XaTek said this week that it has received breakthrough device designation from the FDA for ClotChip, a portable blood-clotting sensor it is developing.
ClotChip is designed to measure a patient’s bleeding risk profile at bedside from a single drop of blood obtained from a fingerstick, much like a glucometer measures a patient’s blood-glucose level. It uses an electrical technique called miniaturized dielectric spectroscopy, which applies an external electric field to the blood drop, then quantitatively measures the impedance within the biologic fluid.
The measurements produced directly correlate to the coagulability or the ability of the blood to clot, which can then be translated into a recognizable measured scale. ClotChip also provides qualitative feedback as to the quality and firmness of the forming blood clot, according to the Cleveland-based company’s website. Such immediate notice can be a critical step in saving the life of someone who may otherwise die from excessive bleeding or clotting, the company said.
A handheld device enabled for WiFi and Bluetooth, ClotChip uses technology conceived nearly 10 years ago by electrical engineers at Case Western Reserve University. In 2016, the university’s technology transfer office granted an exclusive license to XaTek to develop the technology for commercial use.
“I’m tremendously proud of the entire XaTek team and their remarkable efforts, which lead the FDA to believe ClotChip indeed satisfies all of the criteria for Breakthrough Devices Designation for the proposed indication for use,” said XaTek co-founder and CEO John Zak in a news release. “Once commercially available, this device will fulfill a critical and unmet clinical need for the newer generation of drug therapies known as ‘direct oral anti-coagulants,’ for which there is no point-of-care test available today.”
XaTek said it intends to pursue additional indications for use in the near future, potentially including patients on other anti-coagulant therapies, those with hemophilia and other rare bleeding conditions and those with trauma-related indications.