May Health announces data from feasibility studies of its novel Ovarian Rebalancing™ treatment and receives approval from FDA for pivotal trial

• Research presented at the European Society of Human Reproduction and Embryology (ESHRE) meeting demonstrated the early safety and effectiveness results of the company’s investigational treatment for ovulation induction in women with PCOS-related infertility.
• Company to initiate pivotal REBALANCE study evaluating Ovarian Rebalancing in women with infertility caused by PCOS

PARIS – June 26, 2023 – May Health, a clinical-stage medical device company dedicated to helping those living with the endocrine disorder polycystic ovary syndrome (PCOS), today announced new clinical trial results providing preliminary data supporting the safety and effectiveness of its Ovarian Rebalancing™ treatment for inducing ovulation in women with PCOS-related infertility. Early outcomes data from the ULTRA-EU and ULTRA-US feasibility clinical trials were presented at the 39th Annual ESHRE meeting in Copenhagen, Denmark on June 26, 2023.

The company also announced U.S. Food and Drug Administration (FDA) approval of its REBALANCE study, a prospective, multicenter, randomized pivotal study designed to evaluate the safety and effectiveness of Ovarian Rebalancing in women with PCOS-related infertility.

"Infertility is an emotional journey, and current options available to achieve pregnancy are often expensive, invasive, and do not work for all women, adding burden to the experience," said Saad Amer, M.D., Professor of Gynaecology and Reproductive Medicine at the University of Nottingham and lead investigator of the ULTRA-EU trial. "The new data show great promise for Ovarian Rebalancing as a safe and effective office-based treatment to induce ovulation in women who have not achieved results from first-line medications."

Key findings from the ULTRA trials:

- To date, a pregnancy rate of 35% was observed for the twenty-three participants who received Ovarian Rebalancing and completed six months of follow up, including some patients who re-started first-line ovulation induction medication between three and six months.

- Results showed 44% of women ovulated spontaneously during the first three months after undergoing Ovarian Rebalancing.

- The ovulation rate increased to 65% between three and six months, with the re-introduction of first-line medication at three months post procedure.

- In 100% of patients, ablation was achieved successfully in at least one ovary, with 84% of patients receiving the targeted ablation in both ovaries.

- No serious adverse events related to the device were reported. The most common adverse events related to the procedure were mild and included vaginal bleeding, pain, and headache.

“In addition to being the leading cause of infertility, PCOS causes other major health challenges, and women lack options to address the needs of this disorder,” said Anne Morrissey, CEO of May Health. “Our team recognizes the need for innovative treatments for PCOS, and the data from our ULTRA trials show that Ovarian Rebalancing has the potential to shift the treatment landscape for this patient population. We're eager to continue our research with the US pivotal trial and explore additional endpoints in future studies to assess the potential of Ovarian Rebalancing as a treatment for other symptoms of PCOS.”

"The inception of May Health within our medtech accelerator was fueled by a firm belief in the transformative potential of its technology," said Antoine Papiernik, Chairman and Managing Partner of Sofinnova Partners. "The success of these feasibility studies and the FDA's approval of the pivotal REBALANCE study only serve to reinforce our initial conviction. We look forward to seeing this technology revolutionize the field of infertility treatment."

Details of the oral presentation:
Title: The ULTRA trial: transvaginal ULTRAsound-guided ovarian ablation using the novel May Health device in women with PCOS-related infertility: first–in-human feasibility clinical trial
Abstract Number: O-010
Session: New Concepts: PCOS
Presenter: Saad Amer, M.D., Professor of Gynaecology and Reproductive Medicine at the University of Nottingham
Presentation Date & Time: June 26, 2023; 10:15-10:30 am CET
Location: Hall D3

The abstract can be found online here: (https://www.eshre.eu/ESHRE2023/Programme/Searchable#!abstractdetails/0000720750)

About the ULTRA Studies
ULTRA-EU and ULTRA-US, are single-arm feasibility clinical trials, designed to evaluate ovarian ablation with Ovarian Rebalancing in women aged 18-40 who were diagnosed with PCOS and are resistant to first-line ovulation induction drugs. Endpoints include procedure feasibility (successful ablation of at least one ovary), safety, ovulation and pregnancy rates.
ULTRA-EU has enrolled 30 patients at six trial sites, while ULTRA-US enrolled 5 patients at one site. Post-procedure follow-up occurs through 24 months and 12 months, respectively.

About Polycystic Ovary Syndrome (PCOS)
Polycystic ovary syndrome (PCOS) is a common endocrine disorder 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 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 https://www.mayhealth.com/ and by following us on LinkedIn https://www.linkedin.com/company/may-health/

Footnotes:
1. John Hopkins Medicine (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.hopkinsmedicine.org%2Fhealth%2Fconditions-and-diseases%2Fpolycystic-ovary-syndrome-pcos&esheet=52879177&newsitemid=20220909005065&lan=en-US&anchor=Johns+Hopkins+Medicine&index=3&md5=db47605a5ff19c3cc2d217f936432988)Johns

2.CDC (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.cdc.gov%2Fdiabetes%2Fbasics%2Fpcos.html%23%3A%7E%3Atext%3DPCOS%2520is%2520one%2520of%2520the%2Cbeyond%2520the%2520child%252Dbearing%2520years.&esheet=52879177&newsitemid=20220909005065&lan=en-US&anchor=CDC&index=4&md5=87a7e34c796903b5a1685a000e88b5d4)CDC

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