Evolutionary Biologics Inc.
FDA's Center for Biologics Evaluation and Research issued a warning letter to Evolutionary Biologics Inc. (CEO Jim Morrison) on December 30, 2024, finding that three products — EXO RNA™ (exosome), EVO JEL™ (umbilical cord-derived), and EVO HYBRID™ (umbilical cord/placental/amniotic membrane) — are unapproved new drugs and unlicensed biological products marketed with disease-treatment and structure/function claims. The products lack approved BLAs or NDA approvals and fail HCT/P minimal-manipulation and homologous-use criteria under 21 CFR 1271.10(a). FDA also flagged three additional products (EXO RX™, EXO ELIXIR™, EXO PERIO™) for similar concerns and warned that failure to respond adequately may result in seizure and/or injunction.
Flagged claims (12)
Exo Perio can offer solutions for problems like craniofacial, osteochondral, periodontal tissue, nerve, pulp, or endodontics injuries.
EXO RX™ expresses 30 forms of collagen and is ideally suited to repair, rebuild and regenerate tissue while reducing inflammation
EVO JEL™ is ideally suited to repair, rebuild and regenerate tissue while reducing inflammation
EVO HYBRID helps restore and improve your internal wellness by reducing inflammation, regenerating tissue, lengthening telomeres, stimulating neuronal growth, modulating the immune response, and other important factors contributing to homeostasis, longevity, and quality of life.
Can EXO RNATM Benefit Neurodegenerative Diseases? Research has shown that MSC Exosomes can penetrate the blood-brain barrier and stimulate neuronal differentiation, neuronal growth, and suppress inflammatory processes within the brain tissue.
Has been known to reduces [sic] acne
EVO JEL™ … can be used as an alternative to assist with musculoskeletal injuries, ailments involving tissue and joints in both acute and chronic settings.
EXO ELIXIR is designed to regenerate your skin at a cellular level, with exceptional wound healing and anti-inflammatory growth factors that promote tissue engineering and regeneration.
EVO JEL™ is especially effective in orthopedics because it provides cushioning and structural support for tissue and joints while addressing widespread inflammation and modulating an abnormal immune response.
EVO PERIO™ Is a Wharton's Jelly product rich with Mesenchymal Stem Cell exosomes. MSC exosomes induce bone, cartilage, dentin, mucosa, and pulp tissue formation while enhancing oral and craniofacial tissue engineering and regeneration.
EVO HYBRID™ is ideally suited to repair, rebuild and regenerate tissue while reducing inflammation
EXO PERIO has demonstrated unique biological properties including being angiogenic, anti-inflammatory, antifibrotic, antimicrobial and immune privileged. The product has shown a strong tendency to accelerate healing and wound repair.
Required actions (3)
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in action without further notice, including, without limitation, seizure and/or injunction.
In your response, please explain the basis of your determination regarding whether these products require FDA premarket review.
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