AVEXO

A Cell-free PnD Exosome Product

  • AVEXO is a cell-free product manufactured from clinical grade amniotic fluid using a proprietary process to enrich perinatal exosomes and ECM proteins.

  • Rich in growth factors, cytokines, microRNAs, mRNAs, and extracellular matrix components, with anti-inflammatory and anti-fibrotic properties.

  • AVEXO is manufactured for research purposes in an FDA-registered laboratory following aseptic techniques and cGMP-compliant protocols to mitigate contamination risks. Quality assurance testing is performed on all batches to meet FDA standards for safety. Each batch is assessed for exosome quantity, quality, size, content and purity using advanced analytical methodologies.

  • The human amniotic fluid used for production of this product is donated under strict conditions. All donors undergo comprehensive screening and testing to confirm the absence of risk factors for infection from relevant communicable diseases. Testing is conducted by an independent laboratory that adheres to CLIA standards and holds certifications from the FDA, CMS, CAP, and AATB.

AVEXO is currently under development for addressing tissue and organ injuries. It is not FDA approved or licensed for the prevention, treatment, diagnosis, mitigation and/or cure of any disease or condition. It is intended for clinical research and clinical trials. The FDA does not classify AVEXO as a Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) under 21 CFR Part 1271, section 361 of the PHS Act. Instead, it is regulated as a biologic under section 351 of the Public Health Service (PHS) Act. As of now, AVEXO does not have an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application in effect.