Exosomes are small vesicles that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. It has been long known that stem cells have the potential to exert therapeutic effects, but it only now being recognized that exosomes play an important role how these effects occur.
Over the past few years, this recognition has fueled a market for products and technologies leveraging stem cell exosomes. Key events in the formation of this market are highlighted in the timeline below.
Timeline of Exosome Industry Events
May 6, 2014 – Capricor Therapeutics enters exclusive worldwide license with Cedars-Sinai Medical Center for IP relating to exosomes from cardiosphere-derived cells (CDCs).
November 17, 2015 – Codiak Biosciences launches with $80M in investor funding (largest venture-backed exosome. company ever)
December 1, 2016 – Kimera Labs announces 6,000 sq ft, ISO:9001 certified exosome production facility in Florida.
December 8, 2016 – Exosome Diagnostics launches first instrument for exosomal protein (exoProtein) capture and analysis directly from any biofluid.
December 13, 2016, –Creative Medical Technology Holdings files U.S. patent for use of AmnioStem as a production method for exosomes to regenerate damaged brain tissue.
January 26, 2016 – Codiak Biosciences secures $61 million Series B round.
May, 2, 2017– ExoCoBio Inc. raises $11 million in Series A funding round.
May 5, 2017 – Altnia spins out Exopharm Pty Ltd, a specialist company with a patented purification technology called LEAP to make exomeres in large scale and at low cost.
August 7, 2017– RoosterBio Inc. and Exopharm agree to collaborate on a Stem Cell Exomere Program.
May 11, 2018 – Aegle Therapeutics announced the FDA had cleared its first IND application to initiate an exosome clinical trial in severe second degree burn patients. The company launched a Phase 1/2a clinical trial of its lead product AGLE-102 in late 2018. This made it the first extracellular vesicle (EV) company cleared by the FDA to enter clinical trials in humans.
January 28, 2020 – Melbourne-based Exopharm initiated dosing under its first human clinical trial, becoming the first company to test the ability of exosomes to support wound healing. This study is testing Exopharm’s Plexaris product, a cell-free formulation of exosomes sourced from platelets, which in preclinical studies produced a regenerative effect, improving wound closure and reducing fibrosis.
June 26, 2019 – United Therapeutics received approval for its Phase I trial of an exosome-based therapy against bronchopulmonary dysplasia (BDP), a condition common in preterm infants that receive assisted ventilation and supplemental oxygen.
July 14, 2021 – Direct Biologics was granted approval by the U.S. FDA to conduct a clinical trial under an IND application for use of its ExoFlo™ product in the treatment of COVID-19 induced ARDS.
October 2022 – Organicell has received 18 eINDs from the U.S. FDA for Zofin™, an exosome therapeutic derived from perinatal sources. The FDA also approved Organicell for 4 Phase I/II randomized, placebo-controlled trials investigating Zofin™ for COPD, osteoarthritis, COVID-19, and COVID Long Haulers, as well as an Expanded Access trial which was completed and published for Mild to Moderate COVID-19.
To learn more about this rapidly expanding market, view the “The Global Exosome Market – Market Size, Forecast, Trials and Trends, 2022.”
