The US National Institutes of Health (NIH), through its BluePrint MedTech Optimizer Project Awards, has awarded a multidisciplinary team at the University of Pittsburgh an additional US$1.2million in federal funding to accelerate regulatory advancement and commercialisation of a novel, minimally invasive foetal shunt designed to treat foetal hydrocephalus, also called ‘water on the brain’.
The life-saving project is co-led by Stephen Emery, professor of obstetrics, gynaecology and reproductive sciences at Pitt’s School of Medicine and director of the Center for Innovative Foetal 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.
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‘Foetal 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 foetal shunt that will reduce intracranial pressure in utero, mitigating neurological consequences. Unlike existing postnatal shunt systems that are adapted for foetal 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 foetal intervention.
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‘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, 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, the Pitt Seed Project Award, the Richard King Mellon Foundation, and Pediatric Device Initiative Seed Funding. Together, these investments enabled iterative engineering optimisation, preclinical validation and early regulatory planning over the past ten years.
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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 commercialisation and market-entry plans.
‘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 foetal medicine,’ Chun said.