Case series presented at the 2025 SOGH Annual Clinical Meeting shows that complete levator ani muscle avulsions did not fully heal over time, reinforcing the importance of risk reduction.
MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–Materna Medical, a women’s health company pioneering solutions to protect and restore pelvic floor health, announced the presentation of a new case series at the 2025 Society of Ob/Gyn Hospitalists (SOGH) Annual Clinical Meeting, which provides long-term follow-up data confirming the persistence of levator ani muscle avulsions and highlights the risk reduction potential of the Ellora™ Obstetrical System.
Dr. Helai Hesham of Columbia University Irving Medical Center authored the abstract, “Ultrasound Follow-up of Complete Levator Ani Muscle (LAM) Avulsions in EASE Study Phase 2.” This new analysis builds on previously published results from the EASE Phase 2 study,* where a reduction in the number of complete LAM avulsions among first-time mothers who used the investigational Ellora™ Obstetrical System during labor was observed.
This new case series specifically focused on the long-term ultrasound follow-up of participants diagnosed with complete LAM avulsions. The follow-up ultrasounds were conducted between 18 and 40 months postpartum, providing critical data on the long-term persistence of these injuries. Key findings from the case series include:
- The EASE Phase 2 publication reported that LAM avulsions were not observed in those participants who delivered vaginally, completed treatment, and returned for a 3-month follow-up ultrasound in the Device group (0.0%) compared to 10.9% in the Control group (p = 0.040).*
- Follow-up ultrasounds, conducted an average of 27.7 months postpartum, confirmed that complete LAM avulsions did not fully heal over time, reinforcing the need for preventive strategies.
- One of the control participants with an avulsion reported significant pelvic organ prolapse (POP) symptoms more than three years after delivery, highlighting the serious, long-term impact of these injuries.
“These findings underscore the importance of risk reduction,” said Dr. Helai Hesham, the co-principal investigator of the EASE study. “Complete LAM avulsions are detectable by ultrasound, persistent, and clinically significant.”
The EASE study is a multicenter, randomized controlled trial evaluating the safety and effectiveness of the Ellora Obstetrical System. The device is an expanding vaginal dilator being evaluated for its ability to reduce pelvic floor trauma during vaginal delivery. The pivotal trial recently completed enrollment of 420 participants across 20 leading U.S. hospitals.
The poster detailing these findings will be presented during the SOGH Annual Conference, which is taking place September 14-16, 2025, at the Grand Hyatt Seattle in Seattle, Washington.
About 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.
*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
Contacts
Media Contact:
Debbie Donovan
Head of Commercial Operations
Materna Medical, Inc.
[email protected]
