FOLDS Harvest SmartPrep System: Harvest PRP With

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Harvest PRP with SmartPrep System:A System You Can Trust toHarvest Ordering InformationConsistently DeliverHarvest SmartPrep System:The Gold StandardHarvest Technologies is the leader in developing point-of-care cellular platforms to isolate andHarvest SmartPrep Systemconcentrate autologous growth factors, stem cells, and accessory cells that may help optimizeconditions for healing. A decade ago, we introduced the Harvest SmartPrep System, making theuse of autologous growth factors practical in the hospital and clinic setting for the first time. Point-of-care, multifunction platformfor concentrating autologous cellsThe Harvest SmartPrep System has been used in over 1 million procedures to date and counting. More than a decade of proven reliabilityToday, the Harvest SmartPrep System platform is the gold standard in PRP technology. One-button operation 15-minute automated processSMP-2Harvest SmartPrep SystemWS-2Harvest SmartPrep System WorkstationRC-2Harvest SmartPrep System Rolling Transport CaseAPC-30Harvest PRP Procedure Pack for SmartPrep SystemAPC-60Harvest PRP Procedure Pack for SmartPrep SystemAPC-120Harvest PRP Procedure Pack for SmartPrepLK/2Harvest SmartJet Liquid Applicator Kit110V-50/60 HzGenerates 3-4ml PRP. 6/case.Generates 5-10ml PRP. 3/case.Generates 10-20ml PRP. 2/case.2 in.(50mm) Liquid delivery system. 6/case.The Harvest SmartPrep System:Harvest PRP Procedure Packs:LK/4Harvest SmartJet Liquid Applicator Kit Delivers the optimal composition ofa concentrated platelet product3,1 All inclusive procedure packs based on clinical needLK/7Harvest SmartJet Liquid Applicator Kit P roprietary Cell Capture technology ensures consistencyand highest level of reproducibility1 R ecovers the highest percentage of plateletsand corresponding growth factors – up to 80%of available platelets1 D elivers the optimal concentrated platelet product andWBC composition1 Contains increased concentration of stem cells1,11SK/S4 in.(102mm) Liquid delivery system. 6/case.7 in.(178mm) Liquid delivery system. 6/case.Harvest SmartJet Spray Applicator KitSpray delivery system. 6/case.References(1) Data on file(2) Street, J et al, VEGF stimulates bone repair by promoting Angiogenesis and bone turnover, PNAF 2002.The Harvest Technologies PRP separation system is designed to be used for the safe and rapid preparationof autologous platelet rich plasma (PRP) from a small sample of blood at the patients point of care. ThePRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site asdeemed necessary by the clinical use requirements. G enerates the greatest level of reproducibility –only a 5% coefficient of variance1 I n the shortest amount of time – 15 minutes orless from start to finish1 Considered the simplest and easiest system to use1The SmartJet bone grafting liquid applicator is designed to facilitate pre mixing of allograft, autograft orsynthetic bone graft materials for application to an orthopedic surgical site, with I.V. fluids, autologousblood, plasma, platelet rich plasma, or other specific blood component(s) as deemed necessary by theclinical use requirements.The SmartJet grafting liquid applicator is intended for the application of fluids, as deemed necessary by thesurgeons determination of the clinical use requirements, to facilitate the preparation of soft tissue autograftor allograft material prior to the application of the graft material to a repair site.(3) G iusti, I, et al, Identification of an Optimal Concentration of Platelet Gel for Promoting Angiogenesis inHuman Endothelial Cells, Transfusion, 2009; 49:771-778.(4) K usumanto, Y, et al, Platelets and Granulocytes, in Particular the Neutrophils, form ImportantCompartments for Circulating Vascular Endothelial Growth Factor, Angiogenesis, 2003; 6:238-287.(5) E l-Sharkawy,H, et al, Platelet-Rich Plasma: Growth Factors and Pro- and Anti-Inflammatory Properties, JPeriodontol, 2007; 7:661-669.(6) F iore S, et al, Lipoxin A4 Receptor Activation is Distinct from that of the Formyl Peptide Receptorin Myeloid Cells: Inhibition of CD11/18 Expression by Lipoxin A4-Lipoxin A4 Receptor Interaction,Biochemistry, 1995; 34:16678-16686.(7) M assberg, S., et al, Platelets Secrete Stromal Cell-Derived Factor-1α and Recruit BoneMarrow-Derived Progenitor Cells to Arterial Thrombi in Vivo, JEM, 2006; 203:1221-1233.(8) P erry, R., Green, D., Perry’s Chemical Engineers’ Handbook, 7th edition, 1997, 4-3, McGraw-Hill.(9) C enter for Blood Research Laboratories, Sterility of Platelet Concentrates Collected with the SmartPRePSystem and Disposables, TR-063, 2001.(10) K evy, et al, Comparison of Methods for Point of Care Preparation of Autologous Platelet Gel, JECT,2004; 36:28-35.(11) K evy, S., Jacobson, M., and Mandle, B., Defining the Composition and Healing Effect of Platelet-RichPlasma for Regenerative Medicine. Poster Session Presented at: TERMIS-Americas 2010December 5-8, 2010, Orlando, Florida.(12) M arx, R.E and Harrell, D.B. Translational Research: The CD34 Cell Is Crucial for Large-Volume BoneRegeneration from the Milieu of Bone Marrow Progenitor Cells in Craniomandibular Reconstruction,Oral Craniofac Tissue Eng 2012;2;263-271.(13) H ematology Basic Principles and Practice 5th Edition. Hoffman, R., Benz, Jr. E.J., Shattil, S.J., et al,[Eds] Churchill Livingstone Elsevier. Philadelphia, PA 2009.To arrange an evaluation in a hospital or for more information, in the US, call our Customer Service Department800.521.2818In less than 15 minutes, 60 mL ofperipheral blood provides10 mL of an Autologous PlateletHarvest’s mission is to further expand and enhance the useConcentrate with theof autologous bioactive cells that may help optimize theoptimal cellular compositionconditions for healing and improved patient outcomes.*and concentration.*see back panel for indications for useManufactured byHarvest Technologies Corp.40 Grissom Road, Suite 100, Plymouth, MA 02360P:508.732.7500 F:508.732.04000086Harvest Technologies GmbHZehntfeldstr. 240a, D-81825 Munich, GermanyP: 49(0)89 437778-0 F: 49(0)89 437778-10Distributed in the U.S. byTerumo Cardiovascular Group6200 Jackson Road, Ann Arbor, MI 48103-9300P:734-663-4145 TF: 800-521-2818F: 734-663-7981 www.terumo-cvs.com851720SL 021 TCVG 1315 03/2014 Harvest Technologies Corp, Printed in the USA. US and Foreign Patents Pending.Harvest, SmartPrep, APC , BMAC, AdiPrep, SmartJet are registered trademarks of Harvest Technologies Corp.Terumo is a registered trademark of Terumo Corporation.A L L T H E E S S E N T I A L S O F H E A L I N G , N AT U R A L LY

Harvest TechnologiesDeveloping Cellular platforms that may helpoptimize conditions for healing orthopedic sitesWhat is the Optimal Platelet Concentration?How do Stem Cells home to the Repair Site?An Autologous Platelet Concentrate not only accelerates migration of stem cells to the repair sitebut also stimulates proliferation in the microenvironment.Clinically effective Autologous Platelet Concentrate (PRP)contains both stem cells and their homing agent.Physicians recognize that re-establishing blood flow is critical for healing.2 Platelets, WBC’s, and accessory cells contain criticalMigration of stem cells throughout the body requires active navigation, a processcytokines such as VEGF which is well known to stimulate angiogenesis and SDF-1α which actively mobilizes and navigates stemcalled homing. Homing is a multistep process modulated by SDF-1α.7cells to the repair site.Unlocking the Biologic PotentialFurthermore, proliferative assays showed: No PRP device can achieve platelet concentrations thatinhibit angiogenesis1 WBC’s do not inhibit cell proliferation. Harvest PRP is notinflammatory due to the reduced percentage of granulocytescompared to whole blood.1What is the Optimal Composition of an AutologousPlatelet Concentrate (PRP)? Platelet concentrations less than 500 x 103/µL supportproliferation no better than platelet poor plasma (PPP)1It has been documented in the literature that effective cellular therapy requires a scaffold for cell migration,progenitor cells which can be converted into bone or soft tissue, and signal proteins to modulate the repairand regeneration process. These key biologic cells are located in the “buffy coat” layer.The buffy coat is a rich source of cells and proteins that may help optimize the conditions for healing, including:12,13 M ediate cell-to-cell adhesion through the release of variousadhesion molecules and growth factorsGrowth FactorsCytokines and Adhesion MoleculesAABB and FDA/CBER GuidelinesFor Transfusion Therapy130%120%While no system is completely closed, Harvest PRP with SmartPrep System was designed110%to follow AABB guidelines for cell separation.100%200400whole blood sample.Signal Proteins The WBC composition of the Harvest PRP is primarilymononuclear as compared to whole blood whichcontains primarily granulocytes1AngiogenesisTissue GenesisScaffoldInstead of using luer connectors that can be easily contaminated and cannot be disinfected,Harvest PRP disposables incorporate re-sealable injection ports that can be asepticallyclosest system to a closed system on the market today.Harvest Technologies meets state of the art requirements for sterility testing. Preparedwith the SmartPrep System, PRP aliquots were incubated, cultured and sub-culturedover 18 days aerobically and anaerobically. All cultures were negative. Harvest TechnologiesHarvest PRP withSmartPrep System Performance11PlateletsWhole BloodHarvest PRP318 x 10 / µL1560 x 10 / µL33SDF-1α pg/mL19532663 L ower than baseline granulocyte levels limits inflammation whiledelivering a proportionately greater number of stem cells.PDGF ng/mL59.4398.3TGF-ß1 ng/mL85319VEGF pg/mL1166005.83 x 103 / µL21.09 x 103 / µLWBC The predominance of mononuclear and CD34 cells found in theHarvest PRP concentrated platelet product indicates the presenceas well as the concentration of stem 6%In addition to the significant reduction of granulocytes, autologousCD34 platelet concentrates have also been shown to significantly suppress(total cells delivered)Liquid Application(LK/2 Shown)Sterility Testing This composition may help optimize conditions for healing. M ore importantly, CD34 cells are markers for stem cells andthese cells reside in the mononuclear fraction.White Blood Cells (WBC’s)800 1000 1500 3000 5000 6000Platelet Concentration x 103 / µL Baseline level PPP is 100%cells while reducing the granulocyte cells by 60% as compared to the V ascular Endothelial Growth Factors (VEGF): Stimulatesangiogenesis and chemoattractive for osteoblasts CD34 cells as a stem cell marker havebeen identified in the Harvest concentratedplatelet product (PRP)1140%Some contend that concentrated WBC’s may produce an unintended inflammatory responseor inhibit cell proliferation. Not true. What most fail to recognize is the importance of thecomposition of the WBC fraction in the concentrated platelet product.contains 100% more mononuclear (lymphocytes and monocytes)Essential Healing FactorsTopical Spray(SK/S Shown)Biologic Closed System – “A chemical or biological system thatexchanges no matter or energy with the outside environment”8150%What is the Value of White Blood Cells?patented separation process produces a WBC composition that P latelet Derived Growth Factors (PDGF): Chemoattractivefor stem cells and endothelial cells T ransforming Growth Factor Beta (TGF-β): Promotes cellmitosis and differentiation for connective tissue and bone160%What about “Closed Systems” andProduct Sterility?disinfected with alcohol prior to needle entry. Harvest PRP with SmartPrep System is the Unlike other systems, the Harvest PRP and SmartPrep System’s S tromal Derived Factor-1 Alpha (SDF-1α):Actively modulates migration and homingof stem cells to the repair siteCell proliferation: % of baseline control (PPP)stimulate angiogenesis ranged from 1.5 to 3.0 x 106 platelets/µL(1.5 million to 3.0 million platelets per microliter).1,3Platelets48 hr Proliferation Assay of HumanUmbilical Vein Endothelial Cells (n 27)11Recent studies indicate the optimal platelet concentration toDelivery Options171,571has documented sterility of the concentrated platelet product when following themanufacturer’s instructions for use.9All PRP Is Not Created Equal1The technique used for isolating and concentrating platelets hasa direct impact on growth factor availability and functionality.10Enriched BoneGraftsTest tube systems, Lab centrifuges and many other so called “PRP” systems fail to achievethe threshold of platelet concentration and white blood cell composition required.1The Harvest PRP with SmartPrep System consistently and reproducibly generates theoptimal platelet concentration that may help optimize the conditions for healing. Whileno system is fully automated, Harvest PRP with SmartPrep System is assimple as 1,2,3.inflammation by generating endogenous anti-inflammatory compoundssuch as lipoxins.4,5,6Draw bloodConcentrateDeliverPercutaneousInjection

Harvest TechnologiesDeveloping Cellular platforms that may helpoptimize conditions for healing orthopedic sitesWhat is the Optimal Platelet Concentration?How do Stem Cells home to the Repair Site?An Autologous Platelet Concentrate not only accelerates migration of stem cells to the repair sitebut also stimulates proliferation in the microenvironment.Clinically effective Autologous Platelet Concentrate (PRP)contains both stem cells and their homing agent.Physicians recognize that re-establishing blood flow is critical for healing.2 Platelets, WBC’s, and accessory cells contain criticalMigration of stem cells throughout the body requires active navigation, a processcytokines such as VEGF which is well known to stimulate angiogenesis and SDF-1α which actively mobilizes and navigates stemcalled homing. Homing is a multistep process modulated by SDF-1α.7cells to the repair site.Unlocking the Biologic PotentialFurthermore, proliferative assays showed: No PRP device can achieve platelet concentrations thatinhibit angiogenesis1 WBC’s do not inhibit cell proliferation. Harvest PRP is notinflammatory due to the reduced percentage of granulocytescompared to whole blood.1What is the Optimal Composition of an AutologousPlatelet Concentrate (PRP)? Platelet concentrations less than 500 x 103/µL supportproliferation no better than platelet poor plasma (PPP)1It has been documented in the literature that effective cellular therapy requires a scaffold for cell migration,progenitor cells which can be converted into bone or soft tissue, and signal proteins to modulate the repairand regeneration process. These key biologic cells are located in the “buffy coat” layer.The buffy coat is a rich source of cells and proteins that may help optimize the conditions for healing, including:12,13 M ediate cell-to-cell adhesion through the release of variousadhesion molecules and growth factorsGrowth FactorsCytokines and Adhesion MoleculesAABB and FDA/CBER GuidelinesFor Transfusion Therapy130%120%While no system is completely closed, Harvest PRP with SmartPrep System was designed110%to follow AABB guidelines for cell separation.100%200400whole blood sample.Signal Proteins The WBC composition of the Harvest PRP is primarilymononuclear as compared to whole blood whichcontains primarily granulocytes1AngiogenesisTissue GenesisScaffoldInstead of using luer connectors that can be easily contaminated and cannot be disinfected,Harvest PRP disposables incorporate re-sealable injection ports that can be asepticallyclosest system to a closed system on the market today.Harvest Technologies meets state of the art requirements for sterility testing. Preparedwith the SmartPrep System, PRP aliquots were incubated, cultured and sub-culturedover 18 days aerobically and anaerobically. All cultures were negative. Harvest TechnologiesHarvest PRP withSmartPrep System Performance11PlateletsWhole BloodHarvest PRP318 x 10 / µL1560 x 10 / µL33SDF-1α pg/mL19532663 L ower than baseline granulocyte levels limits inflammation whiledelivering a proportionately greater number of stem cells.PDGF ng/mL59.4398.3TGF-ß1 ng/mL85319VEGF pg/mL1166005.83 x 103 / µL21.09 x 103 / µLWBC The predominance of mononuclear and CD34 cells found in theHarvest PRP concentrated platelet product indicates the presenceas well as the concentration of stem 6%In addition to the significant reduction of granulocytes, autologousCD34 platelet concentrates have also been shown to significantly suppress(total cells delivered)Liquid Application(LK/2 Shown)Sterility Testing This composition may help optimize conditions for healing. M ore importantly, CD34 cells are markers for stem cells andthese cells reside in the mononuclear fraction.White Blood Cells (WBC’s)800 1000 1500 3000 5000 6000Platelet Concentration x 103 / µL Baseline level PPP is 100%cells while reducing the granulocyte cells by 60% as compared to the V ascular Endothelial Growth Factors (VEGF): Stimulatesangiogenesis and chemoattractive for osteoblasts CD34 cells as a stem cell marker havebeen identified in the Harvest concentratedplatelet product (PRP)1140%Some contend that concentrated WBC’s may produce an unintended inflammatory responseor inhibit cell proliferation. Not true. What most fail to recognize is the importance of thecomposition of the WBC fraction in the concentrated platelet product.contains 100% more mononuclear (lymphocytes and monocytes)Essential Healing FactorsTopical Spray(SK/S Shown)Biologic Closed System – “A chemical or biological system thatexchanges no matter or energy with the outside environment”8150%What is the Value of White Blood Cells?patented separation process produces a WBC composition that P latelet Derived Growth Factors (PDGF): Chemoattractivefor stem cells and endothelial cells T ransforming Growth Factor Beta (TGF-β): Promotes cellmitosis and differentiation for connective tissue and bone160%What about “Closed Systems” andProduct Sterility?disinfected with alcohol prior to needle entry. Harvest PRP with SmartPrep System is the Unlike other systems, the Harvest PRP and SmartPrep System’s S tromal Derived Factor-1 Alpha (SDF-1α):Actively modulates migration and homingof stem cells to the repair siteCell proliferation: % of baseline control (PPP)stimulate angiogenesis ranged from 1.5 to 3.0 x 106 platelets/µL(1.5 million to 3.0 million platelets per microliter).1,3Platelets48 hr Proliferation Assay of HumanUmbilical Vein Endothelial Cells (n 27)11Recent studies indicate the optimal platelet concentration toDelivery Options171,571has documented sterility of the concentrated platelet product when following themanufacturer’s instructions for use.9All PRP Is Not Created Equal1The technique used for isolating and concentrating platelets hasa direct impact on growth factor availability and functionality.10Enriched BoneGraftsTest tube systems, Lab centrifuges and many other so called “PRP” systems fail to achievethe threshold of platelet concentration and white blood cell composition required.1The Harvest PRP with SmartPrep System consistently and reproducibly generates theoptimal platelet concentration that may help optimize the conditions for healing. Whileno system is fully automated, Harvest PRP with SmartPrep System is assimple as 1,2,3.inflammation by generating endogenous anti-inflammatory compoundssuch as lipoxins.4,5,6Draw bloodConcentrateDeliverPercutaneousInjection

Harvest TechnologiesDeveloping Cellular platforms that may helpoptimize conditions for healing orthopedic sitesWhat is the Optimal Platelet Concentration?How do Stem Cells home to the Repair Site?An Autologous Platelet Concentrate not only accelerates migration of stem cells to the repair sitebut also stimulates proliferation in the microenvironment.Clinically effective Autologous Platelet Concentrate (PRP)contains both stem cells and their homing agent.Physicians recognize that re-establishing blood flow is critical for healing.2 Platelets, WBC’s, and accessory cells contain criticalMigration of stem cells throughout the body requires active navigation, a processcytokines such as VEGF which is well known to stimulate angiogenesis and SDF-1α which actively mobilizes and navigates stemcalled homing. Homing is a multistep process modulated by SDF-1α.7cells to the repair site.Unlocking the Biologic PotentialFurthermore, proliferative assays showed: No PRP device can achieve platelet concentrations thatinhibit angiogenesis1 WBC’s do not inhibit cell proliferation. Harvest PRP is notinflammatory due to the reduced percentage of granulocytescompared to whole blood.1What is the Optimal Composition of an AutologousPlatelet Concentrate (PRP)? Platelet concentrations less than 500 x 103/µL supportproliferation no better than platelet poor plasma (PPP)1It has been documented in the literature that effective cellular therapy requires a scaffold for cell migration,progenitor cells which can be converted into bone or soft tissue, and signal proteins to modulate the repairand regeneration process. These key biologic cells are located in the “buffy coat” layer.The buffy coat is a rich source of cells and proteins that may help optimize the conditions for healing, including:12,13 M ediate cell-to-cell adhesion through the release of variousadhesion molecules and growth factorsGrowth FactorsCytokines and Adhesion MoleculesAABB and FDA/CBER GuidelinesFor Transfusion Therapy130%120%While no system is completely closed, Harvest PRP with SmartPrep System was designed110%to follow AABB guidelines for cell separation.100%200400whole blood sample.Signal Proteins The WBC composition of the Harvest PRP is primarilymononuclear as compared to whole blood whichcontains primarily granulocytes1AngiogenesisTissue GenesisScaffoldInstead of using luer connectors that can be easily contaminated and cannot be disinfected,Harvest PRP disposables incorporate re-sealable injection ports that can be asepticallyclosest system to a closed system on the market today.Harvest Technologies meets state of the art requirements for sterility testing. Preparedwith the SmartPrep System, PRP aliquots were incubated, cultured and sub-culturedover 18 days aerobically and anaerobically. All cultures were negative. Harvest TechnologiesHarvest PRP withSmartPrep System Performance11PlateletsWhole BloodHarvest PRP318 x 10 / µL1560 x 10 / µL33SDF-1α pg/mL19532663 L ower than baseline granulocyte levels limits inflammation whiledelivering a proportionately greater number of stem cells.PDGF ng/mL59.4398.3TGF-ß1 ng/mL85319VEGF pg/mL1166005.83 x 103 / µL21.09 x 103 / µLWBC The predominance of mononuclear and CD34 cells found in theHarvest PRP concentrated platelet product indicates the presenceas well as the concentration of stem 6%In addition to the significant reduction of granulocytes, autologousCD34 platelet concentrates have also been shown to significantly suppress(total cells delivered)Liquid Application(LK/2 Shown)Sterility Testing This composition may help optimize conditions for healing. M ore importantly, CD34 cells are markers for stem cells andthese cells reside in the mononuclear fraction.White Blood Cells (WBC’s)800 1000 1500 3000 5000 6000Platelet Concentration x 103 / µL Baseline level PPP is 100%cells while reducing the granulocyte cells by 60% as compared to the V ascular Endothelial Growth Factors (VEGF): Stimulatesangiogenesis and chemoattractive for osteoblasts CD34 cells as a stem cell marker havebeen identified in the Harvest concentratedplatelet product (PRP)1140%Some contend that concentrated WBC’s may produce an unintended inflammatory responseor inhibit cell proliferation. Not true. What most fail to recognize is the importance of thecomposition of the WBC fraction in the concentrated platelet product.contains 100% more mononuclear (lymphocytes and monocytes)Essential Healing FactorsTopical Spray(SK/S Shown)Biologic Closed System – “A chemical or biological system thatexchanges no matter or energy with the outside environment”8150%What is the Value of White Blood Cells?patented separation process produces a WBC composition that P latelet Derived Growth Factors (PDGF): Chemoattractivefor stem cells and endothelial cells T ransforming Growth Factor Beta (TGF-β): Promotes cellmitosis and differentiation for connective tissue and bone160%What about “Closed Systems” andProduct Sterility?disinfected with alcohol prior to needle entry. Harvest PRP with SmartPrep System is the Unlike other systems, the Harvest PRP and SmartPrep System’s S tromal Derived Factor-1 Alpha (SDF-1α):Actively modulates migration and homingof stem cells to the repair siteCell proliferation: % of baseline control (PPP)stimulate angiogenesis ranged from 1.5 to 3.0 x 106 platelets/µL(1.5 million to 3.0 million platelets per microliter).1,3Platelets48 hr Proliferation Assay of HumanUmbilical Vein Endothelial Cells (n 27)11Recent studies indicate the optimal platelet concentration toDelivery Options171,571has documented sterility of the concentrated platelet product when following themanufacturer’s instructions for use.9All PRP Is Not Created Equal1The technique used for isolating and concentrating platelets hasa direct impact on growth factor availability and functionality.10Enriched BoneGraftsTest tube systems, Lab centrifuges and many other so called “PRP” systems fail to achievethe threshold of platelet concentration and white blood cell composition required.1The Harvest PRP with SmartPrep System consistently and reproducibly generates theoptimal platelet concentration that may help optimize the conditions for healing. Whileno system is fully automated, Harvest PRP with SmartPrep System is assimple as 1,2,3.inflammation by generating endogenous anti-inflammatory compoundssuch as lipoxins.4,5,6Draw bloodConcentrateDeliverPercutaneousInjection

Harvest TechnologiesDeveloping Cellular platforms that may helpoptimize conditions for healing orthopedic sitesWhat is the Optimal Platelet Concentration?How do Stem Cells home to the Repair Site?An Autologous Platelet Concentrate not only accelerates migration of stem cells to the repair sitebut also stimulates proliferation in the microenvironment.Clinically effective Autologous Platelet Concentrate (PRP)contains both stem cells and their homing agent.Physicians recognize that re-establishing blood flow is critical for healing.2 Platelets, WBC’s, and accessory cells contain criticalMigration of stem cells throughout the body requires active navigation, a processcytokines such as VEGF which is well known to stimulate angiogenesis and SDF-1α which actively mobilizes and navigates stemcalled homing. Homing is a multistep process modulated by SDF-1α.7cells to the repair site.Unlocking the Biologic PotentialFurthermore, proliferative assays showed: No PRP device can achieve platelet concentrations thatinhibit angiogenesis1 WBC’s do not inhibit cell proliferation. Harvest PRP is notinflammatory due to the reduced percentage of granulocytescompared to whole blood.1What is the Optimal Composition of an AutologousPlatelet Concentrate (PRP)? Platelet concentrations less than 500 x 103/µL supportproliferation no better than platelet poor plasma (PPP)1It has been documented in the literature that effective cellular therapy requires a scaffold for cell migration,progenitor cells which can be converted into bone or soft tissue, and signal proteins to modulate the repairand regeneration process. These key biologic cells are located in the “buffy coat” layer.The buffy coat is a rich source of cells and proteins that may help optimize the conditions for healing, including:12,13 M ediate cell-to-cell adhesion through the release of variousadhesion molecules and growth factorsGrowth FactorsCytokines and Adhesion MoleculesAABB and FDA/CBER GuidelinesFor Transfusion Therapy130%120%While no system is completely closed, Harvest PRP with SmartPrep System was designed110%to follow AABB guidelines for cell separation.100%200400whole blood sample.Signal Proteins The WBC composition of the Harvest PRP is primarilymononuclear as compared to whole blood whichcontains primarily granulocytes1AngiogenesisTissue GenesisScaffoldInstead of using luer connectors that can be easily contaminated and cannot be disinfected,Harvest PRP disposables incorporate re-sealable injection ports that can be asepticallyclosest system to a closed system on the market today.Harvest Technologies meets state of the art requirements for sterility testing. Preparedwith the SmartPrep System, PRP aliquots were incubated, cultured and sub-culturedover 18 days aerobically and anaerobically. All cultures were negative. Harvest TechnologiesHarvest PRP withSmartPrep System Performance11PlateletsWhole BloodHarvest PRP318 x 10 / µL1560 x 10 / µL33SDF-1α pg/mL19532663 L ower than baseline granulocyte levels limits inflammation whiledelivering a proportionately greater number of stem cells.PDGF ng/mL59.4398.3TGF-ß1 ng/mL85319VEGF pg/mL1166005.83 x 103 / µL21.09 x 103 / µLWBC The predominance of mononuclear and CD34 cells found in theHarvest PRP concentrated platelet product indicates the presenceas well as the concentration of stem 6%In addition to the significant reduction of granulocytes, autologousCD34 platelet concentrates have also been shown to significantly suppress(total cells delivered)Liquid Application(LK/2 Shown)Sterility Testing This composition may help optimize conditions for healing. M ore importantly, CD34 cells are markers for stem cells andthese cells reside in the mononuclear fraction.White Blood Cells (WBC’s)800 1000 1500 3000 5000 6000Platelet Concentration x 103 / µL Baseline level PPP is 100%cells while reducing the granulocyte cells by 60% as compare

Harvest SmartPrep System: The Gold Standard Harvest Technologies is the leader in developing point-of-care cellular platforms to isolate and . The buffy coat is a rich source of cells and proteins that may help optim