URO-1 Announces Presentation Results of Prostate Medical Device Studies at National Urology Meeting

GREENSBORO, N.C., May 10, 2022 /PRNewswire/ -- URO-1 Inc., www.uro1medical.com, an innovator of medical devices for urology and urogynecology, today announced that results of proof-of-concept studies of its SUREcore™ Prostate Biopsy Needle and coreCARE™ Specimen Retrieval Kit will be presented at the annual meeting of the American Urology Association, May 13-16 in New Orleans.

The two products are designed to increase the volume and improve quality of tissue specimens taken during prostate biopsies.

The increased use of molecular testing to complement prostate biopsy in the management of prostate cancer has highlighted the importance of tissue volume. Data from a leading molecular testing laboratory indicate that up to 15% of biopsy specimens fail molecular testing due to inadequate tumor volume.

"In our initial series of studies in trans-rectal and trans-perineal biopsies, the novel SUREcore needle collected 12-21% more volume by weight than conventional biopsy needles," said Jeffrey Proctor, M.D., a urologist in Atlanta. "We have initiated a study to replicate these initial findings and further assess the needle's impact on prostate biopsy tissue integrity, tissue artifact and sample-to-sample consistency. If confirmed, the increase in core volume would be expected to favorably impact tumor volume and tissues available for diagnostic testing."

Recent studies have demonstrated that current methods of retrieving tissue specimens from biopsy needles may compromise tissue integrity, cause workflow inefficiencies and impact analysis of biopsy specimens.

"In our initial study comparing different methods of retrieving animal tissue specimens from the biopsy needle, we found that the coreCARE Specimen Retrieval Kit employing a novel "touch-and-go" method, when compared to conventional methods, resulted in less tissue fragmentation and artifact," said Dan Wiener, M.D., a pathologist in Cartersville, Ga. "Our histology technician reported a significant reduction in the time to prepare prostate biopsy tissues for analysis. A new clinical study that is currently under way will see how well the new "touch-and-go" method works in a clinical environment with various assistants performing the tissue retrieval. We will be looking to see if this method will consistently produce high-quality slides regardless of the experience and technical skills of the person performing them. We will also determine whether or not this novel method results in workflow efficiencies and preserves tissue integrity."

URO-1, established in 2017, is an emerging portfolio company of the North Carolina Biotechnology Center, www.ncbiotech.org, 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.

For more information contact:

Ted Belleza, President and CEO
URO-1, Inc.
831-295-7133
tbelleza@uro1medical.com

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SOURCE URO-1, Inc.