The PURION® Process

 

Human amniotic membrane allografts have been used for a variety of reconstructive surgical procedures since the early 1900s. The use of the amniotic membrane as an allograft has accelerated due to the development of the PURION® Process, which among other things allows the tissue to be dehydrated and sterilized.

The proprietary PURION® Process safely and gently separates placental tissues, cleans and reassembles layers, and then dehydrates the tissue to preserve the key elements associated with healing. The PURION® Process removes blood components while protecting the delicate scaffold of the amniotic membrane, leaving an intact extracellular matrix. The result is a durable graft with natural barrier properties that offers clinicians a clear advantage in soft tissue applications. PURION® processed dehydrated human amnion/chorion allografts can be stored at ambient conditions for up to five years.

The proprietary process has been specifically designed to deliver a clinically effective and minimally manipulated allograft tissue. All placental tissues are recovered under sterile conditions from patients who have been screened for underlying infectious disease. No chemicals are used in the PURION® Process that might result in chemical cross-linking or decellularization.

For more information, please refer to package insert.


Amniotic Membrane Description

 

Human amniotic membrane is comprised of the innermost layer of the placenta and lines the amniotic cavity. The membrane is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. The tissues of the placenta present a very complex interrelationship of materials that possess numerous physiologic characteristics, that can in turn change in importance with the appropriate stage of gestation.  During pregnancy, the placenta permits the passage of nutrients, metabolites and metabolic gases, and provides physical and immunological protection to the developing fetus.  In addition, it produces a variety of steroids and important metabolic hormones.8

Amniotic membrane is a unique material and its composition contains collagen types I, III, IV, V, and VII.  Amniotic membrane is composed of structural extracellular matrix (ECM), that also contains specialized proteins fibronectin, laminins, proteoglycans and glycosaminoglycans. In addition, amniotic membrane contains essential, active, healing growth factors such as epidermal growth factor (EGF), transforming growth factor beta (TGF-b), fibroblast growth factor (FGF), and platelet derived growth factor (PDGF).8 Amniotic tissues have shown little to no HLA-A, B, C antigens and β2 microglobulin.3

amniotic membrane

 

References:

 

  1. Niknejad H; Peirovi H; Jorjani M; Ahmadiani A; Ghanavi J; Seifalian AM "Properties of the amniotic  membrane for potential use in tissue engineering." Eur Cell Mater. (15). 01-JAN-2008. pp 88 - 99.
  2. Rahman I; Said DG; Maharajan VS; Dua HS "Amniotic membrane in ophthalmology: indications and  limitations." Eye. (23)10. 2009. pp 1954–1961.
  3. Baradaran-Rafii A; Aghayan H; Arjmand B; and Javadi M. "Amniotic Membrane Transplantation." Iran J Ophthalmic Res. (2)1. 2007. pp 58-75.
  4. John, T. "Human amniotic membrane transplantation: Past, present, and future.." Ophthal Clin N Am. (16). 2003. pp 43-65.
  5. Adly OA; Moghazy AM; Abbas AH; Ellabban AM; Ali OS; Mohamed BA "Assessment of amniotic and polyurethane membrane dressings in the treatment of burns." Burns - 01-AUG-2010; 36(5): 703-10.
  6. Huiren Tao & Hongbin Fan "Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions." Eur Spine J - 01-AUG-2009; 18(8): 1202-12. (). 2009.
  7. Arora R; Mehta D; Jain V "Amniotic membrane transplantation in acute chemical burns." Eye (Lond). (19)3. 01-MAR-2005. pp 273-8. 
  8. Kay H; Nelson D; Wang Y. “The Placenta: From Development to Disease.” Wiley-Blackwell. 2011.

 

AmnioFIX-logo

AmnioFix® Product Overview
AmnioFix

AmnioFix® is a composite amniotic tissue membrane minimally manipulated to protect the collagen matrix and its natural properties. AmnioFix® reduces scar tissue formation, modulates inflammation in the surgical site, enhances healing, and acts as a barrier.

Human amniotic membrane comprises the innermost layer of the placenta and lines the amniotic cavity. AmnioFix® is processed through the proprietary PURION® Process that combines cleaning, dehydration and sterilization, and it may be stored at ambient conditions for up to 5 years. The proprietary PURION® Process protects the delicate scaffold during processing, leaving an intact collagen matrix. The result is a durable graft with natural barrier properties to optimize surgical performance and ease of use. AmnioFix® is available in sheet/membrane, particulate, and wrap configurations for use in surgical, soft tissue, tendon, and nerve applications. 

 

Sheet/Membrane

ITEM NUMBER SIZE & DESCRIPTION
APS-5160 16 mm disk sheet
APS-5230 2 cm x 3 cm sheet
APS-5212 2 cm x 12 cm sheet
AAS-5330 3 cm x 3 cm sheet
APS-5440 4 cm x 4 cm sheet
AAS-5460 4 cm x 6 cm sheet

 

Wrap

ITEM NUMBER SIZE & DESCRIPTION
TN-5220 2 cm x 2 cm wrap
TN-5240 2 cm x 4 cm wrap
TN-5460 4 cm x 6 cm wrap

 

Safety/ Quality Assurance / Regulatory

 

Epifix-logo                     

EpiFix

MiMedx® Discussion of FDA's Draft Guidance on Homologous Use 
The issuance of the FDA’s Draft Guidance on Homologous Use of Human Cells, Tissues and Cellular and Tissue-Based Products released on October 28, 2015 has created a number of concerns, particularly as it relates to amniotic tissue and MiMedx. MiMedx issued a press release on October 29 responding to some of the concerns that had developed around this complex subject. However, the Company believes that additional commentary and documentation of this regulatory area is appropriate. Therefore, MiMedx has developed these discussion points related to these particular FDA regulations. In addition, the Company has included the information and facts that support our assertion that we are in compliance with the HCT/P, 21 CFR 1271 Regulations on Homologous Use. We have outlined the information herein, and created links to various FDA, and other independent websites where the reader can easily verify the facts on his or her own.
 

EpiFix® Product Overview

EpiFix® is a dehydrated Human Amnion/ Chorion Membrane (dHACM) allograft and is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. EpiFix® is a minimally manipulated, dehydrated, non-viable cellular amniotic membrane allograft that preserves and delivers multiple extracellular matrix proteins, growth factors, cytokines, and other specialty proteins present in amniotic tissue to help regenerate soft tissue.

EpiFix® Amnion/Chorion Membrane Allograft for Acute and Chronic Wound Care

  • Enhances Healing
  • Modulates Inflammation
  • Reduces Scar Tissue Formation

 

EpiFix® is processed using the PURION® Process, a unique approach that provides an added level of tissue safety and ease of use. EpiFix® may be stored at ambient conditions for up to 5 years and is also available in a particulate configuration. With a variety of sizes available, EpiFix® has size-appropriate grafts to minimize wastage.

 
ITEM NUMBER NET EPIFIX® PROVIDED  UPC
GS-5140 1.5 sq cm 855310003087
GS-5180 2.5 sq cm 855310003414
GS-5220 4 sq cm 855310003421
ES-2300† 4 sq cm 855310003766
GS-5024 4.5 sq cm 855310003391
GS-5230 6 sq cm 855310003018
GS-5240 8 sq cm 855310003438
ES-3300† 8 sq cm 855310003483
GS-5330 9 sq cm 855310003445
ES-3500† 9.5 sq cm 855310003858
GS-5340 12 sq cm 855310003452
ES-4400† 12 sq cm 855310003490
GS-5350 15 sq cm 855310003469
GS-5440 16 sq cm 855310003025
ES-5500† 16.9 sq cm 855310003865
GS-5460 24 sq cm 855310003476
GS-5560 30 sq cm 855310003124
GS-5770 49 sq cm 855310003032

 

 Mesh Configuration† Sheet Configuration

 

 

 

 

 

 

 

EpiFix® is processed from human tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act.

Safety/ Quality Assurance / Regulatory

 

OrthoFlo Product Overview

OrthoFlo is an amniotic fluid derived allograft for homologous use to:

  • Protect & cushion
  • ​Provide lubrication
  • Reduce inflammation

OrthoFlo is a unique human tissue allograft that is derived from amniotic fluid, donated by mothers delivering healthy babies by scheduled Caesarean section.

Amniotic fluid, in utero, naturally functions to protect, cushion and lubricate.1 Key elements of amniotic fluid include growth factors, carbohydrates, proteins, lipids, electrolytes, and other nutrients, as well as hyaluronic acid (HA), a principle component that provides viscosity and lubrication in the synovial fluid that surrounds joints.1,2

OrthoFlo is an amniotic fluid derived allograft which helps to cushion, lubricate and protect the joint.2

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

ITEM NUMBER SIZE & DESCRIPTION
LQ-0050 0.5 mL
LQ-0100 1 mL
LQ-0200 2 mL

 

1. Underwood MA, Gilbert WM, Sherman MP. J Perinatol. 2005 May;25(5):341-8.
2. Hui AY, McCarty WJ, Masuda K, Firestein GS, Sah RL. Wiley Interdiscip Rev Syst Biol Med. 2012 Jan-Feb;4(1):15-37.

 

LQ111.002

 
EpiCordTM Product Overview

EpiCord

EpiCordTM is a unique, thick membrane derived from umbilical cord, the structure that protects the arteries and vein that carry essential nourishment and oxygenated blood to and from mother and fetus. EpiCordTM is a minimally manipulated, dehydrated, non-viable cellular umbilical cord allograft for homologous use

  • Provides a protective environment for the healing process
  • Provides a connective tissue matrix to replace or supplement damaged or inadequate integumental tissue
     

Umbilical cord consists of amniotic epithelium and Wharton's jelly containing extracellular matrix composed of collagen, proteoglycans and hyaluronic acid.

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

 

ITEM NUMBER Size
EC-5230 2 cm x 3 cm
EC-5350 3 cm x 5 cm

 

EpiCordTM is processed from human tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act.

Safety/ Quality Assurance / Regulatory

 

 
AmnioCordTM Product Overview

EpiCord

AmnioCordTM is a unique, thick membrane derived from umbilical cord, the structure that protects the arteries and vein that carry essential nourishment and oxygenated blood to and from mother and fetus. AmnioCordTM is a minimally manipulated, dehydrated, non-viable cellular umbilical cord allograft for homologous use

  • Provides a protective environment for the healing process

 

Umbilical cord consists of amniotic epithelium and Wharton's jelly containing extracellular matrix composed of collagen, proteoglycans and hyaluronic acid.

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

 

ITEM NUMBER Size
AC-5230 2 cm x 3 cm
AC-5350 3 cm x 5 cm

 

AmnioCordTM is processed from human tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act.

Safety/ Quality Assurance / Regulatory

 

 

AmnioFillTM Product Overview

Human Placental Tissue Allograft

AmnioFill™ is intended for homologous use as a placental connective tissue matrix to replace or supplement damaged or inadequate integumental tissue for acute and chronic wounds and modulate inflammation, enhance healing and reduce scar tissue formation.

AmnioFill is a minimally manipulated, non-viable cellular tissue matrix allograft that contains multiple extracellular matrix proteins, growth factors, cytokines, and other specialty proteins present in placental tissue to help enhance healing.

AmnioFill Benefits:

  • Human collagen matrix
  • Contains growth factors that modulate inflammation, reduce scarring, and enhance healing
  • Versatile tissue form provides a scaffold for ingrowth in acute and chronic wounds

Shelf Life: 5 years at ambient conditions

AmnioFill is processed from human tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act.

Safety/ Quality Assurance / Regulatory

 

AF110.001

 

 

CollaFixTM Product Overview

CollaFix™ BioBraid – Gapped Achilles Tendon Sheep Study Video

Collagen is the material that binds cells together, holds organs in place, gives tissues their mechanical properties, connects muscles to bone (tendons), and holds joints together (ligaments); it is the framework of the body upon which tissues are built. Tendons and ligaments are composed predominantly of collagen.

The CollaFix™ technology was developed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair. Our materials are designed to function as a temporary mechanical support to allow early rehabilitation after surgical repair, which is crucial for optimal repair of tendons and ligaments. It acts as a scaffold for the emerging repair cells to generate a new tissue. CollaFix™ is also biodegradable and disappears during the repair process and after the repair is complete.

The core of the CollaFix™ technology is based on collagen fibers that are the size of a human hair and are fabricated in continuous lengths of spooled collagen fibers. These fibers are cross-linked with a cross-linking agent that not only makes them incredibly strong, but also makes them biocompatible, functionally long-lived after implantation, and resorbable, with the added advantage that products resulting from the natural degradation process are also biocompatible.

The strength of the CollaFix™ fibers allows the use of standard textile manufacturing equipment to construct CollaFix™ devices. This means that the fibers can be assembled into a variety of configurations and geometries, which can be designed to mimic the natural collagen architecture in tissues. Another advantage of the fiber technology is that it is entirely scalable with respect to size and strength, so the properties can be adapted to target the specific properties of the tissue being repaired.

The CollaFix™ fibers mimic the mechanical properties, particularly strength and stiffness, of natural tendon fibers.  When assembled into braids, the fiber system provides a scaffold for regenerative cells to invade and colonize.  Mechanical loads then induce the reparative cells to regenerate normal tendon tissue.  The braids are as strong as human tendons and thereby allow the repaired tendon to be loaded by exercise immediately after surgery.  These loads stimulate the reparative cells to differentiate into tendon cells and to regenerate normal tendon tissue, instead of scar and a weak repair.

This technology is not yet available for sale.
 

Scientific Publication:

Qiu Y, Lei J, Koob TJ, Temenoff JS. "Cyclic tension promotes fibroblastic differentiation of human MSCs cultured on collagen-fibre scaffolds." Journal of Tissue Engineering and Regenerative Medicine. 2014; doi: 10.1002/term.1880
Click here to view.

 

Posters:

Koob TJ, Brown R. "CollaFix™ BioBraid – Gapped Achilles Tendon Sheep Study"
Click here to view.

Glazebrook M, et al. "CollaFix™ – Techniques in Foot & Ankle"
Click here to view.

Paulos L, et al. "CollaFix™ – Techniques in Rotator Cuff Repair"
Click here to view.

Davis T, Koob TJ. "CollaFix™ Suture – Cosmesis & Applications"
Click here to view.

 

 

Patents

MiMedx® values intellectual property highly and is constantly developing new intellectual property to complement our existing portfolio.

In accordance with Section 287(a) of Title 35 of the United States Code, the reader is hereby placed on notice of MiMedx Group, Inc’s rights in the United States Patents listed on this site and associated with the following products.

 

Amniotic Membrane Allograft Product Lines
 

Covered by one or more of the following U.S. patents and their foreign counterparts
 

8,323,701
8,357,403
8,372,437
8,372,438
8,372,439
8,409,626
8,460,715
8,460,716
8,597,687
8,623,421
8,642,092
8,703,206
8,703,207
8,709,493
8,709,494
8,904,664
8,932,643
9,084,767
9,180,145
9,186,382

 

Additional patent applications pending

Patents associated with the COLLAFIXTechnologies
 

6,565,960
6,821,530
7,901,455
8,177,839
8,367,148
8,858,633
8,940,684
8,946,163
8,986,378
9,005,285
9,078,775
9,125,759
9,155,799
9,179,976

 

Additional patent applications pending

 

Patents associated with the HYDROFIX® Technologies
 

5,981,826
6,231,605
7,879,100
8,038,920
8,172,848
8,172,902
8,246,680
8,475,503
8,603,171
 

Additional patent applications pending

 

 

 SB149.006

 

Safety/ Quality Assurance / Regulatory

Our team is dedicated to providing safe, superior allografts that exceed customer expectations. To better satisfy the requirements and expectations of our customers, the company maintains strict control on quality from the time of tissue donation. The company has developed and implemented a quality management system in compliance with both the Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB). Using this quality management system, the company maintains strict control over each step of the manufacturing process.

In addition to regulating recovery and processing activities, the company has also established guidelines for donor eligibility, screening and testing. All donor records and test results are reviewed by our medical director prior to the release of the tissue. Only tissues that are deemed suitable for transplant are released for use. 
 

MiMedx Amniotic Allografts Are Terminally Sterilized to Enhance Safety Related to Microbiological and Viral Transmission

In light of the media attention and in the wake of concerns related to the Zika virus, the Company is reiterating its long standing processing safety standards for the terminal sterilization of MiMedx amniotic allografts.  The MiMedx flagship amniotic allografts have always been terminally sterilized, and the Company’s proprietary PURION® Process has continually used terminal sterilization as an essential part of the process. To address potential questions related to the Zika virus, MiMedx is reconfirming the rigorous product safety methods and practices followed by the Company in the processing of its amniotic allografts as well as restating its precise standards for screening of placenta donors.

Click here to read the full white paper.

FDA Adverse Reaction Investigation And Reporting Guidance Update

The FDA has issued a guidance document that provides recommendations complying with the requirements under 21 CFR Part 1271, Subparts D and E. The scope of the guidance involves the investigation and reporting of complaints concerning adverse reactions involving communicable diseases in recipients of 361 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). MiMedx assessed the Company’s compliance to the regulation and this guidance while it was in draft form during its public comment period that began in Q1 2015 and ended in Q4 of 2015. This assessment found that MiMedx’s procedures and records were already in full compliance with the FDA’s Adverse Reaction regulations and are consistent with the new Guidance for HCT/Ps.
 

MiMedx® Discussion of FDA's Draft Guidance on Homologous Use 

The issuance of the FDA’s Draft Guidance on Homologous Use of Human Cells, Tissues and Cellular and Tissue-Based Products released on October 28, 2015 has created a number of concerns, particularly as it relates to amniotic tissue and MiMedx. MiMedx issued a press release on October 29 responding to some of the concerns that had developed around this complex subject. However, the Company believes that additional commentary and documentation of this regulatory area is appropriate. Therefore, MiMedx has developed these discussion points related to these particular FDA regulations. In addition, the Company has included the information and facts that support our assertion that we are in compliance with the HCT/P, 21 CFR 1271 Regulations on Homologous Use. We have outlined the information herein, and created links to various FDA, and other independent websites where the reader can easily verify the facts on his or her own.

Click here to read the full white paper.

Licenses and Accreditations

Donor Testing

Screening

To ensure patient safety, donor screening and testing is performed for each donor mother. Donor screening includes a review of both the donor's medical and social history to ensure that the donor has not engaged in behaviors that place her at an increased risk for the transmission of infectious disease, and to ensure that the donor has not shown signs or symptoms of illnesses.

Testing

In addition, each donor is tested for the following infectious diseases:

  • HIV
  • HTLV
  • Hepatitis B
  • Hepatitis C
  • Syphilis
  • CMV

Quality Assurance

All screening and testing results are reviewed according to the company's quality management system, which is designed to meet the requirements specified in the FDA's Good Tissue Practice regulations and in the standards of the American Association of Tissue Banks. All donor screening and testing records are reviewed and accepted by QA personnel before being reviewed by our medical director, a recognized expert in infectious disease testing. Only tissue from donors with acceptable test results are released for transplant.

The company is registered with the Food and Drug Administration and licensed as a tissue bank by the states of California, Georgia, Maryland, and New York. The company is compliant with the tissue bank guidelines of the American Association of Tissue Banks as well as all applicable federal, state and local regulations

 

Reduce Cost to Closure and Minimize Graft Wastage with EpiFix®

DID YOU KNOW?
77% of DFUs and 67% of VLUs have an area of less than or equal to 5 sq cm1

EpiFix® dehydrated Human Amnion/Chorion Membrane allograft provides a scaffold and growth factors for cellular ingrowth, and it reduces inflammation and scar tissue formation for enhanced healing. With a variety of sizes available, EpiFix® minimizes graft waste and overall treatment costs to heal wounds. To that end, MiMedx Supports the CMS 2014 Hospital Outpatient Prospective Payment System Proposed Rule for Skin Substitutes.

Click here to read a white paper on the proposed CMS reimbursement changes, the impact on chronic wound care and new skin substitute product options to help reduce wastage.

While MiMedx is supportive of CMS and its goal to minimize cost and waste in the skin substitute category for hospital outpatient services, the Company has proposed an alternative 4-tiered system for payment based on wound size/complications.

Additional CMS wastage data2:

  • $94 million of the $101 million CMS paid was used for only Apligraf® and Dermagraft®
  • With multiple size appropriate grafts, EpiFix® represents cost savings in the treatment of acute and chronic wounds. 

 

 

1 - James R. Wilcox, RN; Marissa J. Carter, PhD, MA; Scott Covington, MD. Frequency of Debridements and Time to Heal A Retrospective Cohort Study of 312,744 Wounds. JAMA Dermatol. doi:10.1001/jamadermatol.2013.4960 published online July 24, 2013; 2 - Calculated from 2011 CMS Medicare data