BiBBInstruments

”In addition to the recognition of EndoDrill^® GI as a promising new technology at a well-attended lecture, I take with me the exciting discussions with our users from the USA and Sweden. Independently, these doctors have had similar positive experiences and reached the same conclusion: that EndoDrill^® GI provides better tissue samples than today's standard needle instruments", says Dr. Charles Walther, CMO at BiBB.

BiBB's founder and CMO Dr Charles Walther and CEO Fredrik Lindblad visited the ESGE Days congress in Berlin on April 25–27. It was a few intense days of lectures and meetings with users and the industry. For the first time, BiBB arranged a meeting with doctors from the United States and Sweden who have used the new electric-driven EndoDrill^® GI biopsy system. The feedback from these users was consistent: EndoDrill^® GI is a very effective EUS biopsy instrument that already at the first attempt takes core biopsies of a quality that they have not experienced before. Additionally, the EndoDrill device allowed a user-friendly sampling in a more controlled way than manual methods, and thus allowing a higher precision. The doctors also reported that after their initial evaluation, they found EndoDrill^® GI safe, resulting in less blood in the tissue samples. Dr. Antonio Mendoza Ladd, medical director of GI endoscopy at UC Davis Health in Sacramento, California, said that after the first patient cases, the hospital's pathologists and oncologists started asking for EndoDrill^® biopsies because they noticed the difference in quality. In several cases, patients had previously been sampled with standard manually operated fine needles (EUS-FNB) with unclear results, while with the help of core biopsies taken with EndoDrill^® GI, it was possible to establish a diagnosis and thus initiate adapted cancer treatment.

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: 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 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.