The agreement follows key milestones for EndoDrill^® GI, including FDA clearance, recently published clinical studies demonstrating solid results, and initial U.S. sales. In January 2025, BiBB sold its first EndoDrill^® GI biopsy instruments to a leading U.S. university hospital, marking its official entry into the U.S. market. Building on this momentum, BiBB and TaeWoong Medical USA plan a targeted launch of EndoDrill^® GI at select U.S. hospitals in autumn 2025, ahead of a nationwide rollout in 2026.

EndoDrill^® GI is a next-generation EUS biopsy system designed for early detection and diagnosis of gastrointestinal cancers, delivering significant advantages for patients, clinicians, and healthcare providers. A broader U.S. launch marks a major milestone in BiBB’s international expansion strategy.

Comment from Fredrik Lindblad, CEO of BiBB:
"This Letter of Intent marks an exciting and important step for BiBB. Following our first U.S. sale earlier this year, we are now positioned to accelerate our commercial journey in the world’s largest healthcare market. TaeWoong Medical USA is a fast-growing distributor with an innovative portfolio of therapeutic endoscopic ultrasound products, such as stents and RFA devices, and sees EndoDrill^® as a natural extension into diagnostic biopsy solutions. This makes them an ideal partner.

Comments from Minsoo Seo, CEO of TaeWoong USA:
"EndoDrill^® GI represents a new era in diagnostic endoscopy. As a company committed to advancing patient care through innovation, we see EndoDrill^® as a natural complement to our existing therapeutic endoscopic portfolio—including the EUS-guided RFA systems and Niti-S™ stent line."

This strategic partnership is expected to significantly strengthen BiBB’s position in the U.S. and lay the foundation for future growth in other key markets.

About EndoDrill^® GI
EndoDrill® GI is the world’s first CE-marked and FDA-cleared powered biopsy instrument for endoscopic ultrasound (EUS). It enables EUS-guided tissue sampling for gastrointestinal indications, including the pancreas, stomach, esophagus, lymph nodes, and liver. Clinical evaluations are ongoing in both the U.S. and Europe, with the first devices sold in the U.S. in early 2025. A directed U.S. launch of EndoDrill^® GI with TaeWoong Medical U.S. is planned for autumn 2025, followed by a broader nationwide rollout in 2026.

About TaeWoong Medical USA

TaeWoong Medical USA is a fast-growing distributor of innovative gastrointestinal medical devices, committed to improving patient care across the United States. As the exclusive U.S. partner of TaeWoong Medical Co., Ltd. – a global leader in the development and manufacturing of advanced medical technologies — we offer a comprehensive portfolio including esophageal, biliary, colonic, and RFA (radiofrequency ablation) systems, and endoscopic accessories. Based in California, we focus on rapid delivery, clinical excellence, and building strong relationships with healthcare professionals nationwide. Our mission is to bring world-class solutions to the U.S. healthcare market with a deep commitment to innovation, quality, and service. Learn more at www.taewoongusa.com.

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

This disclosure contains information that BiBBInstruments AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on May 2, 2025.

About BiBBInstruments AB

BiBBInstruments AB ("BiBB") is a cancer diagnostics company that develops and manufactures EndoDrill®, a patented product line of electric-driven endoscopic biopsy instruments. EndoDrill® enables tissue sampling with high precision and quality, with the aim of improving the diagnosis of several serious cancers, including those of the stomach, pancreas, liver, lungs, and bladder. BiBB’s product portfolio targets the global market for ultrasound-guided endoscopic (EUS/EBUS) biopsy instruments – the most advanced and fastest-growing segment of endoscopy. In 2023, BiBB’s lead product EndoDrill® GI received 510(k) clearance from the U.S. FDA. In early 2024, CE marking was obtained under the new MDR regulatory framework for all three product variants: EndoDrill® GI, EndoDrill® EBUS, and EndoDrill® URO. As a result, EndoDrill® became the first market-cleared electric-driven endoscopic biopsy system in both the U.S. and Europe. EndoDrill® consists of sterile, single-use instruments paired with a dedicated 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 – and is headquartered at Medicon Village in Lund, Sweden. BiBB’s share (ticker: BIBB) is listed on the Spotlight Stock Market.