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




  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® Product Overview

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. 



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



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® 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.

GS-5140 1.5 sq cm 855310003087
GS-5180 2.5 sq cm 855310003414
GS-5220 4.0 sq cm 855310003421
GS-5024 4.5 sq cm 855310003391
GS-5230 6.0 sq cm 855310003018
GS-5240 8.0 sq cm 855310003438
ES-3300† 8.0 sq cm 855310003483
GS-5330 9.0 sq cm 855310003445
GS-5340 12.0 sq cm 855310003452
ES-4400† 12.0 sq cm 855310003490
GS-5350 15.0 sq cm 855310003469
GS-5440 16.0 sq cm 855310003025
GS-5460 24.0 sq cm 855310003476
GS-5560 30.0 sq cm 855310003124
GS-5770 49.0 sq cm 855310003032


 Mesh Configuration† Sheet Configuration







*Billing units for sheet products calculated by the area of the graft, rounded to the nearest tenth. Billing Units for Mesh allografts calculated by the area of the graft less the area where holes were punched. Billing units are the net square centimeters of material.

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




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.



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.




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



Additional patent applications pending

Patents associated with the COLLAFIXTechnologies


Additional patent applications pending


Patents associated with the HYDROFIX® Technologies


Additional patent applications pending





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.

Licenses and Accreditations

Donor Testing


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.


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®

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