Grafix® is a cryopreserved placental membrane comprised of an extracellular matrix rich in collagen, growth factors, fibroblasts, mesenchymal stem cells (MSCs), and epithelial cells native to the tissue.
• Has all the benefits of fresh placental membrane (serves as a barrier from the environment and thus protects the tissue from infection; reduces inflammation; reduces scarring by supporting wound closure without excessive fibrosis)
• Designed for application directly to acute and chronic wounds
• Flexible, conforming to complex anatomies
• Immune neutral
• Alternative to autologous skin grafting that eliminates the pain, comorbidities and procedure time associated with obtaining autologous grafts
• Available in multiple sizes to reduce wastage
Grafix® is indicated for the treatment of acute and chronic wounds including but not limited to diabetic foot ulcers, venous leg ulcers, traumatic wounds, and burns.
Grafix® should not be used in a wound suspected of having an acute or chronic infection.
1. Intended for use in one patient, on a single occasion only.
2. Do not use if package integrity has been compromised. Once the user breaks the container seal, the tissue grafts must be transplanted or discarded.
3. Tissue may not be sterilized or re-sterilized.
4. Tissue is intended for use by qualified health care specialists such as physicians, podiatrists, or other appropriate health care professionals.
5. The physician is responsible for informing the patient of the risks associated with his/her treatment and the possibility of complications and/or adverse reactions.
6. Caution should be exercised for patients with known sensitivities to the following reagents used for processing, disinfection, and storage that may remain on the product:
• Cryopreservation Solution – Sodium Chloride Irrigation Solution (Saline), Dimethyl sulfoxide (DMSO), Human Serum Albumin
• Disinfection – Gentamicin Sulfate, Vancomycin, Amphotericin B, Dulbecco's Modified Eagle's Medium (DMEM), Water For Injection (WFI)
• Processing Solution – DMEM, Dulbecco's Phosphate Buffered Saline (dPBS), Saline+Anticoagulant Citrate Dextrose Solution, Formula A (ACD-A)
Donor screening methods are limited; therefore, certain diseases may not be detected. The following complications of tissue transplantation may occur:
• Transmission of disease of unknown etiology;
• Transmission of known infectious agents including, but not limited to, viruses, bacteria, and fungi;
• Immune rejection of implanted HCT/P; or
• Loss of function and/or integrity of HCT/P due to resorption, fragmentation, and/or disintegration.
Please promptly report possible adverse event outcomes to Osiris at the email address on this website.
Grafix® has a two year shelf life and should be stored frozen at -75°C to -85°C (-103°F to -121°F).
Native amnion or chorion tissue which contain extracellular matrix, growth factors, and endogenous neonatal cells
Sodium chloride, DMSO, and HSA
1. Duan-Arnold Y, Lavery L, Mao Y, Hoffman T, Johnson A, Danilkovitch A, Kohn J. Clinical Benefits and Cost Effectiveness of Grafix, a Unique Cellular Skin Substitute with Antimicrobial Activity [Poster]. Presented at 9th Annual Translational to Clinical (T2C) Regenerative Medicine Wound Care Conference; March 2016; Columbus, OH.
2. Lavery LA, Fulmer J, Shebetka KA, et al. The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. 2014 Oct;11(5):554-560. doi: 10.1111/iwj.12329.
3. Regulski M, Jacobstein DA, Petranto RD, Migliori VJ, Nair G, Pfeiffer D. A retrospective analysis of a human cellular repair matrix for the treatment of chronic wounds. Ostomy Wound Manage. 2013;59(12):38-43.
|Indicated for chronic vascular ulcers||●|
|Indicated for diabetic ulcers||●|
|Indicated for draining wounds|
|Indicated for partial- and full-thickness wounds||●|
|Indicated for pressure ulcers||●|
|Indicated for surgical wounds||●|
|Indicated for third-degree burns||●|
|Indicated for trauma wounds||●|
|Indicated for venous ulcers||●|
|Variety of sizes||●|
|Educational Material Available||●|
|Free Samples/Trials Available|
|Published Clinical Article Available||●|
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Grafix can be applied in an office or hospital outpatient setting or in an operating room. Prior to application, follow the directions for use found on the package insert.
Change weekly at the discretion of the responsible physician for the duration of treatment.
Non-adherent dressing and outer dressings.
Grafix cryopreserved placental membrane is packaged in a cryobag contained within a heat-sealed pouch. This packaging configuration allows for the introduction of the HCT/P graft into the sterile field.
Donor eligibility is determined based on FDA screening and testing criteria, which includes testing for the following:
Human Immunodeficiency Virus Type 1 Antibody
Human Immunodeficiency Virus Type 2 Antibody
Hepatitis C Virus Antibody
Hepatitis B Surface Antigen
Hepatitis B Core Antibody
Syphilis Rapid Plasma Reagin or Treponemal Specific Assay
Human T-Cell Lymphotrophic Virus Type I Antibody
Human T-Cell Lymphotrophic Virus Type II Antibody
HIV/HCV Nucleic Acid Test (NAT)
Each lot must be sterility negative per USP<71>
Minimum 70% cell viability
Growth factors are present
Osiris Therapeutics, Inc. is a leader in researching and developing regenerative medicine products that improve lives. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care.