Clinical evaluation was on the agenda for BiBBInstruments in 2024. Now the company opens the new year with a first order for EndoDrill GI, placed by UC Davis Health in the USA. BioStock has contacted CEO Fredrik Lindblad to learn more about this commercial milestone.
EndoDrill GI is the world's first electrically powered biopsy instrument for endoscopic use. It is designed to enable the collection of high-quality core tissue biopsies, which improves the possibilities for early and accurate cancer diagnosis in tumors of the gastrointestinal tract. The product is market approved in both Europe and the United States, and the company has been working on clinical validation for some time by introducing the instrument in several clinics in Europe and the United States.
During this preparatory phase for broad commercialization, the instrument has been used, for example, on UC Davis Health in California, USA. The evaluation has resulted in a scientific publication in Endoscopy International Open. Data included the first eight patient cases, and 100 percent diagnostic accuracy was reported after a single needle puncture. In half of the patient cases, EndoDrill GI was also compared to a conventional needle, showing superior tissue samples.
Confirms position as premium product
Following the successful evaluation, UC Davis Health has now chosen to become BiBBInstruments' first paying customer. The initial order for single-use instruments is of a smaller scale, but is being placed at premium pricing, which the company says is a positive first indication that the innovative product is highly valued.
The commercial phase of the company's market launch has thus begun, and it is hoped that more clinics will follow UC Davis Health's example. EndoDrill GI is currently being tested in several hospitals in Europe, while the manufacturing of single-use instruments is being moved to a new contract manufacturer to increase production capacity for what is to come.
It is no secret that BiBBInstruments is being followed by several potential distribution partners. Discussions are ongoing and the fact that the company has now landed its first commercial order is unlikely to worsen the negotiating situation.
CEO comments
BioStock spoke with the CEO Fredrik Lindblad to get his comments on the milestone. 
Fredrik, you have your first paying customer in the US. From an overall perspective, what does the order mean for BiBBInstruments?
– The order is an important acknowledgement that we have developed an innovative biopsy instrument that meets a significant clinical need. It also marks a milestone for the entire team, who have put in many hours to get here. The order is also well-timed for discussions with potential distribution partners this spring.
What are the possibilities for follow-up orders from UC David Health?
– We of course hope that UC Davis Health continues to use EndoDrill GI for sampling, so we look at that positively.
How have you reasoned about pricing EndoDrill GI, given the results you have obtained with the product?
– We believe that the high sample quality with EndoDrill GI, together with the other advantages of the electrically powered system, justifies a price for the disposable instrument that is approximately twice as high as for equivalent manually handled disposable instruments.
You are discussing with potential distribution partners. What signals does this first order send to them?
– I think it sends very positive signals that we, as a small Swedish innovation company without our own sales organization, have managed to sell EndoDrill GI to a leading university hospital in the US. What shouldn't we be able to achieve with a distribution partner behind us?
