A device that says: not yet, little one.
Inside a lab in Mountain View, California, Amelia Degenkolb is working on a problem most people never hear named until it happens to them. Preterm premature rupture of membranes - PPROM - is when the amniotic sac breaks far too early and the clock starts ticking against a pregnancy that was supposed to have months left to run. There has been, in Degenkolb's words, no evidence-supported device to restore that lost fluid. Her company, Novocuff, is building one.
The Novocuff Cervical Control System is designed to stabilize and gently close the cervix, retain amniotic fluid, and hold cervical length so that a fragile pregnancy can keep going. The aim is plain and enormous at once: fewer babies born too soon, in a world where prematurity is the leading cause of infant mortality. As CEO and co-founder, Degenkolb runs the business, the fundraising, and the long march through FDA clearance, while co-founder Donald Lee, the company's technical lead, drives the device design alongside her.
In July 2024 the work got a serious tailwind. Novocuff raised an oversubscribed $26 million Series A, led by AXA IM Alts with a $14 million check, joined by the Laerdal Million Lives Fund, Laborie, RH Capital, Avestria Ventures, and March of Dimes. The money points at one thing: a U.S. multi-center pivotal trial, the RETAIN study, to prove the device can safely buy a pregnancy more time.
It started with a goat.
Before the cap table and the clinical sites, there was a snowstorm in the mountains of southern France. Degenkolb was there learning to make cheese when a pregnant goat escaped into the cold. She found the animal in active labor and helped deliver the kid. The moment lodged in her.
"The delivery was so impactful - it was intense and beautiful at the same time," she has said. "There were so many different aspects to it and it spurred me to start researching the entire process of labor. Ultimately, that's what propelled me back into pursuing a career in engineering." A goat in a blizzard is an unlikely on-ramp to maternal-health medtech. It is also, she would tell you, exactly the point: impact rarely announces itself in a boardroom.
Degenkolb is a Berkeley, California native who first went to the University of Massachusetts, Amherst, then transferred to UC Berkeley on a water polo scholarship, playing Division 1 while studying interdisciplinary subjects with an emphasis on ethics in engineering. She finished with a master's in biomedical engineering from Cal Poly San Luis Obispo in 2012.
Seven years learning to change a standard of care.
Degenkolb spent roughly seven years as the first employee and lead engineer at Alydia Health (formerly InPress Technologies), where she helped develop the Jada System, a device for treating postpartum hemorrhage - one of the most dangerous and time-sensitive events in childbirth. She was, by every account, in the room where the standard of care actually shifted.
That apprenticeship paid off in a way few do: Alydia Health was acquired by Organon for $240 million. The experience also taught her a lesson she now repeats like a thesis statement. "I realized that innovation wasn't just about the novelty of invention," she has said, "it was about assessing the potential impact of those innovations." So she went looking for the place where the impact was largest and the attention smallest.
A former colleague, an invitation, a yes on the spot.
When Donald Lee had a concept for a preterm-labor prevention device but wasn't sure how to bring it to market, he reached out to a former colleague he figured might finally be free - Degenkolb, fresh off the Alydia acquisition. He invited her for coffee. She committed to the venture almost immediately. Two engineers, one whiteboard, and a problem big enough to organize a life around.
The division of labor settled quickly. Lee leads the technical design as CTO; Degenkolb steers the company - business relations, fundraising, and the regulatory gauntlet - while collaborating with him on device design and the commercialization path. Along the way she has picked up a habit of asking physicians for input early, convinced that the nuances of a pregnancy-related study can make or break both the device and the trial behind it.
Where the conviction shows up.
Backers: AXA IM Alts · Laerdal Million Lives Fund · Laborie · RH Capital · Avestria Ventures · March of Dimes
A short ledger of momentum.
The quiet emergency most people never hear named.
Preterm premature rupture of membranes and cervical shortening sit among the leading triggers of preterm birth, which is itself the leading cause of infant mortality globally. When the membranes rupture early, amniotic fluid drains away, and the protective environment a developing baby depends on starts to collapse. For decades the standard response has leaned on antibiotics and watchful waiting, because, as the clinicians studying Novocuff's device put it, there has been no evidence-supported strategy or device to actually restore that fluid.
Novocuff's answer is mechanical and deceptively simple in concept: a device that stabilizes and closes the cervix, holds cervical length, and helps retain amniotic fluid so a pregnancy can continue. The hard part is not the idea - it is proving, with the rigor regulators demand, that the approach is safe and effective for mother, fetus, and newborn all at once. That is the work the Series A is funding, and it is the reason Degenkolb talks about early physician input as non-negotiable rather than nice-to-have.
Building the bench, then the evidence.
A device is only as good as the team and the trial behind it. As the Series A closed, Novocuff added depth in the places that matter for a clinical-stage medtech company, bringing on Kathryn Wine as VP of Clinical Affairs and Marissa VanDeVeer as a clinical engineer. The plan attached to the money is concrete: launch a U.S. multi-center pivotal clinical trial, the RETAIN study, designed to evaluate the device for treating PPROM by comparing the device plus standard care against antibiotics alone.
The trial is being shaped with academic clinical leadership - Dr. Lisa Zuckerwise serves as a national co-principal investigator and site principal investigator at the University of Virginia - and is structured for geographic diversity across U.S. sites, with translated materials so that non-English speakers are not left out of the study. It moves forward pending FDA approval under an Investigational Device Exemption. For Degenkolb, who once helped shift the standard of care for postpartum hemorrhage, the symmetry is hard to miss: another time-critical moment in childbirth, another attempt to give clinicians a tool they currently do not have.
A maker who picked the hardest room in medicine.
Degenkolb calls herself a maker at heart, and the resume reads like one: a competitive athlete who builds with her hands, who once prototyped with almost nothing, who keeps choosing maternal and fetal health precisely because it has been under-built for so long. Women's health innovation, she insists, both can and should be pursued - and she has spent more than a decade proving the sentence with devices rather than slogans.
The next chapter is the hardest yet: carrying the Cervical Control System through a multi-center pivotal trial toward FDA review, in a category where the evidence has to be airtight because the patients are two at once. If it works, the payoff is measured in the most precious currency there is - days and weeks of gestation that a baby gets to keep. That is the wager. Degenkolb, by now, is used to long odds and unlikely beginnings.