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NurExone Biologic Advances Manufacturing and Regulatory Roadmap with Independent Batch Consistency Results for Exosome Production
TMX Newsfile· 2026-02-10 21:03
Core Insights - NurExone Biologic Inc. announced positive results from an independent proteomic analysis that supports its Chemistry, Manufacturing and Controls (CMC) readiness, which is crucial for potential Investigational New Drug (IND) application and subsequent human clinical trials [1][4] Manufacturing Consistency - The analysis demonstrated batch-to-batch consistency in NurExone's exosome production, with four independent batches showing a highly consistent protein "fingerprint," indicating robustness and reproducibility in the manufacturing process [2][4] Therapeutic Potential - The evaluation revealed several therapeutically potential proteins in NurExone's exosomes that were not present in commercial reference samples, highlighting a distinct biological profile associated with inflammation control, cellular resilience, and nerve repair support [3][4] Development Focus - NurExone's near-term development strategy includes milestones aimed at reducing technical and regulatory risks, alongside establishing small-scale clinical manufacturing capabilities in Israel to transition from research-scale to clinical-grade production [4][11] Engagement with Strategic Communications - The company has reengaged Russo Partners LLC for public and investor relations services for an additional 3-to-6-month term, with a monthly fee of US$15,000, subject to TSX Venture Exchange approval [8][9] Company Overview - NurExone is focused on developing regenerative exosome-based therapies for central nervous system injuries, with its lead product, ExoPTEN, showing strong preclinical data for treating acute spinal cord and optic nerve injuries, which are significant market opportunities [11]