BiBBInstruments ( "BiBB”) wants to enable improved sampling of difficult-to-diagnose and life-threatening cancers using the company's electrically powered biopsy instruments for endoscopy, EndoDrillThis technique has been developed specifically to obtain high-quality tissue samples in conjunction with endoscopic ultrasound (EUS) and endobronchial ultrasound (EBUS).
BiBB currently offers three different product variants, two of which have already undergone clinical evaluation. EndoDrill GI is designed to diagnose tumors in the upper gastrointestinal tract, while EndoDrill URO is intended for diagnosing muscle invasive bladder cancer (MIBC). EndoDrill URO is the only product of the three variants that does not use ultrasound guidance as a standard cytoscope is used for examination and tissue sampling. The third variant, EndoDrill EBUS, is in a late stage of development and is intended for use in lung cancer diagnostics.
Positive outcome in bladder cancer study
On Wednesday last week, BiBB announced that the results from the first clinical study with EndoDrill URO have been published in the scientific journal European Urology Open ScienceThe study evaluated 10 patients and compared biopsies taken with EndoDrill URO with samples taken with the standard invasive method of transurethral resection of bladder tumors (TURB). The study aimed to explore the possibility of taking tissue samples of deep-growing tumors in the bladder for the first time during the initial endoscopic examination, thus avoiding the TURB procedure.
The results show that the instrument is safe to use and can take crucial samples earlier in the care process for suspected bladder cancer. This could lead to earlier diagnosis and potentially earlier treatment, thus improving survival.
EndoDrill URO was successful in obtaining a biopsy in 9 out of 10 patients examined. In the tenth case, sampling was limited by large blood vessels. In 6 out of 9 cases, muscle-invasive bladder cancer could be confirmed, and in 7 out of 9 cases, deep growth of the muscle layer of the bladder wall could be assessed. Genetic mutation analysis was also performed in 8 cases, and in 7 of these, the analysis was successful.
The study was planned and conducted by a leading clinical research group, led by Professor Fredrik Liedberg at Skåne University Hospital, whose hypothesis is that early diagnosis with EndoDrill can enable a better and earlier assessment of the depth of the tumor. This would mean an earlier start of treatment and a higher survival for a patient group whose five-year survival is only about 50 percent.
Read more about the background of the study and the market potential for EndoDrill here.
CMO talks about the potential within MIBC
BioStock contacted CMO Charles Walter who told us more.
Given the new findings, what benefits can EndoDrill URO offer patients with suspected MIBC?
– Most importantly, EndoDrill URO was able to provide an earlier confirmed diagnosis, including information on optimal treatment and prognosis. A major problem with current treatment is that the standard diagnostic surgical procedure TURB can delay definitive treatment.
How much earlier can tissue sampling with EndoDrill URO lead to, in the best case scenario?
– There are always variations and many factors to take into account, but in the best case scenario, a successful early biopsy sample with EndoDrill URO could reduce the time to treatment by 1 to 1,5 months. An important question for the research team is to see whether this time reduction can positively affect survival.
A randomized efficacy study will be the next step with this product variant. Can you tell us more about the study?
– The next phase is a randomized clinical trial that will compare early and less invasive tissue sampling with EndoDrill URO with the standard treatment of surgical TURB. The study, which has already been approved by regulatory authorities, will include 64 patients with suspected MIBC, and the rigorous study protocol includes assessment of time to treatment, safety, instrument performance, survival and health economics.
What is the market potential within MIBC?
“If successful, the value created for the patient and healthcare system with an early, accurate and treatment-determining diagnosis through EndoDrill biopsy sampling is significant, and our new biopsy product has the potential to change the current treatment procedure for MIBC. The independent clinical research group uses the phrase “paradigm shift” to indicate the potential of an earlier diagnosis of MIBC.”
– Every year, approximately 600 people are diagnosed with bladder cancer worldwide. In approximately 000 percent of these cases, the cancer grows into the bladder muscle. This represents the market opportunity for EndoDrill URO and there are currently no competing biopsy instruments in the MIBC indication.