BiBBInstruments

"Liver is a challenging and relatively new field for endoscopic sampling. We need to learn more, but it was inspiring to see tissue sampling with true core biopsies”, says Dr. Charles Walther, founder and CMO of BiBB.

Endoscopic ultrasound-guided liver biopsy (EUS-LB) is one of the newest indications for tissue sampling in the organs of the gastrointestinal (GI) tract. The method is a minimally invasive alternative to traditional liver biopsy techniques (percutaneous or transjugular) for diagnosing liver parenchymal diseases. EUS-LB has been developed as an alternative as the method offers several clinical and practical advantages compared to the other methods.

BiBB visited the University Hospital of Münster (UKM) to provide support for tissue sampling of the liver using EndoDrill^® GI. Under the leadership of Professor Barbara Braden and Dr. Michael Praktiknjo, tissue samples were collected with EndoDrill^® GI in two clinical cases to investigate non-malignant liver diseases. In both cases, core tissue biopsies were obtained. Core biopsy sampling is the method that comes closest to a true surgical biopsy, as it provides intact tissue samples with preserved architecture. The samples will now be analyzed to assess the diagnostic results.

About EndoDrill^® GI
EndoDrill^® GI is the world's first market-cleared powered biopsy instrument for endoscopic ultrasound (EUS). The instrument is used for EUS-guided tissue sampling for various indications in the gastrointestinal tract, e.g. pancreas, stomach, esophagus, lymph nodes, and liver. EndoDrill^® GI received FDA 510(k) clearance in the USA in 2023 and CE approval in Europe in early 2024. The product is currently undergoing clinical evaluation in both the USA and Europe. The commercialization phase began in early 2025 with the first order placed by a university hospital in the USA.

This is a translation of the Swedish press release. If there should be any discrepancies, the Swedish language version prevails.

For more information about BiBB, please contact:
Fredrik Lindblad, CEO
E-mail: fredrik.lindblad@bibbinstruments.com
Phone: +46 70 899 94 86
www.bibbinstruments.com

About BiBB

The cancer diagnostics company BiBBInstruments AB develops and manufactures EndoDrill®, a patented product line of electric-driven endoscopic biopsy instruments. The EndoDrill® instruments take high-quality tissue samples with high precision with the goal of improving the diagnosis of several serious cancers, such as stomach, pancreas, liver, lung, and bladder. The product portfolio is aimed at the global market for ultrasound-guided endoscopic (EUS/EBUS) biopsy instruments, which constitute the most advanced and fast-growing area of endoscopy. BiBB received 510(k) clearance from the US FDA for the lead product EndoDrill® GI in 2023. At the beginning of 2024, CE marking according to MDR was also obtained for all three product variants: EndoDrill® GI, EndoDrill® EBUS and EndoDrill® URO. Thus EndoDrill® is the first cleared powered endoscopic biopsy system in both the US and Europe. The EndoDrill® system includes sterile disposable biopsy instruments with associated drive system. The company was founded in 2013 by Dr. Charles Walther, cancer researcher at Lund University and senior consultant in clinical pathology at Skåne University Hospital in Lund. BiBBInstruments is based at Medicon Village in Lund and the BiBBInstruments share (ticker: BIBB) is listed on Spotlight Stock Market.