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| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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The cancer diagnostics company BiBBInstruments AB ("BiBB" or the "Company") announces that additional orders have so far been received from the Company's U.S. distribution partner, TaeWoong Medical USA, with a total value of $31,840 (SEK 300,000) during the fourth quarter. The orders form part of the targeted launch in the U.S. that was initiated in the fall. TaeWoong is focused on establishing regular use at a number of larger reference hospitals, which will serve as the foundation for a broader nationwide launch in 2026. In parallel, discussions are ongoing with potential distribution partners in Europe, with the objective of also introducing EndoDrill® GI to the European market in 2026.
"Additional orders from our partner in the U.S. confirm that the ongoing launch is progressing according to plan and that the BiBB team's tour of U.S. hospitals in November yielded results. The order value to date in the fourth quarter exceeds sales in the third quarter by more than 170 percent," says Fredrik Lindblad, CEO of BiBB.
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 that retrieves intact tissue cores, providing very high histological yield and enabling molecular analysis. The system received 510(k) clearance in the United States in 2023 and CE marking in Europe in 2024. It is currently in clinical use in both regions, and a targeted U.S. launch began in the fall of 2025 in collaboration with TaeWoong Medical USA.
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 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 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 in modern endoscopy. BiBB received FDA 510(k) clearance for its first instrument, EndoDrill® GI, in 2023 and CE marking under the EU Medical Device Regulation (MDR) in 2024 for all three product variants - EndoDrill® GI, EndoDrill® EBUS, and EndoDrill® URO. EndoDrill® is thus the first motor-driven biopsy system approved in both the U.S. and Europe. The U.S. launch of EndoDrill® GI began in fall 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 in clinical pathology at Skåne University Hospital. The Company is headquartered at Medicon Village in Lund and is listed on Spotlight Stock Market (ticker: BIBB).