Swedish cancer diagnostics company BiBBInstruments AB (Spotlight: BIBB) said on Wednesday that it received additional fourth-quarter orders from its US distributor TaeWoong Medical USA worth USD31,840 (SEK 300k).
The orders form part of a targeted US launch initiated in the autumn.
EndoDrill GI is a powered biopsy instrument for endoscopic ultrasound that holds US Food and Drug Administration clearance and CE marking. The system received US 510(k) clearance in 2023 and CE marking in 2024, is in clinical use in both regions, and began its US launch in autumn 2025.
TaeWoong Medical USA is seeking to establish regular use at major reference hospitals to underpin a nationwide launch in 2026, while BiBBInstruments AB is also in discussions with potential European distribution partners with the aim of a 2026 market entry.
BiBBInstruments AB said fourth-quarter order value to date exceeds third-quarter sales by more than 170%.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval