SinglePass, Inc., developer of the SinglePass biopsy closure device, today announced the publication of a multicenter (Hoag Health System, Newport Beach and Irvine, California) retrospective clinical data study in the Journal of Vascular and Interventional Radiology (JVIR). Across 120 consecutive patients followed for 30 days, the SinglePass device achieved a 100% technical success rate with zero clinically significant bleeding events.1
Percutaneous biopsy tract hemorrhage is among the most common complications of image-guided biopsy.2 The SinglePass device applies pinpoint cautery along the needle tract during withdrawal, addressing a bleeding risk that has been considered unavoidable. The multicenter data span liver, kidney, and lung cases.
“Biopsy tract hemorrhage has long been accepted as an inherent risk of our practice, but these data findings make clear that it doesn’t have to be,” said Dr. Alexander Misono, Chief of Interventional Radiology at Hoag Health System and study investigator. “Bleeding complications drive blood transfusions, overnight admissions, and delayed discharge, so 100% technical success and zero clinically significant bleeding events across Hoag’s multicenter cohort are highly impactful results.”
“SinglePass’s collaboration with CATALiST [Center for Accelerating Technology and Life Sciences Translation], Hoag’s biomedical innovation hub, is exactly the kind of collaborative innovation work that directly improves patient outcomes,” said Dr. Michael Brant-Zawadzki, Vice President of Clinical Research Administration and CATALiST. “Our key aim is enabling clinical thought leaders like Dr. Misono and industry innovators like SinglePass to work side by side to speed patient access to the latest technological advancements.”
“This peer-reviewed JVIR publication represents our commitment to clinical evidence and improving patient safety and biopsy care. We are grateful to Dr. Misono and the Hoag team for their partnership in bringing this exciting data to the interventional radiology community and the patients they serve,” said John Zehren, CEO, SinglePass, Inc.
The study is available in the Journal of Vascular and Interventional Radiology: Misono AS, Techasith T, Mesipam A, et al. Safety, effectiveness, and 30-day follow-up of electrocautery biopsy tract closure: retrospective multicenter study. J Vasc Interv Radiol. 2026;37(10):108986. doi:10.1016/j.jvir.2026.108986
Additional clinical research data on the SinglePass device will be presented by physician investigators at the annual congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), September 5–9, 2026, in Copenhagen, Denmark, and at the Symposium on Clinical Interventional Oncology (CIO), November 14–15, 2026, in Fort Lauderdale, Florida.
About SinglePass
SinglePass, Inc. is a medical technology company dedicated to improving patient outcomes and procedural efficiency in interventional radiology. The company’s SinglePass biopsy closure device is FDA-cleared and CE-marked for biopsy tract cauterization in liver, kidney and lung procedures, delivering controlled thermal energy to achieve post-biopsy hemostasis and streamline clinical workflows. SinglePass, Inc. is committed to establishing a new standard of care for biopsy closure. For more information, visit singlepass.co.
About Hoag
Hoag is a nonprofit, regional healthcare delivery system in Orange County, California. Delivering world-class, comprehensive, personalized care, Hoag consists of 1,800 top physicians, 18 urgent care facilities, 13 health & wellness centers, and two award-winning hospitals. Hoag offers a comprehensive blend of healthcare services that includes seven institutes providing specialized services in the following areas: cancer, digestive health, heart and vascular, neurosciences, spine, women’s health, and orthopedics through Hoag’s affiliate, Hoag Orthopedic Institute, which consists of an orthopedic hospital and five ambulatory surgical centers. Hoag is the highest ranked hospital in Orange County by U.S. News & World Report and the only OC hospital ranked in the Top 10 in California, as well as a designated Magnet® with Distinction hospital by the American Nurses Credentialing Center (ANCC). For more information, visit hoag.org.
INDICATIONS FOR USE
The SinglePass SP Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver, kidney, and lung soft tissue.
INTENDED PATIENT POPULATION
The intended patient population consists of adult persons undergoing a solid organ biopsy procedure.
For Healthcare Professional Use Only. Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
Rx Only: Federal (USA) law restricts this device to sale by or on the order of a physician.
CLINICAL REFERENCES
- Misono AS, Techasith T, Mesipam A, et al. Safety, effectiveness, and 30-day follow-up of electrocautery biopsy tract closure: retrospective multicenter study. J Vasc Interv Radiol. 2026;37(10):108986. doi:10.1016/j.jvir.2026.108986
- Sheth RA, Baerlocher MO, Connolly BL, et al. Society of Interventional Radiology quality improvement standards on percutaneous needle biopsy in adult and pediatric patients. J Vasc Interv Radiol. 2020;31(11):1840-1848. doi:10.1016/j.jvir.2020.06.026
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