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Exosomes Treatment provides the most updated information on exosomes therapy. Exosomes Treatment directly consults with the main Company that has the Master Distribution and Sales rights to in the Exosome space. The company is the first company to hold a F.D.A. Master-File with a Biologic Drug Status; held since December 3, 2021.
Our Exosomes’ cells-of-origin are membrane-bound extracellular vesicles (EVs) stem cells derived from human umbilical cord mesenchymal Wharton’s Jelly. The company uses a single source Patient donors per batch and is Third-Party laboratory verified by batch.
Exosomes Treatment provides the most updated information on exosomes therapy. Exosomes Treatment directly consults with the main Company that has the Master Distribution and Sales rights to in the Exosome space. The company is the first company to hold a F.D.A. Master-File with a Biologic Drug Status; held since December 3, 2021.
Our Exosomes’ cells-of-origin are membrane-bound extracellular vesicles (EVs) stem cells derived from human umbilical cord mesenchymal Wharton’s Jelly. The company uses a single source Patient donors per batch and is Third-Party laboratory verified by batch. In addition, unlike any other product on the market each batch is virology tested with zero risk of disease transmission & infectious disease also verified by a Third-Party Laboratory per batch.
The quantity of Exosomes/Count of Exosomes per vial by milliliter (mL) / cubic centimeter (cc)is a minimum of 20 billion for a 1 Milliliter vial, 40 Billion for a 2 Milliliter vial and 100 Billion per 5 Milliliter vial verified by Third-Party Laboratories and batch tested for quantity of growth factors with Endotoxin Report, Certificate of Analysis (C.O.A). and Nanoparticle Tracking Analysis (N.T.A.) shipped with each product batch.
Our product is manufactured in a ISO 5 cleanroom under c.G.M.P. guidelines and can be used as an active product ingredient (A.P.I.) in other F.D.A. regulated products. Additionally, U.S.P. 85 and U.S.P 71 endotoxin and sterility tests have been completed to detect toxins that are released from the cell wall of disrupted gram-negative bacteria and to ensure that a batch of product is sterile
The Company’s Aseptic Manufacturing Process and Current Good Manufacturing Practice (c.G.M.P.) covers all aspects of production keeping our product free from any contamination. The product is stable in a regular freezer -20 Celsius for 3 months before cryogenic storage is needed and holds a United States Patent for Shelf Stable Exosomes for Topical Applications.
The company has over 10 years of research with no sales pre-F.D.A./ Food and Drug Status to any parties and is currently Involved in Many Clinical Studies in a Major U.S. Based School of Medicine. Its Compliance Department head is a former F.D.A./ C.B.E.R. Lead Investigator & N.I.H. (N.I.C.H.D.) fellow. The company is 100% privately owned and all products are proudly made in the United States of America (U.S.A.) by U.S. Citizens.