BiBB’s CEO: “Zagreb confirms good samples and short learning curve”
The clinical introduction is in full swing for BiBBInstruments. The company’s first electric-driven biopsy instrument, EndoDrill GI, continues to impress with high-quality tissue samples, most recently at an introduction of EndoDrill GI at the University Hospital in Zagreb. Meanwhile, the European Patent Office announced the intention to grant the patent application for the EndoDrill technology. BioStock spoke to BiBB’s CEO Fredrik Lindblad to find out more.
BiBBInstruments (BiBB) has developed the world’s first electric-driven endoscopic core biopsy instrument, EndoDrill. The instrument is intended for EUS/EBUS-guided tissue sampling, the most advanced and fast-growing area of endoscopy. The goal is to deliver tissue samples with higher precision and better quality than today’s technology, 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 to sample and diagnose suspected tumours in the organs of the gastrointestinal tract. This is the picture that BiBB’s CEO Fredrik Lindblad drew in a studio interview in relation to recent international recognition. Dr. Antonio Mendoza Ladd of UC Davis even called EndoDrill a “game changer” for its ability to provide more accurate cancer diagnoses, thereby improving patients’ outcomes.
BiBB has received 510(k) approval from the FDA for the main product variant, EndoDrill GI. In Europe, all three of the company’s product variants, EndoDrill GI, EndoDrill EBUS and EndoDrill URO, are covered by CE marking according to the new European regulatory framework MDR.
Successful introduction in Zagreb
EndoDrill GI is already undergoing clinical evaluations in the US and Scandinavia and now the company is also adding Southern Europe to that list. EndoDrill GI was recently introduced at the Sestre Milosrdnice University Hospital in Zagreb, Croatia. Dr. Tajana Pavic, who is head of the unit for interventional gastroenterology, conducted 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 using today’s standard EUS needle biopsy.
The evaluation of the product will continue in Zagreb as well as at the hospitals in the US and Scandinavia and BiBB will introduce the product at several new hospitals around Europe and the US during the fall.
Strengthens the patent portfolio
While EndoDrill GI is being introduced in new hospitals, the European Patent Office (EPO) has given a so-called Intention to Grant on 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 reached out to BibBB’s CEO Fredrik Lindblad for a comment on the latest announcements.
To begin with, Fredrik, EndoDrill GI continues to produce fine tissue samples in clinics – most recently in Zagreb. What is you take on this?
– The initial patient cases in Zagreb went really fantastic – four patient cases and so-called core biopsies in all cases. In three of the cases, we got a “hit” already after the first needle pass and in the last, more complicated case, we got a hit on the second pass. With existing biopsy instruments, it is more common that you need three passes, and that they then usually result in fragmented samples.
What are your reflections on the introduction in Zagreb?
– We were able to confirm that the learning curve is short with an experienced EUS endoscopist. We participated in four patient cases and after those the team in Zagreb was 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 in EUS sampling. They will now continue the evaluation on their own.
When you look at the feedback you have received from the clinics so far, what stands out?
– So far, we have been able to confirm that EndoDrill GI really meets a clinical need by improving tissue sampling for many difficult-to-diagnose tumour changes in the gastrointestinal tract. We see a pattern that the product is quick to introduce and that you most often get unusually fine samples (core biopsies) already at the first needle puncture. This means that sampling can be done faster than with conventional instruments.
What is the most important thing for you in this phase?
– I would say that our top priority during the autumn is to reach as many users as we can manage. Allow new endoscopists to evaluate the EndoDrill GI and thus receive valuable feedback on site. In addition, users are starting to discuss our new product among themselves in hospitals and also at medical conferences. The rumour of the new electric-driven biopsy instrument is thus spreading among EUS endoscopists. Going forward, positive clinical evaluations will be converted into sales.
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