NurExone Receives U.S. Patent Allowance for Exosome Manufacturing, Strengthening Supply Chain Readiness

Executive Summary

• NurExone Biologic Inc. announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent covering its proprietary process for producing exosomes.
• The patent secures exclusive rights to the company’s 3D scaffold and shear-stress based bioreactor system, enabling scalable and reproducible exosome production.
• This milestone strengthens the company's supply chain foundation, alongside the recent acquisition of a GMP-grade Master Cell Bank, supporting the path toward first-in-human clinical trials and future commercial positioning.

Key Details

• Patent Allowance: The USPTO issued a Notice of Allowance for a patent covering the proprietary process for producing exosomes (natural cell-free nanoparticles derived from stem cells).
• Scope of Protection: The patent is part of an extensive international patent family, securing broad global protection. It specifically covers the 3D scaffold and shear-stress based bioreactor system.
• Licensing: The patented manufacturing process is under an exclusive worldwide license to NurExone from the Technion Research and Development Foundation, Ltd.
• Supply Chain Reinforcement: The patent allowance coincides with the acquisition of a Good Manufacturing Practice (GMP)-grade Master Cell Bank in December 2024, reinforcing the core elements of the supply chain.
• Product Validation: Independent benchmarking demonstrated the stronger regenerative potential of the company's exosomes.
• Commercial Strategy: The milestone establishes a foundation for the planned launch of Exo-Top Inc.’s commercial-scale production and business-to-business supply of naïve exosomes.
• Lead Product Context: The company’s lead product, ExoPTEN, has demonstrated strong preclinical data for treating acute spinal cord and optic nerve injury, having previously obtained Orphan Drug Designation.

Notable Quotes

• “This U.S. patent allowance secures long-term protection for our proprietary manufacturing process,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “With patent coverage in place and the recent acquisition of a Good Manufacturing Practice (“GMP”)-grade Master Cell Bank, we have reinforced the core elements of our supply chain. Combined with independent benchmarking that demonstrated the stronger regenerative potential of our exosomes, this milestone strengthens our path towards first-in-human trials and future commercial positioning.”
• “This technology, which originated in my lab at the Technion, represents a unique and scalable method of manufacturing stem-cell derived exosomes. The allowance of this patent validates years of research and ensures that NurExone retains lasting intellectual property as it advances into clinical and commercial phases,” added Prof. Shulamit Levenberg, lead inventor and NurExone Scientific Advisor.