URO-1, Inc. Innovates Biopsy Technology for Enhanced Diagnostics

URO-1, Inc. has launched advanced technologies aimed at improving the accuracy and efficiency of soft tissue biopsy diagnostics. The company’s focus on enhancing biopsy instrumentation and specimen handling is intended to support clinicians and pathologists in delivering precise and reliable diagnostic results.

Ted Belleza, President and CEO of URO-1, founded the company following his personal experience with a prostate biopsy. He noted significant complexities in the biopsy process, stating, “While imaging and molecular diagnostics had moved forward, the basic tools used to collect and transfer tissue samples hadn’t changed much.” This realization prompted him to investigate the diagnostic accuracy challenges faced by prostate biopsies compared to breast biopsies. Belleza’s findings motivated him to create a venture dedicated to improving diagnostic outcomes.

URO-1 is strategically focused on enhancing two critical aspects of the biopsy process: tissue acquisition and specimen handling. The company has developed two complementary technologies—the SUREcore® biopsy instrument and the coreCARE® tissue transfer system. Together, these innovations offer a cohesive approach to tissue collection and preparation, aiming to increase the quality and volume of tissue samples obtained.

The SUREcore® system features multiple configurations, including a disposable 18-gauge needle designed for use with a reusable handpiece. This system aims to secure larger and higher-quality tissue samples while ensuring consistent alignment during the sampling process. Belleza explained the importance of alignment, particularly in targeted procedures guided by MRI-ultrasound fusion, stating that it can significantly influence the diagnosis and risk stratification of prostate cancer.

Research has demonstrated that the 18-gauge needle design enhances tissue sampling characteristics. Comparative studies revealed an approximate 11% increase in tissue volume by weight during transrectal ultrasound-guided procedures and a 21% increase during transperineal biopsies, when compared to standard procedures. Researchers also evaluated factors such as fragmentation and tortuosity, which can impact histologic preparation and interpretation.

The coreCARE® system focuses on the retrieval of specimens immediately after tissue collection. This system utilizes a “touch and go” method, allowing for the biopsy core to be transferred from the needle with minimal manual handling. URO-1 emphasizes that this design maintains tissue orientation and structural integrity, which is crucial for efficient processing in histology laboratories.

Belleza highlighted that the objective of URO-1 extends beyond merely designing instruments. “Every biopsy is part of a diagnostic journey that moves from the procedural suite to the pathology laboratory,” he stated. This holistic perspective aims to strengthen each step of the biopsy process, ultimately enhancing diagnostic accuracy.

Initial adoption of the URO-1 platform in clinical settings has been promising. The company’s biopsy instruments and tissue transfer systems have received approval from the Value Analysis Committee (VAC) within the Novant Health hospital network. URO-1 reports that its devices are currently utilized in multiple hospitals across North Carolina and South Carolina, while ongoing clinical studies evaluate the technological impact on specimen characteristics and diagnostic parameters.

Interim analyses from a multicenter, prospective study involving prostate biopsy procedures indicate that the combination of the novel needle design and retrieval method is associated with larger tissue samples, reduced fragmentation, and less tortuosity compared to standard practices. The U.S. Food and Drug Administration has granted clearance for the SUREcore® and coreCARE® systems, allowing for their application in all soft tissue biopsies, including those of the prostate, breast, liver, lung, kidney, and lymph nodes.

As URO-1 continues to expand its clinical experience, the company is focused on strengthening institutional partnerships. It is a portfolio company of the North Carolina Biotechnology Center, which supports the growth of the life sciences sector in the state. Belleza noted that this collaboration has been instrumental in navigating product development, clinical research, and market expansion.

Looking ahead, URO-1 plans to increase adoption within hospital systems across North Carolina and extend its reach to major healthcare networks throughout the United States, including military hospitals and VA medical centers. The company is also exploring opportunities to introduce its platform to international markets and investigate additional clinical applications in interventional radiology and breast biopsy procedures.

Belleza expressed a broader vision for the company, emphasizing that “every improvement in how tissue is collected and preserved has the potential to support clearer interpretation by the pathologist and more confident clinical decision-making.” With ongoing clinical studies, enhanced partnerships, and continued technology development, URO-1 remains dedicated to transforming biopsy instrumentation and specimen handling systems, contributing to the evolving landscape of soft tissue diagnostics.