BiBBInstruments (BiBB) has developed the world's first electrically powered endoscopic core biopsy instrument, EndoDrill. The instrument is intended for EUS/EBUS-guided tissue sampling, the most advanced and rapidly growing area of endoscopy. The goal is to deliver tissue samples with higher precision and better quality than current techniques, with the aim of improving the diagnosis of cancers in, for example, the stomach, pancreas, liver, lung, and bladder.
International recognition
Many endoscopists have reached the end of the road with existing manually handled needle instruments for sampling and diagnosing suspected tumors in the organs of the gastrointestinal tract. This is how BiBB's CEO explained Fredrik Lindblad in a studio interview the prelude to recently receiving its first international recognition. Dr. Antonio Mendoza Ladd vid UC Davis even called EndoDrill a “game changer” for its ability to lead to more accurate cancer diagnoses and thereby improve patient treatment outcomes.
BiBB has received 510(k) clearance from the US FDA for EndoDrill GI, the most important product variant. In Europe, all three of the company's product variants are covered, EndoDrill GI, EndoDrill EBUS and EndoDrill URO, of CE marking according to the new European regulations MDR.
Successful introduction in Zagreb
EndoDrill GI is already undergoing clinical evaluations in both USA and Scandinavia and now the company is adding Southern Europe to that list. EndoDrill GI was recently introduced at the University Hospital Sisters of Mercy in Zagreb, Croatia. Dr. Tajana Pavic, who is head of the interventional gastroenterology unit, performed four patient cases at the introduction and succeeded in extracting large and intact tissue samples in all cases.
– Nice samples and a very fast procedure, she said in a comment on the fine samples, which were of a quality that she and her team are not used to seeing when used with today's standard EUS needle biopsy.
The evaluation of the product will continue in Zagreb as well as at hospitals in the US and Scandinavia, and BiBB will introduce the product at several new hospitals around Europe and the US this fall.
Strengthens patent portfolio
At the same time as EndoDrill GI is being introduced in new hospitals, we are also informed that the European Patent Office (EPO ), has issued a so-called Intention to Grant to approve BiBB's patent application in the region. This means that the EndoDrill family will be protected on the European market until October 2039.
Comments from the CEO
BioStock sought Bibb's CEO Fredrik Lindblad for a comment on the latest announcements.
To start with Fredrik, EndoDrill GI continues to produce fine tissue samples in clinics – most recently in Zagreb. How do you view this?
– The initial patient cases in Zagreb went really fantastically – four patient cases and so-called core biopsies in all cases. In three cases we got a “full hit” already after the first needle puncture and in the last more complicated case we got a hit at the second puncture. The standard with existing biopsy instruments is that three punctures are required, and that they usually result in fragmented samples.
What else did you take away from the introduction in Zagreb?
– We were confirmed that the learning curve is short with an experienced EUS endoscopist. We participated in four patient cases and after them the team in Zagreb is ready to continue running patient cases on their own, which bodes well for the future. The immediate feedback we received was that EndoDrill GI is easy to use, that sampling is faster and that the biopsy samples are of a quality that they have not seen before with EUS sampling. They will now continue the evaluation on their own.
When you look at the feedback you've received from the clinics so far, what stands out?
– So far, we have confirmed that EndoDrill GI truly fulfills a clinical need by improving sampling in many difficult-to-diagnose tumor changes in the gastrointestinal tract. We see a pattern that the product can be introduced quickly and that unusually fine samples (core biopsies) are often obtained from the first needle puncture. This means that sampling can be faster than with standard instruments.
What is the most important thing for you in this phase?
– I would say that our top priority during the fall is to reach as many users as we can. Let new endoscopists evaluate EndoDrill GI and thereby obtain valuable feedback on site. In addition, users are starting to discuss our new product among themselves in hospitals and also at medical congresses. The word about the new electrically powered biopsy instrument is thus spreading among EUS endoscopists. In the future, positive clinical evaluations will be converted into sales.