MOUNTAIN VIEW, Calif. — Materna Medical, a women’s health company focused on pelvic floor disorder solutions, has completed enrollment in its pivotal EASE trial, evaluating the Ellora™ Obstetrical System—a novel device designed to reduce the risk of pelvic muscle injury during vaginal childbirth in first-time mothers.
The multicenter clinical study enrolled 420 participants across 20 major U.S. hospitals. The trial is designed to assess the safety and effectiveness of the investigational Ellora system—an expanding vaginal dilator intended to help the body better withstand the physical strain of labor. The device was formerly known as the Materna Prep.
“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 Dr. Helai Hesham, urogynecologist and lead investigator at Columbia University Irving Medical Center. “This pivotal trial builds on promising Phase 2 results and could represent a major advancement in maternal care.”
Pelvic floor injuries, particularly complete levator ani muscle (LAM) avulsion, are a significant concern during vaginal childbirth. These injuries are associated with pelvic organ prolapse and can lead to symptoms such as pelvic pain, urinary or fecal incontinence, and sexual dysfunction. The Ellora device aims to reduce the incidence and severity of such injuries by gently expanding and preparing the vaginal canal in advance of delivery.
Materna Medical CEO Tracy MacNeal called the milestone “monumental” for the company and for maternal health. “We are incredibly grateful to the patients and clinical investigators participating in this groundbreaking trial,” she said. “Their commitment brings us closer to offering a much-needed intervention to improve birth outcomes for women worldwide.”
Ariella Golomb, M.D., Board Chair at Materna and a founding partner of InnovaHealth Partners, emphasized the device’s potential to shift the focus in women’s health care. “Traditionally, innovation has focused on treating pelvic health problems after the damage is done. Materna’s approach—aimed at prevention—has the potential to change the standard of care in obstetrics.”
The EASE study is registered under clinical trial number NCT03973281. Results from the trial are expected to inform future regulatory submissions and help shape clinical guidelines around childbirth injury prevention.
