Novocuff, Inc., a women’s health startup led by CEO Amy Degenkolb and COO Donald Lee, has joined Fogarty Innovation to advance a device intended to prevent preterm birth and improve patient outcomes for women and their families. The company will be part of FI’s company accelerator program (CAP), a six-month stay designed to help early-stage companies make progress towards a specific goal.
For Degenkolb and Lee, Novocuff co-founders, joining FI is a bit like coming home. Degenkolb was previously the engineering lead for FI alumni company Alydia Health (Organon), and a 2023 alum of the Ferolyn Fellowship, a high impact mentoring and leadership development program that is one of FI’s educational partners. And both Degenkolb and Lee consider FI board vice chair Fred St Goar, MD, to be one of their earliest and most influential mentors.
Firsthand Experience with Premature Birth
Preterm birth (before 37 weeks) is a leading cause of infant death globally. The March of Dimes Report Card recorded more than 380,000 early births in the U.S. and Puerto Rico in 2022, prompting the organization to highlight it as a significant factor in the nation’s “crisis-level” state of infant and maternal health. The premature birth of these infants means their organs do not have sufficient time to develop fully, increasing their health risks significantly.
Lee, a biomedical engineer with an extensive background in R&D, learned about preterm birth in a very personal way. His wife was 21 weeks pregnant with twins when a routine ultrasound revealed that she had a condition called short cervix and was at a very high risk of preterm delivery. “It was so surprising and shocking to hear that this was not an uncommon condition, yet there was no effective treatment,” he said.
Short cervix accounts for roughly a third of preterm births. Treatment options for the condition have advanced little over the years and focus primarily on bedrest, keeping the head of the bed lower than the feet, and in some cases, sewing the cervix closed, which comes with a long list of risks that significantly limit its application. Lee’s wife spent three weeks on bed rest in the hospital before delivering at 24 weeks. The twins spent the next five months in the neonatal intensive care unit (NICU). Today, thankfully, they are energetic, healthy four-year olds.
During the twins’ long NICU stay, Lee began investigating the causes of short cervix and also observing how few tools OB/GYNs had to address this and other maternal health conditions. Leveraging his engineering background and deep experience in silicone manufacturing, he began prototyping an adjustable silicone device that could be inserted vaginally to apply compression to the cervix and easily adapt to physiologic changes that occur during the second and third trimesters of pregnancy.
As Lee’s idea progressed, he reached out to Degenkolb, a fellow Cal Poly classmate with extensive experience in maternal health. They had worked together earlier in their careers when Lee was an R&D engineer for a medical product silicone manufacturer and Degenkolb was leading engineering and clinical development of Alydia’s Jada System. “I knew that Amy was not only a creative and resourceful engineer and leader, but also a compassionate and courageous person ready to challenge the status quo in maternal health,” Lee said. “We share so many of the same values and I knew she would be the right partner.”
The pair began meeting after their day jobs, working late into the evening after Lee’s children went to bed to build not only a device, but what would become a thriving startup. After Lee and Degenkolb fleshed out a viable business model, they received early financial support from Alydia co-founder Nathan Bair to launch Novocuff. Fairly quickly, they outgrew their makeshift lab space in Lee’s uninsulated garage and paid a visit to FI on the advice of St. Goar. A lot had changed since Degenkolb had first been there, including a new leadership team under CEO Andrew Cleeland and a move to a state-of-the-art 30,000 square-foot facility.
“There is so much kinetic energy at FI,” said Degenkolb. “It’s a place teeming with resources, where a short, drop-by conversation can yield ideas and feedback that can have a big impact on the company. The best part is that the entire FI team, from the leadership to the talented engineers-in-residence, are there to advise and support us. They’ve all been in our shoes and can help us anticipate issues, identify gaps and improve our strategy from a technical, clinical and business perspective,” she said.
Full Speed Ahead
Currently, Novocuff is wrapping up two feasibility studies; one to treat participants with a short cervix and a second study that investigates another indication that is a major driver of preterm birth; premature prelabor rupture of membranes (PPROM). “There is no available treatment for PPROM. If the pregnancy is past 24 weeks, the patient is hospitalized, given antibiotics, and monitored at the hospital until delivery,” said Lee. “Some of the clinicians who are key opinion leaders in the field are frustrated with the lack of treatment options and thought that we might be able to use our device to stop or slow the rate of the leaking amniotic fluid.”
The company is poised to raise its Series A funding to scale manufacturing and support its pivotal trial which is set for the beginning of 2025. “We have powerful momentum plus the right experience to navigate the twists and turns that come with developing a device,” said Degenkolb. “Our next round of funding will help us accelerate our path forward. It’s incredible to see how much trust and support we have among leaders in the maternal health community whose devotion to their patients is second to none. With their encouragement and a robust device, we are ready for the next stage in our growth.”
The Right Place to Take Off
“I love the technology we’re building,” said Lee. “But what drives me on a deeper level is my family’s experience with our twins. If we can bring a treatment to market that helps prevent other families from having to go through this, then we will have done something great, with an immeasurable impact. This personal connection to the problem fuels us as we drive toward meeting our milestones. We know that an effective treatment will not only bring hope to women and families who need it but will also contribute to the body of evidence that that demonstrates how significant the opportunity for innovation is in maternal and women’s health in general.”
Both Lee and Degenkolb believe that FI is the right place to make it happen. “Everyone at FI understands what it takes to build a company that is working toward changing the standard of care in an area of medicine that has long been neglected,” said Degenkolb. “They see how critical it is that the Novocuff device reaches patients across the globe. It’s a powerful feeling to walk into a room where everyone is ready to support you and shares the same perspective— that no goal is too big if it can improve patient outcomes and quality of life.”