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Materna Medical Completes Enrollment in EASE Trial of Ellora™ Obstetrical System Used in First-Time Mothers

via Business Wire

Multi-Center Pivotal Trial Enrolls 420 Participants in Evaluation of Investigational Medical Device Intended to Reduce Risk of Pelvic Floor Muscle Injury due to Vaginal Childbirth

Materna Medical, a women’s health company dedicated to developing innovative solutions for pelvic floor disorders, today announced the successful completion of enrollment in its EASE pivotal trial (NCT03973281). The trial enrolled 420 first-time mothers to evaluate the safety and effectiveness of the investigational Ellora™ Obstetrical System for reducing pelvic muscle injury during vaginal delivery in first-time mothers.

The EASE study is a prospective, randomized controlled clinical trial being conducted at 20 leading U.S. hospital clinical sites and is designed to assess the safety and effectiveness of the Ellora expanding vaginal dilator (formerly Materna Prep device) in reducing pelvic muscle injury during vaginal delivery.

"The completion of enrollment in the EASE study represents an exciting opportunity to understand and potentially reduce the risk of vaginal childbirth-related pelvic floor trauma,” said Helai Hesham, MD, urogynecologist and EASE lead investigator at Columbia University Irving Medical Center, NY. “The rigorous design of this pivotal trial, building on the promising published results of the EASE Phase 2 Study, is essential for evaluating the potential of Ellora to improve maternal health outcomes.” Vaginal childbirth-related pelvic floor injuries, specifically complete levator ani muscle (LAM) avulsion—where a group of pelvic floor muscles detaches from the pelvic bone—are linked to pelvic organ prolapse, whose symptoms can include pelvic pressure, pain, urinary and/or fecal incontinence, and sexual dysfunction. The investigational Ellora Obstetrical System includes an expanding vaginal dilator designed to prepare the vagina to better withstand the strain of childbirth, aiming to reduce the incidence and severity of these significant LAM injuries.

“Completing enrollment in our EASE pivotal trial is a monumental milestone for Materna Medical and is a significant step forward in our mission to protect women from childbirth injuries,” said Tracy MacNeal, CEO of Materna Medical. “We are incredibly grateful to the patients and clinical investigators participating in this groundbreaking trial. Their commitment brings us closer to potentially offering a much-needed intervention to improve birth outcomes for mothers globally.”

“The focus of innovation has traditionally been on the difficult challenge of fixing women’s pelvic health damage that has already occurred, rather than protecting the pelvic floor and preventing these problems from happening in the first place," said Ariella Golomb, MD, Partner and Founder, InnovaHealth Partners, and Materna Board Chair. "Materna's approach to reducing the incidence of pelvic floor injuries is a tremendous opportunity to transform the standard of care in obstetrics and provide women with a chance to enter motherhood without the anatomical setbacks from childbirth. We're thrilled to see this landmark study complete its enrollment."

Results from the Phase 2 EASE trial were published in the August 2024 Issue of the International Urogynecology Journal: “Effect of an intrapartum pelvic dilator device on levator ani muscle avulsion during primiparous vaginal delivery: A pilot randomized controlled trial.”

Materna Medical is now focused on analyzing the EASE study data to support an upcoming FDA submission for the Ellora Obstetrical System.

About Us Materna Medical

Materna Medical is a novel OBGYN platform company defining a $25B market with core technologies addressing unmet needs in women's pelvic health. With headquarters in Mountain View, California, Materna pulls from the top minds in MedTech to truly transform the standard of care in OBGYN. With a diverse team of engineers, scientists, researchers, and commercial leaders, Materna Medical’s mission is to empower women to protect their pelvic health. Our first product, Milli™, is a vaginal dilator to support patients suffering from vaginismus and related painful sex. In 2019, the Milli device launched as a wellness trainer and, in 2023, received FDA clearance to sell over the counter, enabling streamlined access to people suffering from vaginismus. Milli outcomes have been studied in a post-market prospective virtual study named POMPOM. Materna’s second product, Ellora™, is an investigational device used during labor and is intended to reduce pelvic floor muscle injury during vaginal delivery in first-time moms. This product is being studied in the EASE trial, a large, randomized controlled trial in 20 top US hospitals. Materna aims to transform the standard of care in labor and delivery by protecting pelvic floor health for moms.

Reference

Hesham, H., Orejuela, F., Rood, K.M. et al. Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial. Int Urogynecol J 35, 1839–1849 (2024). https://doi.org/10.1007/s00192-024-05881-6

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