For women suffering from Polycystic Ovary Syndrome (PCOS), treatment options have remained largely unchanged for decades. May Health is working to change that with its Ovarian Rebalancing technology, a novel approach that targets the root cause of PCOS-related infertility. Leading this mission is the company’s newly appointed President and CEO, Colby Holtshouse, who brings extensive experience in women’s health and medtech innovation.
“When I first learned about May Health, I did what I always do – I asked my network about the condition,” says Holtshouse. “I was shocked to discover how many women in my circle have PCOS but had never mentioned it. These are people I know really well, yet this significant health challenge hadn’t come up in conversation.”
This pattern of silence around PCOS is one Holtshouse aims to break. With a career spanning leadership roles at Guidant, Medtronic, Organon, Alydia Health, and Pelvalon, she has repeatedly witnessed how women’s health conditions go underdiagnosed and undertreated.
From Cardiovascular Care to Women’s Health
Holtshouse began her career in cardiovascular medtech before finding her way to women’s health through what she describes as “a fortuitous introduction.” The shift opened her eyes to the significant unmet needs in women’s health innovation.
“I started with big companies, primarily in the cardiovascular space with Guidant and Medtronic, then moved to startups,” Holtshouse explains. “My first women’s health product focused on bowel incontinence, a condition I didn’t even know existed. This became a recurring theme in my women’s health journey – every time I encounter a new condition, I’m blown away by how prevalent it is despite so little public discussion.”
This pattern continued when she joined Alydia Health, where she worked on a solution for postpartum hemorrhage. “I had two children and couldn’t have defined postpartum hemorrhage for you,” she admits. “Yet after joining Alydia, I discovered friends who had transfusions after childbirth or other interventions they never talked about.”
The Unaddressed Challenge of PCOS
Holtshouse sees May Health’s technology as addressing a critical gap in women’s healthcare. The company’s Ovarian Rebalancing procedure is designed to restore ovulation in women with PCOS who haven’t responded to first-line medications.
“PCOS affects approximately 10% of women of reproductive age, yet half of those women are never diagnosed,” Holtshouse notes. “For those who are diagnosed, current treatments primarily address symptoms rather than the root cause.”
May Health’s technology, currently being evaluated in the REBALANCE clinical trial in the United States, uses radio frequency energy to ablate excess androgen-producing ovarian tissue through an ultrasound-guided transvaginal procedure. Early feasibility studies have shown promising results.
“In our feasibility studies, we saw 45% ovulation within three months, with women who have conceived and carried children to term. There are now pregnancies from these early studies, which is incredibly motivating,” says Holtshouse. “I get so excited thinking about those families we were able to help, with many more to come.”
The Path to Innovation in Women’s Health
When asked about the challenges of innovating in women’s health compared to other medical fields, Holtshouse acknowledges the hurdles but sees tremendous opportunity.
“After my first women’s health startup, I said I would never do it again – many investors were hesitant, strategics were not active, there are so many headwinds,” she recalls. “But the landscape has improved significantly since 2017. There’s a new level of awareness, more proof points for commercial success, and growing interest from investors willing to put money into novel solutions in this space.”
What brought her back to early stage women’s health in 2018, and back again today after a stint at Organon, was the opportunity to drive groundbreaking innovation. “In cardiology, I launched the third drug-eluting stent to market, building on existing technologies. In women’s health, there are conditions with zero solutions. The opportunity is wide open.”
This was demonstrated during her time at Alydia Health, where their device for postpartum hemorrhage was adopted by over 2,000 hospitals in just three years. “Physicians are hungry for solutions to their patients’ unmet needs,” she explains.
Beyond Fertility: The Future of PCOS Treatment
While May Health’s initial focus is on PCOS-related infertility, Holtshouse envisions broader applications for their technology. “PCOS is so much more than just ovulation,” she acknowledges. “Ovulation is a great signal of overall metabolic health and provides a clear, measurable outcome for our clinical trials, but we’re also collecting data on other symptoms.”
“The vast majority of women living with PCOS at any given time are not actively trying to have babies, but we still want to help them,” Holtshouse emphasizes. “If we can address the syndrome early, that may make the fertility journey easier and also help prevent the long-term health implications.”
As May Health continues to enroll patients in its REBALANCE study through early 2026, Holtshouse’s mission extends beyond just developing a new treatment. “My vision is that by offering a solution, we can help more women get properly diagnosed and treated for PCOS – whether that involves our technology or not.”
