Milestones

2016 Accomplishments

  • Clinical Trial – Western Europe
  • Initiated FDA regulatory process
  • Obtained ISO 13485 Certification
  • Human repeat-exposure skin trial to assess irritation potential
  • Additional biocompatibility data for CE Mark application
  • Intellectual Property (USPTO) Grants for self-assembling peptides
    • Barriers composition of matter patent
    • Hemostasis method of use patent
    • Adhesions method of use patent
    • Leaky tight junctions method of use patent
    • Solid forms composition of matter and methods of use patent

2017 Planned Milestones

  • Announce grant for self-assembling peptidomimetics patent
  • Raise Capital
  • Submit 510(k) filing for external use to US FDA ~mid-year 2017
  • File CE Mark for EU commercialization
  • File IDE for internal surgical clinical trial (for planned PMA application)
  • File additional patent application(s)
  • Establish commercialization strategy
  • Provide data from multiple preclinical programs in pipeline