Surefire Medical raises $11M to back its microcatheter oncology infusion system

An illustration of the Surefire Infusion System in a vein--Courtesy of Surefire Medical

Colorado-based startup Surefire Medical has raised $11 million to help market its microcatheter-based infusion system to deliver embolic agents to liver cancer. The Surefire Infusion System was cleared by the FDA in 2011, but it's in ongoing testing by external investigators to see how it compares to a standard end-hole microcatheter.

This financing is only part of a $14 million total the company is ultimately targeting. It's the most recent financing since the startup raised $18.2 million in a Series B dating from November 2013. Investors in that round included MCG Partners, Partisan Management Group and High Country Ventures.

Embolization via the use of radio- or chemo-therapeutics is a common approach to treating primary and secondary liver cancers, most of which are not amenable to surgical removal. Surefire offers a particular catheter design with an expandable and retractable tip to minimize reflux of those therapeutic agents and maximize the delivery of cancer-fighting agents to tumors.

The latest data for the system was disclosed by the company in March; it showed that in primary or metastatic liver cancer patients the Surefire Infusion System provided better tumor targeting than a standard, end-hole microcatheter.

In the study, 9 patients had two embolizations on the same day--the Surefire Infusion System was used on one, while the end hole microcatheter was used on the other and then nuclear imaging was used to determine the distribution of hepatic emboli. It found that the Surefire system reduced non-target embolization by a mean of 42%, while it increased tumor deposition by an average of 68%.

"The Surefire catheter does indeed alter downstream distribution of microspheres in a potentially beneficial way compared to use of an end hole microcatheter," said the study's principal investigator Alexander Pasciak of the University of Tennessee Graduate School of Medicine in a statement at the time.

"Patients in the study had widely varying conditions representing multiple types of liver cancer, and every stage," he added. "We see zero downside and only potential upside to using Surefire. All patients had more uniform tumor coverage, increased dose deposition in tumor and decreased deposition in healthy liver tissue."

Also, the Surefire Infusion System is in a 25-patient clinical study by Dutch hospital UMC Utrecht to assess its use versus a standard microcatheter to treat colorectal liver metastases with Holmium-166 radioembolization, as well as a 20-patient study by Wright State University that also compares its effectiveness to a standard end-hole catheter in the distribution and penetration of Y-90 glass microspheres.

- here is the SEC filing