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our products
Testing & Validation
20% of every lot manufactured is sent for sterility and endotoxin testing by a 3rd party laboratory. In addition, Vitti Labs requires a Nanocyte Report for each lot and a biannual Characterization Report produced by external laboratories for transparency and validation.
EV-PURE
DECELLULARIZED GROWTH FACTORS AND CYTOKINES
EV-PURE is a decellularized product consisting of nano-sized micropods containing growth factors, cytokines and nucleic acids secreted from the membranes of placental derived Medicinal Signaling Cells. The natural components in this product support healthy cell-cell communication and provide anti-inflammatory effects.
EV-PURE Product Options
EV-PURE 7.5 Billion - 0.5mL
EV-PURE 15 Billion - 1mL
EV-PURE 75 Billion - 5mL
REGULATIONS
Vitti Labs is an FDA registered Tissue Bank which means we implement and maintain FDA regulations, prioritize legal council and perform regular internal audits. Additionally, we implement AATB standards, follow GMP guidelines, and only work with tissue procurement organizations within the United States that follow AATB requirements.
WJ-PURE
WHARTON'S JELLY
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WJ-PURE is a minimally manipulated DSMO free Wharton's Jelly product for homologous use in clinical settings. Manufactured from bio-ethically donated umbilical cords from healthy births . Our proprietary process is absent of harmful enzymes and chemicals to preserve structural integrity and potency. WJ-PURE is rich in Medicinal Signaling Cells (MSC's), cytokines, growth factors, natural nano-particles, and proteins which stimulate healing and repair the body.
WJ-PURE Product Options
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WJ-PURE 1mL
REGULATIONS
Vitti Labs’ WJ-PURE contains live cells but does not claim that it is dependent on the metabolic activity of living cells for its primary function. WJ-PURE contains tissue components such as hyaluronan, elastin, collagen fibers, growth factors, cytokines, and nanoparticles which stimulate cushioning agents, therefore, it is not reliant on the presence nor on the metabolism of the cells in this allograft to create a therapeutic benefit. WJ-PURE does meet the criteria under 1271.3(d) as an HCT/P, and therefore is regulated under 21 CFR 1271 and Section 361 of the PHS Act.
Vitti Labs is an FDA registered tissue bank. We comply with FDA (Federal Drug Administration) regulations. Additionally, we implement AATB (American Association of Tissue Banking) standards, follow GTP (Good Tissue Practices), GMP (Good Manufacturing Guidelines), and WHO (World Health Organization) protocols and procedures.
NS-PURE
TOPICAL
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NS-PURE is a topical extracellular matrix consisting of growth factors, nano sized micropods, collagen elastins, hyaluronan, cytokines, and fibroblasts from amniotic membrane, wharton's jelly, and chorionic villi. NS-PURE has antimicrobial properties and bioactive molecules which stimulate collagen growth, wound healing and promote healthy skin resurfacing.
NS-PURE Product Options
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NS-PURE 1.5mL
REGULATIONS
Vitti Labs’ NS-PURE contains live cells but does not claim that it is dependent on the metabolic activity of living cells for its primary function. NS-PURE contains tissue components such as hyaluronan, elastin, collagen fibers, growth factors, cytokines, and nanoparticles which stimulate cushioning agents, therefore, it is not reliant on the presence nor on the metabolism of the cells in this allograft to create a therapeutic benefit. NS-PURE does meet the criteria under 1271.3(d) as an HCT/P, and therefore is regulated under 21 CFR 1271 and Section 361 of the PHS Act.
Vitti Labs is an FDA registered tissue bank. We comply with FDA (Federal Drug Administration) regulations. Additionally, we implement AATB (American Association of Tissue Banking) standards, follow GTP (Good Tissue Practices), GMP (Good Manufacturing Guidelines), and WHO (World Health Organization) protocols and procedures.
EV-OPTI
LUBRICATING GROWTH FACTOR DROPS
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EV-OPTI DROPS consist of a placental derived matrix providing growth factors, cytokines, trophoblasts, nanoparticles, and nucleic acids. They also contain a lubricant made from high-molecular weighted hyaluronic acid and antimicrobials along with potent concentrations of anti-inflammatory properties that promote wound healing and anti-scarring effects on the surface of the eye.
EV-OPTI Product Options
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EV-OPTI 0.5mL - 10 Day Supply
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*Packaging may be different than illustrated
REGULATIONS
Vitti Labs’ EV-OPTI contains live cells but does not claim that it is dependent on the metabolic activity of living cells for its primary function. EV-OPTI contains tissue components such as hyaluronan, elastin, collagen fibers, growth factors, cytokines, and nanoparticles which stimulate cushioning agents, therefore, it is not reliant on the presence nor on the metabolism of the cells in this allograft to create a therapeutic benefit. EV-OPTI does meet the criteria under 1271.3(d) as an HCT/P, and therefore is regulated under 21 CFR 1271 and Section 361 of the PHS Act.
Vitti Labs is an FDA registered tissue bank. We comply with FDA (Federal Drug Administration) regulations. Additionally, we implement AATB (American Association of Tissue Banking) standards, follow GTP (Good Tissue Practices), GMP (Good Manufacturing Guidelines), and WHO (World Health Organization) protocols and procedures.
Values and Practices
Sourcing
Vitti Labs only accepts bio-ethically donated birth tissue from healthy consenting mothers who have passed a comprehensive medical background check, blood screenings, and are full-term, live, C-section births in the United States. 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 do this to have a 100% FDA and AATB compliant supply chain, validated sterility, and the highest quality procurement.