Clinical Programs

A first-in-class topically applied biopotentiated gel.

Unmet Need

  • Approximately 6.5mm people in US suffer from non-healing wounds
  • Skin wound expenditure is estimated at approximately $20B annually
  • Non-healing skin represents 18% of regenerative medicine

Current Treatment Paradigm

  • Skin market is a large growth space in medicine
    • Rapid aging of the population
    • Increase in incidence of diabetes melitus
  • Wound expenditure is approximately $20 billion/year
  • Current treatment based on basement membrane proteins
    • Collagen, Fibrin, Gelatin, etc
  • Biologic therapies effective but are offered at huge costs
  • There is a great need for off-the-shelf biologics technologies
  • Developing curative next generation exosome technology
    • Harnesses heart’s own regenerative power
    • Cost-effective and scalable
    • Seamless integration with established PCI infrastructure
  • Lead program focused on Acute Myocardial Infraction (RioCORAMI)
    • IND for P1 evaluation secured in July 2019
    • Patient recruitment anticipated in late 2019
    • Platform to reduce myocardial injury and limit adverse remodeling through cardioprotection, reduced inflamation and augmented neovasculogenesis

Overview of Science

PEP (purified exosome product) is the active ingredient of RioPEP

  • Promotes wound healing through:
    • Blood vessel formation
    • Local immunomodulation
    • Large initial increase in granulation tissue
  • Proprietary process allows molecular integration with collagen
    • Leverages collagen fibrils as scaffold for progenitor growth
    • Exosome drive tissue regeneration following delivery

Clinical Trial Testing

RioDERM IND for Phase I testing planned for submission by end of 2019

  • 2 separate trials with 10 patients each
    • Trial 1 – Plastics surgery: Acceleration of healing from skin graft donor site
    • Trial 2 – Wound Therapy: Acceleration of healing from skin graft donor site
  • Based on initial efficacy signals
    • P2 effort undertaken under the same IND to treat 30 additional patients at the highest dose
    • Randomized DBMC format