WESTMINSTER, Colo., USA (July 1, 2011) – Surefire Medical, Inc., a Colorado-based medical device company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on June 30, 2011 to market its novel infusion system, which is the first catheter designed to deliver embolization agents with unhindered forward flow while preventing reflux. The differentiated component of the Surefire® Infusion System is an expandable tip that is deployed prior to infusion of embolization agents, and retracted before removal of the catheter from the patient.

“Surefire Medical designed this unique catheter system with the primary goal of improving safety and efficacy of treating intestinal cancers—principally liver, kidney and pancreas—using interventional vascular techniques,” said Jim Chomas, co-founder and CEO of Surefire Medical. “Receiving FDA clearance of our product allows us to begin the process of really delivering on that goal and launching in the U.S.”

The Surefire Infusion System addresses the principal limitation of current embolotherapy techniques, which is the uncontrolled delivery of the radiation-containing beads or chemo-active beads to non- target tissue. The goal of all infusion procedures is to achieve 100% infusion efficiency, meaning all of the therapy that a physician infuses is delivered to the target tissue.

The Surefire Infusion System is designed to significantly reduce reflux, minimally impact the forward flow, and retain the trackability of standard catheters. Surefire’s expandable tip collapses in forward flow, enabling unaltered flow for infusion. The expandable tip dynamically expands to the vessel wall during static or reverse flow conditions, reducing the backward flow of embolics.

Pre-clinical study results presented at the World Congress of Interventional Oncology in June 2011 suggest the Surefire Infusion System achieves an average infusion efficiency of 99.1 % (+/- 1.0%) compared to 72.8% (+/- 7.4%) with a standard infusion catheter (p=.005).

“I believe the Surefire Infusion System will not only improve patient safety and treatment outcome, but will fundamentally enable the embolization business to expand at even faster rates,” said Dr. Charles Nutting, Chief of Interventional Radiology, Sky Ridge Medical Center in Denver, Colo.

Achievement

Clinical Data Shows Surefire Technology Achieved 79% Objective Response versus 37% Using a Standard Microcatheter in Treating Primary Liver Cancer. Study presented at SIR 2017 Annual Scientific Meeting.