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BiBB’s CEO: “European CE approval is a significant milestone”

BiBB granted CE certification according to MDR

BiBB’s CEO: “European CE approval is a significant milestone”

7 February, 2024

BiBBInstruments has received CE certification for EndoDrill in Europe in accordance with MDR. The certification is valid for all three variants of the EndoDrill product family – diagnostic tissue sampling in pancreas, lungs and urinary bladder cancer – paving the way for a market launch of the lead product EndoDrill GI in Sweden later this year. EndoDrill has thus become the first electric-driven endoscopic biopsy instrument to be cleared in both the US and Europe in less than a year. BioStock reached out to BiBB’s CEO Fredrik Lindblad for a comment.

BiBBInstruments (BiBB) is well on its way towards commercialisation with EndoDrill GI, both in the US and Europe. EndoDrill is the world’s first market-cleared electric-driven EUS-CNB instrument, i.e. a biopsy technique based on core needle biopsy. Read more about this technique here. Clinical pilot trials have demonstrated that the instrument yields tissue samples of markedly superior quality compared to contemporary manual needle techniques.

Two major milestones in a week

Last year, BiBB received 510(k) clearance from the US Food and Drug Administration (FDA) for EndoDrill GI – one of three variants for the EndoDrill product family. This decision opened the door to the world’s largest market for endoscopic instruments. Today, the Swedish medtech company announced the highly anticipated news of being granted a CE certificate according to MDR (the new EU regulation for medical devices, replacing MDD) for the entire EndoDrill product family. This covers all three product variants and gives the company the go-ahead to commercialise EndoDrill in Europe.

The news follows BiBB’s announcement last week that the first clinical procedures with EndoDrill GI in the US were successfully completed at UC Davis Health in Sacramento, California.

Dr Antonio Mendoza Ladd, Medical Director of Endoscopy at UC Davis Health, who conducted the first clinical cases of the EndoDrill GI in the US, had this to say after the procedures:

“This device will be a game changer in my opinion!”

Dr Charles Walther – BiBB’s founder, CMO, and specialist in clinical pathology and cytology at Skåne University Hospital in Lund – was present at UC Davis Health when the procedures were performed with EndoDrill. Stay tuned for a one-on-one interview with Dr Walther about the US experience directly from BioStock’s studio.

CEO insights

BioStock reached out to BiBB’s CEO Fredrik Lindblad to get his take on the importance of the recent news.

Congratulations on the CE certification for EndoDrill in Europe! What does this mean for the company?

BiBBInstruments vd Fredrik Lindblad i BioStocks studio
Fredrik Lindblad, CEO BiBBInstruments

–  Concretely, this means that our entire EndoDrill product family is approved for marketing and sales in Europe. Together with last year’s FDA market clearance of the lead product variant EndoDrill GI in the US, this is our single most important milestone yet.

What will happen now in terms of the planned market introduction?

– We will now immediately use the CE approval for EndoDrill GI. In the near future, we will contact our clinical partners in Sweden to immediately start new clinical activities with a focus on the largest indication pancreatic cancer. We will also benefit from all the interest we received at the Nordic EUS Meeting in Oslo, December 2023. We have a number of endoscopy specialists in Scandinavia who now want to evaluate EndoDrill GI in their departments. In addition, we are planning to start a Swedish multicenter study in the indication pancreatic cancer. This is data that we will need for future global sales success. Later in the year, we will commercially launch EndoDrill GI on the Swedish market.

– The CE approval also includes EndoDrill EBUS (lung cancer) and EndoDrill URO (muscle-invasive bladder cancer), which means that future studies for these product variants will be both easier to administer by our clinical partners and less costly for the company.

Finally, could you briefly comment on the outcome of the clinical procedures with EndoDrill GI in the US and how those will impact BiBB moving forward?

– Through the recent first US patient cases with EndoDrill GI at UC Davis in Sacramento, CA, we have gotten the best possible start in the most important market for EUS biopsy instruments. The plan going forward is to run more patient cases at UC Davis and also to initiate clinical marketing activities in more clinics in the US. In the US and globally our goal is to sign an agreement with one or more global distribution partners for rapid international sales growth.

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.

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