New device for prostate biopsy designed to minimize risk of commonly occurring infections and complications
One in 6 men worldwide develops prostate cancer and they require a prostate biopsy as a key step in the diagnostic pathway. Over 4 million prostate biopsies are performed annually in the USA and EU; this number is growing rapidly. Despite the use of an oral antibiotic risk of infection is up to 7% and complications can be severe even fatal.
Our solution, a Drug-Eluting Biopsy Needle (DEBN) is a biopsy needle with an optimal combination of antibiotics attached to the surface. The antibiotics are released directly to the surgical site during the prostate biopsy procedure delivering the antibiotic and cutting infection rates. DEBN additionally provides (as part of its product set) a similarly coated needle for the administration of the anesthetic, reducing the infection risk associated with the anesthesia element of the procedure.
DEBN’s needles have strong competitive advantages over the current standard in transrectal prostate biopsies. Microbes in the area of the colon through which the needle passes are killed by antibiotics that cover the surface of the DEBN needles. The reduced rate of infection results in significant improvements in patient outcomes and healthcare cost savings.
Trial preparation is advanced, with the CRO contracted, management appointed and regulatory documentation submitted. The DEBN’s product will be trialed in clinics in 8 medical centres Germany and Poland, on a total of 160 patients. The trial will be completed within 12 months (possible as the follow-up period is short).