Impressive US Clinical Case Series presented at ACG 2024 in Philadelphia
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, announces that a recently published clinical case series in the U.S. has been presented at a poster session at the ACG 2024 in Philadelphia, USA. The study outcome demonstrated 100 % diagnostic accuracy after a single needle puncture, and the authors conclude that the EndoDrill® GI has great potential to be implemented as a first option in any scenario where endoscopic ultrasound (EUS)-guided tissue acquisition is indicated.
"We are happy to see the recently published EndoDrill® data presented by the team from UC Davis Health, CA, at the well renowned ACG conference. It confirms a great interest in EndoDrill®, and gastroenterologists and the endoscopy industry get a chance to hear about the experiences firsthand from the users,” says Dr. Charles Walther, founder and CMO of BiBB.
Recently, the first eight clinical patient cases with EndoDrill® GI were published in the US in the Endoscopy International Open. These findings by Dr. Antonio Mendoza Ladd's team at UC Davis Health in Sacramento, California, were presented by Dr. Omar Viramontes at a poster session at the ACG 2024 congress in Philadelphia. This is an annual well-attended congress organized by the American College of Gastroenterology.
EndoDrill® GI was used for tissue acquisition in eight clinical GI cases, including five with solid pancreatic tumors. Diagnostic accuracy was 100 % after a single needle puncture. Pathology revealed that EndoDrill® specimens contained less blood contamination and more evaluable tissue than standard-of-care products (EUS-FNA/FNB). The poster presentation concluded with the authors stating that EndoDrill® GI is safe and effective. They further claim that "It [EndoDrill® GI] has great potential to be implemented as first option in any scenario where EUS-GTA [Endoscopic Ultrasound Guided Tissue Acquisition] is indicated.”
Link to the poster
https://acgposters2024.eventscribe.net/fsPopup.asp?efp=VUJDWElLS0kyMjI3Mw&PosterID=686005&rnd=0.6724276&mode=posterInfo
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, 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 currently being clinically evaluated in the US and Europe.
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.
