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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…]

Organicell To Present Results Of Zofin™ Clinical Studies At The International Society Of Cell And Gene Therapy Annual Meeting

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Miami, FL (May 25th, 2021) – Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced that the Company will be presenting at the annual meeting of the International Society of Cell and Gene Therapy (ISCT) taking place on May 26-28, 2021. [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.

[Read more…]

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…]

Exosomes as a New Class of Cell-Free Therapeutics and Diagnostics

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Exosomes are extracellular vesicles (EVs) of endosomal origin that range in size between 30 and 150 nanometers (nm). Exosomes are formed by the invagination of the cell membrane. This invagination and subsequent budding result in the formation of early endosomes. These early endosomes then mature into late endosomes, which are also called multivesicular bodies (MVBs). Finally, these MVBs migrate and fuse with the plasma membrane to release exosomes outside the cell. [Read more…]

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