For years, providers have had few treatment options for pregnant women experiencing preterm prelabor rupture of membranes (PPROM) or cervical shortening—two conditions that lead to preterm birth. Babies born prematurely often require intensive medical care and may face lifelong developmental and health complications.
“PPROM—when the amniotic sac breaks and leaks before 37 weeks—presents one of the most challenging scenarios we face in practice,” said Lisa Zuckerwise, MD, an associate professor in the Department of Obstetrics and Gynecology and division director of the Maternal-Fetal Medicine (MFM) at the University of Virginia School of Medicine. “Families are often devastated to learn that there are no interventions to retain amniotic fluid and that our best current interventions are antibiotics shown to lengthen latency time to delivery, and steroid administration to promote fetal maturity.”
Cervical shortening, often identified in the second or early third trimester of an ongoing pregnancy, can result in PPROM, pregnancy loss, or spontaneous preterm birth. Current management options for cervical shortening are limited and can include progesterone supplementation, surgical treatment, and close monitoring.
Novocuff, a clinical-stage medical device startup at Fogarty Innovation, is working to create better treatment options. The company has developed the Novocuff Cervical Control System™ (CCS), which is designed to support the cervix, retain amniotic fluid in patients with PPROM, and help maintain cervical length in patients with cervical shortening—with the goal of prolonging pregnancy and reducing the degree of prematurity.
Inspired by experience
The inspiration for both the device and the company came from COO Donald Lee, a biomedical engineer who experienced the fear and helplessness of pregnancy complications firsthand. Seven years ago, when his wife was pregnant with their twin daughters, a routine ultrasound at 21 weeks diagnosed a shortened cervix. She was hospitalized and delivered at just 24 weeks—four months early. The girls spent their first five months in the neonatal intensive care unit (NICU). Today, the family is thriving, but Lee knows they were lucky.
The formative experience left Lee determined to find better options for families facing similar complications. During the twins’ long NICU stay, he immersed himself in the research and began thinking about what better treatment options could look like. He envisioned an adjustable silicone device that could be inserted vaginally to support the cervix while adapting to physiologic changes during pregnancy. As the prototype came together, he brought in Amy Degenkolb, a friend and associate who had led the engineering and clinical feasibility work for Alydia Health’s JADA System for postpartum hemorrhage. Together, they founded Novocuff.
The RETAIN Study
In late 2025, Novocuff received approval from the FDA to launch the RETAIN Study, a randomized, controlled pivotal trial evaluating the safety and effectiveness of the Novocuff CCS in pregnant patients with PPROM. The study is currently enrolling participants across the U.S., including at its two primary sites: Women & Infants Hospital of Rhode Island led by maternal-fetal medicine specialist Dwight Rouse, MD, and the University of Virginia, led by Lisa Zuckerwise, MD.
Kathryn Wine, Novocuff’s VP of Clinical Affairs and a former colleague of Degenkolb’s from Alydia who led the clinical development of the JADA system, now leads the design and execution of the RETAIN Study. “I was so excited when Amy called with the opportunity to return to women’s health and work with a small, passionate study team,” she said. “And then I met Donald and felt so much warmth. His founder’s story is incredibly motivational and emotional. I was thrilled to join the team.”
A self-described “people person,” Wine’s superpowers include listening, relationship-building, and supporting and inspiring study teams. She recognizes the profound responsibilities of a trial that involves two human beings for every enrollment, and utilizes a high-touch approach to balance rigorous data collection, the needs of the women and families dealing with complicated pregnancies, and the time constraints of physicians, research nurses, managers, and study coordinators who are already shouldering the responsibility of patient care.
Empowering pregnant patients with information
As the Novocuff team trains the research teams at each site, the human side of the trial is always top of mind. “We talk with our sites about a respectful approach in terms of how and when they speak with patients about the option of participating in the study, and making sure they understand the potential risks, the potential for benefit, and the aims of a randomized trial,” she said. “Our goal is to empower these soon-to-be moms with information about all their options.”
Patient safety is central to the RETAIN Study design, and the trial includes multiple layers of oversight, including independent safety monitoring. Most notably, participants are hospitalized throughout study participation and continue receiving care from their obstetricians, maternal-fetal medicine specialists, neonatologists, and nursing teams.
A team approach
With ten sites approved for the first stage of the study, Wine feels fortunate to have the support of the entire Novocuff team. “We’re a startup in a clinical stage, which means that no matter what your title is, you’re working on the clinical team,” she chuckles. “Thankfully, everyone is willing to do whatever is needed and we all really enjoy working together.”
While Wine works most directly with senior director of clinical affairs Vaishali Suraj and director of marketing Lisa Tehrani (both former colleagues from Alydia), she receives support from team members across the organization. These include clinical engineer Marissa VanDeVeer; founder and CEO Amy Degenkolb, who frequently visits sites and helps train physicians; co-founder Donald Lee, who supports study operations behind the scenes; and regulatory affairs leader Cindy Domecus and quality leader Rich Ferrick, who help guide regulatory and quality activities.
“We also have two neonatologists and an OB/Gyn supporting us as medical advisors. We couldn’t do this without their review and input on medical questions and background,” Wine said.
Trust and respect
It also helps that finding and activating qualified study sites has been easier than expected – in part because the Novocuff team’s reputation precedes them. “I hear repeatedly that the trust this team has built in women’s health through the work we’ve produced is deeply valued, and it’s an honor to feel that warm reception. There is enthusiasm among MFM and NICU clinicians because they see this as a potential option for treating the actual event of PPROM (loss of fluid) rather than simply managing through it with antibiotics and steroids,” Wine said.
While participation in the trial requires additional time and effort, Wine believes providers are motivated by the limitations of existing treatments. “They want better answers for their patients and are willing to invest time in research that could move the field forward,” she said.
“I am so fortunate to have the opportunity to learn from people who are leading the country in providing care for women with very high-risk pregnancies, and ultimately, for their newborns as well,” she continued. “The respect we see, not only for these patients, but also for the extended families in these scenarios, is amazing.”
For Wine, the work is deeply personal. “I feel like I’m honoring both my daughter and my mother through this effort,” she said. “I know everyone at Novocuff is personally invested in this work. That sense of purpose is present in everything we do.”