BiO2 Medical Inc.
Prophylactic pulmonary embolism protection
This article was originally published in Start Up
Executive Summary
Hospitalized patients are at the greatest risk for a fatal pulmonary embolism within the first 10 days after admission, but traditional inferior vena cava filters to prevent PEs if anticoagulant therapy is contraindicated and/or ineffective are not typically placed in a patient until approximately one week into their hospital stay. BiO2 Medical Inc. is looking to address this treatment gap with its Angel Catheter, a device that incorporates the PE protection of a retrievable, self-expanding nitinol IVC filter attached to a triple-lumen, central venous access catheter.
You may also be interested in...
Finding The Sweet Spot For Real-World Evidence: Aetion Stresses Early Feasibility Assessment
Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.
FDA Gene Therapy Office Chief Prefers Flexibility With Accelerated Approval Confirmatory Trials
Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.
Keeping Track: Return & Renewal At US FDA
Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.