Subject: FDA
XaTek's ClotChip Earns FDA's Breakthrough Device Designation
CLEVELAND, March 3, 2020 /PRNewswire/ -- XaTek Inc. today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development ClotChip, marking a significant and distinguishing step in advancing the company's life-changing portable blood-clotting sensor toward commercialization. The FDA Breakthrough Devices Program was created in 2018 to expedite the development, assessment and review of technologies that "provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions" over existing approved products.
ClotChip measures 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. Such immediate notice can be a critical step in saving the life of someone who may otherwise die from excessive bleeding or clotting.
"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 John Zak, XaTek's co-founder and CEO. "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 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.
About ClotChip
ClotChip is a handheld fully portable device enabled for WiFi and Bluetooth. The device utilizes 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. www.clotchip.com
About XaTek Inc.
XaTek Inc. is a privately held, clinical-stage diagnostic device company based in Cleveland.
The company was founded on the mission of pursuing disruptive innovation that fulfills urgent and emergent healthcare needs. www.clotchip.com
SOURCE XaTek
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