January 2018

FORWARD LOOKING STATEMENT

This presentation includes forward-looking statements, including statements regarding the Company’s ability to achieve the milestones and financial
projections in the “3 and 1 in 20” plan, including 2020 revenues of $560 million, Adjusted EPS of $1.00, and $110 million in revenues from new pain
management products; the Company’s ability to generate in excess of $1 billion in revenues from existing and future products in 2023; the Company’s
ability to sustain 20%+ revenue growth over the long term; the Company’s ability to deliver P&L leverage and improve operating profits; the Company’s
ability to transition to a biopharmaceutical company at an accelerated pace; the Company’s continued ability to sell existing products under Section 361 of
the PHSA prior to the issuance of a BLA; the Company’s ability to expand its sales force; the timing, results, and publication of clinical studies, and the
potential safety and efficacy, and the timing and results of INDs/BLAs; the ability to obtain, and potential incremental revenues from, incremental
commercial reimbursement coverage, including coverage for DFUs and VLUs; the ability to obtain incremental benefits from GPO and IDN contracts, and
the timing of such benefits; the Company’s ability successfully to develop new products and the timing and receipt of pending and anticipated regulatory
clearances and approvals, the timing of product launches, the size of the markets for the Company’s current and future products, and the share of such
markets that the Company will be able to garner; the Company’s ability to continue to increase market share, expand the markets for its products, to
expand internationally, and the timing of such actions; the Company’s ability to grow operating room revenues, to hire additional sales representatives, to
launch additional products, to acquire synergistic companies or products, and to increase demand; and estimated future revenues, including revenues
from pain management. Forward-looking statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will," “goal,”
“target,” “market opportunity” and similar expressions, and are based on our current beliefs and expectations.

Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements.
Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual
results to differ materially from those indicated by such forward-looking statements include the risks that the Company may be unable to transition to a
biopharmaceutical company at an accelerated pace; the Company may be unable successfully to develop anticipated new products; the timing of
anticipated regulatory clearances and approvals may be delayed or denied; adverse regulatory actions against the Company; the markets for the
Company’s current and future products may not be as large as the Company projects or grow as anticipated; the Company may not be able to achieve the
market share it anticipates; the Company may face more and more effective competition; the Company may not continue to achieve significant process
improvements and efficiencies; the Company may be unable to achieve the milestones and financial projections in the “3 and 1 in 20” plan; market
demand for the Company’s products may not grow or could decline; unexpected concerns may arise from additional data or analysis from our clinical
trials; regulatory submissions may take longer or be more difficult to complete than expected; that regulatory authorities may require additional
information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated; and we may be
unable to hire the expected number of sales representatives on a timely basis. For additional risks that might affect the Company, please review the Risk
Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements
speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

2
 INVESTMENT HIGHLIGHTS

• Global Leader Delivering Innovative Placental Tissue Based Regenerative

Therapies and Therapeutic Biologics
• “3 and 1 in 20” Strategic Plan Triples 2015 Revenues to $560M and Delivers
$1.00 of Adjusted Earnings in 2020
• Opportunity to use a Product Under the 361 Regulations while Conducting an
IND Trial for BLA Indications Provides Very Unique Clinical Trial and Revenue
Benefits
• Sustain 20%+ Revenue Growth Over the Long Term
• Greater than 88% Gross Margins and Strong Balance Sheet
• Deliver P&L Leverage in 2017 and Beyond…Operating Profit Improvements
• Since May 2014, Executed $126M of a $130M Share Repurchase Program

3
 COMPANY HIGHLIGHTS

• Industry Leader in the Amniotic and Placental Tissue Market

• Five Innovative Technology Platforms
• Over 100* Issued and Allowed Patents
• Proprietary Purion Processed Placental Tissue Allografts Contains a Milieu
of 529 Proteins (Growth Factors, Chemokines and Cytokines)
• US Pharmacopeia Monograph for MiMedx Allografts with a Stipulated
Strength, Quality, and Purity
• In 2020 Will Complete the Transition to a Biopharmaceutical Company
– Existing Products Remain Regulated through Section 361 of PHSA
– New Products Regulated through Section 351 of PHSA under IND/BLA
– Pain Management, Respiratory Disease and Cardiovascular Disease are Large
Biopharmaceutical Opportunities
*owned and licensed
4
 EXPERIENCED MANAGEMENT TEAM
Parker H. “Pete” Petit William C. Taylor Michael J. Senken Alexandra O. Haden
Chairman & CEO President & COO Chief Financial Officer General Counsel
Kevin D. Lilly Deborah L. Dean Christopher M. Cashman Michael W. Carlton
Senior Vice President, Executive Vice President & Executive Vice President & Senior Vice President,
Sales Chief Compliance Officer Chief Commercialization Officer Global Sales
Scott M. Turner Mark E. Diaz Thornton A. Kuntz Marlene M. DeSimone
Senior Vice President, Senior Vice President, Senior Vice President, Senior Vice President,
Operations & Procurement Commercial Operations HR & Administration Marketing
Dr. Rebeccah Brown Dr. Donald E. Fetterolf Dr. Thomas J. Koob Dr. I. Mark Landy
Vice President, Chief Medical Officer Chief Scientific Officer Senior Vice President,
Global Regulatory Affairs Strategic Initiatives
Dr. Gloria L. Matthews
Senior Vice President,
Research and Development

5
 DELIVERING CONSISTENT SUSTAINABLE GROWTH

• 28 Consecutive Quarters of Sequential Revenue Growth

• Met or Exceeded Revenue Guidance in 27 of Last 28 Quarters
100

90

80

70

60
$’s - Millions

50

40

30

20

10

6
 MIMEDX NAMED #5 ON FORTUNE MAGAZINE'S
TOP 100 FASTEST GROWING COMPANIES OF 2017

7
 PRELIMINARY REVENUE ESTIMATES

• Fourth Quarter Preliminary Revenue

– $90.9 Million
– Grew 33% over 2016 without Stability Biologics
– Exceeded Quarterly Estimate by Almost $3 Million

• Full Year 2017 Preliminary Revenue

– $324.5 Million
– Grew 34% Over 2016 without Stability Biologics
– Exceeded Original Estimate by Approximately $20 Million

8
 SHORT SELL CAMPAIGN

9
 TRANSITION TO A
BIOPHARMACEUTICAL COMPANY
• AmnioFix Injectable (AI) is our Lead Product Candidate
 Micronized version of dHACM
 Covered by our Extensive Placental Tissue Technology Patent Family
 Contains a Milieu of 520+ Cellular Proteins
 Contains 285 Regulatory Proteins
 Includes Factors Required for Soft Tissue Homeostasis and Repair
 Address Multiple Targets with a Unified Mechanism of Action
 Proven Safety Profile
• First 4 INDs Target Musculoskeletal Pain
 Plantar Fasciitis (2)
 Achilles Tendonitis
 Osteoarthritic Knee Pain
• Positive Interim Phase 2B Data Validates AI Therapeutic Effect in Treating Soft Tissue
Pain, Restoring Function and Improving Quality of Life
• Exiting 2020 Biopharmaceutical Sales Approximately 20% of Total Revenue per “3 and 1
in 20” Plan
• Pain Revenues Expected to Significantly Expand when BLA Indications Approved in
2020/2021 (estimated timeframe)
10
 AMNIOTIC MEMBRANE:
MASTER REGULATOR OF BIOLOGY

• Hundreds of Growth Factors and Peptides Associated with Tissue

Generation4
• Immunologically Privileged3 - Highly Biocompatible

Key Actions:
• Modulates (reset) Inflammation2
• Regulates Cell Migration, Proliferation, and Metabolism
• Promotes Angiogenesis and Stem Cell Recruitment
• Reduces Scar Tissue Formation2
• Offers Barrier Properties1
• Enhances Healing5

1 Koob TJ, Rennert R, Zabek N, et al. Int Wound J. 2013 Oct;10(5):493-500. 2 Hao Y, Ma DH, Hwang DG, Kim WS, Zhang F. Cornea. 2000 May;19(3):348-52. 3 Tseng SC, Li DQ, Ma X. J
Cell Physiol. 1999 Jun;179(3):325-35. 4 Tao H, Fan H. Eur Spine J. 2009 Aug; 18(8):1202-12. 5Zelen CM, Serena TE, Denozière G, Fetterolf DE. Int Wound J. 2013 Oct;10(5):502-7.

11
AMNIOTIC MEMBRANE GROWTH FACTOR PROTEOME
- PURION PROCESSED PLACENTAL TISSUES
Vast and Complex Array of Endogenous Bioactive Factors

529 Cellular Proteins

Fibroblast
Growth
Factor

Regulatory Proteins 285 Membrane-Bound Proteins 244

Growth Factors 179 Surface Antigens/Enzymes 61
Immunomodulators 67 Adhesion Receptors 47
Chemokines 39 Signaling Receptors 136

Repair and Regeneration Cell and Tissue Function

Proliferation, Migration, Gene Expression

12
 PLACENTAL TISSUE PRODUCT PORTFOLIO

Sheet dHACM: Micronized dHACM:

Flagship bioactive Amnion/ Same dHACM in an injectable
Chorion grafts containing over 520 configuration
proteins and growth factors with • Smaller wounds
proven enhanced healing power • Various surgical applications
• Smaller wounds • Tendonitis and Osteoarthritis*
• Various surgical applications
• As a barrier membrane
dHACM Core Technology Equivalent

Umbilical Cord Products: Placental Based:

Provide a protective environment Our NEW placental tissue product contains
for the healing process. Growth Factors found in PURION® Processed
• Smaller wounds requiring a tissues and replaces or supplements damaged or
graft that can hold a stitch inadequate integumental tissue to provide a
• Longer site coverage timeframe scaffold for cells to attach and proliferate.
• When a thicker graft is needed • Larger and uneven surface areas >25cm2
for coverage/ padding • NOT injectable

* Conducting IND/BLA program for Plantar Fasciitis, Achilles Tendonitis and Osteoarthritic Knee Pain
13
 5-YEAR STRATEGIC PLAN: “3 AND 1 IN 20”

In 2020: Triple 2015 Revenue, Deliver $1.00 of Adjusted EPS

and Complete Transition to a Biopharmaceutical Company

2020 Assumptions
Organic Rev Growth
*EBITDA 30%

$187M $560M

Wound Care Operating Room Pain Management

* Adjusted
14
 LINE OF SIGHT TO FIRST BILLION DOLLARS
Total Company Revenue ($millions)
OF REVENUE IN 2023

Existing Business
Plus 3 BLA
Indications In
Current IND Trials
has the Potential
to Generate in
Excess of a Billion
“3 and 1 in 20”
Dollars of
Revenue
Revenue in 2023
Guidance
Preliminary 2017 $560M
Revenue
$324.5M

2017 2020 2021 2022 2023

“3 and 1 in 20” Revenue Forecast Polynomial Trend Line 2017 to 2023
Management Estimates

15
 2018 GROWTH DRIVERS

• Continued Expansion of Educational Programs

• New Product Focuses: EpiCord/AmnioCord, and AmnioFill
• Continued Sales Force Expansion
• Incremental Commercial Reimbursement Coverage for:
 DFU, VLU and General Advanced Wound Care Conditions
 AmnioFix Injectable Pain Applications Additional to Cash Pay Market
• Clinical Trial Results and Publications
• Continued Leverage of GPO/IDN Contracts
 5 Group Purchasing Organizations (GPO) contracts in place
- 4 have 80% or sole commitment tiers for Amniotic Tissue/Skin Substitute
- Covers approximately 4,000 hospitals
 40 Integrated Delivery Networks (IDN) Contracts
- Covers approximately 1,300 hospitals
- Many have committed Amniotic Tissue Contracts

16
 5-YEAR STRATEGIC PLAN: “3 AND 1 IN 20”
In 2020: Triple 2015 Revenue, Deliver $1.00 of Adjusted EPS
and Complete Transition to a Biopharmaceutical Company

Revenue Mix 2020 Assumptions

Organic Rev Growth
2020 *EBITDA 30%

$560M
Pain Management
$110M

* Adjusted Wound Care Operating Room Pain Management

17
 2015 U.S. JOINT PAIN INJECTION MARKET

>$4 Billion Peak Revenue at 35% Penetration

SmartTRAK Business Intelligence and Company Estimates – Market Opportunity: 80% of total injections are for tendonitis and osteoarthritic pain

18
 AMNIOFIX IS THE SOLUTION TO OSTEOARTHRITIS
KNEE/SOFT TISSUE TENDONITIS PAIN

• AmnioFix Should be Considered as a REGENERATIVE Option Prior to

Degenerative Steroids and Prescription of Opioids
• AmnioFix has Shown Promise for Longer-Term Relief, Disease Modification
and Potential Resolution
• AmnioFix does not Carry Additional Side Effects
• CDC Guidelines Encouraging Providers to Seek Other Options for Treating
Pain
 Opioids are not First-Line or Routine Therapy for Chronic Pain
 Establish and Measure Goals for Pain and Function
 Discuss Benefits, Risks and Availability of Non-Opioid Therapies with
Patient

https://www.cdc.gov/drugoverdose/pdf/Guidelines_Factsheet-a.pdf

19
 WOUND CARE GROWTH TARGET: 5YR 20% CAGR

Wound Care Growth Drivers

1. Continue To Take Market Share
• Expand Scientific and Clinical Body of Evidence
• Increase Lives Under Coverage Due to New VLU Coverage
• Leverage Safety Advantage of Terminal Sterilization
• Broaden Reach In IDN / GPO Contracts
• New Products Adoption
• New Settings, Long-term Care (LTAC)
2. Expand The Market
• Secondary City Expansion
• Convert Physicians that do not
use AWC Products
• Influence and Improve Referral
Patterns
Wound Care Operating Room Pain Management
3. International Expansion

20
 U.S. WOUND BIOLOGICS MARKET IN 2020

2020 Skin/Dermal Substitute (SDS) Segment Sales Estimate $1.1B

2020 Amniotic Tissue Share Estimate 58% vs. 29% in 2014
2016 SDS Sales Estimate $681M up 16% vs. 2015
2016 MiMedx Amniotic Tissue Share 63%

10%
21% 18%

39%
2015 SDS Segment 2016 SDS Segment 45% 2020 SDS Segment
27%

$587M $681M $1.1B 58%

32%
34% 5%
6%
6%

Amniotic Tissue Allografts Xenografts Cell-Based Bioengineering

SmartTRAK Business Intelligence and
Company Estimates
21
 CHRONIC WOUND MARKET IS UNDERPENETRATED

1.4M Chronic DFU/VLU Wounds - $3B Mkt Opportunity Alone

2015
2016 U.S. Market Facts 6.5M US Patients have
• Annual Cost of Treating Chronic Wounds Chronic Wounds
in the U.S. is $25 Billion
• Skin/Dermal Substitutes is the Largest
Segment at $681 Million 3M are non-
 MiMedx is the Market Leader at 31% healing wounds
• Sales of Placenta Derived / Amniotic Tissue
Products Grew 33% to $305M
 MiMedx is the Market Share Leader at 63%
Under 200K are Treated with
a Skin or Dermal Substitute

SmartTRAK Business Intelligence

22
 EPIFIX VLU MULTICENTER TRIAL
FINAL ANALYSIS
VLU: EpiFix vs. Control % Subjects Complete Wound VLU: Apligraf vs. Control % Subjects Complete
Closure Wound Closure
100% 100%

90% 90%

80% 80%
71%
70% 70%
60%
60% 60% 57%

50% 44% 50%

40%
40% 35% 40% 37%
35%
29%
30% 30% 24%
17% 19% 19%
20% 20%

7% 9%
10% 10% 5%

0% 0%
Week 4 Week 8 Week 12 Week 16 Week 4 Week 8 Week 12 Week 24

EpiFix (N=52) Control (N=57) Apligraf (N=130) Control (N=110)

Please note: Apligraf and EpiFix studies are

The MiMedx Control was More
Efficacious than the Apligraf Control
Controls: Multi-Layer
Compression Therapy with EpiFix
– NuDerm Alginate Apligraf –
Moist Gauze with Zinc Paste
independent of one another
Apligraf Reference: PMA Supplement (P950032)
approval dated 05/22/1998
EpiFix Reference: Published Final Data Report,
Reported Press Release 08/31/2017

23
 OPERATING ROOM GROWTH TARGET: 5YR 20% CAGR

Operating Room Growth Drivers

1. Increase Footprint
• Continue to Hire Direct Surgical Reps
• Deeper Penetration of GPO and IDN
Contracts

2. Expand Product Line

• Product Focuses: AmnioFix, AmnioFix
Injectable, AmnioFill, AmnioCord
• Synergistic Acquisitions

3. Grow Demand
• Publish Clinical Trials Showing
Improved Surgical Outcomes and
Reduced Complications Wound Care Operating Room Pain Management
• Increase Number of VAC Approvals

24
 TARGET HIGH VALUE SURGICAL PROCEDURES

Number of Procedures (000) Addressable Market Value ($M)

4.3M $5.7B

ORTHOPEDICS
Spine, Trauma, Extremities , 2,821
1,528 Sports Medicine

GYN
Hysterectomy, Endometriosis,
$2.9B
1,154 Myomectomy, C-Section, Episiotomy 1,000

PLASTICS
Hand-Tendon and Nerves, Mohs,
652 Scar Revision, Skin Grafting, Surgical 990
Dehiscence, Breast Recon, Burn
GENERAL COLORECTAL
Bariatric, Fistula Repair,
714 GI Anastomosis 714
UROLOGY
Prostatectomy, Partial Nephrectomy,
237 Cystectomy 200

Source: Millenium Research Group, MRG Lap 2014, ASPS Statistics, MiMedx 2015 Annual Plan, MiMedx internal coding data, Management Estimates
25
 PAIN MANAGEMENT CLINICAL PROGRAMS

2018-2021: Management’s Estimation

26
 PLANTAR FASCIITIS:
REPORTED INTERIM PHASE 2B DATA
• Primary Efficacy Endpoint, Pain Relief at 3 Months: AmnioFix Injectable Demonstrated
Clinically Meaningful and Statistically Significant Separation from Placebo (p-value = 0.0001)
• Statistically Significant Results Were Seen at 6 Months (p-value = 0.0005)
• Average Reduction in Pain from Baseline at 3 Months was 77.5% vs. 45.7% for Placebo
• Average Reduction in Pain from Baseline at 6 Months was 85.9% vs. 57.1% for Placebo
• Phase 3 Study Initiating Shortly
0%
At 3 Months Subjects in the Placebo
-10% Group Were Allowed to Undergo
Alternative Therapy
-20%
Percent Reduction from Baseline

-30%

-40%

-50%

-60%

-70%

-80%

-90%

-100%
Baseline 1 Month 2 Months 3 Months 6 Months

AmnioFix Saline
27
 OSTEOARTHRITIS (OA) IS A BOOMING EPIDEMIC

• OA Affects an Estimated 31M Americans

– It is the Most Common form of Arthritis and the Leading Cause of
Disability in American Adults
– Prevalence Increases with Age, Ranging from about 2% Among
Persons under 45 to More Than 80% Among Those Over 75
• 14M Americans Suffer Symptomatic Knee OA
– Affects More Than 2M People Under the Age of 45 and More
Than 6M People Between the Ages of 45 and 64
• Knee OA Contributes More Than $27 Billion in U.S Health Care
Expenditures Annually
• As the World’s Population Ages, it is Estimated that Degenerative
Joint Disease will Impact Over 130M Individuals Globally by 2050

Source: Arthritis Foundation

28
 OPIOID ABUSE AND ECONOMIC BURDEN
ARE OUT OF CONTROL
Cost Burden of Treating Knee OA is Exploding Opioid Abuse Is a National Issue

• Primary TKA – $20,000

• Revision TKA – $25,000
• 2012 US TKA cost burden exceeded $11B
• 2030 Medicare TJA burden is estimated
to exceed $50 billion*
* Wilson NA, Schneller ES, Montgomery K, Bozic KJ. Hip and knee implants:
current trends and policy considerations. Health Aff (Millwood) 2008;27:1587–
98. doi: 10.1377/hlthaff.27.6.1587.

29
 AMNIOFIX INJECTABLE ADDRESSES
ALL STAGES OF KNEE OA

30
ENCOURAGING OSTEOARTHRITIS ATTENUATION DATA

Arthritis Research & Therapy

Hypothesis: ųdHACM is a Disease Modifying
Intervention in a Rat Model of Osteoarthritis

• OA was Induced in Rats Through Medial

Meniscal Transection Surgery

• 24-Hours Post Surgery ųdHACM or Saline was

Intra-Articularly Injected into the Joint

• Microstructural Changes in Cartilage were

Assessed 21-Days Post Surgery

31
 AMNIOFIX INJECTABLE MUSCULOSKELETAL
DEGENERATION TOTAL APPLICABLE MARKET

32,500
32.5

30,000
30.0

27,500
27.5

25,000
25.0
Total Applicable Market ($billions)

22,500
22.5

20,000
20.0

17,500
17.5

15,000
15.0

12,500
12.5

10.0
10,000

7,500
7.5

5,000
5.0

2,500
2.5

-
2017 2020 2021 2022 2023

Out of Pocket Plantar Fasciitis BLA Tendonitis BLA OA Pain BLA DMKOAD

Management Estimates
32
 LINE OF SIGHT TO FIRST BILLION DOLLARS
Total Company Revenue ($millions)
OF REVENUE IN 2023

Existing Business
Plus 3 BLA
Indications In
Current IND Trials
has the Potential
to Generate in
Excess of a Billion
“3 and 1 in 20”
Dollars of
Revenue
Revenue in 2023
Guidance
Preliminary 2017 $560M
Revenue
$324.5M

2017 2020 2021 2022 2023

“3 and 1 in 20” Revenue Forecast Polynomial Trend Line 2017 to 2023
Management Estimates

33
 KEY 2018 MILESTONES

• Initiate Pivotal BLA Phase 3 Plantar Fasciitis Trial

• Initiate Pivotal BLA Phase 3 Achilles Tendonitis Trial
• Initiate BLA Phase 2B Osteoarthritis Knee Pain Trial
• Report DFU Multicenter Data
• Publish GI Anastomosis Data
• First Patent Infringement Trial
• Additional “Reimbursement Wins”

34
 PRELIMINARY FINANCIAL HIGHLIGHTS

• Q4 2017 • Year 2017

– Wound Care Revenue – Wound Care Revenue
• $66.9M • $238.3M
• 27% growth • 30% growth
– SSO Revenue – SSO Revenue
• $24.0M • $86.2M
• 40% growth • 41% growth

• 2017 Q4 Other Results • 2018 Guidance

– Record Cash Collections – Q1 $90.5 - $92.0M
– Strong Cash Flow from Operations – Year $383.0 - $387.0M
– DSO’s in Line with Prior QTR
– Share Repurchase Program Extended
and Authorized Amount Increased
– Zero Debt on Balance Sheet

35
 REFERENCES

1. http://www.apligraf.com/professional/pdf/FDAApprovalLetter.pdf
2. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p000036
3. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480564.htm
4. http://www.prnewswire.com/news-releases/derma-sciences-expands-access-of-its-amniotic-tissue-product-line-with-new-premier-inc-agreement-
300024252.html
5. http://www.accessdata.fda.gov/cdrh_docs/pdf8/k083440.pdf
6. http://ir.alliqua.com/press-releases/detail/544/alliqua-to-launch-biovancer-human-amniotic-membrane
7. http://investor.osiris.com/annuals-proxies.cfm; 2011.
8. www.clinicaltrials.gov. Accessed 03/01/17.
9. Zelen CM, Serena TE, Denozière G, Fetterolf DE. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of
diabetic foot ulcers. Int Wound J. 2013 Oct;10(5):502-7.
10. Zelen CM, Serena TE, Snyder RJ. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion
membrane allograft in the management of diabetic foot ulcers. Int Wound J. 2014 Apr;11(2):122-8.
11. Zelen CM, Gould L, Serena TE, Carter MJ, Keller J, Li WW. A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using
dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic
ulcers. Int Wound J. 2015 Dec;12(6):724-32.
12. Zelen CM, Serena TE, Gould L, Le L, Carter MJ, Keller J, Li WW. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective,
randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. Int Wound J. 2016 Apr;13(2):272-82.
13. Veves A, Falanga V, Armstrong DG, Sabolinski ML. “Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot
ulcers: a prospective randomized multicenter clinical trial.” Diabetes Care. (24)2. 2001. pp 290-5.
14. Marston W, Hanft J, Norwood P, Pollak R. “The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers.” Diabetes Care, Vol 26
#6, June 2000.
15. Driver, V. R., Lavery, L. A., Reyzelman, A. M., Dutra, T. G., Dove, C. R., Kotsis, S. V., Kim, H. M. and Chung, K. C. (2015), A clinical trial of Integra Template for
diabetic foot ulcer treatment. Wound Rep and Reg, 23: 891–900. doi:10.1111/wrr.12357.
16. Snyder RJ, Shimozaki K, Tallis A, Kerzner M, Reyzelman A, Lintzeris D, Bell D, Rutan RL, Rosenblum B A Prospective, Randomized, Multicenter, Controlled
Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds. 2016
Mar;28(3):70-7.
17. Kavros, S; Dutra, T; Gonzalez-Cruz, R; Liden, B; Marcus, B; McGuire, J; Nazario-Guirau, L. The Use of PriMatrix, a Fetal Bovine Acellular Dermal Matrix, in Healing
Chronic Diabetic Foot Ulcers: A Prospective Multicenter Study. Advances in Skin & Wound Care: August 2014 - Volume 27 - Issue 8 - p 356–362. doi:
10.1097/01.ASW.0000451891.87020.69.
18. Lavery A, et al. “The efficacy and safety of Grafix for treatment of chronic diabetes foot ulcers: results of a multi-centre, controlled, randomized, blinded, clinical
trial.” Int Wound J 2014; doi: 10.1111/iwj.12329.
19. Public domain

37
 SDS COMPETITIVE PRODUCT COMPARISON

Apligraf and Dermagraft are registered trademarks of Organogenesis, Inc.

Omnigraft and PriMatrix are registered trademarks of Integra Life Sciences Corporation. AMNIOEXCEL is registered trademark of BioD, LLC, an Integra Life Sciences company.
BIOVANCE is a registered trademark of Alliqua Biomedical, Inc.
Grafix is registered trademark of Osiris Therapeutics, Inc.
References provided at end of presentation.
38
 A SAFER MORE EFFECTIVE PRODUCT IS NEEDED

*
*

* **

*
*
*
**

* Toxic side effects and limited efficacy ** Limited efficacy

39
 OSTEOARTHRITIS PHASE 2B STUDY OUTLINE

A Prospective, Double-Blinded, Randomized Controlled Trial of Micronized

dHACM Injection Compared to Saline Placebo Injection in the Treatment of Osteoarthritis
PURPOSE • To Determine Whether AmnioFix Injectable (mDHACM) is Effective
in the Treatment of Osteoarthritis

DESIGN • Randomized, Multi-Center, Double-Blinded (Patient and Reviewer)

• 318 Patients with Osteoarthritis (Diagnosis of Osteoarthritis (OA) Defined
as Grade 1 to 3 on the Kellgren-Lawrence Grading Scale, VAS > 45)
• 2-Arm Unilateral Treatment with:
– n=159: Placebo (1 ml Normal Saline)
– n=159: AmnioFix Injectable (1ml of 40 mg AI)

PRIMARY • Mean Change in VAS Score Between Baseline and 3 Months

• Mean Change in WOMAC 3.1 Score (Pain, Stiffness and Physical Function)
• Incidence of Adverse Events at 12 Months

SECONDARY • Mean Change in Functional Score as Measured by KOOS at 3 Months

• Long Term KOOS and VAS at 12 Months
* Including any of the following modalities: RICE, Steroid Injection, Stretching, NSAID, Orthotics
40
 PLANTAR FASCIITIS PHASE 2B STUDY OUTLINE

A Prospective, Single-Blinded, Randomized Controlled Trial of Micronized

dHACM Injection Compared to Saline Placebo Injection in the Treatment of PF

PURPOSE • To Determine Whether AmnioFix Injectable (mDHACM) is Effective in the Treatment

of Recalcitrant Plantar Fasciitis

Randomized, Multi-Center, Single-Blind (Patient)

DESIGN •
• 147 Patients with Recalcitrant PF (Confirmed Diagnosis >1 Month and < 18 Months,
VAS > 45, Conservative Usual Care > 1 Month*)
• 2-Arm Unilateral Treatment with:
– n=73: Placebo (1 ml Normal Saline)
– n=74: AmnioFix Injectable (1ml of 40 mg AI)

PRIMARY • Mean Change in VAS Score Between Baseline and 3 Months

• Incidence of Adverse Events at 12 Months

SECONDARY • Mean Change in Functional Score as Measured by FFI-R at 3 Months

• Immuno-Compatibility of First 20 Patients Followed in Each Arm at 3 and 12 Months
• Long Term FFI-R, VAS at 6 and 12 Months
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* Including any of the following modalities: RICE, Steroid Injection, Stretching, NSAID, Orthotics
 PLANTAR FASCIITIS PHASE 3 STUDY OUTLINE

A Prospective, Double-Blinded, Randomized Controlled Trial of Micronized

dHACM Injection Compared to Saline Placebo Injection in the Treatment of PF

PURPOSE • To Determine Whether AmnioFix Injectable (mDHACM) is Effective in

the Treatment of Recalcitrant Plantar Fasciitis

• Randomized, Multi-Center, Double-Blinded (Patient and Reviewer)

DESIGN
• 164 Patients with Recalcitrant PF (Confirmed Diagnosis >1 Month and
< 18 Months, VAS > 45, Conservative Usual Care > 1 Month*)
• 2-Arm Unilateral Treatment with:
– n=82: Placebo (1 ml Normal Saline)
– n=82: AmnioFix Injectable (1ml of 40 mg AI)

PRIMARY • Mean Change in VAS Score Between Baseline and 3 Months

• Incidence of Adverse Events at 6 Months

SECONDARY • Mean Change in Functional Score as Measured by FFI-R at 3 Months

• Long Term FFI-R and VAS at 6 Months

* Including any of the following modalities: RICE, Steroid Injection, Stretching, NSAID, Orthotics
42
 ACHILLES TENDONITIS PHASE 3 STUDY OUTLINE

A Prospective, Double-Blinded, Randomized Controlled Trial of Micronized

dHACM Injection Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis

PURPOSE • To Determine Whether AmnioFix Injectable (mDHACM) is Effective in the

Treatment of Achilles Tendonitis

DESIGN • Randomized, Multi-Center, Double-Blinded (Patient and Reviewer)

• 158 patients with Achilles Tendonitis (Confirmed Diagnosis >1 Month and <
18 Months, VAS > 45, Conservative Usual Care > 1 Month*)
• 2-Arm Unilateral Treatment with:
– n=79: Placebo (1 ml Normal Saline)
– n=79: AmnioFix Injectable (1ml of 40 mg AI)

PRIMARY • Mean Change in VAS Score Between Baseline and 3 Months

• Incidence of Adverse Events at 6 Months

SECONDARY • Mean Change in Functional Score as Measured by FFI-R at 3 Months

• Long Term FFI-R and VAS at 6 Months
* Including any of the following modalities: RICE, Steroid Injection, Stretching, NSAID, Orthotics
43