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NurExone Biologic and BioXtek announced that Exo-Top, NurExone’s wholly owned U.S. subsidiary, 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.
⁽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”
Source – NurExone Biologic
