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Grant Received to Pursue Phase 1b Clinical Trial of CAR-T Immunotherapy Delivery

Surefire to Collaborate with Roger Williams Medical Center and University of Colorado School of Medicine

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Surefire Medical Receives Grant to Pursue Phase 1b Clinical Trial of CAR-T Immunotherapy Delivery through Precision Infusion System

Surefire to Collaborate with Roger Williams Medical Center and University of Colorado School of Medicine

WESTMINSTER, CO—November 15, 2016—Surefire Medical, Inc. announced a grant from the Colorado Office of Economic Development and International Trade (OEDIT) to initiate a Phase 1b immunotherapy clinical trial in patients with liver cancer metastases, HITM-SURE (NCT02850536). The study, in collaboration with Roger Williams Medical Center and the University of Colorado School of Medicine, will investigate the use of the Surefire® Precision Infusion System to deliver chimeric antigen receptor T-cells (CAR-T) directly to liver metastases.

CAR-T therapy has generated impressive results in certain hematologic malignancies. However, its use is associated with severe side effects caused by systemic administration of the therapy. The HITM-SURE trial aims to determine whether precise localized delivery using the Surefire Precision Infusion System can enable the administration of a therapeutic dose for a product candidate in solid tumor while limiting known systemic side effects of CAR-T treatments.

“Administering CAR-T cells through conventional methods to achieve a therapeutic dose in solid tumor applications is not only inefficient, but also frequently limited by severe systemic side effects, such as neurotoxicity and cytokine release syndrome,” said Steven Katz, M.D., Director of the Office of Therapeutic Development at the Roger Williams Medical Center, and the principal investigator of the trial. “We hope to improve the therapeutic window for these treatments by directly administering a smaller but concentrated dose precisely at the tumor site.”

Surefire’s infusion system utilizes a semi-porous expandable tip that increases infusion pressure. In a randomized trial, the Surefire catheter was shown to improve tumor uptake by 68 percent while simultaneously decreasing non-target delivery by 58 percent. Additionally, a multi-center registry showed that the use of the Surefire Precision Infusion System to deliver therapy in the treatment of primary liver cancer (hepatocellular carcinoma or HCC) was associated with a 68 percent complete tumor response and 92 percent objective tumor response. These response rates are considerably higher when compared to the average response rates seen in the literature for this patient population.

“We are thrilled to receive this grant from the State of Colorado,” said Surefire Medical’s President and CEO James Chomas, Ph.D. “This kind of targeted support helps drive innovation and economic development in the state.”

About Surefire Medical
Surefire Medical, Inc. develops, manufactures and markets innovative infusion systems for the Interventional Radiology and Interventional Oncology markets. Surefire’s technology is designed to precisely deliver therapeutic agents through a unique microcatheter with an expandable tip that creates a pressure gradient, driving therapeutic agents deeply into the tumor while minimizing backflow that might otherwise damage healthy tissue. The Surefire Infusion System enables physicians to target tumors with superior accuracy, control and protection. The Surefire Infusion Systems and Surefire Precision have received regulatory approval in the U.S., Europe, Canada, Mexico and Brazil. For more information, please visit