BiBBInstruments AB ("BiBB" or the "Company"), developer of EndoDrill® - the world's first market-cleared powered biopsy instrument for endoscopy - announces that the Company has received new orders from its US distribution partner, TaeWoong Medical USA, with a total value of approximately SEK 1.75 million (USD 178,420). The Company plans for delivery and invoicing of the orders during the fourth quarter of 2026.
At the same time, a highly successful clinical introduction is underway together with Palex Medical Spain at several hospitals across Spain. In parallel, discussions and contract negotiations are ongoing with additional European sales companies within the Palex Group network.
"The new orders are a strong indication of our US partner's confidence in the EndoDrill® system and represent a clear step forward in our commercial development in the US. The fact that the initial customer visits involving clinical cases in Spain have gone very well is also highly encouraging for our continued expansion in Europe," says Fredrik Lindblad, CEO of BiBB.
About EndoDrill® GI
EndoDrill® GI is the world's first market-cleared powered biopsy instrument for endoscopic ultrasound (EUS), with both FDA 510(k) clearance and CE marking. Unlike conventional manual biopsy needles, EndoDrill® uses a powered rotating needle tip designed to obtain intact core tissue samples for histopathology and molecular analysis. The system is currently being commercialized in the US through distribution partner TaeWoong Medical USA. The European commercial launch is commencing in Spain in the autumn of 2026 through distribution partner Palex Medical Spain, representing the first step in BiBB's planned expansion in Europe.
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.
This information is information that BiBBInstruments AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU) No. 596/2014. The information was submitted for publication, through the agency of the contact person set out above, at the time specified by the Company's news distributor in connection with the publication of this press release.
About BiBBInstruments AB
BiBBInstruments AB is a cancer diagnostics company that develops and manufactures EndoDrill®, the world's first series of market-cleared powered biopsy instruments for endoscopy. EndoDrill® is designed to obtain core tissue samples (core needle biopsies, CNB) with high diagnostic accuracy and aims to improve the diagnosis of cancer in, among other organs, 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 EndoDrill® GI in 2023 and CE marking under the MDR for EndoDrill® GI, EndoDrill® EBUS, and EndoDrill® URO in 2024. EndoDrill® is thus the first powered biopsy system to be market-cleared in both the US and Europe. The US launch of EndoDrill® GI commenced in the second half of 2025 together 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, a cancer researcher at Lund University and senior consultant in pathology 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).