Materna Medical’s Pelvic Floor Dilator is Validated in Pilot Study

Materna Medical Inc.’s pelvic dilator device can substantially reduce LAM (levator ani muscle) injury, according to pilot study data. Results are detailed in an International Urogynecology Journal article.
 
The study showed 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, study data indicate.
 
“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, M.D., Columbia University Irving Medical Center, N.Y. “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 one to one to receive either a slow dilation of the pelvic floor muscles with the Materna Prep Device over approximately one hour during the first stage of labor, standard care with no intervention.

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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 occurred in the Materna Prep Device group, while the standard of care group experienced a 10.9% full LAM avulsion rate.
 
“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, Materna Medical is currently enrolling pivotal trial patients to support a U.S. Food and Drug Administration (FDA) marketing submission.
 
Materna Medical is an OBGYN platform company defining a $6 billion market with core technologies addressing unmet needs in women’s pelvic health. With headquarters in Mountain View, Calif., Materna’s 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.