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Direct Biologics Receives FDA Approval to Proceed with Second ExoFlo IND for Post-Acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome

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  • Extracellular Vesicle Isolate Product ExoFlo Shows Strong Potential to Treat COVID-19, Post-Acute COVID-19 Syndrome, and Chronic Post-COVID-19 Syndrome
  • 60-patient trial to be conducted nationally at ambulatory infusion sites

AUSTIN, Texas, June 9, 2021 – Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that it has received FDA approval to initiate a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of Post-Acute COVID-19 Syndrome. This trial is Direct Biologics’ second approved IND, and it represents the first IND ever approved by FDA for the use of extracellular vesicles (EVs) to treat Post-Acute COVID-19 syndrome, Chronic Post-COVID-19 syndrome, or any post-viral syndrome. [Read more…]

The Rise of Exosomes as a Novel Class of Therapeutics

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Today, exosomes are increasingly being investigated as a novel class of therapeutics that could explain the functions of many types of traditional cell therapies. To explain this trend, we contacted an esteemed exosome researcher, Dr. Ramon Coronado Schmilinski. Dr. Coronado Schmilinski was the previous Executive Director at Lester Smith Medical Research Institute and is the current VP Regulatory Affairs and Technology Transfer at Signature Biologics.

In this interview, we discuss how he started working with exosomes while looking for mechanisms used by MSCs to exert their therapeutic effects. We discuss the scientific importance of exosomes, their therapeutic and diagnostic applications, and how exosomes are being used within encapsulation and delivery systems.

Read on to learn how these extracellular vesicles could transform the future of modern medicine as we know it.

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List of Exosome Companies: Tiny Packages, Enormous Potential

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Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. Although exosomes were discovered more than 30 years ago, it was not until recently that the scientific community began to give credit to exosomes for a range of promising traits. [Read more…]

Exosome Research: Who Is Dominating in the Scientific Literature?

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Exosome research is on the rise, fueled by an increasing recognition of the central role that exosomes play in intercellular (cell-to-cell) communication and transportation. As intracellular messengers, exosomes have the potential to mediate many of the therapeutics effects commonly associated with cells, with far fewer risks.

In this article:

  1. Exosome Research by Dr. Gabrielsson
  2. Unicyte AG on Exosomes Therapy
  3. Leading Exosome Research Journals

For competitors within the exosome marketplace, it is vital to assess existing and future trends. One of the best tools for assessing scientific progress is to review rates of exosome research.

When exosome publications are analyzed, U.S. authors have published approximately 40% of the articles and Chinese authors take second place.

When the term “exosome” is searched within scientific literature, Dr. Susanne Gabrielsson from the Karolinska Institutet in Sweden is the leading author, with 37 articles, making her one of the global authorities on exosome research. A full list of Dr. Gabrielsson’s exosome publications can be viewed at this link.

When the term “extracellular vesicles” is searched, Unicyte AG, a regenerative medicine unit of Fresenius Medical Care, takes the lead. Headquartered in Switzerland, the company has published more than 100 papers on exosomes and extracellular vesicles in combination with Prof. Giovanni Camussi. The company is also a market leader in terms of patents and translational programs.

Leading Exosome Journals

Interestingly, two scientific journals have been particularly favorable toward exosome publications, publishing the greatest quantity to date:

PLoS ONE

PloS ONE, a peer-reviewed open access scientific journal published by the Public Library of Science, has published 349 articles with the term “exosome” or “exosomes” in the title. A full list of the articles can be viewed here.

Journal of Biological Chemistry

The Journal of Biological Chemistry, a weekly peer-reviewed scientific journal published by the American Society for Biochemistry and Molecular Biology, has published 167 articles with the term “exosome” or “exosomes” in the title. A full list of the articles can be viewed here.

Google Trend data also shows a clear linear increase in interest in exosome-related topics. To compete for dominance within this market, it is essential to identify trends as they begin to impact the marketplace, not after they are in full effect.

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To learn more, view the “Global Exosome Market – Market Size, Forecast, Trials and Trends, 2021.”

Exosome market report

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