Human perinatal tissue derived allografts have been used in allogeneic transplants since the beginning of the last century. Their anti-inflammatory, anti-microbial, and immune privileged properties make them ideal candidates for novel applications across a wide range of medical disciplines. With continued clinical success, perinatal tissues are increasingly adopted as a preferred treatment platform.
BioStem Technologies suite of perinatal tissue-derived allografts include RHEO™, OROPRO™, AEON™, VENDAJE™, VENDAJE™ AC and VENDAJE™ OPTIC. They are designated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), are minimally manipulated, and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).
VENDAJE is a structural tissue allograft composed of the amnion layer of the placental membrane. VENDAJE is intended for homologous use as a protective covering for soft tissue wounds.
Sterilization
VENDAJE is sterilized via e-beam irradiation.
Preservation
VENDAJE should be stored in a clean, dry environment at ambient (room) temperature.
VENDAJE AC is a structural tissue allograft composed of the amnion and chorion layer of the placental membrane. VENDAJE AC is intended for homologous use as a protective covering for soft tissue wounds.
Sterilization
VENDAJE AC is sterilized via e-beam irradiation.
Preservation
VENDAJE AC should be stored in a clean, dry environment at ambient (room) temperature.
VENDAJE OPTIC is a structural tissue allograft composed of the amnion layer of the placental membrane. VENDAJE OPTIC is intended for homologous use as a protective covering during the repair of ocular surfaces.
Sterilization
VENDAJE OPTIC is sterilized via e-beam irradiation.
Preservation
VENDAJE OPTIC should be stored in a clean, dry environment at ambient (room) temperature.
RHEO is derived from human amniotic tissue and it is intended as a cushioning agent for homologous supplementation.
Sterilization
RHEO is aseptically processed and never irradiated, therefore it is not sterile.
Preservation
RHEO is cryopreserved to -80°C ± 15°C
Product SKU
Size
100-100-1000-001
1 mL
100-200-2000-001
2 mL
OROPRO®
Description
OROPRO is derived from human umbilical cord and is a Wharton's jelly tissue allograft. It is intended as a cushioning agent for homologous supplementation.
Sterilization
OROPRO is aseptically processed and never irradiated, therefore it is not sterile.
Preservation
OROPRO is cryopreserved to ≤-130°C
Product SKU
Size
401-100-1000-001
1 mL
401-200-2000-001
2 mL
NEOFYL®
Description
NEOFYL® is derived from human umbilical cord and is intended as a cushioning agent for homologous supplementation.
Sterilization
NEOFYL® is aseptically processed and never irradiated, therefore it is not sterile.
Preservation
NEOFYL® is stored at ≤-20°C
Product SKU
Size
404-100-0200-001
1 mL
404-200-0400-001
2 mL
PROVISCUS®
Description
PROVISCUS® is derived from human umbilical cord and is intended as a cushioning agent for homologous supplementation.
Sterilization
PROVISCUS® is aseptically processed and never irradiated, therefore it is not sterile.
Preservation
PROVISCUS® is stored at ≤-20°C
Product SKU
Size
403-100-0075-001
1 mL
403-200-0150-001
2 mL
ONIX®
Description
ONIX® is all-natural hyaluronic acid and collagen for aesthetics
Sterilization
ONIX® is aseptically processed and never irradiated, therefore it is not sterile.
Preservation
ONIX® is stored at ≤-20°C
Product SKU
Size
402-100-0030-001
1 mL
402-200-0060-001
2 mL
402-400-0120-001
4 mL
AEON™
Description
AEON™ is derived from human amniotic fluid. It is intended as a cushioning agent for homologous supplementation.
Sterilization
AEON™ is sterilized via e-beam irradiation.
Preservation
AEON™ is stored between 2°C - 10°C
Product SKU
Size
600-050-0500-001
0.5 mL
600-100-1000-001
1 mL
600-200-2000-001
2 mL
600-500-5000-001
5 mL
Quality Matters
BioStem Technologies suite of perinatal tissue-derived allografts are designated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), are minimally manipulated, and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).
BioStem has developed a unique and proprietary technique (BioRetain™) for processing allografts from donated perinatal tissue. This technique focuses on preserving the tissue's endogenous biological properties (cytokines, chemokines, growth factors, etc.) while maintaining the structure and integrity found in fresh perinatal tissue.
At BioStem Technologies, healthy, safe and effective recovery of patients is our main focus. All of our products are produced in our AATB® accredited lab in accordance with the FDA regulations for Good Tissue Practices.
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