Successful case studies with EndoDrill GI continue in Norway and Sweden

The cancer diagnostics company BiBBInstruments AB ("BiBB" or the "Company"), the developer of the world's first market-cleared electric-driven biopsy instrument for endoscopy, informs that clinical evaluation with EndoDrill^® GI has started at two additional hospitals in Scandinavia. Several patient cases have been successfully performed at Haukeland University Hospital in Bergen, Norway, as well as at the University Hospital in Örebro. This means that EndoDrill^® GI is now being evaluated in Sweden (Karolinska University Hospital and Örebro University Hospital), Norway (Haukeland University Hospital) and the USA (UC Davis Health, Sacramento). The evaluations have so far provided a clear picture of a user-friendly, safe, and effective biopsy instrument that has been called, among other things, a "game changer". Further case studies are planned at more hospitals in the US and Europe.

"The continued evaluation of EndoDrill^® GI in Norway and Sweden has provided a consistent picture of a user-friendly biopsy instrument that safely obtains high quality core tissue biopsies. We notice that the interest in EndoDrill^® GI is gradually increasing as we initiate evaluations at new hospitals and participate in congresses," says Dr. Charles Walther, CMO at BiBB.

BiBB's team has recently been on site introducing EndoDrill^® GI in Norway and Sweden. Dr. Khanh Do-Cong Pham at Haukeland University Hospital in Bergen became the first user to evaluate EndoDrill^® GI in Norway. Dr. Pham himself writes about his impression of EndoDrill^® GI on LinkedIn* and he has also posted a video, in which Dr. Pham describes that he managed to obtain a core biopsy of a recurrent gastric cancer to demonstrate deeper infiltration. He further explains that the instrument did not cause any bleeding and can be considered atraumatic (gentle). The evaluation in Bergen will now continue.

During the week, several patient cases were performed at Örebro University Hospital. Dr. Robert Glavas, who previously participated in a pilot study with EndoDrill^® GI, was well acquainted with the instrument. It was the first time BiBB used the new industrialized motor unit, which is significantly more compact than its predecessor. The cases were varied and challenging, involving pancreatic tumors, lymph nodes, and the gastric wall. Sampling with EndoDrill^® GI provided a series of true core biopsies. The evaluation at Örebro University Hospital will now continue.

* https://www.linkedin.com/feed/update/urn:li:activity:7195553432508764160/

About EndoDrill^® GI
EndoDrill^® GI is the world's first market-cleared electric-driven 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, oesophagus, 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 being evaluated clinically in the US and Scandinavia with a planned launch in Sweden later in 2024.

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 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.