Intelligent Bio Solutions resolves all cybersecurity review items for FDA 510(k) submission; on track for H2 2026 filing

INTELLIGENT BIO SOLUTIONS INC.

Completed independent third-party penetration testing; all cybersecurity review items resolved.
100% of medium-risk vulnerabilities remediated; low-risk reduced from 11 to 2 with risk-based justification.
All 19 software bill of materials (SBOM) vulnerabilities fully resolved; documentation aligned with FDA guidance.
510(k) submission targeting codeine detection as initial indication; planned U.S. market entry in multi-billion-dollar drug screening market.
Manufacturing partnership with Syrma Johari MedTech expected to deliver >40% production cost savings and ~20 ppt gross margin improvement.

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