NurExone Granted U.S. Patent for Exosome Manufacturing Process, Enhancing Supply Chain Capabilities
NurExone secures U.S. patent protection for its exosome production method, supporting scale-up and clinical supply chain readiness.
NurExone Biologic has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering its proprietary process for producing exosomes—cell-free nanoparticles derived from stem cells. The company states that this patent is part of a broader international family, providing global protection for its manufacturing approach.
We just interviewed the CEO about their exosomes for spinal cord injury, seen here!
The patent provides exclusive rights to a 3D scaffold and shear-stress-based bioreactor system, which the company says supports scalable and reproducible exosome production. Alongside the GMP-grade Master Cell Bank acquired in December 2024, NurExone is establishing a foundation for its clinical supply chain and preparing for the launch of Exo-Top Inc.’s commercial-scale production and business-to-business supply of naïve exosomes. The manufacturing process is licensed exclusively to NurExone from the Technion Research and Development Foundation, Ltd.
“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.”
Prof. Shulamit Levenberg, lead inventor and NurExone Scientific Advisor, added: “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.”
NurExone focuses on developing exosome-based therapies targeting central nervous system injuries. Its lead product, ExoPTEN, has shown promising preclinical data for treating acute spinal cord and optic nerve injury. The company has obtained Orphan Drug Designation, which it reports will support its clinical trial roadmap in the U.S. and Europe. NurExone also plans to provide exosomes and targeted delivery systems for other indications and has established Exo-Top Inc., a U.S. subsidiary, to support its North American strategy.
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