URO-1 prostate biopsy devices adopted across Novant Health System as clinical study continues

URO-1’s SUREcore biopsy instruments and coreCARE tissue transfer system have been approved for use across the Novant Health hospital network, according to a recent news release.¹ The devices are now in use at 6 of Novant Health’s 23 hospitals in North Carolina and South Carolina.

Both the SUREcore and coreCARE technologies have received FDA clearance for all soft tissue biopsies. The adoption of these platforms comes as the result of the health system’s ongoing clinical evaluation of specimen quality and diagnostic yield for prostate biopsy.

SUREcore is a biopsy instrument designed to obtain a larger volume of tissue compared with conventional core biopsy needles, whereas the coreCARE system is intended to preserve tissue integrity during transfer and processing. These devices are intended to overcome some of the challenges with the current tools for prostate biopsy.

Arthur Cohen, MD, of Novant Presbyterian Pathology Group, who led the health system’s value analysis review, specifically cited concerns about thin or fragmented cores routinely encountered in prostate biopsy specimens.

“Unfortunately, in many cases, the core (prostate biopsy) samples we receive are thin and stringy, of poor and unacceptable quality,” Cohen explained. “When processed and sectioned in the histology laboratory, they are often incomplete with empty gaps. Full and complete sections are essential for accurate diagnosis.”

In the news release, Cohen noted that prior attempts to address the issue with larger-gauge needles were limited by product availability, prompting evaluation of alternative biopsy systems. Cohen then came across the URO-1 platform products, which are designed to obtain a larger biopsy sample.

“SUREcore offers a tremendous advantage for us, which ultimately benefits the patient, because we’re seeing more tissue per biopsy,” Cohen added.

Both the SUREcore and coreCARE devices are being assessed in a prospective, multicenter study with a planned enrollment of 200 patients. An interim analysis of 75 patients in the study has shown that the devices can provide larger tissue specimens with less fragmentation and tortuosity. Notably, use of the devices was also associated with a lower rate of atypical small acinar proliferation (ASAP) diagnoses.

Duke University Hospital is listed as one of 4 study sites, and biopsy slides are being digitized at the University of North Carolina Lineberger Comprehensive Cancer Center for exploratory artificial intelligence–based analysis, supported by a grant from URO-1. URO-1 also plans to launch its products for interventional radiology at an upcoming medical meeting, and is aiming to expand into breast biopsy applications through collaborations with the University of California, Davis and the University of Washington.

REFERENCE

1. Novant's use of URO-1 for prostate biopsies increasing. News release. North Carolina Biotechnology Center. February 3, 2026. Accessed February 4, 2026. https://www.ncbiotech.org/news/novants-use-uro-1-prostate-biopsies-increasing