BiBBInstrument’ founder on the Sahlgrenska evaluation
BiBBInstruments takes another step in the clinical evaluation of EndoDrill GI. Recently, Sahlgrenska University Hospital in Gothenburg joined the growing group of clinics evaluating the instrument. BioStock contacted the company’s founder and CMO Charles Walther to get his thoughts.
EndoDrill GI is the world’s first electrically powered biopsy instrument developed for endoscopic use. It enables the extraction of high-quality core tissue biopsies, which provides early and accurate cancer diagnosis in tumors of the gastrointestinal tract. The instrument is market-cleared in Europe and the US, and BiBBInstruments is now working intensively on clinical market studies before launching the product.
Promising results from clinical collaborations
Tests were carried out at the end of August at the Sestre Milosrdnice University Hospital in Zagreb, Croatia. Under the guidance of Dr. Tajana Pavic and her experienced team in interventional gastroenterology, all biopsies resulted in complete histological diagnoses, confirming the instrument’s high diagnostic accuracy.
On the other side of the Atlantic, the instrument was evaluated in a clinical case series of eight patients at UC Davis Health in California. All biopsies also resulted in high-quality core tissue samples. The results were published in Endoscopy International Open and presented at the prestigious ACG Congress 2024 in Philadelphia.
EndoDrill GI successfully tested at Sahlgrenska
Evaluations have been underway in Sweden since last spring, including at Karolinska University Hospital. BiBB recently announced that it has also conducted the first clinical sampling at Sahlgrenska University Hospital in Gothenburg. The gastroenterologists who tested the instrument, Dr. Per Hedenström and Dr. Riadh Sadik, are described as pioneers in endoscopic ultrasound in Sweden.
Four patient cases were conducted together with BiBB’s founder and CMO, Charles Walther, and overall, high-quality tissue samples were taken. After this initial session, the team at Sahlgrenska will continue the clinical evaluation independently.
– It was very rewarding to be there and see users from yet another of Scandinavia’s leading university hospitals test EndoDrill GI and contribute with feedback, says Charles Walther.
Evaluations are an important part of the product launch strategy. By allowing more clinics to test EndoDrill GI, the company collects valuable clinical feedback and strengthens awareness of the product’s potential.
Founders tell us more
BioStock reached out to Charles Walther for comment on the latest advancements.
You once again took high-quality samples when evaluating the EndoDrill GI. What does this mean for you?
– This means that the instrument works as intended and that users can quickly take core biopsies, i.e., high-quality samples. This is important so that patients can receive the right treatment as soon as possible.
What feedback did you get from the team in Gothenburg?
– An exciting new Swedish method that provides highly visible core biopsies. The equipment is easy to install.
User feedback is identified as an important component of market preparation. Can you give examples of how feedback affects the work?
– The feedback with good samples clearly indicates that EndoDrill GI works as intended and that users can quickly adopt the method. This and the other information we take on board from the users teach us to become better at bringing EndoDrill GI to more clinics.
What are the biggest challenges before the launch of EndoDrill GI and how do you work with these?
– Our short-term goal is to allow more hospitals and users in the US and Europe to test EndoDrill GI as the final step before launching it to selected customers. Starting tests at a new hospital requires quite a lot of preparatory work and coordination, so it is clearly a challenge.
– In parallel, we are working more long-term on a broader launch with a distribution partner. As we recently communicated, this means that we are moving production to a new contract manufacturer in Sweden with high production capacity and are in discussions with several possible global distribution partners.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
