Colby Holtshouse appointed CEO of May Health as PCOS trial advances

May Health, a clinical-stage medtech company based in both Paris and California, has appointed Colby Holtshouse as its new President and CEO. The company, which is advancing a novel treatment for Polycystic Ovary Syndrome (PCOS), continues to enroll patients in its pivotal REBALANCE clinical trial in the United States. Holtshouse brings years of experience in the women's health sector, having held executive roles at companies such as Organon, Alydia Health, and Pelvalon.

Commenting on the appointment, May Health’s Chairman, Robert Auerbach, emphasized the importance of this leadership change as the company moves forward with its investigational Ovarian Rebalancing procedure. He said Holtshouse’s experience with innovative technologies makes her well-positioned to guide the organization through the ongoing clinical trial and toward potential market authorization. The REBALANCE study, conducted under an Investigational Device Exemption (IDE), is designed to support the regulatory pathway for the procedure in the U.S. market.

Ovarian Rebalancing is a minimally invasive, ultrasound-guided transvaginal procedure that applies radio frequency (RF) energy to ablate androgen-producing ovarian tissue. The procedure aims to restore ovulation in PCOS patients who do not respond to oral ovulation induction medications. With its in-office, one-time application, the treatment is designed for same-day recovery and a return to daily activities with minimal discomfort. Prior feasibility studies were completed in Europe and the U.S., and May Health is currently continuing patient enrollment in its IDE trial.

In her official statement, Colby Holtshouse expressed optimism about the ongoing work at May Health, noting, "I am thrilled to join May Health at this important time." She added that the results from feasibility studies give confidence that REBALANCE will provide strong evidence for FDA authorization and eventual clinical adoption.

The company’s leadership transition comes at a time when more attention is being given to treatment alternatives for PCOS-related infertility, a condition affecting millions of women worldwide. With the REBALANCE study underway and a strategic shift in leadership, May Health continues its focus on data-driven validation and potential commercialization of its proprietary technology.

As clinical milestones progress, the company is expected to engage with regulators and medical professionals to determine the future availability of the Ovarian Rebalancing procedure in clinical practice.