Materna Medical Announces Publication of EASE Pilot Study

Groundbreaking Pilot Study Provides Preliminary Evidence of Safety and Effectiveness of Innovative Pelvic Floor Dilator in Reducing Childbirth-Related Injuries in First-time Moms

Materna Medical, Inc., a leading innovator in women's pelvic health solutions, announces the publication of encouraging clinical results in the article “Effect of an intrapartum pelvic dilator device on levator ani muscle avulsion during primiparous vaginal delivery: A pilot randomized controlled trial” in the August Issue of the International Urogynecology Journal.

The publication reports that the use of a pelvic floor dilator (Materna’s Prep Device) reduced pelvic floor muscle injury during vaginal delivery in first-time moms. The injury of interest is called a “full levator ani muscle (LAM) avulsion,” or “LAM injury,” which is when a group of pelvic floor muscles fully detaches from the pelvic bone. By effectively preparing the pelvic floor muscles to better withstand the strain of childbirth, the Materna Prep Device led to a substantial reduction in LAM injury.

“The current standard of care is to allow the pelvic floor muscles to stretch suddenly as the baby’s head passes through the birth canal, which leads to a full LAM avulsion about 15% of the time,” said urogynecologist and EASE lead investigator Helai Hesham, MD, Columbia University Irving Medical Center, NY. “Because these muscles hold the uterus, bladder, and rectum, in place when these muscles are injured, the patient can experience significant symptoms of sexual, urinary, or fecal dysfunction.”

Patients were randomized 1:1 to receive either 1) a slow dilation of the pelvic floor muscles with the Materna Prep Device over approximately one hour during the first stage of labor or 2) standard care with no intervention.

Full LAM avulsions were diagnosed by transperineal ultrasound at three months postpartum by an independent panel of expert urogynecologists. A total of 110 first-time moms completed the study and had their ultrasounds reviewed (46 from the Materna Prep Device subject group and 64 from the Standard of Care control subject group). Remarkably, no full LAM avulsions 0.0% occurred in the Materna Prep Device group, while the Standard of Care group experienced a full LAM avulsion rate of 10.9%.

“Right now, there is no proven way to prevent this injury to the pelvic floor. We are hoping that by slowly pre-stretching the pelvic floor muscles before the start of pushing the baby out, we can significantly reduce the injuries that can lead to pelvic organ prolapse,” said maternal-fetal medicine specialist and EASE investigator Dr. Kara Rood. “The Materna Prep Device is the first device aiming to prevent pelvic muscle injury, so we’re excited to be publishing these results.”

Based on these pilot study outcomes, the pivotal trial is currently enrolling patients to support a marketing submission to the FDA. Learn more at www.easestudy.org.

For more information on Materna Medical, visit MaternaMedical.com.

About Materna Medical

Materna Medical is a novel OBGYN platform company defining a $6B 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 was launched as a wellness trainer, and in 2021, it received FDA clearance as a prescription device. In 2023, it received FDA clearance to sell over the counter, enabling streamlined access to people suffering from vaginismus. Milli outcomes are being studied in a post-market prospective virtual study named POMPOM.

Materna’s second product, Materna Prep, is an investigational device used during labor and is intended to prevent pelvic floor muscle injury during vaginal delivery. 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.

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