Well-executed clinical introduction of EndoDrill[®] GI at Sahlgrenska University Hospital in Sweden
The cancer diagnostics company BiBBInstruments AB ("BiBB" and the “Company”), the developer of EndoDrill®, the world's first market-cleared electric-driven biopsy instrument for endoscopy, announces that the first clinical tissue sampling procedures with EndoDrill® GI at Sahlgrenska University Hospital in Gothenburg have been successfully completed. Expanded market studies at several hospitals in Europe and the USA are an important part of the Company's strategy and represent the first step in the launch of EndoDrill® GI.
“It was very rewarding to be present and witness users from yet another of Scandinavia’s leading university hospitals test EndoDrill® GI and provide feedback,” says Dr. Charles Walther, CMO and founder of BiBB.
BiBB’s founder, Dr. Charles Walther, has this week introduced EndoDrill® GI at Sahlgrenska University Hospital in Gothenburg, one of Northern Europe’s largest hospitals. Gastroenterologists Dr. Per Hedenström and Dr. Riadh Sadik are pioneers in endoscopic ultrasound in Sweden, both in terms of research studies and clinical practice. This experienced team conducted four initial patient cases with EndoDrill® GI sampling. Overall, high-quality tissue samples were collected, and the team will now continue the clinical evaluation independently.
The introduction at Sahlgrenska University Hospital follows BiBB's strategy of carrying out expanded clinical market studies of EndoDrill® GI in the USA and Europe. Just like at Sahlgrenska, new hospitals and users in the USA and Europe are continuously given the opportunity to evaluate EndoDrill® GI, with the aim of gathering clinical data and increasing product awareness. These market studies represent the final step before a directed launch of EndoDrill® GI to selected hospitals.
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 all indications in the gastrointestinal tract, e.g. pancreas, stomach, esophagus, lymph nodes, and liver. EndoDrill® GI received FDA 510(k) clearance in the US in 2023 and CE approval in Europe in early 2024. The product is undergoing clinical evaluation in the USA and Europe in preparation for a planned directed launch.
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: [email protected]
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 electric endoscopic biopsy system in both the US and Europe. The EndoDrill® system includes sterile disposable biopsy instruments with an 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.