Clinical Programs

A first-in-class injectable exosome matrix for soft tissue and orthopaedic healing.

Unmet Need

  • Increasing complexity of surgeries create a need for rapid healing
    • Approaches to date utilize decellularized matricies or hydrogels to serve as a scaffold for healing
  • Trans-vaginal mesh lawsuits have had pay-outs of several billion dollars for irreversible mesh erosion
  • Inflammatory bowel disease affects 3 million people in the US
    • Up to 50% of patients develop debilitating fistulizing disease
    • Crohn’s market is ~$5 billion/year in the US
    • RioGEL addresses wounds/fistula from radiation and surgery
  • Musculoskeletal space represents 20% of regenerative medicine
    • Tendon, cartilage, peripheral nerve and skeletal muscle regeneration remain an unmet need

Current Treatment Paradigm

  • Current models of care are primarily surgical in nature
  • Complication of surgery are treated often with more surgery
  • Total joint replacement and tendon/skeletal muscle/nerve harvest from other sites are utilized to restore function
  • Vaginal meshes are now withdrawn from the market without a good solution for the millions that suffer from erosion
  • Excellent biocompatibility with existing matrix platforms
  • Demonstrated capacity to biopotentiate rapid tissue healing
  • Established FDA pharm/tox pathway allowing rapid IND clearance
  • Delivered subcutaneously/IM in solution – gelling in situ
  • Platform to treat chronic wounds under the skin
  • Treatment of muscular deficits (incontinence)

Overview of Science

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

  • Accelerates subcutaneous healing through
    • Neovasculogenesis
    • Reduction in oxidative stress
    • Local immunomodulation
    • Acceleration of progenitor cell chemotaxis and proliferation
  • Proprietary process allows molecular integration with collagen or fibrin
    • Process fully off-the-shelf for point-of-care applicability
    • Collagen fibrils serve as scaffold for progenitor growth
    • Fibrin serves as a medium for sustained release in tissues
    • Exosome drive tissue regeneration following delivery

Clinical Trial Testing

RioGel IND for Phase I testing is secured

  • Separate trials with 10 patients each (same IND separate protocols)
    • Trial 1 – Cohn’s fistulizing disease

Trial 2 – Radiation mediated fistulizing disease

Trial 3 – Vaginal Mesh Erosion

Based on initial efficacy signals

P2 effort undertaken under the same IND to treat 30 additional patients at the highest dose

Randomized DBMC format