BiBBInstruments AB (“BiBB” or the “Company”), a Swedish cancer diagnostics company, announces the official launch of EndoDrill® GI in the United States together with its partner TaeWoong Medical USA (“TaeWoong”). EndoDrill® GI is the world’s first market-cleared, powered biopsy instrument for endoscopic ultrasound (EUS). The launch has started with the first customer orders, and TaeWoong has submitted an initial commercial order to BiBB valued at approximately USD 11,700. During November and December 2025, several U.S. hospitals will evaluate EndoDrill® GI in clinical use, with BiBB’s team on site to ensure a successful introduction. The initial phase targets selected hospitals to gather user experience before a broader rollout planned for 2026, tapping into the significant potential of the U.S. market.
“It’s rewarding to see our U.S. launch now underway. TaeWoong already has customers evaluating our instruments in their clinical workflows, reflecting growing interest in the technology. We will continue product demonstrations at leading hospitals across the country throughout the fall,” says Fredrik Lindblad, CEO of BiBBInstruments.
About EndoDrill® GI
EndoDrill® GI is the world’s first FDA- and CE/MDR-cleared powered biopsy instrument for endoscopic ultrasound. Unlike manual FNA/FNB needles, the instrument features a motor-driven rotating tip that extracts intact core tissue samples, providing higher histological yield and enabling advanced molecular analysis. The system received FDA 510(k) clearance in the U.S. in 2023 and CE certification in Europe in 2024. It is currently being clinically evaluated in both regions, and a targeted launch has recently been initiated in the U.S. in collaboration with TaeWoong.
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
BiBBInstruments AB is a cancer diagnostics company that develops and manufactures EndoDrill®, the world’s first series of powered endoscopic biopsy instruments. EndoDrill® is designed to obtain core tissue samples (core needle biopsies, CNB) with high diagnostic precision 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 endoscopic ultrasound-guided biopsy instruments (EUS/EBUS) – one of the most advanced and fastest-growing segments in modern endoscopy. BiBB received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its first instrument, EndoDrill® GI, in 2023. In 2024, CE marking was granted under the EU’s new Medical Device Regulation (MDR) for all three product variants – EndoDrill® GI, EndoDrill® EBUS, and EndoDrill® URO – making EndoDrill® the first powered biopsy system cleared in both the U.S. and Europe. The U.S. launch of EndoDrill® GI began in the fall of 2025 in collaboration with TaeWoong Medical USA. The EndoDrill® system consists of sterile single-use biopsy instruments and a proprietary motor-driven drive system. BiBB was founded in 2013 by Dr. Charles Walther, cancer researcher at Lund University and Senior Consultant in Clinical Pathology at Skåne University Hospital. The company is headquartered at Medicon Village in Lund, Sweden, and is listed on the Spotlight Stock Market (ticker: BIBB).