URO-1 reaches new milestones in equity financing, clinical validation and manufacturing

URO-1, a Greensboro medical device company in prostate and soft tissue cancer diagnostics, has secured a new round of equity financing and announced additional milestones since the start of commercialization of its prostate cancer biopsy system in January 2025.

GenHenn Capital, a single-family office investor in life sciences companies, led the new financing round. Terms weren’t disclosed. The financing adds to a Series A round of $8 million announced in early 2024.

In addition, URO-1 has made several recent advancements, including new study results, the development of a manufacturing cleanroom, and presentations at national urology and pathology conferences.

URO-1’s biopsy system consists of the SUREcore set of instruments designed to provide a bigger volume of prostate tissue with higher quality than standard biopsy instruments, and the coreCARE specimen retrieval kit. Both are cleared for all soft tissue biopsies by the U.S. Food and Drug Administration.

The company said a study involving SUREcore and coreCARE validated that the biopsy system produces larger specimens with less fragmentation and tortuosity, or deviation from a straight line. More importantly, use of the SUREcore/coreCARE platform was associated with a significant decrease in the diagnosis of Atypical Small Acinar Proliferation (ASAP). ASAP is a diagnostic category created for those instances when a pathologist is unable to incontrovertibly determine whether or not cell is malignant. 

Per standard of care guidelines, men diagnosed with ASAP return for a second biopsy 3-5 months after the first. Pathologists from NewYork-Presbyterian/Weill Cornell Medical Center, as well as Dan Wiener, M.D., an Acworth, Ga., pathologist, presented their findings at the recent U.S. and Canadian Academy of Pathology conference.

“These key metrics translate into slides that are not only easier and faster for the pathologist to read but also reduce the need for making additional slides,” Wiener said in a statement provided by URO-1. “Time is therefore saved and more tissue is preserved for important studies such as molecular diagnostics.”

Ted Belleza, URO-1 president and CEO, said a multi-center, prospective, randomized control study of SUREcore and coreCARE will start enrolling patients this month. The centers conducting the study are comprehensive cancer centers designated by the National Cancer Institute.

Among URO-1’s additional recent developments, the company has installed a 300-square-foot ISO-certified cleanroom at its Greensboro facility, where the SUREcore needle will be manufactured. Belleza said the company can fulfill forecasted demand through 2026 and that discussions have started with a North Carolina contract manufacturer to plan additional manufacturing capacity.

Also, as part of the recent annual conference of the American Urological Association, URO-1 was in the spotlight with two video interviews and a poster presentation.

SUREcore and coreCARE were the subject of the interviews with urologists, published by the media arm of the Prostate Cancer Foundation. Zachary Klaassen, M.D., of the Medical College of Georgia, interviewed James Wysock, M.D., of NYU Langone Health about the URO-1 biopsy system’s contribution to improvements in prostate cancer diagnosis and care. And in a separate video, Klaassen interviewed Wiener about his findings.

The presentation, by Eric Gwynn, M.D., with New River Urology in Bluffton, S.C., occurred at a meeting of the Engineering and Urology Society held during the AUA conference. Gwynn noted that a biopsy needle meeting current standards of care missed the target 64% of the time, while the novel SUREcore needle only missed in 8% of attempts.

The North Carolina Biotechnology Center provided a $250,000 Small Business Research Loan to URO-1 in 2018.

“URO-1 continues to make strong progress developing its initial idea for a prostate biopsy system into a viable product that improves patient care,” said Kathy Meserve, senior director of investments in the Emerging Company Development group at NCBiotech. “We are very pleased to see the company achieve follow-on funding after NCBiotech’s initial investment.”