BiBBInstruments’ cancer biopsy device, EndoDrill, has earned high praise from physicians who conducted the first clinical cases at Karolinska University Hospital in Stockholm, Sweden. This positive feedback follows the endorsement of EndoDrill as a “game-changer” in endoscopic ultrasound sampling by the Medical Director of Endoscopy at UC Davis in the US. BioStock spoke with BiBB’s CEO Fredrik Lindblad to learn more.

BiBBInstruments (“BiBB”) is pushing forward steadily with preparations for commercialisation activities with its electric-driven endoscopic (EUS) biopsy device for cancer diagnostics, EndoDrill.

Last spring, the company received FDA 510(k) clearance in the US for its lead product variant, EndoDrill GI – used for sampling in the gastrointestinal tract, e.g. pancreatic tumours, and submucosal tumours in the stomach – opening the doors to the world’s largest market for endoscopy. One of the first key steps for commercialisation involved having the device evaluated in a clinical setting at a major US hospital to give physicians there a sense of how the EndoDrill core-needle biopsy (EUS-CNB) instrument outperforms conventional fine-needle biopsy (EUS-FNB) sampling devices. Read more about the benefits of EndoDrill over current EUS biopsy instruments here.

Successful clinical procedures in the US

Earlier this year, BiBB announced that the first clinical procedures with EndoDrill GI in the US were successfully completed at UC Davis Health in Sacramento, California. The reaction from the staff there was positive, and Dr Antonio Mendoza Ladd described the device as a “game changer.”

Since then, the hospital in California has published an article on its website summarising the impressions from the first three patient cases and describing the advantages of EndoDrill GI compared to today’s standard of care, i.e. manually stabbing needle instruments. The key takeaway being that EndoDrill enables more accurate cancer diagnoses leading to improved treatment for patients, which can contribute to better patient outcomes.

Pre-commercial clinical evaluation in Sweden

Not long after, the Swedish medtech company announced being granted a CE certificate according to MDR (the new EU regulation for medical devices, replacing MDD) for the entire EndoDrill product family (EndoDrill GI, EndoDrill EBUS, and EndoDrill URO). The decision gives the company the go-ahead to commercialise EndoDrill in Europe.

Last week, BiBB announced that the first clinical pre-commercial procedures with EndoDrill GI at Karolinska University Hospital (KUH) in Stockholm have been successfully performed.

Physicians at the hospital performed tissue sampling on two patients with tumours in the pancreas and stomach, respectively. In both cases, biopsies taken with EndoDrill have been shown to provide diagnoses. According to BiBB, the instrument was called “FNB on steroids” in the endoscopy room, signalling that it takes larger, more informative biopsies compared to the latest generation of existing EUS instruments (EUS-FNB).

»Expressions such as “FNB on steroids” and “game changer” indicate that the physicians were pleasantly surprised by EndoDrill’s ability to capture better and larger biopsies« — Fredrik Lindblad, CEO BiBBInstruments

CEO insights

BioStock got in touch with BiBB’s CEO Fredrik Lindblad to learn more about how these first clinical evaluations in Sweden impact the commercialisation prospects with EndoDrill GI.

Fredrik, comparing the clinical cases at UC Davis with those at Karolinska University Hospital, are there any major differences worth mentioning, i.e. tumour types, patient groups, or any sampling challenges?

– At both hospitals, we saw physicians taking tissue samples from both stomach and pancreatic tumours. Incidentally, at UC Davis it was the first time ever that EndoDrill GI was used for sampling in the pancreas, i.e. in an organ outside the gastrointestinal tract itself, and it was replicated at Karolinska.

Were there similar outcomes in both scenarios?

– In both the US and Sweden, physicians managed to sample true core biopsies, i.e. the ultimate goal of all sampling of suspected cancer tumours.

Could you explain the reaction, “FNB on steroids?”

– Physicians in the field, endosonographers to be exact, are not really used to obtaining solid “sausage-like” core biopsies with existing manual needle instruments (EUS-FNA/EUS-FNB). These high-quality tissue samples are more common in percutaneous biopsies when using rigid core needle instruments in easily accessible organs such as breasts but are generally not seen in traditional endoscopic sampling. Expressions such as “FNB on steroids” and “game changer” indicate that the physicians were pleasantly surprised by EndoDrill’s ability to capture better and larger biopsies.

Samples were taken on two patients at Karolinska University Hospital. Are there plans for more patient sampling there?

– Yes, we have recently been informed that the physicians have continued successfully on their own, and we have just sent additional instruments to the hospital for an extended evaluation phase.

Do you have more such evaluations planned across Europe? If so, could you give us more details about your plans?

– In the near future, we plan to start case evaluations at a Norwegian university hospital and a Swedish university hospital.

Are you still in contact with both institutions, and if so are you getting any useful feedback regarding EndoDrill’s performance?

– UC Davis Health continues with sampling of patients on its own with the aim of publishing scientific clinical data after a series of cases. Now that the first five patient cases have been performed, the physician in charge told us that other departments – pathology and oncology – have asked for EndoDrill biopsies as they notice the difference. We will meet this physician at the ESGE Days congress in Berlin on April 25-26, where we will further discuss his initial clinical experience. The evaluation at Karolinska in Stockholm is still at an early stage, but the physicians wanted us to send more EndoDrill instruments for an extended case series, which is a promising sign.

Could you tell us more about BiBB’s pre-commercialisation strategy – what are the key steps to take before a full launch of EndoDrill GI on the US and European markets?

– In the near future, we will continue with evaluations at some Scandinavian hospitals. Several physicians showed interest in evaluating the product when we showcased EndoDrill GI for the first time at a Nordic EUS congress in Oslo in Nov/Dec 2023. We strive to convert initial Swedish case evaluations with positive outcome to our first sold instruments.

– In addition, we plan to initiate a clinical multicentre study with EndoDrill GI for sampling in pancreatic cancer together with some of Sweden’s leading university hospitals. This clinical evidence for what is perhaps our most important indication is needed in the long term in the global marketing of EndoDrill GI. Discussions with potential global distribution partners are ongoing, and we will be present at the most important congresses for endoscopic ultrasound devices.

Now that pre-commercial clinical evaluations with EndoDrill GI have been performed successfully at two different hospitals in two different countries, does this increase your confidence in a positive commercialisation process in both the US and Europe?

– I have to say that the recent patient cases fortify our confidence in EndoDrill technology. It has been a great experience to follow physicians and staff in the endoscopy room together with our founder Dr Charles Walther. Personally, it has been rewarding to stand close to physicians who are using EndoDrill GI for the first time and to hear positive exclamations, such as “game changer,” when they acquire unusually large biopsy samples. An efficient and safe product is the foundation for successful commercialisation, so the start of the evaluation phase could not have been better, in my opinion.

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