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UC Davis Health, a university hospital in Sacramento, California, has become its first customer order endodrill gi from Swedish medical device company Bibbinstrument.
The product aims to improve cancer care with its electrically guided biopsy capabilities.
It is designed for EUS-guided tissue sampling for all indications in the gastrointestinal tract, including the pancreas, stomach, esophagus, lymph nodes, and liver.
Bibbinstruments CEO Fredrik Lindblad said: “It feels fantastic to now have our first customer in the US, and the order is proof that we have developed an innovative biopsy product that benefits cancer care.
“This is just the beginning of our commercial journey and a small reward for investors who participate in the ongoing rights issue.”
UC Davis Health’s order follows a successful clinical evaluation of Endodrill GI last year.
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After clinical evaluation, a scientific study was published detailing the results of the first eight patient cases using Endodrill GI.
The study highlighted a 100% diagnostic accuracy rate with just one pass, underscoring the safety of the instrument.
Endodrill GI is the world’s first electric biopsy instrument for endoscopic ultrasound (EUS) procedures, having been cleared for use in the US with FDA 510(k) clearance in 2023 and receiving CE approval in Europe last year .
The instrument is currently being clinically evaluated in Europe and the US, while its production is being shifted to a new contract manufacturer to enable larger-scale production.
Bibbinstruments is in discussions with potential distribution partners in preparation for a wider market launch, which is expected to take place once the production capacity of the Endodrill GI has been increased.
Based in Lund, the company develops devices to improve cancer diagnosis by obtaining high-quality tissue samples with high precision.
Its product portfolio is targeted at the global market for ultrasound-guided endoscopic biopsy instruments, which is the most advanced and fast-growing area of endoscopy.
