BiBB signs exclusive distribution agreement with Palex Medical Spain

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 its first European commercial distribution agreement for EndoDrill^® GI with Palex Medical S.A.U. ("Palex Spain"). Under the agreement, Palex Medical Spain receives exclusive rights to market, sell and commercialize EndoDrill^® GI in Spain. The agreement is intended to serve as a foundation for further commercial expansion within additional European regions of the Palex network. Preparations for the European launch are taking place in parallel with the ongoing U.S. commercialization, which began in 2025 in collaboration with TaeWoong Medical USA.

Comment from Fredrik Lindblad, CEO of BiBB:
"Signing our first European commercial distribution agreement represents an important milestone for BiBB. Palex Medical Spain combines a strong commercial organization with extensive experience in advanced endoscopy and a well-established presence in the Spanish healthcare market. We look forward to introducing EndoDrill^® GI together with Palex and to supporting clinicians with a new approach to tissue acquisition through high-quality core tissue samples.”

The agreement includes exclusivity rights and mutually agreed commercial targets. The agreement covers EndoDrill^® GI only and does not include other products within the EndoDrill^® portfolio. Additional EndoDrill® products may be added to the agreement as they become commercially available.

Palex Group is one of Europe's leading healthcare distribution groups, operating across 11 European regions. The Group employs more than 2,100 people and is headquartered in Barcelona, Spain. Palex Spain is the Group's largest operating company, employing close to 1,000 people and serving healthcare providers throughout Spain.

Commercial launch preparations in Spain have commenced. EndoDrill^® GI has already been successfully used in patient cases at several leading EUS centers in Madrid and Valladolid together with Palex. The positive clinical experience generated through these procedures has provided an important foundation for the commercial launch. The parties have subsequently initiated market development activities, including clinical engagement, target account identification and launch planning.

María Jesús Barrenechea , CBO Spain of Palex:
”The introduction of BiBBInstruments’ EndoDrill^® technology represents an important step forward in our commitment to advanced, patient-centred care. By enabling high-quality core biopsies through a powered, rotating tissue acquisition system, this state-of-the-art technology has the potential to improve the reliability of tissue sampling and support more accurate diagnosis and treatment planning. For patients, this may translate into better-informed clinical decisions and a more efficient diagnostic pathway. For healthcare professionals, EndoDrill^® provides an innovative tool designed to enhance precision and confidence in endoscopic tissue acquisition procedures.”

Spain represents an important European market for endoscopic ultrasound, with approximately 100 hospitals performing EUS procedures. The agreement with Palex Medical Spain is intended to support further commercial expansion within the Palex network. BiBB is currently engaged in discussions regarding additional European territories.

About Palex Group and Palex Medical Spain
Palex Group is a leading European healthcare and medical technology distribution group providing advanced solutions and services to hospitals, healthcare professionals and research institutions. The Group operates through a network of specialized companies with expertise spanning endoscopy, surgery, interventional medicine and hospital solutions.

Palex Spain is the largest operating company within Palex Group, one of Europe's leading healthcare distribution groups. The company employs close to 1,000 people and maintains a dedicated endoscopy organization serving leading hospitals throughout Spain.

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 to facilitate histopathology and molecular analysis. The system is currently being commercialized in the United States through distribution partner TaeWoong Medical USA. The European commercial launch is scheduled to commence in Spain during 2026 through distribution partner Palex Medical Spain, representing the first step in BiBB's planned expansion across 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.

The information was submitted for publication, through the agency of the contact person set out above, at the time stated by the Company’s news distributor upon publication of this press release.

About BiBBInstruments AB

BiBBInstruments AB is a cancer diagnostics company developing and manufacturing 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 organs such as 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 its first instrument, EndoDrill® GI, in 2023 and CE marking under the European Medical Device Regulation (MDR) in 2024 for all three product variants – EndoDrill® GI, EndoDrill® EBUS, and EndoDrill® URO. As such, EndoDrill® is the first powered biopsy system cleared in both the United States and Europe. The U.S. launch of EndoDrill® GI commenced during the second half of 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 pathologist 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).