Materna Medical Launches New Clinical Study for First-Time Moms
Materna Medical (Materna), a MedTech company developing products to help protect women's pelvic health, announced today they have formally initiated a pivotal study for their Materna Prep device. The National Institutes of Health (NIH) funded pivotal study will enroll around 200 patients over 24-months and is intended to support a De Novo application to the U.S. FDA for marketing authorization.
"Materna Prep's first study had extremely encouraging results in 30 patients, where there was a 60% reduction in pelvic floor damage as compared to participants who didn't use a Materna Prep device," said Materna's founder Mark Juravic.
Materna Prep is an investigational medical device being used in a study to evaluate if first-time moms sustain fewer childbirth injuries, which are linked to pelvic floor disorders such as incontinence and prolapse (pelvic organs falling out of place) later in life.
"Women who deliver vaginally are up to nine times more likely to require surgery for prolapse compared to women who deliver exclusively by cesarean section. Injuries to the pelvic floor muscles that occur during vaginal delivery may play an important role in future pelvic floor disorders and we are investigating if the use of the Materna Prep device could help prevent these injuries," commented Dr. Francisco Orejuela, a urogynecologist at Texas Children's Pavilion for Women, associate professor of obstetrics and gynecology at Baylor College of Medicine, and primary investigator for Materna Prep's study.
This study is funded by a $2.2M grant from the NIH. The study includes biomechanical analyses research from Dr. James Ashton-Miller and Dr. John Delancey's Pelvic Floor Research Group at the University of Michigan, and ultrasound imaging research support from Dr. Hans Peter Dietz at the University of Sydney in Australia. These clinicians are some of the most respected thought leaders in Obstetrics and Urogynecology and are credited with discovering the links between childbirth-related injuries and pelvic floor disorders.
According to the doctor's Delancey and Ashton-Miller, "We are excited to see the results from Materna's study. The data collected during this study will offer us new clinically important insights into the biomechanics of childbirth. According to our models of childbirth, we believe the Materna Prep device may shorten the time spent in labor and help prevent birth-related injuries."
Baylor College of Medicine in Houston, Texas will be the leading institution for the study and enroll first-time mothers at Texas Children's Pavilion for Women.
"We believe that these childbirth injuries may be preventable for first-time moms, and we are thrilled to have the support of the NIH as well as the support of the top OB/GYN's in the world," commented Materna Medical's CEO, Tracy MacNeal.
About Materna Medical:
Materna Medical (Materna) is a medical device company that develops products to help improve women's sexual and pelvic health. Materna empowers women to be safe, healthy and heard™. Created from the BioDesign Program at Stanford University, Materna is a start-up-in-residence of the Fogarty Institute for Innovation in Mountain View, CA.
For more information on Materna Medical, visit maternamedical.com.
For more information on Materna Prep's clinical trial, visit maternaprep.com.
About National Institutes of Health:
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation's medical research agency - making important discoveries that improve health and save lives. Thanks in large part to NIH-funded medical research, Americans today are living longer and healthier. Life expectancy in the United States has jumped from 47 years in 1900 to 78 years as reported in 2009, and disability in people over age 65 has dropped dramatically in the past 3 decades. In recent years, nationwide rates of new diagnoses and deaths from all cancers combined have fallen significantly.
For more information about NIH, visit www.nih.gov.
About Baylor College of Medicine
Baylor College of Medicine in Houston is recognized as health sciences university and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 4th for primary care by U.S. News & World Report. Baylor is listed 20th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. The Baylor pediatrics program ranked 8th among all pediatric programs, reflecting the strong affiliation with Texas Children's Hospital where our faculty care for pediatric patients and our students and residents train. Nationally our physician assistant program was ranked 3rd in the health disciplines category and our nurse anesthesia program ranked 2nd. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke's Medical Center, part of CHI St. Luke's Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and genetic counseling as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook and Twitter.
About University of Michigan
Considered one of the foremost research universities in the United States with annual research expenditures approaching $1.5 billion, Michigan is classified among "R1: Doctoral Universities - Very high research activity". It is recognized as the most collaborative research environment in the United States and there is a strong history of collaboration between the schools of Engineering and Medicine. Its comprehensive graduate program offers doctoral degrees in the humanities, social sciences, and science, technology, engineering, and mathematics as well as professional degrees in architecture, business, medicine, law, pharmacy, nursing, social work, public health, and dentistry. A broad variety of schools and disciplines including all of the departments and programs in the College of Engineering are nationally ranked in the top 10. Michigan Medicine has a long history of excellence with 14 adult and 10 pediatric specialties nationally ranked.