Clinical Programs

A first-in-class regenerative exosome designed of intra-arterial delivery.

Unmet Need

  • Prevalent with aging
  • Claims 20 million lives/year
  • Responsible for 1/3 of all deaths worldwide
  • 92 million adults have cardiovascular disease
  • $200 billion in national health expenditures
  • Half of adults will suffer from cardiovascular disease by 2030

Current Treatment Paradigm

  • Treatments at time of heart attack are designed to reduce likelihood of long-term heart failure
  • Currently available therapies for heart failure are palliative
  • Nearly 7 million Americans live with chronic heart failure with only 1 in 3 patients surviving at 5-year follow-up
  • RioCOR aims to improve outcomes following a heart attack, particularly for those patients who are prone to development of heart failure
  • 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 RioCORAMI

  • Promote tissue regeneration, blood vessel formation and repair, influence immune system and promote cell proliferation
  • Proprietary isolation processes and customization for intra-arterial application
  • RioCORAMI is a shelf-stable therapy prepared for delivery with minimal manipulation immediately after stent deployment (PCI)
  • By creating a shelf stable EV platform, RioCOR’s approach is fully integrative with current cardiac procedures, driving a higher rate of adoption

Clinical Trial Testing

RioCOR IND for secured for Phase I testing

  • 15 patients in United States for RioCORAMI Phase I trial dose escaalation
  • Additional 30 patients under the same IND treated at the highest dose
    • Inclusion criteria for Phase I will enroll patients who have received STEMI within 3-12 hours post symptom onset
    • Inclusion for PII and PIII will be adapted to populations with highest efficacy signals
  • RioCORAMI – only biologics-based therapy that can be given off-the-shef at time of stent deployment
  • Pipeline explores broad application in cardiovascular indications beyond Acute Myocardial Infarction