BiBBInstruments (BiBB) has developed EndoDrill, a series of powered endoscopic biopsy instruments used for tissue sampling with endoscopic ultrasound (EUS/EBUS). The instruments enable easier sampling of high-quality and larger tissue samples compared to traditional manual needle instruments. The company’s flagship product, EndoDrill GI, is the first of its kind, designed for sampling true core biopsies in cancer diagnostics within the gastrointestinal tract.
In June, BiBB signed an exclusive distribution agreement with TaeWoong Medical USA for the sale and commercialisation of EndoDrill GI in the U.S. market – one of the company’s most significant milestones to date. The agreement spans to XNUMX, with the possibility of extension to XNUMX, but does not cover future variants such as EndoDrill EBUS and EndoDrill URO.
Pieces added to the puzzle
The collaboration began in early May, at Digestive Disease Week (DDW) in San Diego, the world’s largest GI congress, where the product received positive feedback from leading clinicians. A targeted launch at select hospitals is planned for the fall, followed by a broader rollout in XNUMX. In the QXNUMX report’s CEO statement, Fredrik Lindblad writes that the summer has been dedicated to developing marketing materials and training TaeWoong’s sales team.
Ahead of the U.S. launch, IP protection was strengthened following a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO), i.e. an intention to grant the first EndoDrill patent in the U.S.. Shortly thereafter, BiBB received its third patent approval in Japan. EndoDrill is now protected by approved patents in all key regions: the U.S., Europe, Japan, China, and India, with validity until 2041.
To ensure scalable production and high quality, BiBB has completed the transition to a new Swedish contract manufacturer, Cenova. A validation series has been produced with good results, and additional batches are planned to meet demand in the U.S. market.
Future product variants – EndoDrill EBUS and URO
In addition to working on EndoDrill GI, preparations are underway for the launch of the next product in the series, EndoDrill EBUS, for lung cancer diagnostics. The plan includes starting production, conducting a clinical pilot study, and submitting an FDA application, with the aim of launching in the second half of 2026. Expectations are high for the product, as there is a growing need for core biopsies in lung cancer, where molecular and immunological analysis has become the clinical standard.
Regarding EndoDrill URO, for sampling in muscle-invasive bladder cancer, a pilot study with promising results has previously been published. The company is currently discussing the next steps in the clinical program with clinicians in both Europe and the U.S.
Strengthened financial position
During the quarter, approximately SEK 1,67 million was raised through the exercise of TO1 warrants, with about 30 per cent coming from management and the board. Combined with January’s rights issue of SEK 27,6 million, the cash balance as of June 30 stood at SEK 15,8 million, which the company says is above the budgeted level. The result after financial items for the quarter amounted to SEK -3,8 million.
Comments from the CEO
The distribution agreement is in place, and activities related to the upcoming launch are in full swing. BioStock contacted CEO Fredrik Lindblad to learn more about the quarter and the road ahead.
You’ve made significant strides during Q2 and capped the quarter with a distribution agreement. How would you describe BiBB’s position right now?
- We are now entering a very exciting phase after several years of focused development, regulatory approvals, and clinical studies. What makes the situation particularly special is that our product EndoDrill represents a true innovation – the first powered system of its kind – and thus a valuable new tool in the endoscopists’ toolbox.
What concrete goals have you set for the targeted launch this fall, and which milestones will be critical leading up to the broader launch in 2026?
- Our primary task this fall is to support our partner in the U.S., TaeWoong Medical USA, to ensure that the EndoDrill GI introduction is as successful as possible at their selected hospitals. A strong start with satisfied users lays the foundation for the broader launch in 2026.
You mention that the launch will begin at selected hospitals in the U.S. How have you chosen these?
- Our partner TaeWoong has successfully launched innovative EUS instruments previously, such as GI stents and RFA systems. For the initial targeted launch, they have selected a number of large hospitals that have shown particular interest in new and groundbreaking technology.
What is required to scale up nationally?
- A successful start this fall is critical – that EndoDrill clearly demonstrates its value compared to standard tissue sampling. The first reference customers will be important ambassadors for the broader launch. To succeed nationally, a well-trained sales force, targeted marketing efforts, and high and consistent manufacturing quality are also required.
EndoDrill EBUS is expected to launch in Europe in the second half of 2026. What steps remain before the FDA application can be submitted, and what is the timeline for a U.S. launch?
- The next step is to develop an updated prototype and invest in tools for manufacturing of some remaining components. After that, our new contract manufacturer, Cenova, will begin series production. During the second half of 2026, we expect to have produced the first EBUS instruments for both clinical evaluation and initial customer orders in Europe. In parallel, we plan to submit an FDA 510(k) application, which will allow us to aim for a U.S. launch thereafter.
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