BiBBInstruments has developed EndoDrill GI, an powered biopsy device designed to improve tissue sampling in patients with suspected cancer of the gastrointestinal tract and adjacent organs. Unlike today’s manual needle instruments, which require a stabbing motion that can damage tissue and yield contaminated samples, EndoDrill uses a rotating needle cylinder to extract intact tissue cores – so-called core biopsies.
The instrument is used in EUS-guided procedures, where a physician employs an endoscope combined with ultrasound to locate and sample tissue from deeper structures in the body. The technique provides higher-quality samples, increasing the likelihood of achieving an accurate diagnosis on the first attempt.
Commercial launch underway in the U.S.
After several years of development, BiBB took a major step forward in the third quarter by initiating its first commercial activities. TaeWoong Medical USA placed an initial order valued at approximately USD 11, and several U.S. hospitals have now begun clinical use of the product.
During November and December, BiBB’s focus is on establishing reference clinics, training physicians, and building long-term relationships with specialists who will champion adoption of the technology. The company’s team is currently in an intensive phase, working closely on-site to ensure a smooth and successful rollout. TaeWoong’s receipt of early commercial orders is viewed by BiBB as a strong signal of market confidence.
Eyes on Europe and EndoDrill EBUS
Following this initial phase, a broader rollout of EndoDrill GI in the U.S. is planned for 2026. At the same time, preparations are underway for expansion into Europe. In his CEO letter, Lindblad noted that several potential partners have already been identified, with the goal of signing a European distribution agreement during the first quarter of 2026. The approach will mirror that of the U.S. – beginning with preparatory work, followed by a targeted launch and then a wider market rollout.
In parallel, BiBB is preparing to introduce its next product, EndoDrill EBUS, aimed at improving lung cancer diagnostics. The need for core biopsies is particularly high in this indication, giving the product substantial commercial potential. Together with its manufacturing partner Cenova, BiBB is preparing for production start, which will be followed by a pilot study and a 510(k) submission to the FDA. The goal is to launch by the end of 2026.
New clinical data from Mayo Clinic
Alongside its commercial efforts, BiBB continues to make clinical progress. At Henry Ford St. John Hospital in Detroit, EndoDrill GI has been used for biopsies of the liver and pancreas. In all cases, diagnostic tissue samples were successfully obtained – including one case where a traditional percutaneous needle biopsy had previously failed.
The company also recently reported encouraging results from Mayo Clinic in Jacksonville, Florida, where researchers used EndoDrill GI to collect tissue from patients with solid pancreatic tumours. What makes this project particularly noteworthy is that the Mayo team is using the biopsies in an advanced ex vivo tissue model – a research technique expected to play a key role in the future of precision medicine.
The model involves cutting thin slices of fresh tumour tissue from biopsies, which serve as miniature replicas of the patient’s tumour. The tissue remains viable for a limited time, allowing short-term drug testing outside the body. Such results can help identify the most effective treatment for each specific tumor type/patient – a key step toward truly individualised cancer therapy.
According to the Mayo researchers, EndoDrill GI delivers high-quality tissue samples, a critical factor for successful precision medicine. The next step is to test the approach in additional patients, and if results remain positive, it could pave the way for establishing the product as a new standard in this fast-growing research area.
Global expert joins the team
During the quarter, BiBB also strengthened its organisation with the appointment of Professor Peter Vilmann as scientific advisor – a major addition to the team. Vilmann is a pioneer in the field and co-inventor of the first dedicated EUS biopsy needle. He has already used EndoDrill GI in clinical practice, and his expertise and network are expected to be instrumental in planning upcoming clinical studies and supporting commercial introduction.
Comments from the CEO
BioStock spoke with Fredrik Lindblad, CEO of BiBBInstruments, about the past quarter and the exciting phase that now lies ahead.
You have taken your first steps into the U.S. market. How has the reception been from the clinics you’ve engaged with so far?
– EndoDrill GI has now been successfully introduced at three U.S. university hospitals, and in the coming weeks we’ll be on-site to support implementation at several additional hospitals within TaeWoong’s network.
What role will these first clinics play in the broader rollout?
– Our partner has carefully selected hospitals that are open to adopting innovative EUS technologies. These hospitals and their endoscopists will serve as key reference sites as we move toward broader market adoption.
Which milestones do you aim to reach within the next 6–12 months to consider the U.S. launch a success?
– TaeWoong should have established EndoDrill GI at a set of reference hospitals that are routinely using the instrument for an increasing proportion of their EUS biopsies. The product should also be introduced at additional hospitals in TaeWoong’s U.S. network beyond the initial early adopters, with repeat instrument orders in place. It’s too early to provide numerical forecasts – I’ll return to that once the launch is further along.
In addition to the launch, you’ve reported exciting findings from Mayo Clinic, which used EndoDrill GI in an ex vivo tissue model. Why is the product such a good fit for this type of research?
– Mayo Clinic is using EndoDrill GI in an advanced tumour tissue model to obtain high-quality core biopsies from patients with pancreatic cancer. The aim is to test the efficacy of various drugs outside the body using miniature replicas of the patient’s tumour. The physicians contacted us because their model required better biopsy samples. The pilot study showed that EndoDrill GI provided superior tissue quality compared to standard needles, and they are now following up with additional use.
What would it mean if EndoDrill became a standard tool for ex vivo tissue models?
– It would open an entirely new business area for BiBB – where our technology is used not only for diagnostics but also as a tool in precision medicine and personalised cancer therapy.
You have also recruited a key opinion leader in Professor Peter Vilmann. What will his role be as you enter the market?
– Professor Vilmann, who performed the world’s first EUS biopsies back in 1991, brings extensive clinical experience and a large international network. We’ll benefit from his expertise across multiple areas – from planning larger clinical studies to optimising EndoDrill GI and EndoDrill EBUS, as well as serving as a highly respected reference when introducing the technology to new hospitals.
Looking to 2026, you face a pivotal year with a broader U.S. launch, European expansion, and the market introduction of EndoDrill EBUS. How will you, as a relatively small organisation, manage this?
– We cannot do it alone – that’s why we’ve chosen to work with strong partners, such as contract manufacturer Cenova for production of our single-use instruments, TaeWoong Medical USA for U.S. distribution, and leading clinical experts like Professor Vilmann. We’ll continue to grow the business together with both existing and new partners.
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