NurExone Biologic’s U.S. Subsidiary Exo-Top and Florida-Based BioXtek Sign Strategic LOI for Exosome Manufacturing and Commercialization

TORONTO, Ontario and HAIFA, Israel and POMPANO BEACH, Florida, April 07, 2026 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) and BioXtek Inc. (“BioXtek”) today announced that Exo-Top Inc., NurExone’s wholly owned U.S. subsidiary, (“Exo-Top” and together, with BioXtek, the “Parties”) has entered into a non-binding letter of intent (the “LOI”) with BioXtek, a Florida-based company, to explore a strategic partnership in the field of regenerative therapies for exosome manufacturing and commercialization.

The Parties intend to negotiate a strategic partnership to support U.S. Good Manufacturing Practice (“GMP”) manufacturing, clinical supply, and potential commercialization of bone marrow–derived mesenchymal stem cell (“MSC”) exosomes in the U.S. and international markets. The collaboration is expected to combine Exo-Top’s MSC Master Cell Bank (“MCB”) and exosome production expertise with BioXtek’s U.S. manufacturing infrastructure and commercialization capabilities to accelerate clinical and commercial exosome supply, and expand production capacity. In addition, the partnership is expected to address the growing demand for naïve exosomes across multiple therapeutic areas including the exosome-based regenerative aesthetics market which is experiencing rapid growth and is projected to surpass $1.6 billion by 2034⁽¹⁾.

“This collaboration aims to strengthen our manufacturing readiness, accelerate our clinical timelines, and create additional commercial opportunities for our exosome platform,” said Lior Shaltiel, Ph.D., Chief Executive Officer of NurExone. “BioXtek brings an operational U.S. GMP facility and established manufacturing capabilities, while we contribute our proprietary know-how and MCB, which serves as a standardized source for our MSC exosomes.”

“NurExone has developed a highly compelling exosome platform and demonstrated strong consistency and quality in its production approach,” said Bruce Werber, M.D., Chief Executive Officer of BioXtek. “By combining that with BioXtek’s infrastructure and market presence, we believe this collaboration could help translate the technology into real-world applications and establish a leadership position in the rapidly emerging exosome market.”

A key asset supporting the proposed collaboration is NurExone’s proprietary MCB, designed to enable batch consistency, efficient technology transfer, and scalable GMP production.

Areas of Exploration Under the LOI

• Strengthening MSC exosome manufacturing consistency and readiness:
The Parties will collaborate on manufacturing and quality processes to ensure consistent batch-to-batch production and facilitate GMP readiness.

• GMP supply of exosomes for the U.S. and international markets:
Joint production and market strategies will focus on exosomes for wound care, pain management, and orthopedic treatments. This initiative leverages Florida’s Senate Bill 1768 (CS/CS/SB 1768), which permits the use of certain non-FDA (as hereinafter defined) approved stem cell therapies that meet strict safety and defined regulatory standards. The collaboration may also support the supply of naïve MSC exosomes to additional international markets, subject to applicable regulatory requirements.

• Accelerating planned clinical trials:
BioXtek may support the manufacturing of naïve exosomes for U.S. clinical trials of NurExone’s lead drug candidate, ExoPTEN, supporting a potential path toward U.S. Food and Drug Administration (“FDA”) approval for treatments targeting acute spinal cord injury and optic nerve damage.

Proposed Collaboration Structure:
Under the contemplated collaboration:

Exo-Top will provide platform know-how and support technology transfer to BioXtek for the manufacturing of naïve MSC exosomes.
BioXtek may serve as a Florida-based GMP manufacturing and commercial partner for naïve MSC exosome production and supply.
BioXtek may receive customer-specific distribution rights for naïve MSC exosomes.
Exo-Top may utilize naïve MSC exosomes manufactured under the collaboration in the development of its proprietary therapies and nanodrugs, which use loaded exosomes to deliver therapeutic cargo.

The LOI provides a framework for further discussions between the Parties. Any potential strategic partnership remains subject to customary conditions, including due diligence, completion of remediation and readiness milestones, negotiation and execution of a definitive agreement, board approvals, and receipt of all required regulatory approvals, including from the TSX Venture Exchange (the “TSXV”).

Commercialization and Applications:
Exosomes represent a new frontier in therapeutic applications, regenerative beauty, and wellness, enabling science-driven, minimally invasive treatments. Their rich cargo of growth factors, proteins, and microRNAs is being explored for applications including skin rejuvenation, anti-aging, diabetic ulcers, and hair regeneration.

Exo-Top and BioXtek intend to explore the potential supply and manufacturing of naïve MSC exosomes for applications that may include wound care, pain management, orthopedics and other indications, subject to applicable regulatory requirements and the terms of any definitive agreement, if entered into. Any activities contemplated under the LOI would be conducted in compliance with applicable federal and state laws and regulatory oversight.

About NurExone

NurExone is a 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. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the Company’s 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.

About BioXtek

BioXtek is a Florida-based clinical-stage company with expertise in research, clinical trials, and GMP manufacturing of exosomes and other biological products. The company operates out of Pompano Beach, Florida, has an 11,000 sq. ft. facility with 8 ISO cleanrooms, and has internal quality and manufacturing systems intended to support tissue-processing and biologics-related operations.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Russo Partners LLC
Investor and Media Relations – United States
215 Park Ave S, Suite 1905
New York, NY 10003
Phone: +1-212-845-4200
Email: nurexone@russopartnersllc.com

Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

For additional information about BioXtek, please visit https://bioxtek.com/ or follow BioXtek on LinkedIn.

Dr. Bruce Werber
BioXtek Inc.
316 NE 1st St.
Pompano Beach, FL 33060
Phone: +1-954-247-1977

Forward-Looking Statements

This press release contains certain “forward‑looking statements” within the meaning of applicable Canadian securities laws that reflect the Company’s current expectations and projections about future events. 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 expressions, 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 Parties’ intention to negotiate and enter into a definitive agreement in respect of the proposed strategic partnership; the expected scope, structure and potential benefits of the collaboration (including potential U.S. GMP manufacturing, clinical supply and commercialization activities for naïve MSC exosomes); any proposed technology transfer, scale‑up or manufacturing readiness initiatives; any potential customer-specific distribution rights that may be contemplated; any potential support for the manufacture of materials for future clinical trials for the Company’s lead drug candidate, ExoPTEN; the anticipated ability to scale production and address demand; and any statements relating to regulatory pathways, including potential impacts of state‑level frameworks and applicable federal oversight.

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, the Company has applied several material assumptions, including: that the Parties will be able to complete due diligence satisfactorily; that the Parties will be able to negotiate and execute a definitive agreement on terms acceptable to each Party; that required remediation and readiness milestones (if any) can be achieved within timelines acceptable to the Parties; that required board and regulatory approvals (including acceptance of the TSXV) can be obtained on terms acceptable to the Company; that manufacturing, quality and supply chain initiatives will proceed as anticipated; and that applicable regulatory requirements will permit the contemplated activities in the relevant jurisdictions.

Forward‑looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those expressed or implied by the forward‑looking statements, including, without limitation: the risk that the LOI is non‑binding and that the Parties may not enter into a definitive agreement; the risk that due diligence, remediation or readiness milestones are not completed satisfactorily or on anticipated timelines; the risk that required approvals (including TSXV acceptance) are not obtained or are obtained on different terms; risks associated with manufacturing scale‑up, GMP readiness, validation, quality systems and regulatory compliance; the risk that anticipated commercial or operational benefits are not realized; and the risks described under the heading “Risk Factors” in the Company’s disclosure documents, including its annual information form dated August 27, 2024, available under the Company’s profile on SEDAR+ at www.sedarplus.ca.

Readers are cautioned not to place undue reliance on forward‑looking statements. Forward‑looking statements are made as of the date of this press release and, except as required by law, the Company assumes no obligation to update or revise them to reflect new events or circumstances.

Neither TSXV nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

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^⁽¹^⁾ InsightAce Analytic: “Regenerative Aesthetics Exosome Products Market Size, Share & Trends Analysis Distribution by Application, By Biological Source, By Product Format, End User, and Segment Forecasts, 2025-2034”

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