July 2, 2020
NIH Grant Funds RESCUE Trial of Thrombolex Bashir Catheter
July 2, 2020—Thrombolex Inc. has announced that it was awarded a $3 million Small Business Innovation Research (SBIR) Direct-to-Phase II grant from the National Heart, Lung and Blood Institute (NHLBI) section of the National Institutes of Health to fund the company’s pivotal RESCUE trial under an investigational device exemption.
RESCUE will study the company’s Bashir endovascular catheter platform for the treatment of up to 125 patients with acute, submassive, pulmonary embolism (PE) at up to 20 centers in the United States.
Brian Firth, MD, Chief Scientific Officer of Thrombolex, serves as Principal Investigator on this SBIR grant and is being assisted by Riyaz Bashir, MD, of Temple University in Philadelphia, Pennsylvania. Dr. Bashir is the co-inventor of the Bashir endovascular catheter. The RESCUE Steering Committee includes Anthony Comerota, MD; Kenneth Rosenfield, MD; Akhilesh Sista, MD; and Victor Tapson, MD.
In the company’s announcement, Dr. Firth stated, “With the strong support of the NHLBI, we have an opportunity to advance the treatment of patients with acute PE and have the potential to reduce bleeding complications, enhance clot resolution and improve hospital economics.”
Dr. Sista added, “Based on the impressive early results of the first-in-human (FIH) study, I am excited to see a larger set of real-world data using the Bashir endovascular catheter.”
Last year, Thrombolex completed the FIH trial, which met its primary safety and feasibility endpoints and resulted in no major bleeding or other adverse events. The FIH data showed large and rapid reduction in right heart strain, as evidenced by a mean reduction in right-to-left ventricle ratio of 36.7% (P < .0009), as well as a 37.1% mean reduction (P < .0005) in pulmonary clot burden, as measured by the Modified Miller Index after mean infusion of 13.7 mg of recombinant tissue plasminogen activator over 8 hours.