Direct Biologics, A Regenerative Biotechnology Company With A Groundbreaking Extracellular Vesicle (Ev) Platform Technology, Announced That The Us Fda Has Approved The Company To Proceed With Its Phase 3 Clinical Trial Using Its Investigational Ev Drug, Exoflo, To Treat Acute Respiratory Distress Syndrome (Ards) Due To Covid-19.According To A Company Press Release, Direct Biologics Is The First And Only Ev Company To Receive Fda Phase 3 Approval For An Investigational New Drug (Ind) Indication To Date. The Phase 3 Trial Will Be Conducted Under The Auspices Of The First Regenerative Medicine Advanced Therapy (Rmat) Designation Approved By The Fda For An Ev Therapeutic, Making Direct Biologics One Of Only 70 Companies In The History Of The Fda To Have Been Officially Awarded Rmat. Like The Fast Track And Breakthrough Designations, The Rmat Was Created By The Fda To Expedite Approval For Promising Regenerative Medicines Which Demonstrate The Ability To Treat Serious Life-Threatening Diseases.
