URO-1 Achieves Multiple Milestones Toward Commercializing Its Breakthrough Products for Prostate Biopsy & Other Procedures

The company has reached its goal to raise $5.0M in Series A financing, which was originally led by Acorn Campus of Taiwan, following a recent sizeable investment by angel investors from Tennessee and Kentucky. It also announced positive results from initial clinical studies of its FDA-cleared SUREcore™ biopsy needle and coreCARE™ specimen-retrieval kit for prostate biopsy.

“Achievement of our financing goals will accelerate replication and extension of the initial study results and drive completion of a suite of procedure-specific SUREcore soft tissue biopsy instruments and coreCARE specimen-retrieval kits for prostate and other organs,” said Ted Belleza, president, and chief executive officer of URO-1.

Indicated for use in soft tissue biopsy, the two devices were designed to improve the procedure, reduce workload and improve workflow in the clinic and the pathology lab. They are optimized for trans-rectal, trans-perineal, and targeted prostate biopsy.

“In side-by-side comparisons with the same sized standard of care prostate biopsy needles, the SUREcore needle consistently delivered full, continuous cores with less sample-to-sample variability and significantly greater (12-21%) tissue volume by weight,” said John J. Smith III, M.D., chief medical officer for URO-1. “Use of the coreCARE Specimen Retrieval Kit, compared with current specimen-retrieval methods, preserved tissue integrity and reduced tissue artifact, which resulted in significantly reduced specimen preparation time and facilitated interpretation by pathology.”

Results of the studies will be submitted to a peer-reviewed medical journal for publication.

The SUREcore needle is cleared by the FDA for use with all current reusable prostate biopsy handpieces.

Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer, the most common cancer in American men and the second most common worldwide. However, in up to 40 percent of prostate biopsies, the aggressiveness of the disease is either underestimated or overestimated and in most of these cases, the pre-surgical assessment of aggressiveness is upgraded upon surgery.

Deficiencies in sampling and retrieval of biopsy tissue can adversely affect a pathologist’s interpretation of prostate biopsy.

The need for better biopsy instruments became clear to Belleza, a serial entrepreneur in medical technology when he was biopsied for prostate cancer nearly 7 years ago. “This is antiquated,” he thought at the time.

His opinion was confirmed by discussions with urologist friends who told him the field had changed little since they were trained decades previously. One urologist told him, “If there ever was a procedure begging for innovation, it is prostate biopsy,” Belleza said.

More accurate and efficient prostate biopsies are needed now more than ever because biopsies are being performed more frequently as part of active surveillance in men with low-risk disease, due to advancements in genomic testing and improved imaging.

This has created a need for significantly improved higher volume/lower artifact samples from the same sized needle and more efficient workflow in and between the urology clinic and the pathology lab.

About 240,000 new cases of prostate cancer are diagnosed each year in the United States, with 29,000 deaths.

URO-1, established in 2017, is an emerging portfolio company of the North Carolina Biotechnology Center which in 2018 provided a $250,000 loan to support the company’s early product development.

In addition to its biopsy products, the company has developed the Repris™ Bladder Injection System for injecting onabotulinumtoxinA (BOTOX®️) in the bladder wall to treat women with overactive bladder. Clinical studies demonstrate that its use is associated with improved outcomes, increased patient comfort and reduced dropout rates for repeat treatment.