Grafix® is a cryopreserved placental membrane that retains the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts and epithelial cells of the native 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® may be used to repair acute and chronic wounds, including but not limited to: diabetic foot ulcers, venous leg ulcers, pressure ulcers, dehisced surgical wounds, burns, acute surgical wounds, Pyoderma Gangrenosum, and Epidermolysis Bulosa. The product is limited to homologous use as a wound cover. Grafix® may be used in wounds encompassing both Upper Extremity and Lower Extremity acute and chronic wounds. Grafix® naturally conforms to complex anatomies and may be used over exposed bone, tendon, joint capsule, and muscle.
There are no known contraindications for Grafix®.
Intended for use in one patient, on a single occasion only.
Do not use if package integrity has been compromised. Once the user breaks the seal on the pouch, the tissue grafts must be transplanted or discarded.
The tissue may not be sterilized or re-sterilized.
The tissue is intended for use by qualified healthcare specialists such as physicians, podiatrists, or other appropriate healthcare professionals.
The same medical/surgical conditions or complications that apply to any medical/surgical procedure may occur during or following application.
The healthcare professional is responsible for informing the patient of the risks associated with his/her treatment and the possibility of complications or adverse reactions.
Caution should be exercised for patients with known sensitivities to the following reagents used for processing, disinfection, and storage and may remain on the product:
- Cryopreservation Solution: 5% v/v Dimethyl Sulfoxide, 1% v/v Human Serum Albumin (25% solution), 94% Sodium Chloride (0.9% solution)
- Disinfection Solution: 0.5% v/v Gentamicin Sulfate, 0.1% v/v Vancomycin reconstituted in Water For Injection (WFI), 1% v/v Amphotericin B, 98.4% Dulbecco’s Modified Eagle’s Medium (DMEM).
- Processing Solution: DMEM, Dulbecco’s Phosphate Buffered Saline (DPBS), 11% Anticoagulant Citrate Dextrose Solution in Saline, 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 Grafix®; or
• Loss of function and/or integrity of Grafix® 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 minimum 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.
|Contact manufacturer for usage guidelines|
|Indicated for acute wounds||●|
|Indicated for chronic wounds||●|
|Indicated for diabetic ulcers||●|
|Indicated for pressure ulcers||●|
|Indicated for surgical wounds||●|
|Indicated for third-degree burns||●|
|Indicated for venous ulcers||●|
|Shelf life greater than 2 years|
|Shelf life limited|
|Variety of sizes||●|
|Educational Material Available||●|
|Free Samples/Trials Available|
|Published Clinical Article Available||●|
Deep Tunneling wounds
Diabetic Foot Ulcers
Venous Leg Ulcers
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 sterile cryobag contained within a heat-sealed pouch. This packaging configuration allows for the introduction of Grafix® into the sterile field.
Neither Osiris Therapeutics, Inc. (Osiris), nor its affiliates expressly or by implication warrant any tissue selected, recovered, processed or distributed by itself, distributors, representatives, or agents. Please promptly report adverse outcomes to Osiris at the address on this website.
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/HBV Nucleic Acid Test (NAT)
West Nile Virus Nucleic Acid Test (NAT)
Each lot must be sterility negative per USP<71>
Minimum 70% cell viability
Growth factors are present in Grafix PRIME®
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.