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BiBBInstruments AB ("BiBB" or the "Company") announces that a clinical case series demonstrating positive results for EndoDrill® GI was presented at Digestive Disease Week (DDW) 2026 in Chicago, the world's leading congress in gastroenterology and advanced endoscopy, attracting over 13,000 attendees from around the globe. In the presented case series from Henry Ford Health in Detroit, the authors concluded that "EndoDrill® device demonstrated strong diagnostic utility in an effective and safe manner." The BiBB team attended the congress together with the Company's U.S. distribution partner TaeWoong Medical USA.
"It is highly encouraging to see a high-profile clinical center present further positive clinical experience with EndoDrill® GI at the world's leading congress in advanced endoscopy. The results are promising and consistent with previous studies," said Fredrik Lindblad, CEO of BiBBInstruments.
The poster, entitled "Exploring the impact of the endoscopic ultrasound-guided motorized fine needle biopsy `EndoDrill' device for liver biopsy and additional cases: A case series", was presented at DDW 2026 in Chicago on May 5.
The case series included six patient cases in which EndoDrill® GI was used for endoscopic ultrasound-guided biopsy procedures. According to the authors, adequate tissue was obtained in all cases, enabling diagnosis in all six patients.
The authors describe EndoDrill® GI as a powered biopsy instrument with significant diagnostic potential and a favorable safety profile in the limited patient series. No serious adverse events were reported, and only one minor, transient bleeding event was noted.
In the discussion section of the poster, the authors highlight that adequate tissue sampling is essential for molecular pathology and personalized treatment, and that EndoDrill® GI demonstrated diagnostic utility across several different clinical scenarios. Digestive Disease Week (DDW) annually gathers leading physicians, researchers, and medtech companies in gastroenterology, hepatology, and advanced endoscopy from around the world.
About EndoDrill® GI
EndoDrill® GI is the world's first powered biopsy instrument for endoscopic ultrasound (EUS) with both FDA clearance and CE marking. Unlike conventional manual FNA/FNB needles, the instrument features a powered rotating needle tip designed to acquire intact tissue cores (core needle biopsies), enabling high histological yield and molecular analysis. The system received FDA 510(k) clearance in the U.S. in 2023 and CE marking in Europe in 2024. It is currently used clinically in both regions, and the U.S. market launch commenced during the second half of 2025 in collaboration with TaeWoong Medical USA.
For more information, please contact:
Fredrik Lindblad, CEO
Email: fredrik.lindblad@bibbinstruments.com
Phone: +46 70 899 94 86
www.bibbinstruments.com
This is a translation of the Swedish press release. In the event of any discrepancy, the Swedish language version shall prevail.
The information was submitted for publication, through the agency of the contact person set out above, at the time stated by the Company's news distributor upon publication of this press release.
About BiBBInstruments AB
BiBBInstruments AB is a cancer diagnostics company developing and manufacturing EndoDrill®, the world's first series of market-cleared powered endoscopic biopsy instruments. EndoDrill® is designed to obtain core tissue samples (core needle biopsies, CNB) with high diagnostic accuracy and aims to improve the diagnosis of cancers in organs such as the stomach, pancreas, liver, lungs, and urinary bladder. The product portfolio targets the global market for ultrasound-guided endoscopic biopsy instruments (EUS/EBUS), one of the most advanced and fastest-growing segments within modern endoscopy. BiBB received FDA 510(k) clearance for its first instrument, EndoDrill® GI, in 2023 and CE marking under the European Medical Device Regulation (MDR) in 2024 for all three product variants - EndoDrill® GI, EndoDrill® EBUS, and EndoDrill® URO. As such, EndoDrill® is the first powered biopsy system cleared in both the United States and Europe. The U.S. launch of EndoDrill® GI commenced during the second half of 2025 in collaboration with TaeWoong Medical USA. The EndoDrill® system consists of sterile single-use instruments and a proprietary drive system. BiBB was founded in 2013 by Dr. Charles Walther, cancer researcher at Lund University and senior consultant pathologist at Skåne University Hospital. The Company is headquartered at Medicon Village in Lund, Sweden, and its shares are listed on Spotlight Stock Market (ticker: BIBB).