The National Institutes of Health (NIH), though its BluePrint MedTech Optimizer Project Awards, has awarded a multidisciplinary team at the University of Pittsburgh an additional $1.2 million in federal funding to accelerate regulatory advancement and commercialization of a novel, minimally invasive fetal shunt designed to treat fetal hydrocephalus, also called “water on the brain.”
The life-saving project is co-led by Stephen Emery, MD, professor of obstetrics, gynecology and reproductive sciences at Pitt’s School of Medicine and director of the Center for Innovative Fetal Intervention at UPMC Magee-Womens Hospital, and Youngjae Chun, professor of industrial engineering at the Swanson School of Engineering, with a secondary appointment in the Department of Bioengineering, and director of the Translational Medical Device Research Laboratory.
“Fetal hydrocephalus is a condition that occurs when cerebrospinal fluids build up in the brain,” Chun said. “Untreated, it can cause seizures, developmental delays, impaired vision, and even death.”
The Pitt team of researchers has designed a fetal shunt that will reduce intracranial pressure in utero, mitigating neurological consequences. Unlike existing postnatal shunt systems that are adapted for fetal use, this novel device was created specifically for the biomechanical and anatomical constraints of the intrauterine environment. It reflects an engineering-driven design strategy tailored specifically to fetal intervention.
“This award represents a new milestone in more than a decade of sustained institutional and regional support that has enabled our team to progress from early proof-of-concept to translational readiness,” added Chun.
Initial feasibility studies were supported through two grants from the Swanson School’s Center for Medical Innovation (CMI), providing critical seed funding during the earliest stages of device conception and prototyping. Subsequent development was advanced through support from Pitt’s Clinical and Translational Science Institute (CTSI), the Pitt Seed Project Award, the Richard King Mellon Foundation, and Pediatric Device Initiative Seed Funding. Together, these investments enabled iterative engineering optimization, preclinical validation, and early regulatory planning over the past ten years.
With the additional funding, the team will now advance comprehensive preclinical performance validation, execute design verification and manufacturing readiness activities, refine regulatory strategy and prepare for FDA submission, and further develop commercialization and market-entry plans.
The team continues to collaborate closely with investigators at Magee-Womens Research Institute, including Nika Hazen, NIH Project Team Lead Michael Masterman-Smith, and Paul Yoo. The team also includes Vahid Seresht Beheshti as a graduate student researcher. Additional key partners include product development collaborator Sage Product Development, Martin G. Piazza, a pediatric neurosurgeon at Children’s Hospital, UPMC, and Joseph Hanke from the McGowan Institute for Regenerative Medicine Preclinical Study Team.
“This project represents how sustained funding, interdisciplinary collaboration, and engineering-driven innovation can transform early-stage concepts into clinically deployable technologies that address critical unmet needs in fetal medicine,” Chun said.
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