Materna Medical Announces Publication of EASE Pilot Study
2024年8月7日 - 2:00AM
ビジネスワイヤ(英語)
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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Debbie Donovan Head of Commercial Operations Materna Medical,
Inc. Marketing@MaternaMed.com