Materna Medical Successfully Finishes Recruitment in EASE Study for ElloraTM Maternity Device, Primarily Employed in New Mothers
Mountain View, California-based Materna Medical, a women's health company focused on developing innovative solutions for pelvic floor disorders, has announced the successful completion of enrollment in the EASE pivotal trial. This trial, with the identifier NCT03973281, enrolled 420 first-time mothers across 20 US hospital sites as of July 31, 2025.
The EASE trial is a prospective, randomized controlled study evaluating the safety and effectiveness of Materna Medical's Ellora Obstetrical System. This system, an expanding vaginal dilator, is designed to reduce pelvic floor muscle injury, particularly complete levator ani muscle (LAM) avulsion, during vaginal delivery.
The Ellora device showed promising outcomes in reducing pelvic muscle trauma related to childbirth in earlier Phase 2 results, published in August 2024. The current pivotal EASE trial builds on these findings to assess whether the device can significantly improve maternal health by lessening pelvic floor injuries such as muscle detachment. These injuries are linked to pelvic organ prolapse and related symptoms like pelvic pressure, pain, urinary and/or fecal incontinence, and sexual dysfunction.
At this time, the final results assessing effectiveness and safety have not yet been released. The EASE study is being conducted at 20 leading U.S. hospital clinical sites.
Materna Medical's team consists of engineers, scientists, researchers, and commercial leaders. Their mission is to empower women to protect their pelvic health. The company's first product, MilliTM, is a vaginal dilator for patients with vaginismus. Milli device launched as a wellness trainer in 2019 and received FDA clearance to sell over the counter in 2023.
The ElloraTM Obstetrical System is Materna Medical's second product. It is being studied in the EASE trial, a large, randomized controlled trial. 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 significant LAM injuries.
[1] Source: Materna Medical press release, dated August 1, 2025.
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