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

• 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

Normal “Complex” Wound Repair

Reprinted by permission from Macmillan Publishers Ltd.©2007

Wound Repair Proteins Role in Healing

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

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

• 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.

Restore The Balance

The AutoloGel™ System

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

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

Re established balance to Wound Bed

Reprinted by permission from Macmillan Publishers Ltd.©2007

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 wounds1

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

% Healed

40

50

60

70

80

90

100

30 70 120 210 300 420

Beta-Thromboglobulin Dose RangingWound Healing Correlation Study

n=151

p<0.01n=149

p<0.001n=66

p<0.001n=133

p<0.001n=148

p<0.001n=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.

16

13

19

8

0

5

10

15

20

25

AutoloGel Control

TotalHealed

Majority Wounds n= 35≤ 7 cm2 in Area and ≤ 2 cm3 in Volume

81.3% Healed 42.1% Healed

p = 0.0364

NumberWounds

Significantly more healing (81.3%) with AutoloGel™ Mean time to healing was 6 weeks with AutoloGel™

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

21

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

$0

$10,000

$20,000

$30,000

$40,000

$50,000

AutoloGel

Std Care

Ultrasound

Graft A

Graft B

Graft C

Single GF

NPWT

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

2.50

2.55

2.60

2.65

2.70

2.75

2.80

2.85

2.90AutoloGel

Std Care

Ultrasound

Graft A

Graft B

Graft C

Single GF

NPWT

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

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

1. Phlebotomy Small volume blood draw frompatient the day of application

2. Separation Blood centrifugation separates red blood

cells from the platelet rich plasma (PRP)

3. ProcessingPRP is processed and easily activated at the point of care using the Wound Dressing & Reagent Kits

4. ApplicationGel is applied topically in a thin contact layer to the wound bed and covered with a thin film and secondary dressing of choice

26

The AutoloGel System – A Simple Procedure

AutoloGel™ System – Platelet Rich Plasma Gel

AutoloGel™ texture and consistency can vary due to patients blood chemistriesAutoloGel™ 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)

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.

The Experience

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

AutoloGel Case Study SeriesRight Ischial Pressure Ulcer

Arrows Indicate Extent of Undermining

Wound Duration: 2 yrsHealed: 1 Month

L = 4.7 cmW = 4.2 cmD = 2.3 cm

Source: Data on File, Cytomedix, Inc.

AutoloGel Case Study Series:Abdominal Dehiscence with Undermining

Patient 64 year old male

Initial wound volume (cm3)

212.6

ProviderAmbulatory

clinic Change in VolumeFull

closure

Previous wound duration

5+ years Weeks to this volume reduction:

5 ½

Wound severityFull thickness No. of AutoloGel

Treatments6

Source: Data on File, Cytomedix, Inc.

AutoloGel Case Study Series:Ischial Pressure Ulcer following NPWT

Patient 49 yr old paraplegic female

Initial wound volume(cm3)

1.75 cm3 4.87 cm3

Provider Home Care Change in Volume +178% Full closure

Previous wound duration

Weeks to this volume change

3 5

Woundseverity

Stage IV No. of AutoloGel Treatments

6

3 weeks of NPWT 5 weeks of AutoloGel

NPWT AutoloGel

Source: Data on File, Cytomedix, Inc.

AutoloGel Case Study Series:Heel Pressure Ulcer; Paraplegic w/Spina Bifda

Patient27 year old male

Initial wound Area/Volume

Area – 6.09 cm2

Volume – 3.04 cm3

Provider Home careChange in

Area/Volume Full closure

Previous wound duration

156 weeks (3 years)

Weeks to this endpoint 7.3 weeks

Woundseverity Stage III

No. of AutoloGel™ Treatments 7

Source: Data on File, Cytomedix, Inc.

AutoloGel Case Study Series:Stage IV Coccygeal

Patient64 year old male

Initial wound Area/Volume

Area – 88.0 cm2

Volume – 219 cm3

ProviderLong term care

Change in Volume99% Volume Reduction

Previous wound duration > 1 year

Weeks to this endpoint 10 weeks

Woundseverity Stage IV

No. of AutoloGel™ Treatments 12

Source: Data on File, Cytomedix, Inc.

AutoloGel Case Study Series:Bilateral Trochantric Ulcer following NPWT

Patient 76 yr old female

Initial wound volume(cm3)

17 cm3 49 cm3 3 cm3 23 cm3

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 AutoloGel L Hip R Hip L Hip R Hip

0

10

20

30

40

50

60

70

80

0 10 20 30 40 50 60 70 80 90 100 110 120

Volume-Left Hip

Volume-Right Hip

VAC – 74 Days AutoloGel – 49 Days

Vo

lum

e –cm

3

Days of Treatment

0

10

20

30

40

50

60

0 10 20 30 40 50 60 70 80 90 100 110 120

Area-Left Hip

Area-Right Hip

VAC – 74 Days AutoloGel – 49 Days

Are

a –

cm

2

Days of TreatmentSource: Data on File, Cytomedix, Inc.

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.

The AutoloGel System™1. Provides plasma derived fibrin/fibronectin scaffolding to form proper clot

2. AutoloGEL is not a concentrate, but a physiologically relevant formulation of growth factors, cytokines, chemokines and other natural wound repair proteins

3. Derived from the patients own blood (autologous) to provide personalized context

4. Delivers MMP Inhibitors (TIMPs) found in Plasma to Inhibit destructive protease activity known to be elevated in chronic wounds

5. Provides Human Serum Albumin to Wound Bed Blocks Neutrophil Spreading and Release of Damaging Free Radicals present in chronic wounds

6. Supplements ascorbic acid depleted during inflammation or dietary insufficiency – Increased collagen gene transcription– Incorporation of hydroxyproline and proper collagen formation – Scavanges free radicals

7. Provides a Moist Wound Environment

RESTORE THE BALANCE