Despite some turbulence for BiBBInstruments in the early parts of 2021, the Swedish medtech has been able to take some key steps in its clinical evaluation of the world’s first CE-marked electromechanical biopsy instrument – EndoDrill Model X. BioStock got in touch with CEO Fredrik Lindblad to get his thoughts on the challenges and most important milestones reached by the company in 2021 and his expectations for 2022.
Looking back on 2021, Lund-based medical device company BiBBInstruments “BiBB” demonstrated resilience and determination in its ambition to bring to market a novel and better cancer diagnostics instrument – the EndoDrill Model X. This is the first CE-marked electromechanical endoscopic biopsy device for cancer diagnostics. Based on core needle biopsy (CNB), it is designed to provide better tumour sampling compared to conventional EUS (Endoscopic Ultrasound)-guided biopsy sampling methods like fine needle aspiration (EUS-FNA) or fine needle biopsy (EUS-FNB).
Read more about BiBB’s device and vision here, with a more detailed breakdown of how EndoDrill overcomes some of the shortcomings of conventional instruments.
Positive clinical outcome despite challenges
During 2021, the company has run two clinical validation studies with the Model X – EDMX01, for stomach tumours, and EDUX02, a pilot study in patients with suspected muscle invasive bladder cancer. Due to the pandemic, patient recruitment efforts in the studies were partially hindered.
However, a more substantial obstacle to patient recruitment came in April when the company was forced to temporarily halt all recruitment due to a production issue caused by an external supplier. BiBB was able to tackle the issue head on and quickly replaced the supplier, and thus resume patient recruitment just one month later.
Thanks to the swift response by the company, by the end of 2021, BiBB’s first study with EndoDrill, EDMX01, was completed successfully, and earlier than expected. After evaluating only seven out of twenty planned patients, results pointed to a high level of effectiveness and safety for EndoDrill. The device consistently takes deep high-quality tissue samples (core biopsies) from tumours in the upper gastrointestinal (GI) tract in a safe way, even in comparison to leading competing EUS-FNB instruments. These deeply situated tumours are generally very difficult to diagnose.
Read more about the completion of this study here.
Key steps towards potential commercialisation
BiBB kept its focus during the year, taking key steps to ensure smooth sailing in the company’s future commercialisation efforts. During Q2, the company submitted its third international patent application regarding EndoDrill. Patent protection is an important part of BiBBInstrument’s strategy, and, since 2018, the company has applied for three patents for EndoDrill: one European and two international applications. These are currently being processed, i.e., patent pending.
All the while, considering that the US market is the world’s largest market for EUS biopsy instruments, BiBB has been in dialogue with the FDA to investigate the appropriate regulatory strategy for a market approval of EndoDrill in the US.
Additionally, since EndoDrill is CE-marked according to the older MDD regulations, just before Christmas BiBB submitted a comprehensive application for MDR certification in accordance with the EU’s new regulation for medical devices. Certification according to MDR is a requirement to be able to continue to place products on the EU market and other markets where the CE marking applies. MDR certification is expected to take place during the latter half of 2022.
All in all, BiBB was able to stave off significant challenges during 2021 and keep focusing on collecting clinical evidence suggesting that biopsy sampling with EndoDrill is safe and effective for the diagnosis of several of the most serious cancers. BioStock reached out to BiBB’s CEO Fredrik Lindblad to get his take on 2021 and what’s to come for the company in 2022.
»We have a lot of interesting activities and milestones looking into 2022. Initially, we expect our pilot GI-study to be published and presented at a scientific congress. We are also in advanced discussions with some Swedish university hospitals about starting post-market studies with our CE-marked system. The endoscopists seem to be very curious to evaluate our new electromechanical biopsy instrument in several indications, such as pancreas, lymph nodes and subepithelial lesions (SEL) tumours in the GI tract, all of which are difficult to diagnose with conventional EUS methods.« — Fredrik Lindblad, CEO BiBBInstruments
Fredrik, when taking a look back at 2021, how would you sum up BiBB’s achievement in just a few words?
– It was definitely a very challenging year for the team that ended in a very positive way. After a lot of obstacles and hard work during the prevailing pandemic, we could wrap up the year with the completion of our first pilot clinical study showing very promising data. For us, it is a clear signal that we are on the right track, and our belief that we have developed an extraordinary product for early cancer diagnosis has consequently been strengthened. I am also proud that our team was able submit the EU MDR application before year end.
What is your take on the fact that the EDMX01 trial ended early?
– The doctors’ enthusiasm spread to the entire team, and for us it is a clear indication that we have developed a long-awaited, effective EUS biopsy instrument. This may be the first step towards establishing sampling of true core biopsies in endoscopy. In fact, we follow a trend that has already taken place for percutaneous needle biopsy when sampling tissue in the breast and prostate. Also, in endoscopy it has become necessary to enable larger tissue samples with more specific information to meet the ever-increasing requirements of precision medicine.
When do you expect the EDUX02 to be completed?
– Previously, we thought the bladder cancer study would end in December, but now we expect to recruit the remaining few patients in quarter 1 2022. We are eagerly awaiting the completion of this pilot study as the subsequent larger efficacy study depends on the achievement of certain endpoints in the pilot trial.
Finally, what are you most excited about for BiBB during 2022?
– Oh, we have a lot of interesting activities and milestones looking into 2022. Initially, we expect our pilot GI-study to be published and presented at a scientific congress. We are also in advanced discussions with some Swedish university hospitals about starting post-market studies with our CE-marked system. The endoscopists seem to be very curious to evaluate our new electromechanical biopsy instrument in several indications, such as pancreas, lymph nodes and subepithelial lesions (SEL) tumours in the GI tract, all of which are difficult to diagnose with conventional EUS methods.
– For the study program relating to bladder cancer, the pilot study will be completed, published, and presented. Assuming a positive result, an efficacy study, including 64 patients, will start during the Spring.
– It will also be an intensive year in the quality and regulatory area as we are aiming for FDA 510(k) clearance for EndoDrill. Additionally, our ISO 13485 quality management system for medical devices will be re-certified, and we strive to receive an initial EU MDR certification in the second half of 2022.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.