BiBBInstruments secures exclusive distribution agreement in the U.S.

BiBBInstruments has developed EndoDrill GI, a powered biopsy instrument designed to enhance endoscopic tissue sampling for suspected cancer in the gastrointestinal tract and adjacent organs. Unlike current manual needle instruments, which require a stabbing motion that can damage tissue and result in blood-contaminated samples, EndoDrill uses a rotating drill cylinder to extract intact tissue cores – so-called core biopsies.

The instrument is used in ultrasound-guided endoscopy (EUS), where a physician uses an endoscope combined with ultrasound to locate and sample deeper structures in the body. The technology enables higher sample quality, increasing the likelihood of obtaining an accurate diagnosis on the first attempt.

Following a series of milestones, such as FDA clearance and positive clinical results, BiBBInstruments entered the U.S. market in January when selling the first EndoDrill GI to a leading American university hospital.

Letter of intent followed by distribution agreement

The next step in the company’s U.S. market entry came in May when it signed a letter of intent regarding EndoDrill GI with TaeWoong Medical USA, a subsidiary of South Korean TaeWoong Medical. The partnership began during Digestive Disease Week in San Diego, the world’s largest gastroenterology congress, where the parties jointly conducted customer demonstrations.

Now, the next step has been taken with the signing of an exclusive distribution agreement for EndoDrill GI in the U.S. market. The agreement grants TaeWoong exclusive rights to distribute EndoDrill GI in the U.S. until the end of 2028, with an option to extend the agreement for an additional two years, until the end of 2030.

Future product variants within the EndoDrill portfolio – such as EndoDrill EBUS for lung cancer diagnostics and EndoDrill URO for bladder cancer – are not covered by the current agreement. The agreement also includes a detailed business plan outlining the commercial strategy, from preparations to market launch. Broadly, the plan involves a targeted introduction of EndoDrill GI in 2025, followed by a full-scale launch in the U.S. market in 2026.

Comments from the CEO

BioStock contacted the CEO Fredrik Lindblad to learn more about the agreement and its significance for EndoDrill’s launch.

Fredrik, congratulations on the agreement. As a first question, what does the agreement mean for BiBBInstruments' commercial strategy in the American market?

– The agreement is a significant milestone in BiBB’s history and provides access to the world’s single largest endoscopy market. Through an exclusive partnership with an established player that already has a well-developed customer base in endoscopic ultrasound, we gain faster access to leading clinics and decision-makers. We see this as the starting point for building a long-term presence in the U.S., with the goal of positioning EndoDrill as a new first-choice tool for EUS-based tissue sampling.

Can you tell us a little more about your partner?

– TaeWoong Medical USA is a fast-growing subsidiary of South Korean TaeWoong Medical, which operates in over 70 countries. TaeWoong is a pioneer in therapeutic products for endoscopic ultrasound (EUS), including Niti-S series metal stents and the first FDA-cleared RFA system for EUS. With EndoDrill GI in their portfolio, TaeWoong can now also offer a leading product for diagnostic tissue sampling to the same customer group.

The agreement is fixed-term until 2028, with the possibility of extension. Why have you settled on that arrangement?

– We opted for a three-year agreement to give both parties time to build the market together and establish an effective collaboration. At the same time, we want to maintain strategic flexibility. The option to extend to five years reflects our confidence in the partnership and our ambition to create a long-term, scalable business in the U.S. – the world’s largest market.

What conditions must be met for the contract to be extended?

– The agreement is automatically extended after the initial period unless either party terminates it with six months’ notice. No specific performance conditions are required for the extension, but both parties have the option to end the collaboration if they wish. At the same time, there is a shared ambition to begin discussions well in advance about a new, long-term agreement.

Can you tell us something about the financial structure of the agreement?

– At this stage, we are keeping business-critical details between us and our new partner.

Is it possible to say anything more about what the actual launch plan together with TaeWoong Medical USA looks like?

– The collaboration began in early May when we showcased EndoDrill GI at TaeWoong’s large booth at the DDW congress in San Diego. Broadly, sales training, development of marketing materials, and initial product demonstrations will take place during the third quarter. This will be followed by a soft launch in the fourth quarter, targeting carefully selected “EUS innovators” – physicians with high patient volumes and an interest in new technology.

– EndoDrill GI will also be showcased at U.S. congresses in the fall and presented in digital formats, such as webinars. In 2026, a more nationwide launch will begin, with the goal of gradually building recurring sales of the single-use instruments.

Finally, what expectations do you have for the collaboration?

– We see great potential in this collaboration, not least because it is built on shared ambitions and a clear focus on innovation within EUS. TaeWoong has already demonstrated its ability to successfully launch advanced products globally, and in the U.S., they have a sales force with a proven track record of introducing innovative products successfully.

– However, the most critical success factor is the unique clinical value of the product – EndoDrill GI is a differentiated biopsy instrument that can improve diagnostics while generating recurring revenue through its disposable nature. This is a partnership that strengthens our commercial strategy and has the potential to drive significant value growth over time.