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Don’t be Sidelined by an Injury www.amniofix.com What is AmnioFix? AmnioFix is a human amniotic membrane allograft. There have been over 500,000 allografts distributed for use in various types of surgery and wound care. Other forms of amniotic membrane have been used for almost 100 years. Why AmnioFix? The use of amniotic tissue has been documented in published literature since the early 1900s. Amniotic membrane has been the subject of many scientific publications evaluating its use in: Modulation of Inflammation Reduction of Scar Tissue Formation Enhancing Healing All of the amniotic membrane tissue for AmnioFix is donated by healthy consenting mothers undergoing scheduled Caesarean sections. The amniotic membrane is the cover (membrane) surrounding the baby, and is typically discarded after the baby is born. The recovery of the membrane does not affect the baby or the delivery process. Therefore, the donation process does not share the ethical concerns associated with embryonic tissue. All tissue donors are tested for infectious diseases, similar to the testing done for blood donation. The amniotic membrane then undergoes a validated proprietary process to thoroughly cleanse and preserve the tissue, called the PURION ® Process. The steps of the PURION Process include: cleansing the tissue, drying the tissue, and sterilization. AmnioFix allografts are procured and processed in the United States according to the standards and/or regulations established by the American Association of Tissue Banks (AATB) and the United States Food and Drug Administration (FDA). Patents and patents pending see: www.mimedx.com/patents AmnioFix ® , PURION ® , and MiMedx ® are registered trademarks of MiMedx Group, Inc. AmnioFix ® is processed by MiMedx Tissue Service, LLC 1775 West Oak Commons Court NE, Marietta, GA 30062 ©2016 MiMedx Group, Inc. All Rights Reserved. www.mimedx.com AI142.001 References 1. Koob TJ, et al. Int Wound J. 2013 Oct;10(5):493-500. 2. Koob TJ, et al. J Biomed Mater Res B Appl Biomater. 2014 Aug;102(6):1353-62. 3. Koob TJ, et al. Vasc Cell. 2014 May 1;6:10. 4. Koob TJ, et al. A Primer on Amniotic Membrane Regenerative Healing. 1st ed. Grand Rapids, MI: MiMedx/Color House Graphics. 2015. 5. 21 CFR 1271.3(c) † As of January 1, 2016 Since 2006, as the premier leader in regenerative medicine, MiMedx ® has been dedicated to advancing healing through innovative biomaterial products and bioimplants. To date, over 25 clinical and scientific papers have been published in peer-reviewed journals on our PURION Processed amniotic membrane allografts. The company’s proprietary PURION Process and its multi-layer grafts are covered by over 20 issued patents, with more than 80 patents pending. PURION Processed allografts are clinically effective and more than 500,000 allografts have been distributed to date with no adverse reactions attributed to our products. Ask your Doctor How AmnioFix ® Could Help
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What is AmnioFix? Don’t be Sidelined by an InjuryAmnioFix ® Case Study: Partial Thickness Tear Patellar Tendon Origin RECALCITRANT TO: conservative treatment, anti-inflammatory

Jul 26, 2020

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Page 1: What is AmnioFix? Don’t be Sidelined by an InjuryAmnioFix ® Case Study: Partial Thickness Tear Patellar Tendon Origin RECALCITRANT TO: conservative treatment, anti-inflammatory

Don’t be Sidelined by an Injury

www.amniofix.com

What is AmnioFix?AmnioFix is a human amniotic membrane allograft. There have been over 500,000 allografts distributed for use in various types of surgery and wound care. Other forms of amniotic membrane have been used for almost 100 years.

Why AmnioFix?The use of amniotic tissue has been documented in published literature since the early 1900s. Amniotic membrane has been the subject of many scienti�c publications evaluating its use in:

• Modulation of In�ammation • Reduction of Scar Tissue Formation • Enhancing Healing

All of the amniotic membrane tissue for AmnioFix is donated by healthy consenting mothers undergoing scheduled Caesarean sections. The amniotic membrane is the cover (membrane) surrounding the baby, and is typically discarded after the baby is born. The recovery of the membrane does not affect the baby or the delivery process. Therefore, the donation process does not share the ethical concerns associated with embryonic tissue.

All tissue donors are tested for infectious diseases, similar to the testing done for blood donation. The amniotic membrane then undergoes a validated proprietary process to thoroughly cleanse and preserve the tissue, called the PURION® Process. The steps of the PURION Process include: cleansing the tissue, drying the tissue, and sterilization.

AmnioFix allografts are procured and processed in the United States according to the standards and/or regulations established by the American Association of Tissue Banks (AATB) and the United States Food and Drug Administration (FDA).

Patents and patents pending see: www.mimedx.com/patents

AmnioFix®, PURION®, and MiMedx® are registered trademarks of MiMedx Group, Inc.AmnioFix® is processed by MiMedx Tissue Service, LLC

1775 West Oak Commons Court NE, Marietta, GA 30062©2016 MiMedx Group, Inc. All Rights Reserved. www.mimedx.com AI142.001

References1. Koob TJ, et al. Int Wound J. 2013 Oct;10(5):493-500.2. Koob TJ, et al. J Biomed Mater Res B Appl Biomater. 2014 Aug;102(6):1353-62.3. Koob TJ, et al. Vasc Cell. 2014 May 1;6:10.4. Koob TJ, et al. A Primer on Amniotic Membrane Regenerative Healing. 1st ed. Grand Rapids, MI: MiMedx/Color House Graphics. 2015.5. 21 CFR 1271.3(c)† As of January 1, 2016

Since 2006, as the premier leader in regenerative medicine, MiMedx® has been dedicated to advancing healing through innovative biomaterial products and bioimplants. To date, over 25 clinical and scienti�c papers have been published in peer-reviewed journals on our PURION Processed amniotic membrane allografts. The company’s proprietary PURION Process and its multi-layer grafts are covered by over 20 issued patents, with more than 80 patents pending. PURION Processed allografts are clinically effective and more than 500,000 allografts have been distributed to date with no adverse reactions attributed to our products.†

Ask your Doctor How AmnioFix® Could Help

Page 2: What is AmnioFix? Don’t be Sidelined by an InjuryAmnioFix ® Case Study: Partial Thickness Tear Patellar Tendon Origin RECALCITRANT TO: conservative treatment, anti-inflammatory

AmnioFix modulates in�ammation, reduces scar tissue formation,

and enhances healing

You and your doctor may consider AmnioFix as an option if: You have been diagnosed with an injury resulting in in�ammation, have been using a conservative treatment such as anti-in�ammatories, physical therapy, and bracing that have not provided symptomatic relief of in�ammation, or if you want a non-steroidal option or have reached your limit of steroid injections.

Is AmnioFix right for me?

How do I prepare for a treatment? You will be scheduled for an evaluation and consultation to determine if AmnioFix is a viable treatment option for you. The entire AmnioFix treatment process is very short and is generally performed on an outpatient basis.

How do I care for my treatment site? The site might appear red and be tender to the touch. You may apply ice and elevation as needed. Initially, the procedure may cause some localized soreness and discomfort; this may last 2-3 days. If you have questions following your treatment, please consult your doctor.

What happens after my treatment? Your physician may prescribe some rehabilitation exercises or direct you to a rehabilitation facility. For AmnioFix to work optimally, it is important that you follow the physician directed post-treatment care.

Treatment information

Conservative treatments of oral or topical anti-in�ammatories and rest usually will help heal in�ammation resulting from injury. If additional treatment is needed, your doctor may recommend AmnioFix. AmnioFix contains naturally occurring growth factors for homologous use* to modulate in�ammation, reduce scar tissue formation, and enhance healing.

How can AmnioFix help my injury?

• Modulates In�ammation

• Reduces Scar Tissue Formation

• Enhances Healing

AI142.001

What are growth factors?Growth factors are powerful agents

that our bodies produce to signal cells to come to the target site, help the site to heal,

and help your own cells regenerate the damaged tissue. AmnioFix contains some of the most

important growth factors needed for healing.

Which growth factors are in AmnioFix?There have been 226 different growth factors, specialized cytokines, and enzyme inhibitors identi�ed in AmnioFix.1-4 The following are some of the most notable regulatory factors that help enhance healing:

• Transforming Growth Factor Beta (TGF-ß)

• Fibroblast Growth Factor (FGF)

• Platelet Derived Growth Factor A & B (PDGF AA & BB)

*Homologous use means the tissue performs the same basic function or functions in the recipient as in the donor.5

Page 3: What is AmnioFix? Don’t be Sidelined by an InjuryAmnioFix ® Case Study: Partial Thickness Tear Patellar Tendon Origin RECALCITRANT TO: conservative treatment, anti-inflammatory

PATIENT: 42 year-old male drummer6 months right shoulder painMRI: Supra/Infraspinatus calcific tendinitisTendon degeneration/partial tears

Case Study: Calcific Tendinitis & Partial RTC TearRECALCITRANT TO: Anti-inflammatory medsPT, acupuncture, chiropractic carePRIOR TREATMENT: 2 Levage/Aspirations Month 1, Month 3. Reduced Pain by 25%

AMNIOFIX® TREATMENT: AmnioFix® Injectable (40 mg)(1) Ultrasound guided injection Month 8 RESULTS: Soft tissue healing and reduced symptoms by >90%

MONTH 8 AMNIOFIX® INJECTION

PROGRESSION OF HEALING OVER 4 MONTHS

MONTH 1 FIRST LEVAGE/ASPIRATION

MONTH 3 SECOND LEVAGE/ASPIRATION

MONTH 8 MONTH 12

MONTH 10 FIRST FOLLOW-UP MRI

MONTH 12 SECOND FOLLOW-UP MRI

Photos Courtesy of Rahul Desai, MD; RestorePDX Sports & Spine, Portland, OR

AmnioFix

®

Patents and patents pending see: www.mimedx.com/patentsAmnioFix®, PURION®, and MiMedx® are registered trademarks of MiMedx Group, Inc. 1775 West Oak Commons Court NE, Marietta, GA 30062 ©2015 MiMedx Group, Inc. All Rights Reserved. www.mimedx.com AI122.004

• 5 year shelf life stored at ambient temperature• Over 350,000 allografts distributed to date

AmnioFix® is processed using the PURION® Process, a unique approach that provides an easy to use allograft stored at ambient conditions.

Page 4: What is AmnioFix? Don’t be Sidelined by an InjuryAmnioFix ® Case Study: Partial Thickness Tear Patellar Tendon Origin RECALCITRANT TO: conservative treatment, anti-inflammatory

PATIENT: 30 year-old male with basketball injury, worsening infrapatellar knee painMRI: After 6 months, partial thickness tear patellar tendon origin

AmnioFix

®

Case Study: Partial Thickness Tear Patellar Tendon OriginRECALCITRANT TO: conservative treatment, anti-inflammatory meds PRIOR TREATMENT: >30 sessions of PT, no prior injections

AMNIOFIX® TREATMENT: AmnioFix® Injectable (40 mg) (1) ultrasound guided injection month 6 RESULTS: >90% improvement of symptoms

ULTRASOUND GUIDED INJECTION

Patents and patents pending see: www.mimedx.com/patentsAmnioFix®, PURION®, and MiMedx® are registered trademarks of MiMedx Group, Inc. 1775 West Oak Commons Court NE, Marietta, GA 30062 ©2015 MiMedx Group, Inc. All Rights Reserved. www.mimedx.com AI123.004

AmnioFix® is processed using the PURION® Process, a unique approach that provides an easy to use allograft stored at ambient conditions.• 5 year shelf life stored at ambient temperature• Over 350,000 allografts distributed to date

MONTH 6 INITIAL MRI 5 WEEKS POST INJECTION

Photos Courtesy of Rahul Desai, MD; RestorePDX Sports & Spine, Portland, OR