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), 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, 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 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.”
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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.”
Source: PRNewswire