Unlike establishments registered as producers and distributors of exosome products, Kimera Labs is specifically registered for amniotic and umbilical cord tissue processing, which includes the production of MSC exosomes. With the guidance of FDA biologic license approval process experts, including highly acclaimed clinical investigators, experienced clinical research
organizations and respected regulatory attorneys, Kimera Labs is actively engaged in scientific research and pre-clinical studies in pursuit of investigational new drug trials using MSC exosomes. In October 2017, the US FDA inspected the Kimera Labs facility, the production of its amniotic fluid product, Amnio2X, and its perinatal MSC exosome product, XoGlo®. No Form 483 observations were noted
during this inspection. On August 22, 2019, the FDA sent its establishment inspection report indicating the end of that investigation with no deficiencies noted. Kimera Labs conducts extensive exosome research to remain compliant with the FDA November 2017 guidance regarding cell-based therapies therapies with a view toward submission and approval of Biologics License Applications to use Kimera exosomes for specific clinical indications.