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Dr. Sarel will present “Regulatory Challenges in the Clinical Development of ExoPTEN: MSC EVs Loaded with PTEN-siRNA” on October 28, followed by a panel discussion on how developers of exosome therapeutics can better approach regulatory approval. The invitation reflects strong international interest in NurExone’s lead program, ExoPTEN, a drug under development that combines regenerative and anti-inflammatory mechanisms to repair Central Nervous System damage.

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The study was conducted in collaboration with Prof. Ygal Rotenstreich team at the Goldschleger Eye Institute at Sheba Medical Center, one of the world’s leading hospitalsⁱ. It demonstrated that ExoPTEN’s biological activity increases with higher dosing levels in animals with optic nerve injury, resulting in consistent and measurable recovery of visual function. The findings show that ExoPTEN’s regenerative effect is reproducible, quantifiable, and scales with dose.

“Reproducibility is the key challenge in science, and now we have a first validation of the results,” said Prof. Michael Belkin, Professor Emeritus of Ophthalmology at Tel Aviv University and Scientific Advisor to NurExone. “These results confirm that ExoPTEN has the potential impact of a true therapeutic, producing reproducible repair of damaged optic nerves in small animals, advancing our ability to address vision loss in patients with optic nerve damage, such as glaucoma and related conditions.”

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The Indianapolis facility would serve as Exo-Top’s U.S. manufacturing base, transferring NurExone’s proprietary exosome production process into the American market. The GMP compliant site would produce exosomes both for NurExone’s therapeutic pipeline and for a growing business-to-business opportunity in regenerative aesthetics.

“Indiana’s commitment to building its life sciences cluster, outstanding logistics and strong incentives offer make Indianapolis the ideal home for Exo-Top, and we are honored to consider expanding into Indiana with the support of the Indiana Office of Commerce,” said Jacob Licht, CEO of Exo-Top. “By joining this ecosystem, we would contribute to Indiana’s biomanufacturing growth while securing a U.S. foundation for our therapeutic and commercial programs.”

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The Israel Patent Office has granted the Company’s Patent, entitled “Production of Extracellular Vesicles from Stem Cells.” This grant aligns with NurExone’s recently announced U.S. Notice of Allowance for the same priority family of applications.

“While our clinical and commercial manufacturing of exosomes will be based in the U.S. through our Exo-Top Inc. subsidiary, expanding jurisdictional coverage further strengthens NurExone’s international intellectual property portfolio,” said Dr. Lior Shaltiel, CEO of NurExone.

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“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.”

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