Josh Fessel, Former NIH Worker

How has the SBIR program impacted your life:

I personally witnessed the SBIR program change the treatment of patients with life-threatening blood clots in their lungs. I was the program officer for the SBIR grant that supported the partnership between Temple University and Thrombolex, Inc. to conduct the RESCUE trial (https://clinicaltrials.gov/study/NCT04248868).

The trial was designed to "demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism." The trial consistently enrolled ahead of milestones with outstanding safety monitoring, and the results of the trial supported FDA clearance for use of the Bashir Endovascular Catheter to treat acute submassive PE (https://evtoday.com/news/thrombolex-bashir-catheter-cleared-by-fda-to-treat-acute-pulmonary-embolism-1).

Without the SBIR program support, this trial might not have happened, and the 900,000 per year in the U.S. who experience pulmonary embolism would not have this innovative drug-device combination therapy available to them.