BiBBInstruments enters Sahlgrenska
| Published November 19, 2024

BiBBInstruments founder about the evaluation at Sahlgrenska

BiBBInstruments is taking 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 reached out to the company’s founder and CMO Charles Walther to hear his thoughts.

EndoDrill GI is the first electrically powered biopsy instrument in the world developed for endoscopic use. The instrument enables the extraction of high-quality core tissue biopsies, which improves the conditions for early and accurate cancer diagnosis in tumors of the gastrointestinal tract. The instrument is marketed in Europe and the USA and BiBBInstruments is now working intensively on clinical market studies ahead of a product launch.

Promising results from clinical collaborations

Among other things, tests were carried out at the University Hospital at the end of August. Sisters of Mercy in Zagreb, Croatia. Under the leadership 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 has been 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 the scientific journal Endoscopy International Open and was presented at the prestigious ACG Congress 2024 in Philadelphia.

EndoDrill GI is successfully tested at Sahlgrenska

Here in Sweden, evaluations have been underway since this spring, including on Karolinska University Hospital and BiBB recently announced that they have now also carried out the first clinical tests on Sahlgrenska Universitetssjukhuset in Gothenburg. The gastroenterologists who tested the instrument, Dr. Per Hedenstrom and then Riadh Sadik, are described as pioneers in endoscopic ultrasound in Sweden.

Together with BiBB's founder and CMO Charles Walther Four patient cases were conducted and overall high-quality tissue samples were obtained. After this initial session, the Sahlgrenska team will continue the clinical evaluation independently.

– It was very rewarding to be there myself and see users from yet another of Scandinavia's leading university hospitals test EndoDrill GI and provide feedback, says Charles Walther.

The evaluations are an important part of the strategy for a product launch. By giving more clinics the opportunity to test EndoDrill GI, the company collects valuable clinical feedback while also strengthening awareness of the product's potential.

Founder tells more

BioStock contacted Charles Walther for comment on the latest progress.

Charles Walther, founder of BiBBinstruments
Charles Walther, founder of BiBBinstruments

To start with, you are once again managing to obtain high-quality samples when evaluating 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 quickly as possible.

What feedback did you receive from the team in Gothenburg?

– A new exciting Swedish method that provides clearly visible core biopsies. The equipment is easy to install.

User feedback is highlighted as an important component of market preparation. Can you give examples of how feedback influences the work?

– The feedback with good samples is a clear indication to us that EndoDrill GI works as intended and that users can quickly adopt the method. This and the other information we take from users, teaches us to become better at bringing EndoDrill GI to more clinics.

What are the biggest challenges ahead of the launch of EndoDrill GI and how are you working on these?

– Our short-term goal is to have more hospitals and users in the US and Europe test EndoDrill GI as the final step before a launch to selected customers. It takes quite a bit of preparatory work and coordination to start testing at a new hospital, so it is definitely a challenge.

– In parallel, we are working more long-term towards a broader launch with a distribution partner. This means, as we recently communicated, that we are moving production to a new contract manufacturer in Sweden with high production capacity and that we are in discussions with several possible global distribution partners.