Materna Medical successfully finishes the recruitment phase in the EASE trial, evaluating the ElloraTM Obstetrical System applied in initial motherhood cases.
In a groundbreaking development for women's health, Materna Medical's Ellora Obstetrical System has shown potential in reducing pelvic muscle injuries during vaginal delivery. The results from the Phase 2 EASE trial, which enrolled 420 first-time mothers, were published in the August 2024 issue of the International Urogynecology Journal.
The EASE trial, with the identification number NCT03973281, is a prospective, randomized controlled clinical study being conducted at 20 leading U.S. hospital clinical sites. The trial aims to assess the safety and effectiveness of the Ellora device, an intrapartum pelvic dilator, in reducing pelvic muscle injury during vaginal delivery.
The Ellora device is designed to prepare the vagina to better withstand the strain of childbirth, thereby potentially reducing the incidence and severity of complete levator ani muscle (LAM) avulsion. This type of injury is linked to pelvic organ prolapse, a condition that can cause symptoms like pelvic pressure, pain, urinary and/or fecal incontinence, and sexual dysfunction.
Dr. Helai Hesham, a urogynecologist and EASE lead investigator at Columbia University Irving Medical Center, NY, expressed excitement about the trial's potential to reduce the risk of vaginal childbirth-related pelvic floor trauma.
Materna Medical, a platform company in the OBGYN sector, is dedicated to developing innovative solutions for pelvic floor disorders. The company's team comprises engineers, scientists, researchers, and commercial leaders. Their mission is to empower women to protect their pelvic health, transforming the standard of care in labor and delivery.
Materna Medical's headquarters are located in Mountain View, California. Their 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.
Currently, Materna Medical is focused on analyzing the EASE study data to support an upcoming FDA submission for the Ellora Obstetrical System. For detailed efficacy and safety metrics, consulting the August 2024 issue of the International Urogynecology Journal or Materna Medical’s detailed announcements would be necessary.
In addition, Materna Medical is conducting a post-market prospective virtual study named POMPOM for the Milli device. The company is targeting a $25B market in the OBGYN sector.
[1] International Urogynecology Journal, August 2024 issue.
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