The targeted, one-time ovarian ablation procedure aims to induce ovulation for women seeking solutions for infertility related to the endocrine disorder polycystic ovary syndrome (PCOS)
PARIS, FRANCE / ACCESSWIRE / December 20, 2022 / May Health, a clinical-stage medical device company dedicated to helping those living with the endocrine disorder polycystic ovary syndrome (PCOS), today announced that it has completed treatment of the first five participants enrolled in a U.S. feasibility study of its investigational Ovarian Rebalancing treatment, a one-time, ultrasound-guided transvaginal ablation procedure designed to activate natural ovulation in those with PCOS-related infertility.
The study is evaluating the safety and effectiveness of Ovarian Rebalancing in women living with PCOS-related infertility, one of the most common hormonal endocrine disorders among people of reproductive age, affecting nearly 7 million women in the U.S. In addition to being a common cause of infertility, PCOS is a challenging lifelong endocrine disorder that is associated with insulin resistance, Type 2 diabetes, and increased risk of heart disease and stroke. PCOS can also present vexing day-to-day struggles with irregular menstruation, acne, thinning scalp, excessive body hair growth, high blood pressure, and sleep apnea. May Health is investigating Ovarian Rebalancing for the purpose of inducing ovulation through the ablation of ovarian tissue using radiofrequency (RF) energy. In future clinical work the company aims to study the impact of Ovarian Rebalancing as a broader treatment for PCOS symptoms.
"I am pleased we were able to quickly complete treatment of the first five patients and I'm eager to continue investigating this potentially transformative approach to PCOS treatment," said Karl Hansen, M.D., Ph.D., Chair of the Department of Obstetrics and Gynecology at the University of Oklahoma College of Medicine and lead investigator. "Current treatments are insufficient for women living with PCOS who are seeking solutions to their fertility challenges. Women with PCOS need a procedure that can establish ovulation, make family planning more feasible, and reverse the other life-altering symptoms of this disorder. I am eager to do the clinical research necessary to bring this innovative approach to patients."
To date, May Health has enrolled 23 patients in feasibility studies in the U.S. and Europe, with encouraging early outcomes of inducing ovulation and achieving pregnancy. Evidence from these studies is intended to serve as proof of concept for the treatment and be used to inform the design of a future pivotal study and marketing application in the U.S. and to also support a marketing application in Europe.
"Women living with PCOS have limited options right now," said Anne Morrissey, CEO of May Health. "They deserve safe and effective treatments that address the underlying causes of their symptoms. By restoring natural ovulation in a straightforward office procedure, Ovarian Rebalancing has the potential to transform the PCOS treatment landscape and give women greater control over their health and future. My team is motivated to continue our clinical research and use what we learn to improve our approach, so women and families everywhere can benefit from this treatment."
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 small amounts.1 In many cases, those with PCOS are unable to produce enough of the hormones needed to ovulate and become pregnant, which can lead to the development of ovarian cysts.1 PCOS is one of the most common causes of female infertility, affecting 10% of U.S. women of reproductive age.2 PCOS is also a lifelong challenge that goes beyond fertility issues. Women with PCOS are often insulin resistant, increasing their risk for Type 2 diabetes; more than half of PCOS sufferers will develop Type 2 diabetes by age 40 and they are also at increased risk of heart disease, stroke, and endometrial cancer.2 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.2
About May Health
May Health, formerly AblaCare, is a clinical-stage medical device company committed to developing treatment options for women living with PCOS. The company is currently investigating its Ovarian Rebalancing treatment in clinical studies; Ovarian Rebalancing is a novel approach to PCOS-related fertility that has the potential to be a safe, straightforward option for activating natural ovulation. May Health is led by a team of serial medtech and women's health entrepreneurs and executives with extensive experience in product development, validation, and launch. The company has raised €10M in a Series A led by Sofinnova Partners and was founded in 2017 by the firm's medtech acceleration team, Sofinnova MD Start. May Health is headquartered in Paris, France. 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 €2.5 billion under management. For more information, visit: sofinnovapartners.com.
1 Johns Hopkins Medicine
2 CDC
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SOURCE: May Health
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