Press release from Companies
Publicerat: 2025-03-25 09:15:41
The cancer diagnostics company BiBB Instruments AB ("BiBB" or "the Company"), which develops EndoDrill® – the world's first market-cleared electric driven biopsy instrument for endoscopy – announces that a retrospective analysis conducted in the U.S. and Europe will be presented at ESGE Days in Barcelona on April 3. The study includes real-world data from the use of EndoDrill® GI for core tissue sampling in 28 patients across five university hospitals in the U.S. and Europe. The authors conclude that the overall initial experience with EndoDrill® GI was positive and that their findings suggest the device is both effective and safe. BiBB’s team will be present at the moderated presentation in Barcelona.
"We look forward to the presentation of retrospective data from the multicenter study on the use of EndoDrill® GI at the ESGE meeting. Furthermore, we are pleased to see that the published abstract shows that our instrument can deliver diagnostic samples quickly and safely”, says Dr. Charles Walther, founder and Chief Medical Officer (CMO) of BiBB.
New clinical data on EndoDrill® GI (also referred to as “EUS-CB”, Endoscopic Ultrasound-Guided Core Biopsy) will be presented at a moderated poster presentation titled "Initial Experience With A New Endoscopic Ultrasound Electric Core Biopsy Device" on April 3 at ESGE Days in Barcelona. This retrospective 'real-world' study in the U.S. and Europe was coordinated by Dr. Antonio Mendoza Ladd of UC Davis Health, USA. The study included 28 patients who underwent biopsy sampling with EndoDrill® GI at five university hospitals in Sacramento, Bergen, Stockholm, Linköping, and Zagreb.
The most common tumor sites were pancreas, retroperitoneum, and stomach. In 22 patients, the first and only needle pass (puncture) with EndoDrill® GI was sufficient to provide diagnostic tissue. In comparison, international guidelines recommend 3–4 passes with EUS-FNA and 2–3 passes with EUS-FNB respectively to obtain sufficient diagnostic material. Mild bleedings occurred in two patients and were successfully treated endoscopically.
The authors conclude, "The overall initial experience with this new EUS-CB device was positive. Our findings suggest that the device is effective and safe. Its effectiveness at obtaining adequate tissue with one pass could potentially shorten the overall duration of the procedure. Prospective studies comparing it to FNA/FNB needles will be required to further assess performance and safety."
Poster Session, April 3
Section: ERCP and EUS: What's new? Poster: “Initial Experience With A New Endoscopic Ultrasound Electric Core Biopsy Device”.
Link: https://esge2025.process.y-congress.com/ScientificProcess/Schedule/?sessionGuid=1068abfd-4c5d-4b13-8966-7d9f8901fdf6&setLng=en
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 in various indications within the gastrointestinal tract, such as the pancreas, stomach, esophagus, lymph nodes, and liver. EndoDrill® GI received FDA 510(k) clearance in the United States in 2023 and CE approval in Europe in early 2024. The product is currently undergoing clinical evaluation in both the United States and Europe. The commercialization phase began in early 2025, when the first order was received from a university hospital in the U.S.
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
