Rx Regenerative Biopharmaceuticals

Our product is a purified amniotic fluid that is more potent than comparable amniotic based fluids. It is processed from FRESH amniotic fluid and frozen once prior to shipment. It is acellular amniotic fluid - there are no cells in the final product, it has a 2-fold greater amount of amniotic fluid volume per vial than most competitors. We have found that competitors have in 1 cc about 50% Amniotic Fluid and 50% Glycerol or 50%-20% DMSO/albumin, while our product has 100% Amniotic Fluid.

The Amniotic Fluid is collected from elective c-section donations and immediately processed to remove live cells and vernix, the wax substance that coats the newborn and can cause embolisms if introduced into the bloodstream. The Fluid is then packaged and frozen, not cryopreserved, at -80 degrees Celsius until delivered overnight to the clinic/physician.

Cryopreservation implies the use of cryopreservant (DMSO) which we do not include. Because of this, the product can be stored in a clinic’s regular freezer for a period of up to 6 months, or in a Dewar -80 degrees Celsius and below for much longer periods, a year and more.

This product is both pro-inflammatory and anti-inflammatory. It is similar to PRP in the types of growth factors it contains, but unlike PRP, which causes inflammation, this product modulates the inflammatory process. The cytokines floating in the matrix will up-regulate inflammation recruiting cells to the area, and down-regulate cells once the process is complete.

These amniotic fluid matrix products are minimally manipulated human tissue allografts, aseptically prepared for homologous use. They aid in supplementing and replacing connective tissue that is damaged or inadequate. Amniotic fluid is a rich source of nutrients, cytokines and the growth factors necessary for fetal development and maturation and naturally protects the fetus from hard blows or harsh temperatures. With this in mind, this amniotic fluid matrix product it is a perfect match for synovial fluid in joints and its properties that are anti-scarring, anti-adhesion and anti-inflammatory make it essential for healing tissue damage.

Although corticoid steroid injections are a commonplace solution for inflammation and pain relief within the medical community, the properties in these injections lead to cartilage destruction by disrupting the proliferative and remodeling process of healing. Meanwhile, the amniotic fluid provides natural lubrication and anti-inflammatory properties to create the ideal environment to proliferate and remodel damaged tissue.

In clinical application, amniotic fluid matrix products are best utilized for minimally invasive treatment of damaged or inadequate tissue with its anti-inflammatory, anti-microbial and regenerative properties. Damaged tissue can be repaired at a more efficient rate when the extracellular matrix that this product provides places ease on the infiltration, attachment and proliferation of cells. It also supplies surgical and wound sites with an anti-microbial and anti-inflammatory environment, effectively promoting tissue regeneration.

This product is processed from donated human tissue from full term caesarian section deliveries with adherence to American Association of Tissue Banks (AATB) standards. It is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Administration.