"Jean-Francois Morin is a leading life sciences investor and his expertise will serve May Health as we continue on this momentum to advance our therapy and raise more funds in the future."

Ultimately, the goal of May Health is to provide treatment options women living with PCOS, and to make fertility treatment more accessible for millions of women.

"Women’s health has historically been an underserved space, with a lack of research and funding leading to limited innovation. May Health is a clinical-stage company committed to uncovering a new option for women with PCOS-related infertility," said Morrissey.

"Success will mean we have an FDA-cleared product that provides women with another option to treat PCOS-related infertility."

Note: Join us for our conversation: The Future of Fertility, May 22 from 4pm PT-6 pm PT online. Panelists: Bambi Francisco Roizen (Founder and CEO, Vator); Dr. Archana Dubey (Chief Medical Officer, United Healthcare); Dr. Jean Gekas (CEO, Genoscience); La Keisha Landrum Pierre (Partner, Emmeline Ventures); Dr. Tammy Mahaney (Suncoast Ventures); Dr. Jillian Lopiano (Chief Health Officer, Wisp); Dr. Tendai Chiware, M.D., (Director, Third Party Reproduction Program, GENESIS Fertility & Reproductive Medicine)

(Image source: mayhealth.com)