Single Pass Begins Post-Market Evaluation of its Biopsy Tract Closure Device

Single Pass Inc. has begun patient enrollment in B-S.A.F.E. (Biopsy with SinglePass: Assessing Fast & Effective Tract Closure), a global, post-U.S. Food and Drug Administration market evaluation to generate real-world evidence of the SinglePass electrocautery biopsy closure device.

Despite the millions of solid organ percutaneous biopsies performed successfully each year, unintended bleeding post-procedure is a real risk requiring additional procedures, longer hospital stays, and increased costs. And in rare instances, the complications can be devastating.

The SinglePass device is designed to cauterize the biopsy tract immediately after tissue extraction, offering a novel approach to reduce bleeding complications, enhance procedural efficiency, and optimize patient observation time.

“Single Pass’s global post-market evaluation—B-S.A.F.E.—reflects our commitment to innovation backed by evidence,” SinglePass CEO John Zehren stated. “We’re honored to work alongside frontline clinicians to validate real-world safety, usability, and performance, bringing an innovative solution for patients undergoing biopsy procedures.”

B-S.A.F.E. is a multicenter post-market device evaluation that will assess reduction in post-biopsy bleeding and complications, post-biopsy observation time and workflow optimization.

“The SinglePass device represents a transformational advancement in the world of core needle biopsy,” said Dr. Alexander Misono, M.D., RPVI, chief of Interventional Radiology at Hoag Hospital Irvine in Irvine, Calif. “With the ability of SinglePass to provide immediate and reliable tract closure, we are already witnessing an inevitable shift in the way we manage bleeding risk and patient recovery. I’m proud to contribute to this evaluation and help drive the future standard of care.”

“I use SinglePass on every visceral biopsy for both tumor and parenchyma, including kidney and liver!” remarked Dr. Francis Kang, clinical chief of Interventional Radiology at Robert Wood Johnson University Hospital in New Brunswick, N.J. “This device efficiently seals biopsy channels, significantly reducing bleeding risks and improving patient safety across all my biopsy procedures.”

Single Pass Inc. is a privately held medical device company dedicated to enhancing safety and workflow efficiency in image-guided biopsy procedures. Its flagship product, the SinglePass Electrocautery Biopsy Closure Device, enables clinicians to cauterize the biopsy tract in a single step, potentially improving patient outcomes and reducing procedural complexity. The company is headquartered in Lake Forest, Calif.