Technology Platform

MonoTx operates a public umbilical cord blood bank that serves as the foundation of its platform. All cord blood units are collected following full-term deliveries and are sourced from healthy, consented donors who undergo comprehensive maternal infectious disease screening, including testing for hepatitis B, hepatitis C, HIV-1/2, and syphilis. 

The MonoTx cord blood bank is: 

  • AABB-accredited 
  • Registered with the U.S. FDA as a Human Cell & Tissue Establishment 
  • Affiliated with the World Marrow Donor Association (WMDA) 

The bank stores more than 10,000 cord blood cell packs that meet high-quality standards as starting material for both clinical and translational research applications, ensuring long-term supply continuity and batch-to-batch reproducibility. 

MonoTx employs the automated, closed, GMP-compatible processing system to fractionate fresh umbilical cord blood into three primary components: 

Fraction 

Composition 

Therapeutic Application 

Relevant MonoTx Patent  

Mononuclear Cells (MNCs) 

Lymphocytes, monocytes, hematopoietic and endothelial progenitor cells 

Neurological repair (HIE, stroke) via paracrine-induced neurogenesis 

PT-2021-01 

Cell-Free Plasma 

Exosomes, growth factors, cytokines, extracellular vesicles 

Source material for ERP® exosome products across various indications 

PT-2019-02 

This automated separation step, covered by the licensed patent portfolio (PT-2019-02 (US Patent No. US 12,576,201 B2), establishes a clean plasma source optimized for downstream exosome isolation while preserving cellular fractions for therapeutic applications. 

Proprietary Exosome Isolation Technology

Exosomes are isolated exclusively from the plasma fraction of umbilical cord blood using MonoTx’s proprietary, polyethylene glycol (PEG)–based precipitation technology, now protected by a granted US patent (US 12,576,201 B2, issued March 2026) with additional filings in Europe, China, Hong Kong and India.   The process involves plasma clarification, PEG-mediated exosome precipitation under controlled cold incubation, low-speed centrifugation to collect exosome pellets, and resuspension in a validated buffer. 

Key advantages of the MonoTx exosome isolation process include: 

  • High recovery efficiency: >90% of plasma-derived exosomes recovered, substantially exceeding ultracentrifugation-based methods 
  • Gentle processing: Low-speed centrifugation preserves exosome membrane integrity and biological activity, avoiding the shear damage associated with traditional ultracentrifugation (>100,000g) 
  • High-concentration output: Produces exosome preparations at >1010 particles/mL 
  • Scalability: Process is scalable from 1 mL to multi-liter volumes, compatible with commercial GMP manufacturing 

Delivery and Formulation Technologies

The MonoTx platform encompasses multiple proprietary formulation and delivery approaches, each optimized for a specific therapeutic indication: 

Delivery System 

Description 

Indication 

Patent 

Topical Eye Drops 

ERP® formulated as preservative-free ophthalmic solution 

Ocular surface disease, dry eye, limbal stem cell deficiency 

PT-2026-03 

Intravitreal Injection 

ERP® administered directly into the vitreous cavity 

Aging-related eye diseases (glaucoma, AMD, cataract, RP) 

PT-2025-01 

HAMA Hydrogel Microspheres 

Injectable hyaluronic acid methacryloyl microspheres for sustained exosome release over weeks to months; microfluidic manufacturing for uniform particle sizing 

Glaucoma (sustained neuroprotection of retinal ganglion cells) 

PT-2026-02 

Synthetic miR-26a-5p Mimic 

Chemically synthesized miRNA mimic as an alternative to exosome-encapsulated delivery 

Cellular senescence across multiple organ systems; aesthetic skincare 

PT-2025-02 

Topical Gel 

Carbomer-based gel containing ERP® + recombinant human fibronectin for daily wound application 

Chronic wounds, diabetic ulcers, surgical incisions, burns, scar management 

PT-2026-01 

Intravenous Infusion 

UCB MNC or RCF administered via IV within 24 hours of neurological injury 

HIE, neonatal stroke, cerebral palsy 

PT-2021-01 

Platform Differentiation

The MonoTx platform is differentiated from other exosome and cell therapy approaches by: 

Differentiator 

Significance 

Regulatory-grade UCB sourcing 

AABB-accredited, FDA-registered, WMDA-affiliated cord blood bank ensures donor traceability, safety screening, and long-term supply 

Youngest blood source 

UCB contains the most potent and least immunogenic exosomes compared to adult peripheral blood or bone marrow sources 

Mechanism-defined, not empirical 

miR-26a-5p/CDK1 molecular pathway provides a scientific rationale for therapeutic activity, distinguishing MonoTx from “black-box” exosome approaches 

Granted patent protection 

US patent (US 12,576,201 B2) and China patent (CN120437174B) provide enforceable exclusivity on manufacturing and core therapeutic applications 

Multi-product economics 

Single UCB unit yields at least 3 therapeutic products (mononuclear cells, exosomes, platelets), maximizing asset utilization 

Cell-free and cell-based modalities 

Platform supports both off-the-shelf exosome products (scalable, no HLA matching) and MNC/RCF cell therapies (paracrine-mediated, no engraftment required) 

Vertically integrated 

Cord blood bank → automated fractionation → proprietary isolation → characterized product — full chain control, rare in the exosome field 

Near-term revenue 

ERP® already supplied to aesthetic companies for skincare products, providing non-dilutive revenue while pharmaceutical pipeline advances 

This integrated technology platform enables MonoTx to advance cell-free regenerative therapeutics with strong translational and commercial potential.