Novocuff, Inc., a clinical-stage, maternal health medical device company, today announced approval from the U.S. Food and Drug Administration of its Investigational Device Exemption (IDE) application for the RETAIN Study. The study is a randomised, multicenter, pivotal trial evaluating the Novocuff Cervical Control System (CCS).
The RETAIN study evaluates the safety and effectiveness of the Novocuff CCS, a medical device intended to retain amniotic fluid and extend gestation in singleton pregnancies complicated by preterm prelabor rupture of membranes (PPROM) as early as 24 weeks. The trial will be conducted at leading research hospitals across the U.S., enrolling up to 272 participants.
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Dr. Lisa Zuckerwise, Maternal Fetal Medicine (MFM) Specialist and Associate Professor, Department of OB/GYN, and Division Director of the MFM Program at the University of Virginia School of Medicine, and Dr. Dwight Rouse, MFM Specialist at Women’s & Infants Hospital of Rhode Island and faculty at the Warren Alpert Medical School at Brown University, are the Co-Principal Investigators for RETAIN. Dr. Zuckerwise explained, “RETAIN is an essential evaluation of a potential new treatment option for patients with PPROM, and I look forward to getting this important research underway.”
PPROM, defined as prelabor rupture of the amniotic sac before 37 weeks gestation, affects 3-4% of pregnancies in the U.S. and accounts for nearly one-third of preterm births. It carries high risks for mothers and babies, including infection and many short and long-term complications of prematurity. Current treatment for PPROM includes antibiotics, corticosteroids, magnesium sulfate as appropriate, and inpatient monitoring. No treatment options for PPROM are intended to retain amniotic fluid. Participants allocated to the Novocuff CCS group will receive standard treatment in addition to the device.
Additional therapies for PPROM are urgently needed. Dr. Rouse stated, “This approval marks a significant milestone in evaluating a potential new option for a condition where historically there has been a dearth of innovation.”
“IDE approval represents a foundational step toward our mission to improve outcomes for mothers and babies,” said Amelia Degenkolb, CEO of Novocuff. “We are committed to generating high-quality clinical evidence to evaluate the potential of this therapy to redefine the standard of care.”
