Clinical Data Shows Surefire Technology Provides 80% Complete Response Rate for Bridge-to-Transplant Primary Liver Cancer Treatment versus 52% for Standard Microcatheter

Surefire Medical, Inc., the developer of site-specific delivery devices for the Interventional Oncology market, announced today results from a retrospective analysis of 85 bridge-to-transplant liver cancer patients treated with transarterial chemoembolization (DEB-TACE) that shows therapy delivery with the Surefire Infusion System was associated with an 80 percent complete response in one treatment versus 52 percent with a standard endhole microcatheter. In addition, the analysis shows a statistically significant lower recurrence rate of liver cancer at one month of 13 percent using Surefire technology versus 52 percent recurrence with a standard microcatheter.

All the patients were diagnosed with hepatocellular carcinoma (HCC) and were eligible for a liver transplant.  In a subanalysis cohort, twenty-three patients received a transplant with five patients treated using a Surefire device while 18 were treated using a standard microcatheter. Pathological review of explanted livers demonstrated that the use of Surefire technology improved tumor uptake – 89 percent of the chemo beads were delivered to the tumor in the Surefire procedures versus 55 percent in standard microcatheter procedures. Further pathological review showed a consistently high mean percentage of tumor necrosis for Surefire procedures of 89 percent versus 56 percent in standard microcatheter procedures.

This study of bridge-to-transplant patients with HCC provides further evidence to suggest that Surefire may be a more effective tool to downstage patients for transplant when compared with a standard endhole microcatheter," said Lance Stein, MD, Transplant Hepatologist, Piedmont Transplant Institute. "As evidenced in this and previous clinical studies, the use Surefire technology in embolization procedures optimizes penetration of therapy in tumors, which potentially increases complete response rates and spares healthy tissue. The data also showed consistently high tumor necrosis was achieved with the Surefire."

The study included a review of all treatment naïve cirrhotic patients who were treated with DEB-TACE in 2015 through 2016 with solitary HCC tumors less than 6.5 cm. The investigators conducted a blinded review of radiological response rates. Some of the patients included in the study were subsequently transplanted, which allowed for blinded pathological review of tumor necrosis and bead distribution in explanted liver. The liver toxicity profile did not show any increase for patients in the study.

In addition to this study, which was recently presented at the 2017 American Transplant Congress, Surefire Medical has five clinical studies currently underway. Chief among the Surefire studies is a multi-center randomized controlled study comparing tumor response and medical outcomes for HCC patients who undergo DEB-TACE with Surefire versus a standard microcatheter. Full details can be found at ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02748161.

About Surefire Medical

Surefire Medical, Inc. develops, manufactures and markets targeted delivery devices for the Interventional Oncology markets. Surefire's core technology consists of a microcatheter with a unique expandable tip that improves tumor uptake while protecting healthy tissue. It enables physicians to target tumors with superior accuracy, control and protection. Learn more: www.surefiremedical.com.