BiBBInstruments (BiBB) has developed a series of electrically powered endoscopic biopsy instruments, EndoDrill, which is used in endoscopic ultrasound (EUS/EBUS) tissue sampling. The instruments make it easier for endoscopists to take higher quality and larger samples compared to traditional, manual needle instruments. The company's main product, EndoDrill GI, is the first of its kind and designed for sampling true core biopsies in cancer diagnostics of the gastrointestinal tract.
Last year showed several clear examples of the product's capabilities, including eight patient cases with EndoDrill GI in the US that were reported in the scientific journal Endoscopy International OpenThe results showed 100 percent diagnostic accuracy after a single needle puncture, and the quality of the tissue samples surpassed that of corresponding samples taken with conventional needle instruments.
First commercial step taken
Following the good results, the company was rewarded with its first commercial order from the University Hospital at the end of January. UC Davis Health in the US. This initial order is of a smaller scale but was placed at a premium pricing, confirming the product's position as a premium product.
Initial liver biopsies performed
Endoscopic ultrasound-guided liver biopsy (EUS-LB) is the latest biopsy method for liver sampling. In February, the first patient cases with EUS-LB were performed with EndoDrill GI at the University Hospital Münster (UKM) in Germany. Here too, the sampling resulted in genuine core biopsies.
Shortly thereafter, further sampling was reported with resulting high-quality core biopsies of the liver and pancreas – this time at Henry Ford St. John Hospital in Detroit. This will be the second US hospital to initiate clinical evaluation of EndoDrill GI. BiBB believes that EUS-LB is an emerging indication and the initial liver sampling shows the product's potential to improve diagnostics also for patients with liver diseases.
Sees great potential in lung
In addition to EndoDrill GI, we are also developing EndoDrill EBUS, which refers to ultrasound-assisted sampling of the lungs. The company sees great potential in EndoDrill EBUS as EBUS increasingly becomes the preferred method for diagnosing and staging lung cancer. The instrument's capacity to deliver abundant core tissue biopsies could meet pulmonologists' growing need for samples for both diagnostics, staging and genetic analysis, making it a potential game-changer in the market.
CE approval is in place and the plan going forward is to start a pilot study and begin work on submitting an FDA 510(k) application, with the goal of introducing the product next year.
The first commercial step has now been taken, with a broader launch planned to start later this year. To continue the journey, 2025 began with strengthening the cash. SEK 27,6 million was raised through a unit issue, which also included series TO1 warrants. The redemption will take place May 22 - June 6 and, if fully exercised, the company can be provided with an additional approximately SEK 9 - 16,5 million.
CEO comments
With funding in place, production capacity is now being scaled up, while discussions are underway with potential distribution partners. The goal is to sign agreements with one or more partners during the year, with whom commercialization can be shifted to the next gear.
In other words, BiBB is in a very interesting position, which is why BioStock contacted the CEO Fredrik Lindblad to find out more.
You have started 2025 with a high news flow. How would you describe the position that BiBB has today?
– We have exciting times ahead. We operate in a fast-growing market segment where no revolutionary product innovations have been launched in the last decade. Our EndoDrill concept, which enables efficient sampling with an electrically powered rotating needle, has so far proven to work better than conventional methods. The goal is to have more and more doctors evaluate EndoDrill GI and to begin sales in the fall through one or more distribution partners.
Regarding the initial liver biopsies, how does that strengthen the case for EndoDrill GI?
– We have seen endoscopic ultrasound-guided liver biopsies (EUS-LB) as a possible bonus indication. Now, clinical use seems to be increasing, which suddenly makes this a more concrete opportunity for EndoDrill. The EndoDrill GI trials have just started, so it is too early to predict what this means for us, but we are following the development with great interest.
How do you assess the market potential for liver as an emerging indication and what plans do you have to further explore liver biopsies with EndoDrill GI?
– Liver biopsy, traditionally performed with a rigid needle inserted through the skin, is the gold standard for diagnosis and selection of treatment options for several liver diseases. The less invasive method EUS-LB is establishing itself as an alternative, as it has several clinical and practical advantages compared to conventional techniques. A growing area of application for EUS-LB is the investigation of non-alcoholic fatty liver disease (NAFLD), an indication that is becoming increasingly common.
– As previously mentioned, we will return to the possibilities of EndoDrill GI in the EUS-LB area when the clinical evaluation has progressed further.
How do you see the prospects of signing agreements in the near future?
– Our goal is to have a distribution agreement in place within the next six months, and we are in discussions with several interested parties in the US and Europe. Before we can begin sales with one or more distributors, the ongoing transfer of manufacturing of our disposable instruments to a Swedish volume manufacturer must be completed. The new contract manufacturer is expected to be up and running during the summer, after which a larger series of instruments will be produced.
What are the key steps to ensure that EndoDrill GI and EndoDrill EBUS can embark on a successful commercial journey in the US and Europe, respectively, in 2025 and 2026?
– The first step is, as mentioned, to ensure that we have a contract manufacturer who can produce larger series of the disposable instrument with high and consistent quality. Agreements with distribution partners will be the key to commercial success. We aim to sign agreements with distributors who see great benefits with our unique biopsy method and where EndoDrill is given high priority in their product offering. In addition, further evidence will be collected through post-market clinical studies.
