Today we’re pleased to announce that our groundbreaking neurosurgical device research has been recognized with a $5.4 million Congressionally Directed Medical Research Programs (CDMRP) grant. This grant catapults our efforts to redesign the implantable medical devices used to treat hydrocephalus, including acute hydrocephalus often sustained by soldiers in combat as a result of a Traumatic Brain Injury (TBI), pediatric hydrocephalus, and hydrocephalus in seniors, which is often diagnosed as dementia.
“Hydrocephalus impacts people of all ages, but especially infant children, where life-saving surgical treatments often fail within months, requiring repeated invasive brain surgeries. This is unacceptable. This grant accelerates our commercialization of a new standard of care.”
Lora Allemeier
Chief Executive Officer, Cerulean Scientific
Building on our mission to reinvent the most commonly used and prone-to-fail implantable medical devices, hydrocephalus shunts are a rich target. The $5.4M will fund groundbreaking studies that began at Washington University and will now continue at Cerulean Scientific and Virginia Commonwealth University, with the goal of advancing this technology to 510(k) clearance by the U.S. Food and Drug Administration (FDA).
Hydrocephalus impacts millions of people worldwide, including many undiagnosed cases in veterans and misdiagnosed cases in seniors
- Often diagnosed in infants, hydrocephalus is caused by an increased cerebrospinal fluid (CSF) in the brain, increasing pressure that squeezes the brain against the skull. Untreated, it leads to comas or death.
- Within the military community, experts believe that two-thirds of our current and former military service members are suffering from moderate to severe TBI and are at risk of developing hydrocephalus – more than 24,000 potential cases.¹
- Hydrocephalus also affects seniors: 700,000 older Americans are estimated to have developed hydrocephalus, which is often undiagnosed or misdiagnosed as Alzheimer’s, Parkinson’s, or another related dementia.²
Hydrocephalus surgical treatments fail too often, from underlying causes we have the potential to prevent
Across many healthcare categories, implantable medical device failure is ubiquitous. When implantable medical devices fail, patients suffer, and healthcare costs balloon. This is especially true in the treatment of hydrocephalus where the standard of care involves treatment with an implanted brain shunt, which fail at an astonishing rate with each device failure requires additional brain surgery, compounding cost, suffering, and risk – including the risk of cognitive impairment.
- 40% fail within one year
- 98% fail within 10 years³
“Shunt occlusion has potentially devastating neurologic consequence to the afflicted patient, and is a massive challenge in the long-term care of patients suffering from hydrocephalus. The promising data around Cerulean Scientific’s approach opens an avenue for dramatically improving the lives of patients with hydrocephalus.”
Dr. Patrick Codd
Neurosurgeon, Duke University
About Cerulean Scientific
Cerulean Scientific is a medical device company developing and commercializing a new category of implantable medical devices that resist the leading causes of device failure: Blood clotting, obstruction and infection. Founded in 2016 and working from Duke University’s life sciences entrepreneurship hub, our team boasts 100 years of combined experience developing and commercializing medical devices. Our durable, omniphobic Cerulean Surface Technology™ was inspired by the pitcher plant and originated at Harvard’s Wyss Institute for biologically-inspired engineering.
About the Grant
This work was supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $5,386,587, through the Peer Reviewed Medical Research Program under Award Number HT9425-24-1-0461. Opinions, interpretations, conclusions, and recommendations contained herein are those of the author(s) and are not necessarily endorsed by the Department of Defense.
