NurExone Planning to Establish First U.S. Commercial Manufacturing Facility in Indiana
Secures Incentive Offer of up to US$255K to Establish Operations in Indianapolis
TORONTO and HAIFA, Israel and INDIANAPOLIS, Sept. 16, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biopharmaceutical innovator in exosome-based regenerative therapies, is pleased to announce that its U.S. subsidiary, Exo-Top Inc. (“Exo-Top”), is planning to establish its first U.S. commercial exosome production facility in Indianapolis, Indiana.
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.”
“Indiana would be a natural fit for Exo-Top’s U.S. establishment, and we look forward to the potential high-quality jobs and local economic benefits this investment would create,” said Secretary of Commerce David Adams. “The state offers the right environment for Exo-Top to scale production and strengthen NurExone’s U.S. supply chain.”
Indiana is home to one of the largest life sciences sectors in the U.S., generating more than $99 billion in annual economic outputi and attracting over $1.5 billion in venture investments since 2019ii. Industry employment has grown nearly seven times faster than the broader private sector, supported by global anchors such as Eli Lilly and advanced logistics infrastructureiii. These strengths make Indiana a strategic and attractive location for companies like Exo-Top preparing to scale.
Exo-Top’s potential new Indianapolis operations would anchor NurExone’s North American presence, complementing the Company’s progress toward first-in-human clinical trials of ExoPTEN and its plans to uplist to a major U.S. stock exchange.
About the Indiana Office of Commerce
The State of Indiana’s Office of Commerce was created by Governor Mike Braun to align and accelerate the state’s economic development efforts and is led by Indiana Secretary of Commerce David J. Adams.
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 marketsiv. 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:
Mr. Jacob Licht
Chief Executive Officer (ExoTOP)
Phone: +1 240 421 9755
Email: jacob@nurexone.com
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com
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: NurExone establishing a commercial exosome manufacturing facility in Indianapolis, Indiana and the benefits thereof; the Company progressing towards first in-human trials; projected business-to-business opportunities in regenerative aesthetics; the Company’s receipt and utilization of workforce assistance from the City of Indianapolis’ Indy Economic Development Corporation and EmployIndy Business and Recruitment Solutions initiative; 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: NurExone will establish a commercial exosome manufacturing facility in Indianapolis, Indiana and the realize on the benefits thereof; the Company will progress towards first in-human trials; the Company will receive and utilize workforce assistance from the City of Indianapolis’ Indy Economic Development Corporation and EmployIndy Business and Recruitment Solutions initiative; 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; the inherent uncertainty of preclinical drug development, including the risk that product candidates may not advance to clinical trials or receive regulatory approval; the possibility that results from preclinical studies and early-stage trials may not predict later outcomes; the uncertain timing, cost, and outcome of preclinical and clinical development activities; risks related to the clinical trial process, including potential delays or failure to achieve effective trial design or positive results; the inability to obtain or maintain required regulatory approvals; limited market acceptance of the Company’s products, even if approved; the potential emergence of competing therapies that are safer, more effective, or more affordable; rapid technological change that may impact the relevance of the Company’s technologies; the Company’s dependence on key personnel and strategic partners; the inability to obtain adequate financing; risks related to the Company’s ability to protect its intellectual property; the possibility that the Company’s technologies, including its exosome-based platforms, may not achieve their intended therapeutic impact; the inability to produce or scale exosome-based products for clinical use; limited adoption in regenerative medicine or cell therapy applications; lack of growing clinical demand in targeted indications; failure to meet planned development milestones or achieve commercial breakthroughs; the Company’s inability to have long-term protection of its intellectual property and/or manufacturing process; the Company’s exosomes will be not be regenerative; the Company and Exo-Top will be unable to advance into clinical and/or commercial phases, launch commercial-scale production and/or business-to-business exosome supply, achieve scalability and/or advance their manufacturing methods; the Company will not advance the optimization of ExoPTEN’s manufacturing processes and analytical methods; the Company will not prepare regulatory submissions; the Company will not launch first-in-human clinical trials; NurExone will not establish a commercial exosome manufacturing facility in Indianapolis, Indiana, or at all, and/or the be unable to realize on the benefits thereof; the Company will not receive and/or utilize workforce assistance from the City of Indianapolis’ Indy Economic Development Corporation and EmployIndy Business and Recruitment Solutions initiative; and the NurExone platform technology will offer novel solutions to drug companies; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other 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 https://ihif.org/wp-content/uploads/2023/08/IHIF-Incentivizing-lab-space-white-paper.pdf
ii https://biocrossroads.com/wp-content/uploads/2025/04/Elevating-Indiana-A-Transformative-Year-in-Life-Sciences.pdf
iii https://biocrossroads.com/wp-content/uploads/2025/04/Elevating-Indiana-A-Transformative-Year-in-Life-Sciences.pdf
iv Spinal cord injury, Glaucoma
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