LAKE FOREST, Calif.–(BUSINESS WIRE)–SinglePass Inc., a medical technology company dedicated to improving patient outcomes and procedural efficiency in interventional radiology, today announced that the B-S.A.F.E. (Biopsy Safety and Feasibility Evaluation) Study has reached 500 enrolled cases — the halfway point of its 1,000-case target.
The multi-center study assesses the SinglePass Electrocautery Device — FDA cleared for liver, kidney, and lung biopsy tract cauterization and CE Marked for solid organ biopsies — across leading U.S. and European institutions. Key endpoints include patient outcomes, safety profile, post-procedure observation time, and procedure time. Enrolling 500 cases in less than one year underscores accelerating adoption and triggers a planned interim analysis offering an early look at outcomes and workflow efficiencies.
“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.” — Dr. Francis Kang, B-S.A.F.E. Study Lead Investigator, Clinical Chief of Interventional Radiology, Robert Wood Johnson University Hospital, New Brunswick, NJ
Designed to address both clinical and economic value, the SinglePass device proactively cauterizes the biopsy tract to minimize complications and streamline post-procedure observation — delivering meaningful benefits for patients and institutions alike.
“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.” — Dr. Alexander Misono, B-S.A.F.E. Study Investigator, Newport Harbor Radiology Associates, Chief of Interventional Radiology, Hoag Hospital, Newport Beach, CA
The study continues toward full enrollment, with upcoming milestones including interim analysis results and peer-reviewed publication.
“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.” — John Zehren, Chief Executive Officer, SinglePass Inc.
About SinglePass
SinglePass Inc. is a medical technology company dedicated to improving patient outcomes and procedural efficiency in interventional radiology. The SinglePass Electrocautery Device is FDA-cleared and CE Marked for biopsy tract cauterization in solid organ and lung procedures, delivering controlled thermal energy to minimize post-biopsy complications and streamline clinical workflows. Please visit https://www.singlepass.co for more information.
Contacts
Media Contact:
Yvette Thomas | Marketing Manager | [email protected] | 877-331-5477
