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FloBio Receives FDA’s Breakthrough Device Designation for Bleeding Risk Diagnostic Test
Rapid Detection of Modern Blood Thinners Could Reduce Preventable Complications in US Hospitals
PHILADELPHIA, October 17, 2023 — FloBio, a medical diagnostics company, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. FloBio’s test determines blood clotting status and whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs). This information would help emergency and critical care clinicians make informed treatment decisions about drug reversal to reduce serious bleeding, a major cause of preventable complications and death in US hospitals.
Today millions of Americans use DOACs, a highly effective and widely used drug for managing atrial fibrillation and deep vein thrombosis. DOACs can elevate bleeding risk and complicate emergency care. Clinicians do not have effective bedside diagnostics to assess DOAC status. This makes it difficult to adequately prevent or manage bleeding in the face of trauma, invasive surgeries, stroke, and other medical conditions. Major bleeding events related to blood thinners carry up to 20% mortality within 30 days, drive longer hospital stays, and raise readmission rates.
FloBio is developing the first precision, point-of-care DOAC detection test to help emergency medical professionals make more informed choices, such as whether to use drugs that reverse the effects of DOACs. Designed for in-vitro diagnostic use, the automated hemodynamic assay gives a complete picture of a patient’s blood clotting status, including anticoagulation caused by DOACs. The novel device platform combines hemodynamic flow and discrete clot activation to mimic physiological blood clotting and rapidly produce a comprehensive DOAC drug assessment at the patient’s bedside.
“Every year hundreds of thousands of Americans taking DOACs experience emergencies. It is critical that physicians have tools to rapidly detect DOACs so they definitively know whether to proceed with drug reversal to safely manage patients. We are encouraged that the FDA has recognized that our device has the potential to provide more effective diagnosis and treatment of life-threatening diseases and conditions. Our team looks forward to working with the FDA to accelerate the development, assessment, and commercialization of our technology, which so clearly fills a void in the market,” said Jerri Ann Thatcher, Founding CEO.
FloBio is a Philadelphia-based medical diagnostics company with the mission of saving lives by bringing precision diagnostics to hemostasis testing. FloBio’s vision is to provide clinicians with rapid, actionable information that enables optimal decision-making and cost-effective management of blood clotting abnormalities and serious bleeding. It is developing a novel point-of-care IVD platform with its first DOAC test granted Breakthrough Device Designation by the US Food & Drug Administration. FloBio was formed in 2017 after spinning out from the University of Pennsylvania.