Single Pass launches 1,000-patient global study to validate real-world biopsy tract closure safety

Single Pass Inc., a California-based medical device developer focused on enhancing procedural safety during biopsies, has announced the launch of a global post-market evaluation of its proprietary SinglePass™ electrocautery biopsy tract closure device. The initiative, named B-S.A.F.E. (Biopsy with SinglePass: Assessing Fast & Effective Tract Closure), commenced with its first patient enrollment and will span more than 1,000 procedures across 20 global clinical centers. The study aims to generate real-world data to evaluate the device’s impact on bleeding complications, workflow optimization, and overall procedural efficiency in solid organ biopsies.

Introduced following regulatory market clearance in the United States, the SinglePass electrocautery system represents a novel approach to sealing biopsy tracts. By cauterizing the tissue channel immediately post-extraction, it addresses the long-standing issue of post-biopsy hemorrhage—a risk that, while statistically rare, poses significant patient care and economic burdens when complications occur.

How is Single Pass’s global biopsy tract closure study expected to influence post-market adoption of electrocautery innovation?

The B-S.A.F.E. study reflects a coordinated effort by Single Pass Inc. to broaden physician awareness and institutional trust in electrocautery-based tract closure as a standard-of-care enhancement. Solid organ biopsies, including those targeting kidney and liver tissue, are routinely performed under image guidance and are associated with relatively low complication rates. However, post-procedural bleeding—even if uncommon—can lead to prolonged observation, repeat interventions, and in rare instances, life-threatening outcomes.

Institutional sentiment around this new technology has been broadly favorable. Clinical leadership involved in the trial, including physicians from major U.S. medical centers such as Hoag Hospital Irvine and Robert Wood Johnson University Hospital, have already expressed strong confidence in the SinglePass system. Dr. Francis Kang, Clinical Chief of Interventional Radiology at Robert Wood Johnson, stated that he utilizes the device in every visceral biopsy for tumor and parenchymal assessments, citing improved patient safety and workflow integration.

According to procedural feedback from the early trial enrollees and physicians, the SinglePass device enables clinicians to quickly seal the biopsy tract, thereby reducing bleeding risk and enhancing operational turnaround. This supports its potential value as an intraoperative tool in both inpatient and outpatient biopsy settings.

What makes Single Pass’s electrocautery solution different from traditional biopsy closure approaches?

Historically, the medical community has relied on passive or indirect methods to manage post-biopsy bleeding, such as compressive techniques, patient positioning, and extended post-procedure monitoring. Some specialized techniques include the use of gel foam or embolization for high-risk patients, but these are typically reserved for complex cases due to cost, time, and clinical overhead.

The innovation from Single Pass Inc. lies in its active cauterization strategy. The SinglePass™ device enables clinicians to thermally close the biopsy tract immediately following tissue acquisition, minimizing open time for blood flow and effectively reducing the potential for hemorrhage. This procedural step is conducted in a single action, hence the device name, and is engineered to integrate seamlessly with existing biopsy protocols.

By directly cauterizing the tract instead of waiting for hemostasis via natural clotting or supportive materials, the approach offers a standardized method to reduce variability across different procedural environments. This also supports a more predictable observation period, potentially allowing for faster discharge, lower admission rates, and improved patient throughput in interventional suites.

How does the B-S.A.F.E. evaluation study aim to validate SinglePass’s clinical utility in real-world settings?

The B-S.A.F.E. evaluation is structured as a multicenter, post-market evidence collection initiative focusing on four primary metrics: reduction in post-biopsy bleeding events, decrease in procedure-related complications, efficiency of patient observation time, and workflow optimization in interventional radiology.

Each of the 1,000+ procedures included in the study will be observed for immediate and short-term outcomes associated with tract closure. Participating centers will contribute procedural data from diverse global settings, including both academic and community hospitals, ensuring a comprehensive dataset that reflects variability in technique, patient demographics, and institutional protocols.

John Zehren, CEO of Single Pass Inc., emphasized that this real-world assessment reinforces the company’s evidence-first strategy: “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.”

The trial is expected to run over the course of 12–18 months, with interim data anticipated by early 2026. Insights generated from the evaluation will inform broader reimbursement discussions, help refine clinical guidelines, and potentially catalyze adoption among healthcare systems seeking to minimize procedural complications.

What are experts saying about the potential for Single Pass to redefine biopsy safety standards?

Interventional radiologists participating in the B-S.A.F.E. trial view SinglePass’s technology as a potential game-changer in procedural risk mitigation. Dr. Alexander Misono, Chief of Interventional Radiology at Hoag Hospital Irvine, called the device a “transformational advancement in core needle biopsy,” stating that its reliable tract closure is already influencing procedural habits and institutional recovery protocols.

Although no formal efficacy data from the B-S.A.F.E. study have yet been published, anecdotal physician reports suggest measurable reductions in observation time and complication management. These real-world endorsements form the initial basis for anticipated broader institutional uptake once trial outcomes are officially reported.

From a commercial lens, analysts expect positive sentiment from hospital procurement divisions and radiology departments, particularly in large integrated delivery networks (IDNs) where procedural standardization is a priority. Institutions evaluating the device may also weigh its cost against potential reductions in bleeding-related readmissions, bed occupancy, and resource utilization.

How does this evaluation reflect Single Pass’s broader clinical and market development strategy?

As a privately held company, Single Pass Inc. is focusing its commercial strategy around clinical validation, real-world safety documentation, and procedural simplicity. The B-S.A.F.E. initiative exemplifies this data-first mindset, seeking to address skepticism in device adoption through quantifiable clinical outcomes rather than anecdotal marketing.

The firm’s flagship device is not just a technical tool, but a process-oriented enhancement aimed at streamlining biopsy protocols. If B-S.A.F.E. data support reductions in post-biopsy complications and improved throughput metrics, analysts believe Single Pass could expand its footprint in both the U.S. and key international markets including Europe, Asia, and the Middle East—particularly in radiology centers with high volumes of liver and renal biopsies.

From a product development standpoint, Single Pass may eventually explore complementary procedural tools or adjunct innovations to extend its ecosystem, particularly if this first generation proves effective at reducing downstream risk.

What is the long-term outlook for electrocautery-based biopsy closure adoption following B-S.A.F.E.?

Looking ahead, institutional observers believe Single Pass is strategically positioned to define a new clinical category within percutaneous biopsy workflows. As real-world evidence accumulates and interim trial data are released, medical systems may re-evaluate their procedural standards for managing tract-related bleeding.

Given the financial pressures facing hospital systems—including cost-per-procedure, staffing efficiencies, and readmission penalties—the promise of a device that improves safety while reducing operating complexity is likely to resonate across procurement channels. Analysts expect that regulatory data from B-S.A.F.E. could also support future submissions to international health authorities, unlocking additional markets.

Moreover, if the device receives widespread clinical endorsement following publication of study findings, it could help shape future biopsy guidelines issued by radiology and oncology societies. Such an outcome would further solidify electrocautery-based tract closure as a new standard of care in solid organ biopsy.