BiBBInstruments’ CEO: “Agreements with distribution partners will be key to commercial success”
BiBB kicks off 2025 with a commercial breakthrough, as EndoDrill GI is now being used by its first paying customer. With higher-quality tissue samples compared to conventional technology and a bolstered cash position, the Lund-based company is now fully focused on continuing to establish the product and securing agreements with global distribution partners.
BiBBInstruments (BiBB) has developed a series of electric-driven biopsy instruments for endoscopic use, EndoDrill, used for tissue sampling with endoscopic ultrasound (EUS/EBUS). These instruments make it easier for endoscopists to obtain larger, higher-quality samples compared to traditional manual needle instruments. The company’s flagship product, EndoDrill GI, is the first of its kind and designed for sampling true core tissue biopsies in cancer diagnostics within the gastrointestinal tract.
Last year provided several clear examples of the product’s capabilities, including eight patient cases with EndoDrill GI in the US, reported in the scientific journal Endoscopy International Open. The results showed 100 percent diagnostic accuracy after a single needle puncture, with the quality of tissue samples surpassing those obtained with conventional needle instruments.
First commercial step taken
Following these strong results, the company was rewarded with its first commercial order from university hospital UC Davis Health in the US at the end of January. While this initial order is modest in scope, it was placed at a premium price, reinforcing the product’s position as a premium offering.
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 using EUS-LB with EndoDrill GI were performed at Münster University Hospital (UKM) in Germany. Here, too, the samplings resulted in true core biopsies.
Shortly thereafter, additional samplings yielding high-quality core biopsies in the liver and pancreas were reported – this time at Henry Ford St. John Hospital in Detroit. This marks the second US hospital to begin clinical evaluation of EndoDrill GI. BiBB believes EUS-LB is an emerging indication, and the initial liver samplings highlight the product’s potential to improve diagnostics for patients with liver diseases as well.
Eyes significant potential in the lung
Alongside EndoDrill GI, BiBB is also developing EndoDrill EBUS, intended for ultrasound-guided sampling in the lungs. The company sees substantial potential in EndoDrill EBUS, as EBUS is increasingly becoming the preferred method for diagnosing and staging lung cancer. The instrument’s ability to deliver abundant core tissue biopsies could address pulmonologists’ growing need for samples for diagnostics, staging, and genetic analysis, positioning it as a potential game-changer in the market.
CE approval is already in place, and the next steps include launching a pilot study and beginning the submission process for a 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 this journey, 2025 began with a SEK 27.6 million cash infusion through a unit issue, which also included TO1 series warrants. Exercise of these warrants will take place between May 22 and June 6, potentially providing the company with an additional SEK 9–16.5 million if fully utilised.
CEO comments
With financing secured, production capacity is now being scaled up while discussions with potential distribution partners are underway. The goal is to sign agreements with one or more partners during the year, enabling the company to shift into the next gear of commercialisation.
BiBB is thus in a highly interesting position, prompting BioStock to reach out to CEO Fredrik Lindblad for more insights.
You have kicked off 2025 with a large news flow. How would you describe BiBB’s current position?
– We have exciting times ahead. We are operating in a fast-growing market segment where no revolutionary product innovations have been launched in the past decade. Our EndoDrill concept, which enables efficient sampling with an electric-driven rotating needle, has so far proven to outperform conventional methods. The aim is to let more physicians evaluate EndoDrill GI and begin sales this fall through one or more distribution partners.
Regarding the initial liver biopsies, how does this strengthen the case for EndoDrill GI?
– We have viewed liver biopsies guided by endoscopic ultrasound (EUS-LB) as a potential bonus indication. Now, clinical use seems to be increasing in scope, suddenly making this a more tangible opportunity for EndoDrill. Trials with EndoDrill GI have just begun, 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 are your plans 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 diagnostics and treatment selection in several liver diseases. The less invasive EUS-LB method is establishing as an alternative with several clinical and practical advantages over conventional techniques. A growing application for EUS-LB is the investigation of non-alcoholic fatty liver disease (NAFLD), an indication that is becoming increasingly common.
As mentioned earlier, we will revisit the opportunities with EndoDrill GI in the EUS-LB space once clinical evaluation has progressed further.
What is your outlook for signing agreements in the near term?
– 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 start sales with one or more distributors, the ongoing transfer of manufacturing for our disposable instruments to a Swedish volume producer must be completed. The new contract manufacturer is expected to be operational this summer, after which a larger batch of instruments will be produced.
What are the key steps to ensure EndoDrill GI and EndoDrill EBUS can embark on a successful commercial journey in the US and Europe in 2025 and 2026?
– The first step, as mentioned, is ensuring we have a contract manufacturer capable of producing larger batches of the disposable instrument with consistently high quality. Agreements with distribution partners will be key to commercial success. We aim to sign deals with distributors who recognise the significant benefits of our unique biopsy method and prioritise EndoDrill in their product offerings. Beyond that, further evidence will be gathered through post-market clinical studies.
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.
