NurExone Secures U.S. Patent for Proprietary Exosome Manufacturing Technology
核心洞察
NurExone Biologic received U.S. patent allowance for its proprietary 3D scaffold and shear-stress based bioreactor system for producing stem cell-derived exosomes (搜索).
The patent protection, combined with a GMP-grade Master Cell Bank acquired in December 2024, establishes a robust foundation for clinical supply chain and commercial-scale production.
Independent benchmarking demonstrated stronger regenerative potential of NurExone's exosomes (搜索), strengthening the path toward first-in-human trials for ExoPTEN.
NurExone Biologic Inc. (搜索) has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering the company's proprietary process for producing exosomes (搜索), natural cell-free nanoparticles derived from stem cells. The patent secures exclusive rights to NurExone's 3D scaffold and shear-stress based bioreactor system, enabling scalable, reproducible exosome production for its regenerative therapy pipeline.
"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."
Manufacturing Technology and Intellectual Property
The patented technology originated in the laboratory of Prof. Shulamit Levenberg at the Technion (搜索) and represents what the company describes as a unique and scalable method of manufacturing stem-cell derived exosomes (搜索). The patent is part of an extensive international patent family, with the Israel Patent Office also granting patent protection for the same priority family of applications.
Prof. Shulamit Levenberg, lead inventor and NurExone Scientific Advisor, noted that "this technology, which originated in my lab at the Technion (搜索), represents a unique and scalable method of manufacturing stem-cell derived exosomes (搜索). 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 patented manufacturing process operates under an exclusive worldwide license to NurExone from the Technion (搜索) Research and Development Foundation, Ltd.
Clinical Development Progress
Combined with the GMP-grade Master Cell Bank acquired in December 2024, this patent milestone establishes what the company characterizes as a robust foundation for NurExone's clinical supply chain. Independent benchmarking has demonstrated the stronger regenerative potential of the company's exosomes (搜索), according to Dr. Shaltiel, which "strengthens our path towards first-in-human trials and future commercial positioning."
The company's lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury (搜索). NurExone has obtained Orphan Drug Designation, which facilitates the regulatory roadmap towards clinical trials in the U.S. and Europe.
Commercial Strategy and Financing
The patent protection supports the planned launch of Exo-Top Inc. (搜索)'s commercial-scale production and business-to-business supply of naïve exosomes (搜索). NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy, with clinical and commercial manufacturing of exosomes planned to be based in the U.S.
To support these initiatives, NurExone closed a non-brokered private placement of 930,376 units at C$0.68 per unit for aggregate gross proceeds of C$632,655.68. "The completion of this financing provides incremental capital to support our preclinical pipeline and U.S. manufacturing initiatives," said Eran Ovadya, CFO of NurExone. "It also positions us well as we prepare to accelerate our growth strategy."
Industry Engagement
The company is expanding its presence in the U.S. market through participation in key industry conferences. Dr. Ina Sarel, Head of CMC, Quality and Regulation, will present on NurExone's exosome manufacturing platform at the 7th Annual Exosome-Based Therapeutic Development Summit in Boston, co-hosting a fireside discussion on harmonizing the exosome regulatory landscape.
Dr. Shaltiel will speak at the Bioprocess International Conference in Boston, with a presentation entitled "From Antibodies to siRNA-Loaded Exosomes (搜索): AbbVie (搜索) vs. NurExone in Advancing Spinal Cord Injury (搜索) Treatments." These conferences provide opportunities for the company to showcase its proprietary ExoTherapy technology and engage potential partners and investors.