BiBB signs exclusive distribution agreement with TaeWoong Medical USA

BiBBInstruments AB ("BiBB" or the "Company"), developer of EndoDrill® – the world's first market-cleared powered biopsy instrument for endoscopy – announces today that the Company has signed an exclusive distribution agreement with TaeWoong Medical USA ("TaeWoong") for the sales, marketing, and commercialization of its flagship product EndoDrill® GI in the U.S. market. The agreement follows a previously announced Letter of Intent on May 2, 2025. The collaboration began during DDW in San Diego, May 4–6 – the world’s largest GI congress – where EndoDrill® GI was showcased and received strong interest. The next step is a joint, targeted launch of EndoDrill® GI at selected U.S. hospitals in autumn 2025, followed by a broader national rollout in 2026.

"The ability to quickly move from a letter of intent to a final agreement is a sign of strength and commitment. We are very pleased to initiate this partnership with TaeWoong, which has a strong presence in endoscopic ultrasound (EUS). Together, we aim to ensure that more patients in the U.S. gain access to optimal tissue sampling and diagnosis with EndoDrill® GI – enabling earlier and more personalized treatment," says Fredrik Lindblad, CEO of BiBBInstruments.

TaeWoong Medical USA is a subsidiary of South Korea-based TaeWoong Medical Co., Ltd., which develops, manufactures, and sells advanced medical devices in more than 70 countries worldwide. TaeWoong offers a wide range of innovative therapeutic products for endoscopic ultrasound (EUS). With EndoDrill® GI in its portfolio, TaeWoong can now provide endoscopists with unique solutions for the entire clinical pathway – from efficient tissue sampling to advanced endoscopic treatment.

EndoDrill® GI is a next-generation powered EUS biopsy system designed for early detection and diagnosis of gastrointestinal cancers. The product offers significant benefits to patients, healthcare systems, and providers. The agreement with TaeWoong marks an important milestone in BiBB’s international expansion.

Key terms of the distribution agreement

i)Exclusive distribution rights and contract term
The agreement grants TaeWoong exclusive rights to distribute EndoDrill® GI in the U.S. market. The agreement runs through 2028, with an option to extend through 2030. Future product variants – EndoDrill® EBUS (lung cancer) and EndoDrill® URO (bladder cancer) – are not included in the agreement.

ii)Business plan
The agreement also includes a detailed business plan outlining the path from preparations and targeted launch in 2025 to full-scale commercialization in 2026. The plan covers marketing strategy, sales, price positioning, and established sales targets.

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 atwww.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

About BiBB

BiBBInstruments AB (“BiBB”) develops and manufactures EndoDrill® – the world’s first market-cleared, powered biopsy instrument for endoscopy. EndoDrill® enables rapid and high-quality core needle biopsies (CNB) for the diagnosis of serious cancers, including gastric, pancreatic, liver, lung, and bladder cancer. The product portfolio targets the fast-growing global market for endoscopic ultrasound-guided biopsy instruments (EUS/EBUS). EndoDrill® GI is FDA-cleared and CE-marked, with U.S. launch starting in 2025 in collaboration with TaeWoong Medical USA. EndoDrill® EBUS and EndoDrill® URO were CE-marked in 2024 and are planned for gradual launch. BiBB was founded by Dr Charles Walther and is headquartered at Medicon Village in Lund, Sweden. The share (BIBB) is listed on Spotlight Stock Market.

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