2730 South Val Vista Dr. #188 Gilbert, AZ
6625 South Rural Road, #104 Tempe, AZ
Gilbert: Monday-Thursday: 7:30AM-5:30PM
Tempe: Monday, Thursday: 7:30AM-6:30PMTuesday, Wednesday: 7:30AM-5:30PM
VITTI-PURE is a minimally manipulated, bio-ethical human umbilical cord harvested product from donated human tissue manufactured under GTP, cGMP, AATB and FDA HCT/P 361 guidelines.
A “NO STICK,NO SPIN, NO DOUBT” PRODUCT. VITTI-PURE provides Protein Rich Support for homologous applications such as joint cushioning and tissue support. VITTI-PURE is an excellent source of glycosaminoglycans, hyaluronic acid, chondroitin, and glucosamine as well as naturally occurring proteins and lipids that provide excellent structural support.
VITTI-PURE contains a complex extracellular matrix with original relevant characteristics such as compressibility, flexibility, cushioning, and tensile strength. These characteristics are to encourage healthy mechanical activity of your joints and tissue which may support repair. PRP has been used incorrectly as a structural support matrix, but it is in fact NOT one. It’s only structural ability is a fibrin network made of an inflammatory fibrous non-globular protein. PRP is intended to be used to mix with bone graf materials to enhance bone graft handling properties. VITTI-PURE’s intended use is to support mechanical activity of joints and tissue through homologous use.
PRP must rely on the body’s own available resources to support repair to the sight of injury. However, as people age, their body no longer carries an abundance of natural bio-materials that healthy support needs to take place. Because of this, low innate healing potential occurs which results in poor repair of the body. VITTI-PURE’s structural tissue extracellular matrix is dense with bio-materials that support the mechanical activity of joints and tissue therefore encouraging the repair.
Tissues that physically support or serve as a barrier or conduit, or connect, cover,or cushion in the donor are generally considered structural tissues for the purposesof determining the applicable regulatory definition.Examples of structural tissues include:
Structural tissues utility for reconstruction, repair, and replacement uses the original relevant characteristics of structural tissues such as support, strength, flexibility, cushioning, covering, and compressibility.
Structural tissues may contain both extracellular matrix and cellular components because any alteration of these components that relates to the structural tissue’s utility for reconstruction, repair, or replacement would generally be considered more than minimal manipulation.
For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement
Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient. Recipients Cells or tissues may or maynot be identical to the donor cells or tissues but may perform one or more of the same basic functions in the recipient cells or tissues performed in the donor. An HCT/P may perform the same basic function or functions even when it is not used in the same anatomic location where it existed in the donor.
VITTI-PURE is DMSO free, and our proprietary process is absent of harmful enzymes and chemicals to preserve integrity.
The Manufacturer’s intent is that these human cellular tissue products are regulated under 21 CFR 1271.10 under section 361 of the PHS Act. This includes following the June 2020 guidance document by the Food and Drug Administration (FDA), Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous in context to structural tissues regulated under section 361 of the PHS Act.
Testing And Validation
20% of every lot manufactured is sent for sterility and endotoxin testing by a 3rd party CLIA Certified laboratory. All of our processes have multiple safety and validation testing steps to ensure the quality and consistency of each lot.
Vitti Labs’ VITTI-PURE may contain live cells but does not claim that it is dependent on the metabolic activity of living cells for its primary function. VITTI-PURE contains structural tissue. These structural tissues contain both extracellular matrix such as elastin, hyaluronan, collagen fibers, and fibronectin and naturally occurring tissue components such as growth factors, cytokines and nanoparticles for homologous application. VITTI-PURE is not reliant on the presence nor on the metabolism of the cells in this product to create a therapeutic benefit. VITTI-PURE does meet the criteria under 1271.3(d) as an HCT/P, and is regulated under 21 CFR 1271 and Section 361 of the PHS Act. Vitti Labs is and FDA registered tissue bank. We comply with FDA (Federal Drug Administration) regulations. Additionally, we are AATB (American Association of Tissue Banking) accredited, cGMP (Current Good Manufacturing Practices) certified, follow GTP (Good Tissue Practices), and WHO (World Health Organization) protocols and procedures. All VITTI LABS HCT/P products are regulated solely under section 361 of the PHS Act and the regulations in 21 CFR 1271.
Gilbert: Monday-Thursday: 7:30AM-5:30PM
Tempe: Monday, Thursday: 7:30AM-6:30PM Tuesday, Wednesday: 7:30AM-5:30PM
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