LAKE FOREST, Calif. — SinglePass Inc. said its ongoing B-S.A.F.E. study has reached 500 enrolled cases, marking the halfway point toward its 1,000-case goal as adoption of its biopsy technology expands.
The multi-center study is evaluating the company’s electrocautery device, which is cleared in the United States for use in liver, kidney, and lung biopsy tract cauterization and approved in Europe for solid organ biopsies. Researchers are examining patient outcomes, safety, procedure time, and post-procedure observation requirements.
Company officials said reaching 500 cases in under a year highlights growing clinical use of the device and will trigger a planned interim analysis to assess early results and workflow impact.
“Being part of the B-S.A.F.E. study is a unique opportunity to help build the early evidence base for a technology that could genuinely change how we approach biopsy procedures. The data we’re generating today could shape clinical practice for years to come.” said Dr. Francis Kang, lead investigator of the study and clinical chief of interventional radiology at Robert Wood Johnson University Hospital in New Brunswick, New Jersey.
The SinglePass device is designed to cauterize the biopsy tract during procedures to reduce bleeding and streamline recovery, with the goal of improving both patient outcomes and operational efficiency.
“SinglePass has become so integrated into our clinical workflow that it would be hard to imagine life without it. Stopping bleeding in the tract is extremely powerful. Just as compelling is SinglePass’s potential to reduce post-procedural recovery time and improve care efficiency, saving important and limited healthcare resources. B-S.A.F.E. is already validating this, and I expect more exciting data to come.” said Dr. Alexander Misono, a study investigator and chief of interventional radiology at Hoag Hospital in Newport Beach, California.
The study is continuing toward full enrollment, with additional milestones expected to include interim findings and publication of results in peer-reviewed journals.
“Five hundred cases prove this technology resonates. Clinicians are confident, it’s fitting naturally into their workflows, and momentum is building across the Interventional Radiology community. We’re committed to generating evidence to make tract cauterization the new standard for biopsy closure.” said John Zehren, chief executive officer of SinglePass Inc.
