Materna Medical Successfully Enrolls All Participants in ElloraTM Obstetrical System Trial for First-Time Mothers in EASE Research
The EASE pivotal trial (NCT03973281), a significant study focusing on the safety and effectiveness of the investigational Ellora™ Obstetrical System, is currently underway at 20 leading U.S. hospital clinical sites [1]. The trial, which enrolled 420 first-time mothers, is designed to assess the potential of Ellora in reducing pelvic muscle injury during vaginal delivery [1].
The Ellora system is an expanding vaginal dilator, specifically designed to prepare the vagina to better withstand the strain of childbirth. This is crucial as injuries to the levator ani muscle (LAM), whose avulsion is linked to pelvic organ prolapse and related symptoms such as pelvic pressure, pain, and incontinence, are common in vaginal childbirth [1].
Mountain View, California-based Materna Medical, a platform company focusing on the $25B market of women's pelvic health, is the developer of the Ellora Obstetrical System. The company's mission is to empower women to protect their pelvic health [1].
Materna Medical's team consists of engineers, scientists, researchers, and commercial leaders, all working towards transforming the standard of care in labor and delivery by protecting pelvic floor health for mothers. The company's first product, Milli™, a vaginal dilator designed for patients with vaginismus, was launched as a wellness trainer in 2019 and received FDA clearance to sell over the counter in 2023 [1].
The Ellora expanding vaginal dilator, previously known as the Materna Prep device, is the focus of the EASE study. As of July 2025, the trial completed enrollment, but the results on the system’s effectiveness in reducing pelvic muscle injury have not yet been published or released publicly [1]. The trial builds on promising earlier phase 2 data, and the completion of this pivotal trial is expected to provide rigorous evidence regarding Ellora’s potential to improve maternal pelvic floor outcomes after vaginal delivery [1].
The results from the Phase 2 EASE trial were published in the August 2024 Issue of the International Urogynecology Journal. Additionally, Milli outcomes have been studied in a post-market prospective virtual study named POMPOM.
Materna Medical is now focused on analyzing the EASE study data to support an upcoming FDA submission for the Ellora Obstetrical System. With the successful completion of the EASE trial, Materna Medical continues to demonstrate its commitment to improving maternal health outcomes and empowering women to protect their pelvic health.
[1] Data sourced from Materna Medical's official website and press releases.
The results from the Phase 2 EASE trial, focusing on the Ellora Obstetrical System, were published in the August 2024 Issue of the International Urogynecology Journal. This system, designed to reduce pelvic muscle injury during vaginal delivery, is a key component of Materna Medical's mission to empower women and improve maternal health outcomes, particularly in the field of women's pelvic health. The completion of the EASE trial adds to Materna Medical's ongoing effort to provide rigorous evidence supporting the use of innovative therapies and treatments in women's health, contributing to the broader discourse on health-and-wellness and medical-conditions.
