In 2019, Donald Lee and his wife were expecting their twins when his wife went into labor four months early. Born at just 24 weeks, their daughters spent five months in the NICU, a period marked by fear, uncertainty, and sleepless nights. This experience required deep resilience as a family. The Lees were told that nothing more could have been done to prevent the premature birth of their twins. Unsettled by the lack of treatment options available to his wife, Donald resolved to develop a solution to help other families. What started as a deeply personal event sparked the idea that evolved into the Novocuff Cervical Control System™.

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In 2021, Donald reached out to Amy Degenkolb, a fellow Cal Poly San Luis Obispo engineering alumni with extensive experience in maternal health technology. The two met to discuss the idea and were inspired by their shared commitment to improve outcomes associated with high-risk pregnancy. By the end of their conversation, Novocuff was born.

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Over the next few years, Amy and Donald consulted with clinicians, refined the device design, and developed the business plan. They built early clinical units and conducted two first-in-human feasibility studies in Panama that evaluated the device in participants with PPROM and cervical shortening. After securing Series A funding and joining Fogarty Innovation as a Company-in-Residence, the team expanded and designed its US pivotal clinical trial, enrolling pregnant patients with PPROM. The RETAIN Study received Investigational Device Exemption (IDE) approval from the FDA and opened in 2025 in collaboration with Maternal-Fetal Medicine leadership and acclaimed research institutions across the United States.

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Today, Donald’s twins are growing and thriving. Similarly, Novocuff has grown into a passionate, committed team dedicated to working with its research partners. Together, they are driving the mission forward to advance medical technology and improve outcomes for moms and babies.