MAY HEALTH APPOINTS SEASONED MEDTECH EXECUTIVE, COLBY HOLTSHOUSE, AS PRESIDENT AND CEO

Rhea-AI Summary

May Health has appointed Colby Holtshouse as President and CEO to lead the company's development of its novel Ovarian Rebalancing™ technology. The technology is a one-time transvaginal ablation procedure designed to restore ovulation in women with Polycystic Ovary Syndrome (PCOS), affecting 10% of women.

The company is currently conducting the REBALANCE study, an IDE clinical trial to support FDA marketing authorization. The procedure uses radio frequency energy to ablate excess androgen-producing ovarian tissue, aiming to establish regular ovulatory menstrual cycles. This in-office treatment is designed for same-day recovery with minimal discomfort.

Holtshouse brings executive experience from Organon, Alydia Health, and Pelvalon. May Health has completed clinical feasibility studies in Europe and the U.S. and is actively enrolling patients for its IDE clinical study in the United States.

Positive

• Company completed clinical feasibility studies in both Europe and U.S.
• Technology addresses large market opportunity (10% of women affected by PCOS)
• Procedure offers same-day recovery with minimal downtime
• New CEO brings relevant industry experience in women's health sector

Negative

• Product still requires FDA marketing authorization
• Technology to patients resistant to oral medication
• Currently in clinical trial phase with no guaranteed success

Leadership transition comes as Company focuses on clinical evaluation of its novel Ovarian Rebalancing™ technology, a one-time transvaginal ablation procedure designed to restore ovulation in women with PCOS, a leading cause of infertility

PARIS, March 10, 2025 /PRNewswire/ -- May Health, a Paris- and California-based, clinical-stage medical device company dedicated to the development of a new treatment for Polycystic Ovary Syndrome (PCOS), today announced that Colby Holtshouse has joined the Company as President and CEO. Colby brings a wealth of senior leadership and women's health expertise to the organization, having held executive positions with Organon (NYSE: OGN), Alydia Health, and Pelvalon.

"I am delighted to have Colby join and lead the company as we look to complete the REBALANCE study, a landmark investigational device exemption (IDE) clinical trial which is being conducted to support marketing authorization for our Ovarian Rebalancing procedure so that we can bring it to millions of women who experience PCOS-related infertility," commented Dr. Robert Auerbach, May Health Chairman. "Colby has deep experience bringing groundbreaking technologies to market, making her the ideal fit to spearhead May Health as we continue to validate the technology and drive towards commercialization."

"May Health is pioneering a first-of-its-kind treatment for PCOS, a condition that affects 10% of women and presents serious health challenges, including infertility," stated Antoine Papiernik, Chairman and Managing Partner at Sofinnova Partners and the former Chairman of May Health. "We are excited to welcome Colby to guide the company in bringing this therapy to women around the world."

May Health's proprietary technology, Ovarian Rebalancing, is an investigational treatment designed to restore ovulation in patients with PCOS who are resistant to oral ovulation induction medication. The ultrasound-guided, transvaginal procedure utilizes radio frequency (RF) energy to ablate excess androgen-producing ovarian tissue in order to establish regular ovulatory menstrual cycles. The goal of this one-time, in-office procedure is to allow for same-day recovery and return to normal activities with minimal patient discomfort and downtime. May Health previously completed clinical feasibility studies in Europe and the U.S. and is actively enrolling for its IDE clinical study in the United States.  

"I am thrilled to join May Health at this important time. Following the strong clinical feasibility results, we are encouraged that the REBALANCE study will provide the evidence necessary for U.S. FDA marketing authorization and for broad adoption by physicians and patients seeking options for PCOS-related infertility," Colby shared. "I look forward to working with the May Health team to deliver the Ovarian Rebalancing procedure to women suffering from PCOS-related infertility."

About Polycystic ovary syndrome (PCOS)

Polycystic ovary syndrome (PCOS) is a common endocrine condition where the ovaries produce abnormal levels of androgens, which are male sex hormones that are usually present in women in lesser amounts. In many cases, those with PCOS are unable to ovulate and become pregnant. PCOS is one of the most common causes of female infertility, affecting roughly 10% of reproductive-aged women.  Other common, persistent symptoms of PCOS include irregular menstruation, acne, thinning scalp, excess hair growth on the face and body, high blood pressure, and sleep apnea. PCOS is a lifelong challenge that can significantly increase a patient's risk for Type 2 diabetes,  heart disease, and stroke. The condition is also associated with an increased risk of pregnancy complications.

About May Health

May Health is a Paris- and California-based clinical-stage medical device company developing novel treatments for women with Polycystic Ovary Syndrome (PCOS). The company is currently investigating its Ovarian Rebalancing^™ technology as a treatment for PCOS-related infertility in the REBALANCE clinical study. The FDA-approved IDE study is being conducted to support marketing authorization. The May Health Ovarian Rebalancing procedure is a novel approach to PCOS-related infertility issues and is intended to induce ovulation in patients resistant to oral medical therapy. May Health is led by a team of serial medtech and women's health entrepreneurs and executives with extensive experience in product development, therapy validation, and commercial launch. In 2024, the Company completed a $25M Series B raise co-led by Trill Impact and BPI France to complement the earlier €10M in a Series A led by Sofinnova Partners.  May Health, formerly known as Ziva Medical and Ablacare was founded in 2012 by serial medical device innovators Neil Barman, Andy Wu and Garrett Schwab, and then acquired in 2017 by Sofinnova's medtech acceleration team, Sofinnova MD Start.  May Health is headquartered in Paris, France, with its US team based in Menlo Park, CA. For more information, visit www.mayhealth.com.

About Sofinnova Partners

Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future. Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €4 billion under management. For more information, visit: sofinnovapartners.com.

About Trill Impact 

Trill Impact is an established Impact House with around EUR 1.3 billion in assets under management. Its impact investment strategies span Buyout, Ventures and Microfinance, supported by experienced professionals based in Europe and North America. Trill Impact aims to be a force for positive change through impact private investments, delivering Real Returns and Lasting Impact for the benefit of investors, businesses and society at large – encouraging others to follow. For more information, please visit: www.trillimpact.com.

About BPIFrance

Bpifrance Investissement is the management company that handles Bpifrance's equity investments. Bpifrance is the French national investment bank: it finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extra financial services (training, consultancy) to help entrepreneurs meet their challenges from innovation to export. For more information, please visit: https://www.bpifrance.com/.

Media Contact
Charlene Herndon
SPRIG Consulting
charlene@sprigconsulting.com

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SOURCE May Health

FAQ

What is May Health's Ovarian Rebalancing technology for PCOS treatment?

It's a one-time transvaginal ablation procedure using RF energy to ablate excess androgen-producing ovarian tissue, designed to restore ovulation in women with PCOS who don't respond to oral medication.

What is the current status of May Health's REBALANCE clinical trial?

The REBALANCE study is an ongoing IDE clinical trial actively enrolling patients in the United States to support FDA marketing authorization.

How does May Health's PCOS treatment differ from traditional treatments?

It's a one-time, in-office procedure with same-day recovery, unlike traditional ongoing medications, designed for patients resistant to oral ovulation induction medication.

What experience does new CEO Colby Holtshouse bring to May Health?

Holtshouse brings senior leadership and women's health expertise from executive positions at Organon (OGN), Alydia Health, and Pelvalon.