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A biotechnology company focused on regenerative medicine in the areas of wound care, angiogenesis, and inflammation. Advanced Tissue Regeneration Technologies
A biotechnology company focused on regenerative medicine in the areas of wound care, angiogenesis, and inflammation. Advanced Tissue Regeneration Technologies
RESTORE THE BALANCE
The AutoloGel System™
The Science
Natural Wound Healing - A Complex Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Diegelmann R, Evans MC. Wound Healing:An Overview of Acute, Fibrotic and Delayed Healing. 2004.Frontiers in Bioscienece 9:283-289
Normal “Complex” Wound Repair Reprinted by permission from Macmillan Publishers Ltd.©2007
Wound Repair Proteins Role in Healing
Chronic Wounds – Imbalanced Environment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Ref 7 & 9 Goldman
Chronic Wound – Stuck in Inflammatory Singer AJ, Clarke RA, (1999) Cutaneous wound healing NEJM ©1999 Massachussetts Medical Society, All Rights Reserved
Chronic Wounds – Inflammatory Stage ,[object Object],[object Object],[object Object],[object Object]
Restore The Balance
The AutoloGel ™  System
The AutoloGel System – Restore the Balance ,[object Object],[object Object],[object Object],[object Object]
The AutoloGel System – Restore the Balance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Re established balance to Wound Bed Reprinted by permission from Macmillan Publishers Ltd.©2007
The AutoloGel System – Restore the Balance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],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.
The Evidence
[object Object],[object Object],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
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™
Economic Analysis of Wound Therapies ,[object Object],[object Object],[object Object],[object Object],[object Object],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
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
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
The AutoloGel System
The AutoloGel System – For Chronic Wounds ,[object Object],[object Object],The only PRP system designed for use in chronic wounds
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],The AutoloGel System – A Simple Procedure
AutoloGel™ System – Platelet Rich Plasma Gel   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The AutoloGel ™  System - Dressing Change N-Terface ™   Primary Dressing Secondary Dressing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The Experience
Patient Experience with AutoloGel System ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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.
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
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
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
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
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
NPWT comparison cost ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Source: Data on File, Cytomedix, Inc.
The AutoloGel System™ ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
RESTORE THE BALANCE

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AutoloGel

  • 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
  • 6.
  • 7. Normal “Complex” Wound Repair Reprinted by permission from Macmillan Publishers Ltd.©2007
  • 8. Wound Repair Proteins Role in Healing
  • 9.
  • 10. Chronic Wound – Stuck in Inflammatory Singer AJ, Clarke RA, (1999) Cutaneous wound healing NEJM ©1999 Massachussetts Medical Society, All Rights Reserved
  • 11.
  • 14.
  • 15.
  • 16. Re established balance to Wound Bed Reprinted by permission from Macmillan Publishers Ltd.©2007
  • 17.
  • 19.
  • 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.
  • 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
  • 25.
  • 26.
  • 27.
  • 28.
  • 30.
  • 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
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  • 38.