French company hits milestone with ‘transformative’ approach to PCOS treatment

The French medical device company May Health has completed the treatment of the first five participants enrolled in a study of ovarian rebalancing treatment for PCOS-related infertility.

According to May Health, Ovarian Rebalancing is a one-time, ultrasound-guided transvaginal ablation procedure aimed at activating natural ovulation.

The study is evaluating the safety and effectiveness of the investigational treatment in women living with PCOS-related infertility, one of the most common hormonal endocrine disorders among people of reproductive age, affecting nearly seven million women in the US.

The company is investigating the solution for the purpose of inducing ovulation through the ablation of ovarian tissue using radiofrequency (RF) energy, with the aim to study its impact as a broader treatment for PCOS.

Karl Hansen, chair of the department of obstetrics and gynaecology at the University of Oklahoma College of Medicine and lead investigator, said: “I am pleased we were able to quickly complete treatment of the first five patients and I am eager to continue investigating this potentially transformative approach to PCOS treatment.

“Current treatments are insufficient for women living with PCOS who are seeking solutions to their fertility challenges.

“Women with PCOS need a procedure that can establish ovulation, make family planning more feasible, and reverse the other life-altering symptoms of this disorder.

“I am eager to do the clinical research necessary to bring this innovative approach to patients.”

Anne Morrissey, CEO of May Health, said: “Women living with PCOS have limited options right now. They deserve safe and effective treatments that address the underlying causes of their symptoms.

“By restoring natural ovulation in a straightforward office procedure, Ovarian Rebalancing has the potential to transform the PCOS treatment landscape and give women greater control over their health and future.

“My team is motivated to continue our clinical research and use what we learn to improve our approach, so women and families everywhere can benefit from this treatment.”

To date, May Health has enrolled 23 patients in feasibility studies in the US and Europe, with encouraging early outcomes of inducing ovulation and achieving pregnancy.

Evidence from these studies is intended to serve as proof of concept for the treatment and be used to inform the design of a future study and marketing application in the US and to support a marketing application in Europe.