Materna Medical Activates All US EASE Prep Pivotal Clinical Trial Sites
High-level study director supervising clinical research on new devices in OBGYN
MOUNTAIN VIEW, Calif. /ACCESSWIRE/March 31, 2022 / Materna Medical, an OBGYN platform company dedicated to protecting women’s pelvic health, announced the completion of activation of the fifteenth US clinical study site participating in the pivotal EASE trial. This clinical study is evaluating the safety and effectiveness of the Prep device and will determine whether use of the device can reduce pelvic floor damage in first-time mothers during labor and delivery.
A pilot study was published in the International Journal of Urogynecology by Dr. Francisco Orejuela and Baylor College of Medicine. In this study of 36 nulliparous women, there was a 60% reduction in pelvic floor muscle damage in the appliance group (n=27), compared to participants in the control group.
Pelvic floor disorders such as prolapse and incontinence are linked to pelvic muscle damage sustained during childbirth.1 Up to 25% of women will suffer from pelvic floor disorders such as prolapse or incontinence2 and are at least 9 times more likely to experience these symptoms if they delivered a baby vaginally.3
The EASE trial expanded on the successful funding in 2021 of a $10 million Series A2, led by Wavemaker 360 Health, a healthcare venture capital fund. The trial was initially funded by a $2.2 million grant from the NIH, including biomechanical analyzes from Dr. James Ashton-Miller and Dr. John Delancey’s Pelvic Floor Research Group at the University of Michigan. .
Most of the fifteen clinical study sites include principal investigators who are members of the Society of Maternal Fetal Medicine, and some have co-principal investigators in urogynaecology. “The leaders of SMFM bring an incredible level of quality and insight to clinical research in labor and delivery, and the EASE Trial is thrilled to share this journey of innovation with the leaders of these preeminent hospitals,” said commented Tracy MacNeal, President and CEO of Materna Medical. “The urogynecology community has also joined in this study in an exciting way, bringing together two important areas of clinical leadership in the EASE trial.”
The EASE trial is led by Dr. Ronald Wapner, a maternal-fetal medicine physician, director of reproductive genetics at Columbia University and chair of the Perinatal Research Consortium. Other study leaders are Dr. Francisco Orejuela, associate professor of OBGYN and urogynecology at Baylor College of Medicine and Dr. Helai Hesham, associate professor of obstetrics and gynecology, female pelvic medicine and reconstructive surgery. , urogynecology.
Dr. Ron Wapner commented that “The EASE trial shows the importance of the obstetric community working with urogynaecologists to study and hopefully improve the impact of childbirth on women’s long-term health. “.
The EASE trial is an intersection of two important disciplines in the field of women’s health: obstetrics and urogynecology. While urogynecologists are typically the clinicians who treat women after sustaining pelvic floor injuries during childbirth, the Materna device procedure takes place in obstetrics during labor and delivery.
Dr. Helai Hesham remarked, “The EASE trial reflects the vital relationship that exists between obstetrics and urogynaecology in the area of women’s health. The pelvic floor has always bound us as clinicians, but we are entering a new era where pelvic innovation and research aimed at improving the lives of women enriches us and the lives of our patients.
Dr. Francisco Orejuela noted: “The EASE trial offers a unique opportunity to study an innovative strategy for the reduction of pelvic floor injuries at the time of vaginal delivery, and its negative consequences on the quality of life of women at the future.
1 Bortolini MA, Drutz HP, Lovatsis D, Alarab M. Vaginal birth and pelvic floor dysfunction: current evidence and implications for future research. International journal of urogynecology. 2010 (8):1025-30.
2 Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in American women. JAMA. 2008;300(11):1311-1316.
3 Quiroz LH, Muñoz A, Shippey SH, Gutman RE, Handa VL. Vaginal parity and pelvic organ prolapse. The Journal of Reproductive Medicine. 2010 Mar;55(3-4):93.
About Materna Medical:
Materna Medical is a new OBGYN platform company that defines a significant market in the most common pelvic conditions that women face. Materna developed its proprietary pelvic floor technologies through Stanford University’s Biodesign program and continues as a company-in-residence at Fogarty Innovation in Silicon Valley. Materna’s first product, Milli, received 510(k) clearance in December 2021 to help relieve symptoms of vaginismus and associated dyspareunia (painful intercourse). Materna’s pipeline product, Prep, is an investigational device aimed at reducing pelvic floor injury during childbirth.
For more information about Materna Medical, visit maternamedical.com.
For more information about the Materna Prep clinical trial, visit maternaprep.com.
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