EXOSOMES

We are experts nationally and internationally for their skill and expertise in not only providing the “Purest products” in the world, but for also training our practitioners on the current protocols, procedures and techniques associated with the regenerative medicine arena. We provide the best products world-wide and believe research is invaluable and are constantly engaged in peer, physician, and patient collaboration. We set the standards for excellence by “exceeding” all federal and state regulatory guidelines through a proactive approach. We consistently and regularly test our products and facility to ensure we maintain and exceed the industry standards.

Using our Proprietary Patented Processing techniques and following minimally manipulative procedures, our process does not alter the regenerative properties of the placental tissue. Our products maintain the integrity of the original source material and the relevant characteristics relating to its utility for soft tissue supplementation that is required for tissue repair.

• All products undergo independent sterility testing and are manufactured in a GMP & GTP Facility.
• All products are HCT/P compliant under Section 361 of the Public Health Service Act according to 21 CFR Part 1271.10. They are regulated as a human cell and tissue product – for homologous use only.

We only accept bio-ethically donated birth tissue from healthy consenting mothers in the United States who have passed a comprehensive medical background check, blood screenings, and have full-term, live, C-section births. In addition, we only work with tissue procurement organizations within the United States who use collection techniques that follow the AATB guidelines, prioritizing the health and safety of the mother and baby above procurement. We strive to have an FDA and AATB compliant supply chain and the highest quality procurement.

We implement and maintain quality and regulatory assurance in alignment with FDA (Federal Drug Administration) regulations. We do so by building strict protocols to uphold these requirements. In addition, we follow the guidelines set forth by the AATB (American Association of Tissue Banking), cGMP (Current Good Manufacturing Practices), GTP (Good Tissue Practices), and WHO (World Health Organization), while exceeding the protocols and procedures to meet applicable requirements.