NurExone to Showcase Breakthrough in Facial Nerve Regeneration at ISEV 2025
NurExone Biologic (NRXBF) has announced breakthrough findings in facial nerve regeneration using their ExoPTEN therapy, marking their third therapeutic indication alongside spinal cord injury and optic nerve regeneration programs. Preclinical studies demonstrated significant functional recovery in facial nerve injury models, potentially addressing conditions like Bell's palsy and Ramsay Hunt Syndrome.
The research, conducted at the Israel Institute of Technology, validates PTEN downregulation as a strategy for axon regrowth. The therapy could target a market where approximately 30% of patients experience long-term functional impairment. The company's ExoTherapy platform utilizes exosomes for precise, minimally-invasive delivery of treatments to injured tissues.
NurExone is preparing an Investigational New Drug (IND) application for ExoPTEN in acute spinal cord injury. The technology is protected by a U.S. patent owned by the Technion, with worldwide exclusive licensing to NurExone, and has been granted in Japan, Russia, and Israel.
NurExone Biologic (NRXBF) ha annunciato risultati rivoluzionari nella rigenerazione del nervo facciale grazie alla loro terapia ExoPTEN, segnando la terza indicazione terapeutica dopo i programmi per lesioni del midollo spinale e rigenerazione del nervo ottico. Studi preclinici hanno mostrato un recupero funzionale significativo in modelli di lesione del nervo facciale, con potenziali applicazioni per condizioni come la paralisi di Bell e la sindrome di Ramsay Hunt.
La ricerca, condotta presso l'Istituto di Tecnologia di Israele, conferma la downregolazione di PTEN come strategia per la rigenerazione degli assoni. La terapia potrebbe rivolgersi a un mercato in cui circa il 30% dei pazienti soffre di disabilità funzionali a lungo termine. La piattaforma ExoTherapy dell'azienda utilizza esosomi per una somministrazione precisa e minimamente invasiva dei trattamenti ai tessuti lesionati.
NurExone sta preparando una domanda di Nuovo Farmaco Sperimentale (IND) per ExoPTEN nelle lesioni acute del midollo spinale. La tecnologia è protetta da un brevetto statunitense di proprietà del Technion, con licenza esclusiva mondiale a NurExone, ed è stata concessa anche in Giappone, Russia e Israele.
NurExone Biologic (NRXBF) ha anunciado hallazgos revolucionarios en la regeneración del nervio facial mediante su terapia ExoPTEN, marcando su tercera indicación terapéutica junto con los programas de lesión de la médula espinal y regeneración del nervio óptico. Estudios preclínicos demostraron una recuperación funcional significativa en modelos de lesión del nervio facial, con potencial para tratar condiciones como la parálisis de Bell y el síndrome de Ramsay Hunt.
La investigación, realizada en el Instituto de Tecnología de Israel, valida la regulación a la baja de PTEN como estrategia para el crecimiento axonal. La terapia podría dirigirse a un mercado donde aproximadamente el 30% de los pacientes experimentan discapacidad funcional a largo plazo. La plataforma ExoTherapy de la compañía utiliza exosomas para una administración precisa y mínimamente invasiva de tratamientos a tejidos lesionados.
NurExone está preparando una solicitud de Nuevo Fármaco en Investigación (IND) para ExoPTEN en lesiones agudas de la médula espinal. La tecnología está protegida por una patente estadounidense propiedad del Technion, con licencia exclusiva mundial para NurExone, y ha sido concedida en Japón, Rusia e Israel.
NurExone Biologic (NRXBF)는 ExoPTEN 치료법을 이용한 안면신경 재생에 획기적인 성과를 발표했으며, 이는 척수 손상 및 시신경 재생 프로그램에 이어 세 번째 치료 적응증입니다. 전임상 연구에서 안면신경 손상 모델에서 유의미한 기능 회복이 확인되었으며, 이는 벨 마비 및 램지 헌트 증후군과 같은 질환 치료에 도움이 될 수 있습니다.
이스라엘 공과대학에서 수행된 연구는 축삭 재생을 위한 PTEN 하향 조절 전략을 입증했습니다. 이 치료법은 약 30%의 환자가 장기적인 기능 장애를 겪는 시장을 목표로 할 수 있습니다. 회사의 ExoTherapy 플랫폼은 손상된 조직에 치료제를 정확하고 최소 침습적으로 전달하기 위해 엑소좀을 활용합니다.
NurExone은 급성 척수 손상을 위한 ExoPTEN의 임상시험용 신약(IND) 신청을 준비 중입니다. 이 기술은 Technion이 소유한 미국 특허로 보호받고 있으며, NurExone에 전 세계 독점 라이선스가 부여되었고 일본, 러시아, 이스라엘에서도 특허가 승인되었습니다.
NurExone Biologic (NRXBF) a annoncé des résultats révolutionnaires dans la régénération du nerf facial grâce à leur thérapie ExoPTEN, marquant leur troisième indication thérapeutique après les programmes de lésion de la moelle épinière et de régénération du nerf optique. Des études précliniques ont démontré une récupération fonctionnelle significative dans des modèles de lésion du nerf facial, avec un potentiel pour traiter des affections telles que la paralysie de Bell et le syndrome de Ramsay Hunt.
La recherche, menée à l’Institut de Technologie d’Israël, valide la régulation négative de PTEN comme stratégie pour la repousse des axones. La thérapie pourrait cibler un marché où environ 30 % des patients souffrent d’une déficience fonctionnelle à long terme. La plateforme ExoTherapy de la société utilise des exosomes pour une administration précise et peu invasive des traitements aux tissus lésés.
NurExone prépare une demande d’Investigational New Drug (IND) pour ExoPTEN dans les lésions aiguës de la moelle épinière. La technologie est protégée par un brevet américain appartenant au Technion, avec une licence exclusive mondiale accordée à NurExone, et a été délivrée au Japon, en Russie et en Israël.
NurExone Biologic (NRXBF) hat bahnbrechende Ergebnisse bei der Regeneration des Gesichtsnervs mit ihrer ExoPTEN-Therapie bekannt gegeben und damit ihre dritte therapeutische Indikation neben Programmen zur Rückenmarksverletzung und Sehnervregeneration markiert. Präklinische Studien zeigten eine signifikante funktionelle Erholung in Modellen von Gesichtsnervverletzungen, mit Potenzial zur Behandlung von Erkrankungen wie Bell-Lähmung und Ramsay-Hunt-Syndrom.
Die Forschung, durchgeführt am Israelischen Technologischen Institut, bestätigt die Herunterregulierung von PTEN als Strategie für das Axonwachstum. Die Therapie könnte einen Markt adressieren, in dem etwa 30 % der Patienten langfristige funktionelle Beeinträchtigungen erfahren. Die ExoTherapy-Plattform des Unternehmens nutzt Exosomen für eine präzise, minimalinvasive Verabreichung von Behandlungen an verletzte Gewebe.
NurExone bereitet eine Investigational New Drug (IND)-Anmeldung für ExoPTEN bei akuten Rückenmarksverletzungen vor. Die Technologie ist durch ein US-Patent geschützt, das dem Technion gehört, mit weltweiter exklusiver Lizenzierung an NurExone, und wurde in Japan, Russland und Israel erteilt.
- Successful preclinical results in facial nerve regeneration, expanding into third therapeutic indication
- Technology protected by granted patents in multiple countries
- Single manufacturing process serving multiple high-value indications, improving economic efficiency
- Advancing toward IND submission for acute spinal cord injury
- Still in preclinical stage with no approved products
- Therapeutic efficacy in humans yet to be demonstrated
Exosome-Based ExoPTEN Targets Three High-Value Nerve Injury Indications
TORONTO and HAIFA, Israel, April 24, 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 presenting new data at the 2025 International Society for Extracellular Vesicles (ISEV) Annual Meeting being held in Vienna April 24-27.
The ISEV presentation will feature facial nerve regeneration, marking the Company’s third therapeutic indication, alongside its ongoing programs in spinal cord injury and optic nerve regeneration. In a preclinical model of facial nerve injury, NurExone’s lead candidate, ExoPTEN was shown to promote significant functional recovery and regeneration. These findings open, for the first time, a new potential therapeutic avenue for peripheral nerve injury conditions such as Bell's palsy, Ramsay Hunt Syndrome (Herpes Zoster Oticus), and other infections that damage the facial nerve. Approximately
The study, conducted in collaboration with the Levenberg lab at the Israel Institute of Technology led by Ayelet Lotan, MD-PhD candidate, is being presented at ISEV. Partially sponsored by NurExone, the preclinical study was conducted independently in an academic setting and offered potential confirmation of PTEN downregulation as a strategy to promote axon regrowth and facial nerve regeneration.
Prof. Shulamit Levenberg, PhD, Co-Founder of NurExone, Director of the Technion Center for 3D Bioprinting added “I’m thrilled to see yet another indication, facial nerve regeneration, emerge from our early pioneering work on ExoPTEN. It’s deeply rewarding to watch this science evolve from academic discovery into a drug pipeline with real clinical potential.”
ExoPTEN, will also be featured in a poster presentation by Dr. Isabelle Solomon and Dr. Sharon Baumgarten-Soueid entitled “Exosome platform: ExoPTEN as a breakthrough therapy for acute spinal cord injury, nerve regeneration and beyond”. In two validated spinal cord injury models, ExoPTEN improved motor, sensory, and structural outcomes. The Company is preparing to submit an Investigational New Drug (IND) application for ExoPTEN in the indication of acute SCI.
“We have already shown three indications which can be addressed by the same ExoPTEN drug. This attests to its therapeutic breadth," said Dr. Tali Kizhner Director of Research and Development at NurExone. She added “A single manufacturing process serving multiple high-value indications significantly enhances the economic model, and positions us to deliver scalable impact across the nerve regeneration landscape.”
NurExone’s ExoTherapy platform enables precise, minimally-invasive delivery of therapies to injured tissues using exosomes as an advanced delivery system. With a growing body of preclinical data and an IND in preparation for acute spinal cord injury, the company is advancing toward clinical translation in several high-impact indications.
The current findings are part of a granted U.S. patent owned by the Technion, for which the company holds a worldwide exclusive license. This patent has also been granted in several other countries, including Japan, Russia, and Israel, with additional applications pending worldwide. The patent allows the company to enforce and apply the technology for various indications related to nerve injury
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: info@nurexone.com
Oak Hill Financial Inc.
2 Bloor Street, Suite 2900
Toronto, Ontario M4W 3E2
Investor Relations – Canada
Phone: +1-647-479-5803
Email: info@oakhillfinancial.ca
Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
Allele Capital Partners
Investor Relations – U.S.
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com
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 Company will present its preclinical findings at ISEV, as outlined herein; the results of the Company’s preclinical trials and its suggestion of a promising treatment pathway for SCI; 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.
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 realizing 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 fulfilling 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 carrying out its pre-clinical trials and realizing upon the benefits of the pre-clinical trials; the Company maintaining 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 Company’s ability to present its preclinical findings at ISEV, as outlined herein; 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; and the NurExone platform technology will offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.
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 Company will not present its preclinical findings at ISEV, as outlined herein; 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; 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
_____________________________
1 Peitersen, E. (2002). Bell's palsy: the spontaneous course of 2,500 peripheral facial nerve palsies of different etiologies. Acta Otolaryngol Suppl, (549), 4–30. Available at: Europe PMC
2 https://www.openpr.com/news/3929404/bell-s-palsy-treatment-market-forecast-to-2030-advancements
FAQ
What are the three therapeutic indications targeted by NurExone's ExoPTEN treatment (NRXBF)?
What percentage of facial nerve condition patients could benefit from NurExone's (NRXBF) treatment?
What is the current development stage of NurExone's (NRXBF) ExoPTEN therapy?
Which countries have granted patents for NurExone's (NRXBF) nerve regeneration technology?
