Despite the challenges driven by the pandemic and some production issues during the first half of 2021, Swedish medtech BiBBInstruments has managed to keep to the scheduled clinical timelines for evaluating the world’s first CE-marked electric biopsy instrument – EndoDrill Model X. BioStock reached out to CEO Fredrik Lindblad for a comment.
Endoscopic ultrasound (EUS), a minimally invasive procedure to assess gastrointestinal and lung diseases, is a relatively new cancer diagnostics method and the fastest growing endoscopic procedure. However, today’s manual EUS biopsy instruments have several limitations and do not live up to the requirements set by the more individualised cancer treatments of the future.
The main goal for BiBBInstruments is to revolutionize the EUS tissue acquisition and cancer diagnostics arena by offering smarter and more efficient biopsy instruments. The company plans to do so not by building a new market, but rather by replacing the existing manual biopsy instruments with the company’s own electric EndoDrill Model X for all sampling with EUS.
Read more about the world’s first CE-marked electric biopsy instrument and its benefits here.
Bypassing challenges in Q2
As alluded to in BiBBInstrument’s Q2 report, the first part of 2021 put in front of a series of obstacles to try to derail it from reaching its goal. First, of course, was the pandemic, which made it challenging to proceed with patient recruitment in the company’s 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.
However, the more significant challenge came in April when the company was forced to temporarily halt patient recruitment due to a production issue caused by an external supplier for the company. BiBBInstruments was able to tackle the issue head on, and quickly replace the supplier, and thus resume patient recruitment just one month later. This means that both studies’ timelines remain on schedule and are planned to be completed in 2021.
Read more about the clinical trials here.
Third patent application
In the midst of all the commotion regarding the production issue, BiBBInstruments kept its focus and submitted its third international patent application regarding EndoDrill Model X. Patent protection is an important part of BiBBInstrument’s business strategy, and a solid patent portfolio will go a long way towards ensuring smooth sailing in the company’s commercialisation efforts.
BioStock was able to get in touch with BiBBInstrument’s CEO Fredrik Lindblad to get his thoughts on the year so far and his expectations for what is to come in the rest of 2021.
Fredrik, 2021 has presented some key challenges to BiBBInstruments, but you were able to overcome these obstacles. What was going through your mind during this period and how does it feel to know that your clinical timelines are back on schedule?
– I have to admit that it was really tough to suffer from an underperforming supplier just when the Covid situation seemed to slightly improve at our participating hospitals. I am proud that our team was able to solve the problems in a short time and that we could resume both studies.
Speaking of which, how is patient recruitment going now for both studies and what do those timelines look like?
– After our clinical partners’ summer break, we expect a more normal enrolment pace during the autumn. I have to say that our confidence in the product has gradually increased, and we really look forward to completing the studies during the year followed by the publication of each study.
Finally, what milestones are you most looking forward to in the months ahead?
– Due to the extreme workload, it will be very nice for the whole team when we submit the complete MDR application. However, the most important milestones ahead of us are the completion of our clinical pilot trials.
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