NurExone Announces Plan to Submit Pre-Investigational New Drug Meeting Request to U.S. Food and Drug Administration; Company Is Developing Non-Invasive Biologically-Guided Exosome Therapy for Traumatic Spinal Cord Injury

On November 2, 2022, NurExone Biologic Inc. (TSXV: NRX) (FSE: J90), a biopharmaceutical company developing biologically-guided exosome therapy ("ExoTherapy") for patients with traumatic spinal cord injuries, was pleased to announce the Company's plan to submit a Pre-IND meeting request to the FDA. Prior to submission of a New Investigational Drug (IND) application, in September 2022, the Company submitted a request for an Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meeting, which is an informal, non-binding meeting that is offered by the U.S. FDA to companies at an early stage in product development. In an official response to the Company's INTERACT meeting request, the FDA informed NurExone that the Company is beyond the stage of participating in this informal meeting and is instead appropriate for the next type of formal meeting, known as a Pre-IND meeting in connection with the development of ExoPTEN, NurExone's first ExoTherapy product.

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