Exosome therapy is somewhat new to the erectile dysfunction arena. So, naturally, due caution is warranted. There are many bad actors in this market and the FDA has issued reports on concerns related to exosome cases. When digging through all of this, it can be hard to know what information to trust, so we’re going to break it down below:
Who Produces Exosomes?
First off, exosomes are made and used in your body organically. As a natural part of your body, there have been no long-term negative side effects reported from this treatment.
Exosomes are not a synthetic or man-made chemical, they’re an important part of your body that contain things such as protein and DNA. Exosome therapies, such as the newly popular ExoFlo service, are completely organic and natural. The exosomes are sourced from human bone marrow mesenchymal stroma/stem cells.
Direct Biologics, the company that produces ExoFlo, is working in complete agreement with the FDA. They take their safety concerns very seriously and maintain “Current Good Manufacturing Practices” (CGMP), which is the most superior standard of processing and manufacturing controls.
What About FDA Approval?
Exosomes are very closely related to what the FDA refers to as HCT/Ps (Human Cellular or Tissue products). This means they are governed very similarly to HCT/Ps. For now, the FDA approves no products with exosomes just like there are no approved HCT/Ps. The FDA requires HCT/Ps to be registered and does not require prior FDA approval. As long as the products are meant for homologous use and are minimally manipulated, they are safe.
What does homologous use mean? Basically it’s using an HCT/P to heal or repair a patient in the same way the donor’s body would use the cells or tissue. Exosomes assist with cell communications in everyone. And since exosomes are naturally found in everyone’s body and are performing the same function for the recipient as the donor, it falls under ‘homologous use.’
Direct Biologics’ ExoFlo is a minimally manipulated tissue that has one single donor for each lot. ExoFlo contains no animal products, chemicals or drugs in the processing and isolation of the exosome products. Direct Biologics is actively seeking FDA approval and working hard to ensure a safe to use product.
In fact, Direct Biologics just recently received FDA approval to proceed with their second ExoFlo IND (Investigational New Drug) for post-acute COVID-19 syndrome and chronic post-COVID-19 syndrome last week. This is exciting and promising news for this amazing product.
You can rest assured that Revived Performance for Men has your safety in mind. Our Denver office follows a strict standard maintained by Sarah Kurts. Sarah is a Board Certified Physician Assistant and graduated with distinction from the University of Virginity. She earned her Physician Assistant degree from the University of Colorado Health Sciences Center.
If you’re interested in learning more about exosomes, feel free to check out our ExoFlo page. If you have any questions or you’re ready to fix your ED, please contact us at (720) 263-9344 or schedule a free consultation online.