NurExone Biologic Inc. , a pioneering biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent covering the Company’s proprietary process for producing exosomes, natural cell-free nanoparticles derived from stem cells. The patent is part of an extensive international patent family, securing broad global protection and strengthening the company’s worldwide market position.

“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.”

The patent secures exclusive rights to NurExone’s 3D scaffold and shear-stress based bioreactor system, enabling scalable, reproducible exosome production. Together with the GMP-grade Master Cell Bank acquired in December 2024, this milestone establishes a robust foundation for NurExone’s clinical supply chain and the planned launch of Exo-Top Inc.’s commercial-scale production and business-to-business supply of naïve exosomes. The patented manufacturing process is under an exclusive worldwide license to NurExone from the Technion Research and Development Foundation, Ltd.