May Health, a clinical-stage medical device company focusing on polycystic ovary syndrome (PCOS), presented promising results from the ULTRA-EU and ULTRA-US feasibility clinical trials for its Ovarian Rebalancing treatment at the 39th Annual European Society of Human Reproduction and Embryology (ESHRE) meeting.
The trials demonstrated the treatment’s safety and effectiveness in inducing ovulation in women with PCOS-related infertility. The company also received FDA approval for a pivotal trial to further evaluate the treatment.
Ovarian Rebalancing offers a potential office-based alternative for women who have not responded to initial medications. These advancements bring hope to women struggling with PCOS-related infertility and signify a significant step forward in improving treatment options for PCOS.
“Infertility is an emotional journey, and current options available to achieve pregnancy are often expensive, invasive, and do not work for all women, adding burden to the experience,” said Saad Amer, M.D., Professor of Gynaecology and Reproductive Medicine at the University of Nottingham and lead investigator of the ULTRA-EU trial. “The new data show great promise for Ovarian Rebalancing as a safe and effective office-based treatment to induce ovulation in women who have not achieved results from first-line medications.”
“In addition to being the leading cause of infertility, PCOS causes other major health challenges, and women lack options to address the needs of this disorder,” said Anne Morrissey, CEO of May Health. “Our team recognizes the need for innovative treatments for PCOS, and the data from our trials show that Ovarian Rebalancing has the potential to shift the treatment landscape for this patient population. We’re eager to continue our research with the US pivotal trial and explore additional endpoints in future studies to assess the potential of Ovarian Rebalancing as a treatment for other symptoms of PCOS.”