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FDA clearance opens US market for BiBBInstruments


FDA clearance opens US market for BiBBInstruments

20 April, 2023

Medtech company BiBBInstruments recently received 510(k) clearance from the FDA for its lead product, EndoDrill GI. Now, the company expects also a new market approval in Europe  –  a CE certificate according to MDR – for all products in the EndoDrill product portfolio within 3-6 months. BioStock contacted CEO Fredrik Lindblad for a comment. 

Lund-based BiBBInstruments (BiBB) aim to revolutionise the sampling of hard-to-detect and life-threatening cancers through a new type of endoscopic ultrasound (EUS) biopsy instrument, EndoDrill. With the help of a motorised rotating hollow needle, the instrument can provide solid tissue samples of higher quality compared to current endoscopic devices. This increases the chances of a complete diagnosis and thus an earlier start of treatment.

Multiple parallel target indications

The EndoDrill system includes a product portfolio with three product variants. Two have undergone initial clinical evaluation. Notably, the first clinical trial with EndoDrill GI for the diagnosis of deep tumours in the stomach was completed earlier than expected in 2021 after producing very convincing data. Learn more.

According to BiBB, this product variant has great potential within the largest indication for EUS biopsy, pancreatic cancer. The company intends to focus on this indication next. CEO Fredrik Lindblad talked to BioStock about BiBB’s plans for within pancreatic cancer in a previous interview.

As for EndoDrill URO, BiBB’s second product variant, the company’s clinical partner completed a pilot study last year regarding muscle-invasive bladder cancer, MIBC. The next step is a scientific publication of the study results. The third product variant, EndoDrill EBUS, is at the end of the development phase and is indicated for lung cancer.

FDA 510(k) clearance opens up opportunities in the US

Based on BiBBInstrument‘s regulatory documentation with impressive results in comparative tests, the company received FDA clearance for its flagship product, EndoDrill GI on March 30. The market reacted positively, and the share rose by a maximum of 140 per cent. Most importantly, however, is that this decision opens up several opportunities for the Swedish company on the world’s largest market. Watch Fredrik Lindblad comment on the news in BioStock’s studio here.

Comments from the CEO

BioStock contacted CEO Fredrik Lindblad to find out more about the implications of the FDA clearance, the MDR certification and what the plans look like going forward.

Fredrik, how important is the FDA clearance for EndoDrill GI?

– It feels fantastic that we can now offer the only electric-driven endoscopic biopsy instrument for improved tissue sampling on the US market with EndoDrill GI. Thanks to our dedicated team, we have managed to become the first with an FDA clearance for the next generation EUS biopsy instrument.

Does this change your previous plans to conduct clinical studies with EndoDrill GI in pancreatic cancer in Sweden?

– Our strategy has been based on the expectation that we would receive an MDR certificate in Europe before the FDA clearance in the USA. This would have us continue our clinical market studies domestically. With FDA clearance coming first, it gives us the opportunity to start clinical market activities in the US a little faster than we expected. This week we are visiting the ESGE Days congress in Dublin and we have planned meetings with potential clinical partners, so these are exciting times.

What benefits do you see in possibly conducting clinical studies in the US?

– In medical technology, much revolves around the US, which is by far the largest market also in endoscopy. Several of the largest players, as well as potential distribution partners for BiBB, are American companies. So, being visible already now and being able to start clinical marketing activities in the US will open many opportunities for future commercialisation.

BiBBInstruments vd Fredrik Lindblad i BioStocks studio
BiBBInstruments CEO Fredrik Lindblad

You plan, given a European market approval (CE certificate according to MDR), to carry out a first launch of EndoDrill GI in Sweden during the year. Could this be relevant in the US market instead?

– Our plan to start launching in Sweden at the end of the year depends on when EndoDrill receives CE marking in accordance with MDR regulations. Despite the fact that the MDR process has been prolonged, there is still a realistic possibility that we can sell our first EndoDrill systems to Swedish hospitals during the year. The FDA clearance will initially be used to begin clinical marketing activities.

Finally – your CE approval according to the new European MDR regulation continues to be delayed. What is the reason for this and when do you hope to have this in place?

– It is true that the MDR process has been protracted for us, which BiBB certainly shares with a clear majority of companies that have submitted MDR applications to hard-pressed notified bodies in Europe. The CE marking for EndoDrill according to the old MDD directive expired in August last year, which has affected our clinical activities. Now, however, after in-depth talks with our review body, we have a clear plan to check off the only remaining remark in our MDR application.

– We expect to receive the CE certificate within approximately 3-6 months. The certificate will have a broad and extended indication that includes all three instruments in the EndoDrill product family. Regulatory approvals in both the US and Europe will bring great opportunities for us. More information will be communicated later in the spring.

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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