NaviFUS

Executive Summary

NaviFUS Corp. is a Taiwan-based biotechnology company pioneering non-invasive focused ultrasound (FUS) technology to transiently open the blood-brain barrier (BBB) for targeted drug delivery to the central nervous system. Its lead platform, the NaviFUS neuronavigation-guided transcranial FUS system, is being evaluated in clinical trials for glioblastoma, drug-resistant epilepsy, and stroke rehabilitation. Additionally, the company markets NAVIRFA, an optical 3D needle-tracking system for minimally invasive ablation procedures. NaviFUS aims to address significant unmet needs in neurological and oncological indications by enabling safer, more effective delivery of therapeutics across the BBB. NaviFUS has completed early-stage clinical studies demonstrating proof-of-concept for BBB opening and safety. The company expects to release key Phase 2 data for glioblastoma in the second half of 2026, which could serve as a pivotal catalyst. Furthermore, regulatory clearance for NAVIRFA in new markets or expanded indications may provide near-term commercial upside. With a growing pipeline and strategic partnerships, NaviFUS is positioned to capitalize on the expanding field of focused ultrasound in neurology and oncology.

Upcoming Catalysts (preview)

• H2 2026Phase 2 glioblastoma data readout45% success
• Q4 2026FDA 510(k) clearance for NAVIRFA needle-tracking system70% success