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Amnion-derived Matrix FRAMEWORK FOR HEALING & REPAIR

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Presentation on theme: "Amnion-derived Matrix FRAMEWORK FOR HEALING & REPAIR"— Presentation transcript:

1 Amnion-derived Matrix FRAMEWORK FOR HEALING & REPAIR
AMNION-DERIVED ALLOGRAFT; Facilitates Wound Healing Facilitates Repair Reduces Inflammation Reduces Scar Tissue Formation Promotes Epithelialization Amnion-derived Matrix About Us Medavations, Inc. is an innovative healthcare solutions company focused on providing high quality and cost effective regenerative therapy, and state-of-the-art surgical products to enhance patient care and improve clinical outcomes. 1. de Rotth, A. Plastic repair of conjunctival defects with fetal membrane. Arch Ophthalmol. 1940;23: 2. Fairbairn N.G et. al. The clinical applications of human amnion in plastic surgery. Journal of Plastic, Reconstructive & Aesthetic Surgery (2014) 67, 3. Insausti CL, Alcaraz A, Garcia-Vizcaino, et al. Amniotic membrane induces epithelialization in massive posttraumatic wounds. Wound Repair Regen 2010;18:368e77. 4. Faulk WP, Matthews R, Stevens PJ, Bennett JP, Burgos H, Hsi BL. Human amnion as an adjunct in wound healing. Lancet 1980;1:1156e8. Medapro-CF is processed in ISO Class 5 environments and amnion derived tissue allografts are regulated by the FDA under section 361 of the PHS Act; 21 CFR 1271. Processing and Determination Eligibility by Integogen, LLC., Tallahasse, FL. FRAMEWORK FOR HEALING & REPAIR

2 Amnion-Derived Matrix
More Than A Single Layer More Than Wound Care Medapro-CF is a complex tissue matrix carefully derived from human amnion membrane using a proprietary and gentle process to protect the therapeutic properties contained within its multiple layers. By preserving essential proteins, growth factors, cells, and the collection of molecules known as the Extracellular Matrix(ECM), Medapro-CF is able to provide a robust framework to support healing and repair. If you think an amniotic-derived allograft product is only useful as an adjunct for wound care, know that Medapro-CF is a versatile, chorion-free allograft that can be administered in a wide variety of surgical applications as well. Since the use of minimally manipulated Human Amnion Membrane has been well documented for over 75 years1, it has shown these additional therapeutic benefits when a biological covering or scaffolding is called: Reduced Scar Tissue Formation – By including an epithelial cell layer along with the ECM, Medapro-CF has an opportunity to provide a number of growth factors not only responsible for the proliferation, migration and differentiation of epithelial cells, but also for the formation of tissue granulation through the proliferation of fibroblasts. At the same time, the presence of hyaluronic acid in the ECM may help inhibit excessive fibrosis and scar formation, providing a natural balance for the amnion’s healing support.2 Pain Management – As a biological covering material, Medapro-CF allografts can be applied on top of a wound to help prevent desiccation and excessive fluid loss. By also protecting exposed nerve ends though, the amnion provides an added analgesic effect to the patient.2 Chronic Wound Management - Multiple studies have reported superior wound healing when human amnion membrane has been applied to areas of stalled healing following large traumatic soft tissue loss in patients unfit for complex reconstruction3 and, following the application of amnion to chronic leg ulcers of varying aetiology.4 Epithelial Cells Basement Membrane Compact Layer Fibroblast Layer Spongy Layer Layers associated with the amniotic membrane More Than A Graft While our Medapro-CF dry graft is available in a variety of sizes and configurations, there are some additional benefits to keep in mind regarding this powerhouse allograft. The collection of multiple components found within the amniotic membrane contain a wide array of therapeutic characteristics such as; Anti-Inflammatory, Anti-Adhesion, and Anti-Scarring, just to name a few. These molecules are also anti-bacterial and anti-microbial allowing them to function in high bacterial environments which makes Medapro-CF a valuable alternative to use when and where the healing process needs a kick-start.

3 Amnion-Derived Matrix
More Than A Single Layer More Than Wound Care Medapro-CF is a complex tissue matrix carefully derived from human amnion membrane using a proprietary and gentle process to protect the therapeutic properties contained within its multiple layers. By preserving essential proteins, growth factors, cells, and the collection of molecules known as the Extracellular Matrix(ECM), Medapro-CF is able to provide a robust framework to support healing and repair. If you think that an amniotic-derived allograft product is only useful as an adjunct for wound care, know that Medapro-CF offers a variety of delivery options for use in other clinical applications where the benefits of an amnion-derived matrix are called for. Regardless of form, whether a graft, an injectable, or even a powder, the proven characteristics of a minimally manipulated Human Amnion Membrane have shown therapeutic outcomes in: Reduced Scar Tissue Formation – By including an epithelial cell layer along with the ECM, Medapro-CF has a chance to provide a number of growth factors responsible both for the proliferation, migration and differentiation of epithelial cells, as well as for the formation of granulation tissue through the proliferation of fibroblasts. At the same time, the presence of hyaluronic acid in the ECM may help inhibit excessive fibrosis and scar formation, providing a natural balance for the amnion’s healing support.1 Pain Management – As a covering material, Medapro-CF allografts can be applied to a wound bed to help prevent desiccation and excessive fluid loss. By also protecting exposed nerve ends though, the amnion provides an added analgesic effect to the patient.1 Wound Management - Chronic wounds represent a major financial burden on healthcare services worldwide. Multiple studies have reported superior wound healing following the application of amnion to chronic leg ulcers of varying aetiology.2 Amnion has also been applied to areas of stalled healing following large traumatic soft tissue loss in patients unfit for complex reconstruction.3 Epithelial Cells Basement Membrane Compact Layer Fibroblast Layer Spongy Layer Layers associated with the amniotic membrane More Than A Graft While Medapro-CF is available in a variety of graft sizes, Medapro-CF Injectable is a micronized amnion allograft* which can be administered by injecting or spraying into a wound or injury to promote the natural healing process—just like our traditional graft products. Medapro-CF Injectable can be utilized for difficult to reach locations where a traditional graft may not lay properly and can provide more unique delivery options and better outcome control for a variety of applications. *Also available as a micronized powder.

4 Biotechnology for Healthcare
More Than A Single Layer More Complicated Than Simply Wound Care Medapro-CF is a complex tissue matrix carefully derived from human amnion membrane using a proprietary and gentle process to protect the therapeutic properties contained within its multiple layers. By preserving essential proteins, growth factors, and the collection of molecules known as the Extracellular Matrix(ECM), Medapro-CF is able to provide a robust framework to support healing and repair. Chronic wounds represent a major financial burden on healthcare services. The measured use of minimally manipulated amnion-derived allografts like Medapro-CF however, may help to address some of the challenges associated with wound care management. In fact, multiple studies have demonstrated the clinical value of using amniotic membrane derived products. From introducing them to areas of stalled healing following large traumatic soft tissue loss in patients unfit for complex reconstruction2, to reporting superior wound healing following the application of amnion to chronic leg ulcers of varying aetiology.1, minimally manipulated amnion allografts such as Medapro-CF have a clinically proven track record in promoting the natural healing process. Epithelial Cells Basement Membrane Compact Layer Fibroblast Layer Spongy Layer Layers associated with the amniotic membrane More Than A Graft While our Medapro-CF dry graft is available in a variety of sizes and configurations, there are some additional benefits to keep in mind regarding this powerhouse allograft. The collection of multiple components found within the amniotic membrane are conducive to functioning in high bacterial environments, modulating inflammation, and down regulating scar tissue formation, making them a valuable alternative to use when and where the promotion of the natural healing process is needed. A Message To Our Partners We are wholly committed to providing best of class services to our Federal, State, and Local partners with a cost-conscious, patient-centric approach, and we are firmly committed to educating healthcare providers in the methods and the delivery of state-of-the-art biotechnologies which deliver high quality, clinical outcomes to a broader range of patients. 1. Faulk WP, Matthews R, Stevens PJ, Bennett JP, Burgos H, Hsi BL. Human amnion as an adjunct in wound healing. Lancet 1980;1:1156e8. 2. Insausti CL, Alcaraz A, Garcia-Vizcaino, et al. Amniotic membrane induces epithelialization in massive posttraumatic wounds. Wound Repair Regen 2010;18:368e77.

5 Amnion-derived Matrix
have reported superior wound healing following the application of amnion to chronic leg ulcers of varying aetiology.1 Amnion has also been applied to Not all amniotic allografts are the same, though, and the difference lies in the composition of the source tissue. Amnion-derived Matrix Chronic wounds represent a major financial burden on healthcare services. The measured use of minimally manipulated amnion-derived allografts like Medapro-CF, however, may help to address some of the challenges associated with wound care management. Multiple studies have demonstrated the benefits of using an amniotic membrane derived allograft from applying it to areas of stalled healing following large traumatic soft tissue loss in patients unfit for complex reconstruction2, to the covering with of amnion to chronic leg ulcers of varying aetiology.1 More Than A Graft While Medapro-CF is available in a variety of sizes, Medapro-CF Injectable is a micronized, fluid matrix* which can be administered by injecting or spraying into a wound or injury to promote the natural healing process—just like our traditional graft products. Medapro-CF Injectable can be utilized for difficult to reach locations where a traditional graft may not lay properly and provides more administration options and better outcome control for a variety of applications. *Also available as a micronized powder. More Than A Single Layer Medapro-CF is a chorion-free allograft that is carefully derived from amnion using a proprietary and gentle process to protect multiple tissue layers rich in Extracellular Matrix (ECM) components. By preserving the therapeutic and regenerative proteins, cells, and growth factors found in the ECM, Medapro-CF is able to provide a robust framework to support repair and healing. More Than Simple Wound Care Regardless of form—whether a graft, injectable, or powder—minimally manipulated amnion allografts like Medapro-CF have shown therapeutic outcomes beyond just simple wound care, like reduced inflammation and reduced scar tissue formation on surgical incisions. And as a covering material, Medapro-CF allografts can be applied to a wound bed to help prevent desiccation and excessive fluid loss. But by also protecting exposed nerve ends, the amnion provides an added analgesic effect to the patient.3 Epithelial Cells Basement Membrane Compact Layer Fibroblast Layer Spongy Layer Layers associated with the ECM 1. Faulk WP, Matthews R, Stevens PJ, Bennett JP, Burgos H, Hsi BL. Human amnion as an adjunct in wound healing. Lancet 1980;1:1156e8. 2. Insausti CL, Alcaraz A, Garcia-Vizcaino, et al. Amniotic membrane induces epithelialization in massive posttraumatic wounds. Wound Repair Regen 2010;18:368e77. 3. Fairbairn N.G et. al. The clinical applications of human amnion in plastic surgery. Journal of Plastic, Reconstructive & Aesthetic Surgery (2014) 67, Medapro-CF is processed in ISO Class 5 environments. Medapro-CF is regulated by the FDA under 21 CFR 1271.

6 Amnion-Derived Matrix
More Than A Single Layer More Than Wound Care Medapro-CF is a complex tissue matrix carefully derived from chorion-free human amnion allograft using a proprietary and gentle process that protects the regenerative properties found within the multiple layers of the amniotic membrane. By preserving essential proteins, growth factors, cells, and by preserving the collection of molecules contained in the Extracellular Matrix(ECM), the framework necessary to help facilitate regeneration and repair is left intact. If you think that an amniotic-derived allograft product is only useful as an adjunct for wound care, know that Medapro-CF offers a variety of delivery options for use in other clinical applications where the benefits of an amnion-derived matrix are called for. Regardless of form, whether a graft, an injectable, or even a powder, the proven characteristics of a minimally manipulated Human Amnion Membrane have shown therapeutic outcomes in: Reduced Scar Tissue Formation – By including an epithelial cell layer along with the ECM, Medapro-CF has a chance to provide a number of growth factors responsible both for the proliferation, migration and differentiation of epithelial cells, as well as for the formation of granulation tissue through the proliferation of fibroblasts. At the same time, the presence of hyaluronic acid in the ECM may help inhibit excessive fibrosis and scar formation, providing a natural balance for the amnion’s healing support.1 Pain Management – As a covering material, Medapro-CF allografts can be applied to a wound bed to help prevent desiccation and excessive fluid loss. By also protecting exposed nerve ends though, the amnion provides an added analgesic effect to the patient.1 Wound Management - Chronic wounds represent a major financial burden on healthcare services worldwide. Multiple studies have reported superior wound healing following the application of amnion to chronic leg ulcers of varying aetiology.2 Amnion has also been applied to areas of stalled healing following large traumatic soft tissue loss in patients unfit for complex reconstruction.3 Epithelial Cells Basement Membrane Compact Layer Fibroblast Layer Spongy Layer Layers associated with the amniotic membrane More Than A Graft Chronic wounds represent a major financial burden on healthcare services worldwide. Human Amnion Membrane(hAM) has been shown to be a potential therapeutic alternative in Wound Management. For years, amnion derived allografts have been applied to areas of stalled healing following large traumatic soft tissue loss in patients unfit for complex reconstruction.3 Multiple studies have also reported superior wound healing following the application of amnion to chronic leg ulcers of varying aetiology.2 Since amnion membrane is an immunoprivileged product and has natural characteristics to With being an immunoprivileged membrane which chaving the natural characteristics to down regulate inflammation of of the amnion membrane components in hAM to help reduce inflammationsuch high concentrations of the essential molecules necessary to facilitate repairproteins, growth factors, cytokines, integrins, and extracellular molecules found in the composition of the hAM, and the ability to deliver these components directly to the wound site, it is no wonder why Human Amnion Allograft has the ability to both enhance and accelerate the body’s natural healing process.

7 A FRAMEWORK FOR REGENERATION & REPAIR
Anti-Inflammatory. Anti-Adhesive. Anti-Microbial. Angiogenic. Amnion-Derived Matrix Medapro-CF is processed in ISO Class 5 environments. Medapro-CF is regulated by the FDA under 21 CFR 1271. 1. Fairbairn N.G et. al. The clinical applications of human amnion in plastic surgery. Journal of Plastic, Reconstructive & Aesthetic Surgery (2014) 67, 2. Faulk WP, Matthews R, Stevens PJ, Bennett JP, Burgos H, Hsi BL. Human amnion as an adjunct in wound healing. Lancet 1980;1:1156e8. 3. Insausti CL, Alcaraz A, Garcia-Vizcaino, et al. Amniotic membrane induces epithelialization in massive posttraumatic wounds. Wound Repair Regen 2010;18:368e77. A FRAMEWORK FOR REGENERATION & REPAIR

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