TORONTO and HAIFA, Israel, May 08, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a preclinical-stage biotechnology company pioneering exosome-based therapies for central nervous system injuries, is pleased to announce that its preclinical data on optic nerve regeneration study was presented today at the Annual Meeting of the Association for Research in Vision and Ophthalmology (“ARVO) in Salt Lake City Utah, the world's largest and most respected vision science conference.

The data, presented by Prof. Ygal Rotenstreich, lead investigator and Director of the Retinal Research Lab at Sheba Medical Center, showed that ExoPTEN restored retinal activity and improved optic nerve structure in a controlled rat model of optic nerve compression. The study, initially announced in July and December 2024, has since been expanded to include a larger group of animals.

Prof. Ygal Rotenstreich commented “We’re proud to present this progress in optic nerve regeneration at ARVO, where the future of vision science is shaped”. He further noted “Our presentation generated a lot of interest from our peers and the scientific community who are anxiously awaiting real breakthroughs in this field.

Prof. Michael Belkin, founder of Tel Aviv University's Goldschleger Eye Research Institute where the study took place and a member of NurExone’s Scientific Advisory Board, noted “The results presented at ARVO show a distinct possibility that ExoPTEN can be used in treating optic nerve pathologies. We are proceeding to study an actual glaucoma model to examine the possibility of treating optic nerves which cause vision incapacitation from this common disease.”

Dr. Lior Shaltiel, CEO of NurExone also added “We’re seeing damaged neurons survive and regain function in models that were previously considered irreversible, challenging long-standing assumptions in neurodegeneration. Acute glaucoma carries a high risk of irreversible blindness and an associated economic burden that costs the healthcare system billions per year¹. By preserving vision in even a fraction of these cases, a therapy, like ExoPTEN, could deliver clinical and economic value.”

The therapy for acute glaucoma is being developed as part of NurExone’s broader ExoTherapy™ platform, which also includes programs for spinal cord and facial nerve regeneration. In preclinical spinal cord studies, ExoPTEN restored motor function in 75% of animals following complete transection. Like its ophthalmic applications, the spinal and facial nerve programs use the same exosome-based product, supporting a modular and scalable approach to nervous system repair.

The ARVO Annual Meeting is the largest and most respected gathering in vision research, bringing together over 10,000 experts from academia, industry, and clinical practice. NurExone’s inclusion in the ARVO scientific program reflects growing recognition of exosome-based strategies as a potential new frontier in regenerative medicine.

About NurExone

NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”), OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar markets ⁱ. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.

For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Allele Capital Partners
Investor Relations – U.S. and Canada
Phone: +1 978-857-5075
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to: the Company receiving all regulatory approvals; the Company advancing towards clinical and commercial breakthroughs in regenerative medicine; the Company enhancing its presence in key markets; the advancement of the Company’s therapeutic programs and clinical milestones; the results of the Company’s preclinical trials and its suggestion of a promising treatment pathway for spinal cord injury (“SCI”); the results of the Company’s preclinical trials and its suggestion of a promising treatment pathway for glaucoma; the Company developing groundbreaking therapies for regenerative medicine in several indications; ExoPTEN having the potential to address vision loss and improve patient lives; the Company is advancing toward clinical translation in several high-impact indications; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health.

These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including: the Company will realize on the benefits of exosome loaded drugs in regenerating or repairing damaged nerves; the ability of the Company’s products to be used for patient treatment; the Company will fulfill its intended future plans and expectations; there being growing clinical demand for innovative treatments in spinal cord, optic nerve, and other therapeutic areas; the Company will carry out its pre-clinical trials and realize upon the benefits of the pre-clinical trials; the Company having the ability to maintain its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and cell therapy applications; the Company will receive all regulatory approvals; the Company will have clinical and commercial breakthroughs in regenerative medicine;  the Company will be able to realize its future development plans, operational initiatives, and strategic objectives; the Company’s ability to advance its therapeutic programs and clinical milestones; the results of the Company’s preclinical trials and its ability to be a promising treatment pathway for SCI; the Company’s ability in advancing toward clinical translation in several high-impact indications; the results of the Company’s preclinical trials and its suggestion of a promising treatment pathway for glaucoma; the Company developing groundbreaking therapies for regenerative medicine in several indications; ExoPTEN having the ability to address vision loss and improve patient lives; the Company having the ability to advance toward clinical translation in several high-impact indications; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health

Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to: the Company’s early stage of development; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; dependence on the Company’s strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the inability to obtain adequate financing; the inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; risks that the Company’s intellectual property and technology won’t have the intended impact on the Company and/or its business; the Company’s inability to carry out its pre-clinical trials and realize upon the stated benefits of the pre-clinical trials; the inability of the Company to realize on the benefits of exosomes; the inability of the Company to produce and/or supply exosomes for a wide range of applications; the inability of the Company’s products to be used for patient treatment; there not being broader adoption in the field and/or cell therapy applications; the inability of the Company to fulfill its intended future plans and expectations; there not being growing clinical demand for innovative treatments in spinal cord, optic nerve, and/or other therapeutic areas; the inability of the Company to collaborate with pharma companies; the Company’s inability to realize upon the stated potential for exosome-loaded drugs in regenerating or repairing damaged nerves; the Company’s inability to maintain its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and/or cell therapy applications; the Company’s inability to expand into further studies; the Company will not receive all required regulatory approvals; the Company will not have clinical and/or commercial breakthroughs in regenerative medicine; the Company will be unable to enhance its presence in key markets; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; the Company will not realize its future development plans, operational initiatives, and strategic objectives; the Company will not advance its therapeutic programs and clinical milestones; the Company will not engage with regulatory agencies; the results of the Company’s preclinical trials not being a promising treatment pathway for SCI; the Company not advancing toward clinical translation in several high-impact indications; the Company not developing groundbreaking therapies for regenerative medicine in several indications; ExoPTEN not addressing vision loss or improving patient lives; the Company does not advance toward clinical translation in several high-impact indications; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s Annual Information Form dated August 27, 2024, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

ⁱ Spinal cord injury , Glaucoma

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