- Neurosurgical applications including hydrocephalus shunts
- Vascular access devices including hemodialysis catheters and vascular grafts
Cerulean Scientific is using our thin layer perfluorocarbon technology to develop medical devices that resist clotting, obstruction and infection: three reasons implantable medical devices ubiquitously fail.
Ten percent of Americans have an implanted medical device. However, these life-saving devices are plagued by complications and frequently fail. Thrombosis/clotting is the leading cause of failure for blood-contacting medical devices, and obstruction/blockage is the leading cause of failure for neurological shunts and catheters. In addition, more than 50% of the 2 million healthcare-associated infections in the US annually can be attributed to implantable medical devices.
These problems often force a patient to undergo additional surgeries to remove and replace the compromised device and can cause fatal problems like sepsis or lack of blood flow. Surgical revisions and ensuing complications are also incredibly expensive: treatment of hydrocephalus, which causes fluid buildup in the brain in both children and seniors, costs billions per year to treat in the US alone.
Wyss researchers created a super-repellent, Thin Layer Perfluorocarbon (TLP) coating specifically designed to prevent clots and biofilms from forming on medical devices. The coating consists of a chemically inert perfluorocarbon material that is already approved by the Food and Drug Administration (FDA) for many medical applications.
They also developed a simple, two-step process that can attach the coating to materials ranging from plastic to glass and metal. When applied to catheters and perfusion tubing, TLP repels all blood components and bacteria that can lead to infectious biofilms. In studies in pigs, the TLP coating kept an arteriovenous (AV) shunt in direct contact with blood clear of blockages for 8 hours, even in the absence of the commonly administered anti-coagulant heparin.
The TLP coating significantly reduced the risk of bloodstream infections as well. TLP surfaces remain stable under clinically relevant shear stresses – or rates of blood flow seen in catheters, central lines and dialysis machines – and can be stably stored for more than a year in normal temperature and humidity conditions.
TLP was born from a collaboration between Wyss Core Faculty members Joanna Aizenberg and Don Ingber. Aizenberg’s lab had created bioinspired SLIPS surfaces, which emulate the physics of the super-slippery lip of the pitcher plant, to create surfaces that repel nearly any substance. To maximize its utility, her team iterated on the original material to create a version made of FDA-approved substances to speed its journey to the market for medical applications. To help ensure that it could be easily applied to the various materials that make up medical devices, a team from Ingber’s lab jumped in to help create a simple manufacturing process.
In June of 2016, Cerulean Scientific licensed exclusive use of TLP in medical devices after reading initial results published in Nature Biotechnology.
Cerulean Scientific is developing and commercializing infection-, obstruction-, and clotting- resistant implantable medical devices. Cerulean has received over $6.4 million in National Institutes of Health grants to advance their medical devices toward clinical trials and have also secured an agreement with a Fortune 200 medical device company. Cerulean is prioritizing the development of devices for applications with high failure rates, dire complications, and burgeoning healthcare costs, and where patient numbers are growing.
The first product applications they are pursuing target the standard of care hydrocephalus shunt and vascular access for End Stage Renal Diseases (ESRD), including hemodialysis catheters and vascular grafts where a vascular catheter is used for hemodialysis treatment. Where device failure is ubiquitous, Cerulean devices will resist clotting, obstruction and infection, requiring fewer surgeries, reducing patient suffering, and lowering treatment costs. CEO Lora Allemeier presented Cerulean Scientific at the RESI Conference at JPM in January 2024.
The company has completed four large animal studies and aims to launch its first product in 2025.
*The banner image is a Scanning Electron Microscope (SEM) image showing how red blood cells coagulate to form a blood clot, which is a common and life-threatening risk associated with the use of implanted medical devices. Credit: Wyss Institute at Harvard University.