AutoloGel
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AutoloGel

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The AutoloGel System utilizes a unique technology that enables rapid isolation and activation of platelet rich plasma (PRP) from a patient’s own blood. The PRP is subsequently processed to produce......

The AutoloGel System utilizes a unique technology that enables rapid isolation and activation of platelet rich plasma (PRP) from a patient’s own blood. The PRP is subsequently processed to produce a gel for application to the wound bed, re-establishing a balance needed for natural healing to occur. AutoloGel contains growth factors, cytokines and chemokines that are essential for normal wound healing. The AutoloGel System is used at the point-of care and is the only PRP System indicated for use in exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically-debrided wounds.

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  • 1. A biotechnology company focused on regenerative medicine in the areas of wound care, angiogenesis, and inflammation. Advanced Tissue Regeneration Technologies
  • 2. A biotechnology company focused on regenerative medicine in the areas of wound care, angiogenesis, and inflammation. Advanced Tissue Regeneration Technologies
  • 3. RESTORE THE BALANCE
  • 4. The AutoloGel System™
  • 5. The Science
  • 6. Natural Wound Healing - A Complex Process
    • The human body heals itself naturally
    • Four Stages of Healing
      • Hemostasis>>Inflammatory>>Proliferation>>Remodeling
    • Healthy wounds heal because of:
      • A moist wound environment
      • Adequate blood flow to the wound bed
      • Delivery of nutrients and proteins
      • to the wound bed
    • These wound repair proteins include:
      • Growth Factors
      • Cytokines
      • Chemokines
    Diegelmann R, Evans MC. Wound Healing:An Overview of Acute, Fibrotic and Delayed Healing. 2004.Frontiers in Bioscienece 9:283-289
  • 7. Normal “Complex” Wound Repair Reprinted by permission from Macmillan Publishers Ltd.©2007
  • 8. Wound Repair Proteins Role in Healing
  • 9. Chronic Wounds – Imbalanced Environment
    • Wounds that do not heal within 30 days are considered chronic
    • Chronic wounds are typically accompanied by edema, ischemia, lack of perfusion create an imbalance of blood derived growth factors, cytokines, and chemokines in the wound bed
    • Imbalances in the relative levels of growth factors, chemokines, and cytokines cause delays in progressing the wound
    • Single growth factors and concentrated
    • growth factors do not establish this complex,
    • balance, making them incomplete solutions
    Ref 7 & 9 Goldman
  • 10. Chronic Wound – Stuck in Inflammatory Singer AJ, Clarke RA, (1999) Cutaneous wound healing NEJM ©1999 Massachussetts Medical Society, All Rights Reserved
  • 11. Chronic Wounds – Inflammatory Stage
    • The lack of balance caused by a deficiency in the wound bed of naturally occurring growth factors, cytokines, chemokines can cause wounds to stall in the inflammatory stage
    • The body is unable to heal itself due to a lack of cellular proteins and nutrients
    • Wounds caught in a prolonged inflammatory stage are linked to infection, tissue damage by free radicals and proteases.
    • A cycle of wound deterioration is then supported by inflammatory mediators, causing the wound to actually worsen.
  • 12. Restore The Balance
  • 13. The AutoloGel ™ System
  • 14. The AutoloGel System – Restore the Balance
    • AutoloGel harnesses the natural healing process
      • The patients’ own blood derived growth factors, cytokines and chemokines delivered as a proprietary formulation directly to the prepared wound bed
      • Re-establishes the natural, balanced environment in the wound
      • Restored balance allows non healing, chronic wounds to become healthy and capable of self healing
  • 15. The AutoloGel System – Restore the Balance
    • AutoloGel provides essential nutrients and proteins to the wound
      • Plasma derived fibrin and fibronectin scaffolding
      • Platelet releasate gel containing growth factors, cytokines and chemokines
      • Proprietary formulation targeting improved collagen synthesis and removal of damaging free radicals
      • MMP inhibitors found in plasma that inhibit destructive protease activity
      • Serum albumin to block the spread of neutrophils and free radicals
      • A moist wound environment
  • 16. Re established balance to Wound Bed Reprinted by permission from Macmillan Publishers Ltd.©2007
  • 17. The AutoloGel System – Restore the Balance
    • AutoloGel is designed to optimize cellular response
      • Physiologically relevant formulation
      • Optimal, non concentrated, platelet concentration
      • Formulation enhancements to manage inflammatory response
      • Designed specifically for the chronic wound management setting
      • Documented clinical success in chronic wounds 1
    1 Driver VR, Hanft J, Fylling C, Beriou JM. A Prospective Randomized Controlled Trial of Autologous PRP Gel for the Treatment of Diabetic Ulcers. Ostomy & Wound Management . Jun 2006; 52(6):68-87.
  • 18. The Evidence
  • 19.
    • %
    • Healed
    Beta-Thromboglobulin Dose Ranging Wound Healing Correlation Study n=151 p<0.01 n=149 p<0.001 n=66 p<0.001 n=133 p<0.001 n=148 p<0.001 n=81 Beta Thromboglobulin (Mean ng/ml) All Wound Volumes Source: Data on File, Cytomedix. Inc. BTG predicts natural response mechanisms for wound healing; displays an optimal range for platelet concentration for balancing the wound bed
  • 20. AutoloGel System™ Randomized Controlled Trial in Diabetic Foot Ulcer Source: Driver VR, Hanft J, Fylling C, Beriou JM. A Prospective Randomized Controlled Trial of Autologous PRP Gel for the Treatment of Diabetic Ulcers. Ostomy & Wound Management . Jun 2006; 52(6):68-87. Majority Wounds n= 35 ≤ 7 cm 2 in Area and ≤ 2 cm 3 in Volume 81.3% Healed 42.1% Healed p = 0.0364 Number Wounds Significantly more healing (81.3%) with AutoloGel™ Mean time to healing was 6 weeks with AutoloGel™
  • 21. Economic Analysis of Wound Therapies
    • Cost effectiveness sensitivity analysis using published data on different wound therapies.
      • Findings shows AutoloGel System™ to cost less and have better quality of Life adjusted years over saline gel, standard wound care, tissue engineered grafts, ultrasound devices; single growth factor or NPWT
      • Analysis used published peer reviewed clinical outcomes to establish predictors for unbiased computer model.
      • Analyzed 200,000 patient experiences
      • Long term outlook of 5 year impact is more reflective of true cost of wound management to the US healthcare system
    A cost effective alternative for the management of hard to heal wounds Fylling C, Dougherty E. Evidence Based Cost Effectiveness of Platelet Rich Plasma (PRP) Gel versus Alternative Therapies for the Treatment of Diabetic Foot Ulcers. Poster and Oral Presentations. Clinical Symposium on Advances in Skin & Wound Care October 26-30, 2008
  • 22. Sensitivity Analysis: AutoloGel vs Alternative Therapies Costs over 5 Years (2006 USD) Fylling C, Dougherty E. Evidence Based Cost Effectiveness of Platelet Rich Plasma (PRP) Gel versus Alternative Therapies for the Treatment of Diabetic Foot Ulcers. Poster and Oral Presentations. Clinical Symposium on Advances in Skin & Wound Care October 26-30, 2008
  • 23. Sensitivity Analysis: AutoloGel vs Alternative Therapies QALY over 5 Years (Quality – Adjusted Life Years) Fylling C, Dougherty E. Evidence Based Cost Effectiveness of Platelet Rich Plasma (PRP) Gel versus Alternative Therapies for the Treatment of Diabetic Foot Ulcers. Poster and Oral Presentations. Clinical Symposium on Advances in Skin & Wound Care October 26-30, 2008
  • 24. The AutoloGel System
  • 25. The AutoloGel System – For Chronic Wounds
    • Indicated for use in exuding wounds such as leg ulcers, pressure ulcers and diabetic ulcers and for the management of mechanically or surgically debrided wounds .
    • FDA 510k clearance 9/2007
    The only PRP system designed for use in chronic wounds
  • 26.
    • 1. Phlebotomy
      • Small volume blood draw from
      • patient the day of application
    • 2. Separation
    • Blood centrifugation separates red blood
    • cells from the platelet rich plasma (PRP)
    • 3. Processing
    • PRP is processed and easily activated at the point of care using the Wound Dressing & Reagent Kits
    • 4. Application
    • Gel is applied topically in a thin contact layer to the wound bed and covered with a thin film and secondary dressing of choice
    The AutoloGel System – A Simple Procedure
  • 27. AutoloGel™ System – Platelet Rich Plasma Gel
    • AutoloGel ™ texture and consistency can vary due to patients blood chemistries
    • AutoloGel™ application flexibility for clinician convenience
      • Directly from the syringe,
      • Using the the blunt needle for deep crevices, tunneling undermining
      • Using provided veil * as an application tool
      • Using gloved hand to insure good contact with the wound surface
      • * (N-Terface™ – non woven, adherent or absorptive)
  • 28. The AutoloGel ™ System - Dressing Change N-Terface ™ Primary Dressing Secondary Dressing
    • AutoloGel™ may be used up to twice a week for eight (8) weeks
    • The practitioner may elect to continue for up to twelve (12) weeks
    • AutoloGel System™ should be used in conjunction with standard of care
    • for comprehensive wound management
    • AutoloGel™ primary dressing should not be changed for 24-48 hours to allow
    • absorption. Carefully irrigate to prevent disturbing new granulation
    • The secondary dressing may be changed as needed.
  • 29. The Experience
  • 30. Patient Experience with AutoloGel System
    • Abdominal Surgical Dehiscence
    • Bilateral Trochanter PU following NPWT
    • Ischial Pressure Ulcer following NPWT
    • Ischial Pressure Ulcer – Quad
    • Heel Pressure Ulcer
    • Stage IV Coccygeal Pressure Ulcer
    • BKA Contra lateral Limb in Diabetic
    • Calf Pressure Ulcer in Paraplegic
    • Abdominal Dehiscence with undermining
    • Gluteal Pressure Ulcer
    • And more types of chronic wounds
  • 31. AutoloGel Case Study Series Right Ischial Pressure Ulcer Arrows Indicate Extent of Undermining Wound Duration: 2 yrs Healed: 1 Month L = 4.7 cm W = 4.2 cm D = 2.3 cm Source: Data on File, Cytomedix, Inc.
  • 32. AutoloGel Case Study Series: Abdominal Dehiscence with Undermining Source: Data on File, Cytomedix, Inc. Patient 64 year old male Initial wound volume (cm 3 ) 212.6 Provider Ambulatory clinic Change in Volume Full closure Previous wound duration 5+ years Weeks to this volume reduction: 5 ½ Wound severity Full thickness No. of AutoloGel Treatments 6
  • 33. AutoloGel Case Study Series: Ischial Pressure Ulcer following NPWT 3 weeks of NPWT 5 weeks of AutoloGel NPWT AutoloGel Source: Data on File, Cytomedix, Inc. Patient 49 yr old paraplegic female Initial wound volume (cm 3 ) 1.75 cm 3 4.87 cm 3 Provider Home Care Change in Volume +178% Full closure Previous wound duration Weeks to this volume change 3 5 Wound severity Stage IV No. of AutoloGel Treatments 6
  • 34. AutoloGel Case Study Series: Heel Pressure Ulcer; Paraplegic w/Spina Bifda Source: Data on File, Cytomedix, Inc. Patient 27 year old male Initial wound Area/Volume Area – 6.09 cm 2 Volume – 3.04 cm 3 Provider Home care Change in Area/Volume Full closure Previous wound duration 156 weeks (3 years) Weeks to this endpoint 7.3 weeks Wound severity Stage III No. of AutoloGel™ Treatments 7
  • 35. AutoloGel Case Study Series: Stage IV Coccygeal Source: Data on File, Cytomedix, Inc. Patient 64 year old male Initial wound Area/Volume Area – 88.0 cm 2 Volume – 219 cm 3 Provider Long term care Change in Volume 99% Volume Reduction Previous wound duration > 1 year Weeks to this endpoint 10 weeks Wound severity Stage IV No. of AutoloGel™ Treatments 12
  • 36. AutoloGel Case Study Series: Bilateral Trochantric Ulcer following NPWT NPWT AutoloGel L Hip R Hip L Hip R Hip Source: Data on File, Cytomedix, Inc. Patient 76 yr old female Initial wound volume (cm 3 ) 17 cm 3 49 cm 3 3 cm 3 23 cm 3 Provider Long Term Acute Care Change in Volume 84% 54% Full closure Full closure Previous wound duration Weeks to this volume reduction 11.5 11.5 4 4 Wound severity Stage IV No. of AutoloGel Treatments 4 4
  • 37. NPWT comparison cost
    • Average weekly cost for NPWT = $500-800
    • Average length of therapy = 5 weeks
    • Cost of therapy = $2,500-$4,000
    • Average weekly cost for AutoloGel = $320-660
    • Average length of therapy = 5 weeks
    • Cost of therapy = $1,600-$3,300
    • Effective wound management PLUS savings
    • of up to 60% compared to NPWT
    Source: Data on File, Cytomedix, Inc.
  • 38. The AutoloGel System™
    • Provides plasma derived fibrin/fibronectin scaffolding to form proper clot
    • AutoloGEL is not a concentrate, but a physiologically relevant formulation of growth factors, cytokines, chemokines and other natural wound repair proteins
    • Derived from the patients own blood (autologous) to provide personalized context
    • Delivers MMP Inhibitors (TIMPs) found in Plasma to Inhibit destructive protease activity known to be elevated in chronic wounds
    • Provides Human Serum Albumin to Wound Bed Blocks Neutrophil Spreading and Release of Damaging Free Radicals present in chronic wounds
    • Supplements ascorbic acid depleted during inflammation or dietary insufficiency
      • Increased collagen gene transcription
      • Incorporation of hydroxyproline and proper collagen formation
      • Scavanges free radicals
    • Provides a Moist Wound Environment
  • 39. RESTORE THE BALANCE