NeuroSense Therapeutics Announces Successful Completion of Commercial Manufacturing Scale-Up for PrimeC in Preparation for Potential Canadian Market Launch

Core Insights - NeuroSense Therapeutics has successfully scaled up the production of its ALS therapy, PrimeC, to commercial levels, marking a significant step towards commercialization in a projected $100-150 million Canadian market opportunity [1][4] - The company has enhanced its supply chain with comprehensive Chemistry, Manufacturing, and Controls (CMC) improvements, ensuring a robust infrastructure for commercial launch [2][3] - NeuroSense is collaborating with a global Contract Development and Manufacturing Organization (CDMO) for the production of PrimeC, with validated analytical methods and a confirmed shelf life of at least 36 months at room temperature [3][4] Manufacturing and Regulatory Strategy - The manufacturing milestone is seen as a critical advancement in the company's commercialization roadmap, positioning PrimeC for rapid entry into the Canadian market upon regulatory approval [4] - NeuroSense is pursuing early market entry through the Notice of Compliance with Conditions (NOC/c) pathway with Health Canada, aimed at expediting access to therapies for serious conditions [4] - The company’s patent protection for PrimeC extends through 2042, reinforcing its market position and long-term growth strategy [4] Market Potential and Company Overview - The potential peak annual revenue for PrimeC in Canada is estimated between $100 million and $150 million, addressing significant unmet medical needs in ALS treatment [4] - NeuroSense focuses on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's, which represent significant unmet medical needs [5]