IDE Approval Awarded to Novocuff for RETAIN Study

Novocuff Inc. has earned U.S. Food and Drug Administration Investigational Device Exemption (IDE) approval for the RETAIN study, a randomized, multi-center, pivotal trial evaluating the Novocuff Cervical Control System (CCS).

“IDE approval represents a foundational step toward our mission to improve outcomes for mothers and babies,” Novocuff CEO Amelia Degenkolb commented.. “We are committed to generating high-quality clinical evidence to evaluate the potential of this therapy to redefine the standard of care.”

The RETAIN study is evaluating the safety and efficacy 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 enroll up to 272 participants at U.S. research hospitals.

Dr. Lisa Zuckerwise, Maternal Fetal Medicine (MFM) specialist and associate professor in the 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 study’s co-principal investigators. “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,” Dr. Zuckerwise said.

Defined as prelabor rupture of the amniotic sac before 37 weeks gestation, PPROM affects 3% to 4% of U.S. pregnancies 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. “This approval marks a significant milestone in evaluating a potential new option for a condition where historically there has been a dearth of innovation,” Dr. Rouse stated.

Novocuff Inc., a privately held medical device company in residence at Fogarty Innovation, is pioneering an innovative treatment option for PPROM.