May Health Welcomes New CEO Colby Holtshouse to Advance Innovative PCOS Treatment
In a significant move for the medical device sector, May Health has appointed Colby Holtshouse as its new President and Chief Executive Officer. This transition comes as the company intensifies its focus on the clinical evaluation of their innovative Ovarian Rebalancing™ technology, which offers hope to women suffering from Polycystic Ovary Syndrome (PCOS), a leading cause of infertility. Colby Holtshouse joins May Health with extensive experience in women's health. She has played pivotal roles in previous companies such as Organon, Alydia Health, and Pelvalon, making her particularly attuned to the challenges and opportunities in the sector.
Dr. Robert Auerbach, Chairman of May Health, expressed his enthusiasm about Holtshouse's appointment, stating, "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. This study is crucial for gaining marketing authorization for our Ovarian Rebalancing procedure, intended to help millions of women experiencing infertility due to PCOS." The REBALANCE study is a pivotal clinical trial designed to validate the effectiveness of May Health's Ovarian Rebalancing technology.
PCOS is a common endocrine disorder impacting around 10% of reproductive-age women, often leading to irregular menstrual cycles and complications with fertility. Traditional treatments often include oral medications, which do not work for all patients. May Health's Ovarian Rebalancing procedure is designed for those who have not responded adequately to these conventional therapies.
Utilizing a minimally invasive, ultrasound-guided transvaginal approach, the Ovarian Rebalancing procedure employs radio frequency (RF) energy to ablate excess androgen-producing ovarian tissue. This is aimed at restoring normal ovulatory cycles without requiring extensive recovery time, enabling patients to resume their everyday lives quickly.
Antoine Papiernik, Chairman and Managing Partner at Sofinnova Partners, mentioned, "May Health is pioneering a first-of-its-kind treatment for PCOS, critically needed by women facing infertility issues. With Colby Holtshouse at the helm, we believe the company is well-positioned to bring this cutting-edge therapy to those in need."
Holtshouse herself expressed excitement regarding her new role and the potential impact of the REBALANCE study. She stated, "I am thrilled to join May Health at this important time. The results from our clinical feasibility studies instill confidence that the REBALANCE study will yield the necessary evidence for U.S. FDA marketing authorization, thereby assisting many more women dealing with PCOS-related infertility."
The REBALANCE study is currently in the process of enrolling participants across the United States, and the company previously completed clinical feasibility studies in both Europe and the U.S. These studies have provided a strong foundation for moving forward into the next phase of clinical trials. May Health’s commitment to innovation is further underscored by a successful funding round where it raised $25 million in Series B funding led by Trill Impact and BPI France, complementing an earlier €10 million in Series A funding from Sofinnova Partners.
May Health, previously known as Ziva Medical and Ablacare, was founded in 2012 by a team of seasoned medical device innovators. Following its acquisition in 2017 by Sofinnova's medtech acceleration unit, Sofinnova MD Start, the company has focused on advancing solutions aimed at improving women’s health. With its headquarters located in Paris and a team in Menlo Park, California, May Health is poised to make significant strides in the realm of women’s health solutions. In conclusion, Holtshouse's leadership might be a game changer for May Health and its groundbreaking technology focused on addressing the critical issues faced by women suffering from PCOS, ensuring that their innovative treatment reaches those who need it most as they continue to validate and commercialize their technology.
Dr. Robert Auerbach, Chairman of May Health, expressed his enthusiasm about Holtshouse's appointment, stating, "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. This study is crucial for gaining marketing authorization for our Ovarian Rebalancing procedure, intended to help millions of women experiencing infertility due to PCOS." The REBALANCE study is a pivotal clinical trial designed to validate the effectiveness of May Health's Ovarian Rebalancing technology.
PCOS is a common endocrine disorder impacting around 10% of reproductive-age women, often leading to irregular menstrual cycles and complications with fertility. Traditional treatments often include oral medications, which do not work for all patients. May Health's Ovarian Rebalancing procedure is designed for those who have not responded adequately to these conventional therapies.
Utilizing a minimally invasive, ultrasound-guided transvaginal approach, the Ovarian Rebalancing procedure employs radio frequency (RF) energy to ablate excess androgen-producing ovarian tissue. This is aimed at restoring normal ovulatory cycles without requiring extensive recovery time, enabling patients to resume their everyday lives quickly.
Antoine Papiernik, Chairman and Managing Partner at Sofinnova Partners, mentioned, "May Health is pioneering a first-of-its-kind treatment for PCOS, critically needed by women facing infertility issues. With Colby Holtshouse at the helm, we believe the company is well-positioned to bring this cutting-edge therapy to those in need."
Holtshouse herself expressed excitement regarding her new role and the potential impact of the REBALANCE study. She stated, "I am thrilled to join May Health at this important time. The results from our clinical feasibility studies instill confidence that the REBALANCE study will yield the necessary evidence for U.S. FDA marketing authorization, thereby assisting many more women dealing with PCOS-related infertility."
The REBALANCE study is currently in the process of enrolling participants across the United States, and the company previously completed clinical feasibility studies in both Europe and the U.S. These studies have provided a strong foundation for moving forward into the next phase of clinical trials. May Health’s commitment to innovation is further underscored by a successful funding round where it raised $25 million in Series B funding led by Trill Impact and BPI France, complementing an earlier €10 million in Series A funding from Sofinnova Partners.
May Health, previously known as Ziva Medical and Ablacare, was founded in 2012 by a team of seasoned medical device innovators. Following its acquisition in 2017 by Sofinnova's medtech acceleration unit, Sofinnova MD Start, the company has focused on advancing solutions aimed at improving women’s health. With its headquarters located in Paris and a team in Menlo Park, California, May Health is poised to make significant strides in the realm of women’s health solutions. In conclusion, Holtshouse's leadership might be a game changer for May Health and its groundbreaking technology focused on addressing the critical issues faced by women suffering from PCOS, ensuring that their innovative treatment reaches those who need it most as they continue to validate and commercialize their technology.
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