BiBBInstruments AB reported that the first clinical study with EndoDrill® URO for muscle-invasive bladder cancer has been scientifically published in European Urology Open Science. The study shows that EndoDrill® URO safely can take treatment-based tissue samples earlier in the care chain in case of suspicion of deep-growing tumors in the urinary bladder.  The research group concludes that it is now warranted to follow up the pilot study with a randomized efficacy study, which is already planned and regulatory approved.

The study has now been published in the scientific journal European Urology Open Science 53 (2023) 78-82 titled "Urodrill - a novel MRI-guided endoscopic biopsy technique to sample and molecularly classify muscle-invasive bladder cancer without fractionating the specimen during transurethral resection" (note that "Urodrill" is identical to the product EndoDrill® URO). The purpose of the study was to investigate whether it is possible to take tissue samples of deep-growing tumors for the first time already at the initial endoscopic examination of the bladder. With an early diagnosis, the more invasive standardized surgical procedure (TURB) could be avoided and treatment of patients with MIBC could be started earlier.

The study compared biopsies taken with EndoDrill® URO with tissue samples taken during the surgical procedure. The publication shows good results with the new biopsy instrument EndoDrill® URO. EndoDrill® URO managed to take a biopsy in 9 out of 10 examined patients and in the tenth case the tumor was very close to large blood vessels, which meant that user could not go so deep in the individual case. In 6 out of 9 cases, muscle-invasive bladder cancer could be confirmed and in 7 out of 9 cases, the muscle layer of the bladder wall, i.e., deep growth, could be assessed.

In 8 cases, genetic mutation analysis was performed and in 7 of these, the analysis was technically successful. No complications related to tissue sampling with EndoDrill® URO were noted. The large research team concluded that it is possible to take treatment-based tissue samples with EndoDrill® URO early on if bladder cancer is suspected.