SinglePass Biopsy Closure Device Demonstrates 100% Technical Success and No Clinically Significant Bleeding in Multicenter Study
SinglePass, Inc., developer of the SinglePass biopsy closure device, has announced the publication of new multicenter clinical data evaluating the safety and effectiveness of its technology for closing biopsy tracts. The retrospective study, conducted across Hoag Health System locations in Newport Beach and Irvine, California, analyzed outcomes in 120 consecutive patients who underwent image-guided biopsies and were followed for 30 days.
According to the published findings, the SinglePass device achieved a 100% technical success rate, with investigators reporting zero clinically significant bleeding events during the 30-day follow-up period. The results, published in the Journal of Vascular and Interventional Radiology (JVIR), provide additional clinical evidence supporting the use of electrocautery-based biopsy tract closure as a strategy for addressing bleeding risks associated with percutaneous biopsy procedures.
The study included biopsy procedures involving the liver, kidney, and lung, providing clinical data across multiple organ systems and demonstrating the potential applicability of the SinglePass technology to a range of image-guided biopsy procedures.
Addressing a Common Complication of Image-Guided Biopsy
Percutaneous biopsy is an established diagnostic procedure used to obtain tissue samples from organs and lesions for pathological evaluation. Image guidance, including ultrasound and computed tomography, allows physicians to accurately position biopsy needles and collect tissue while minimizing unnecessary disruption to surrounding structures.
Despite advances in imaging, needle technology, and procedural techniques, bleeding along the biopsy tract remains one of the recognized complications of percutaneous biopsy. When a needle passes through tissue and is subsequently withdrawn, the resulting tract can potentially provide a pathway for blood to escape from injured vessels.
In many clinical settings, physicians use a variety of measures to reduce or manage bleeding risk following biopsy. However, the possibility of biopsy tract hemorrhage has historically been viewed as an inherent risk associated with penetrating tissue to obtain diagnostic samples.
SinglePass is designed to address this challenge directly.
The device applies pinpoint cautery along the needle tract during withdrawal, with the objective of providing localized closure of the tract and helping reduce bleeding. Rather than treating hemorrhage only after it occurs, the technology is intended to address the potential source of bleeding during the biopsy procedure itself.
The newly published multicenter data provide clinical evidence regarding the use of this approach in real-world biopsy procedures.
Study Evaluates 120 Consecutive Patients
The retrospective study evaluated 120 consecutive patients treated at Hoag Health System facilities in Newport Beach and Irvine, California. Patients were followed for 30 days following their biopsy procedures, allowing investigators to evaluate both immediate procedural outcomes and subsequent clinical events.
A key finding was the device’s 100% technical success rate. Technical success indicates that the device could be successfully used to perform the intended biopsy tract closure procedure.
Equally notable was the absence of clinically significant bleeding events during the follow-up period. For interventional radiologists and healthcare providers, the prevention of clinically meaningful bleeding can have important implications for patient management, recovery, and healthcare resource utilization.
The study incorporated liver, kidney, and lung biopsies, allowing the investigators to assess SinglePass across different anatomical locations and procedural scenarios.
The results add to the growing body of evidence examining technologies designed to improve the safety profile of minimally invasive diagnostic procedures.
Potential Impact on Patient Care
Bleeding complications following biopsy can create additional challenges for both patients and healthcare providers. Depending on severity, bleeding may require additional monitoring, interventions, blood transfusions, or extended hospitalization.
Even when bleeding does not become life-threatening, it can affect a patient’s recovery and potentially delay discharge from the healthcare facility.
Dr. Alexander Misono, Chief of Interventional Radiology at Hoag Health System and an investigator in the study, highlighted the potential clinical importance of the findings.
“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,” Misono said.
He noted that bleeding complications can contribute to blood transfusions, overnight admissions, and delayed discharge. Against this background, he described the combination of 100% technical success and zero clinically significant bleeding events observed in the Hoag multicenter cohort as highly impactful.
The findings could be particularly relevant as healthcare systems continue to emphasize minimally invasive procedures, outpatient care, shorter hospital stays, and improved patient safety.
Collaboration Between Clinicians and Medical Technology Developers
The study also highlights the role of collaboration between clinical investigators and medical technology companies in developing and evaluating new approaches to patient care.
SinglePass collaborated with CATALiST, the Center for Accelerating Technology and Life Sciences Translation, Hoag’s biomedical innovation hub. The initiative is intended to bring clinical expertise and technology development together to accelerate the evaluation and adoption of emerging healthcare technologies.
Dr. Michael Brant-Zawadzki, Vice President of Clinical Research Administration and CATALiST, emphasized the importance of this collaborative model.
“SinglePass’s collaboration with CATALiST, Hoag’s biomedical innovation hub, is exactly the kind of collaborative innovation work that directly improves patient outcomes,” Brant-Zawadzki said.
He explained that a central objective of the initiative is to enable clinical experts such as Dr. Misono and technology innovators such as SinglePass to work together in advancing new solutions and helping patients gain access to emerging technologies.
Such partnerships can play an important role in translating promising medical technologies from development into clinical practice. Direct input from physicians can help technology developers address practical procedural needs, while clinical research provides an opportunity to assess how new devices perform in real-world healthcare environments.
Peer-Reviewed Evidence Strengthens Clinical Profile
The publication of the study in JVIR provides peer-reviewed evidence concerning the safety and effectiveness of electrocautery biopsy tract closure.
The study, titled “Safety, effectiveness, and 30-day follow-up of electrocautery biopsy tract closure: retrospective multicenter study,” was authored by Misono AS, Techasith T, Mesipam A, and colleagues.
The publication appears in volume 37 of the Journal of Vascular and Interventional Radiology, with the citation listed as J Vasc Interv Radiol. 2026;37(10):108986.
For SinglePass, the peer-reviewed publication represents an important step in establishing clinical evidence for the device and its approach to biopsy tract management.
John Zehren, CEO of SinglePass, said the publication reflects the company’s commitment to clinical evidence and patient safety.
“This peer-reviewed JVIR publication represents our commitment to clinical evidence and improving patient safety and biopsy care,” Zehren said. He also recognized Dr. Misono and the Hoag team for their collaboration in bringing the findings to the interventional radiology community.
Continued Clinical Research Planned
SinglePass’s clinical development program is expected to continue with additional presentations planned at major medical meetings.
Physician investigators will present additional clinical research data on the SinglePass device at the annual congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), scheduled for September 5–9, 2026, in Copenhagen, Denmark.
Additional research will also be presented at the Symposium on Clinical Interventional Oncology (CIO), taking place November 14–15, 2026, in Fort Lauderdale, Florida.
These upcoming presentations are expected to provide further opportunities for interventional radiologists and other specialists to review clinical experience with the technology, discuss biopsy tract closure strategies, and evaluate the potential role of electrocautery in improving procedural outcomes.
Advancing Biopsy Safety Through Tract Closure
The publication of the 120-patient retrospective multicenter study represents a significant milestone for SinglePass as the company continues to develop technologies aimed at improving the safety and efficiency of image-guided biopsy.
The study’s findings—100% technical success and no clinically significant bleeding events over 30 days—provide encouraging evidence for the use of the SinglePass device in liver, kidney, and lung biopsy procedures. While the retrospective nature of the research means that additional prospective studies may be valuable for further establishing the technology’s clinical performance, the published results offer important real-world data regarding electrocautery-based biopsy tract closure.
As image-guided biopsy continues to play an important role in the diagnosis and management of cancer and other diseases, technologies that can help reduce procedure-related complications may contribute to improved patient experiences and more efficient healthcare delivery.
By applying targeted cautery during needle withdrawal, SinglePass seeks to make biopsy tract closure an integrated part of the procedure rather than relying solely on managing bleeding after it develops.
With peer-reviewed clinical evidence now published and additional research presentations planned for major interventional radiology and oncology meetings, SinglePass is continuing to build the clinical foundation for its biopsy closure technology. The company’s focus on collaboration with physicians and healthcare institutions also underscores the importance of clinical evidence in determining how emerging medical devices can contribute to safer, more streamlined biopsy care.
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).