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, reduces 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. 

AmnioFix®

Sheet/Membrane

Item Number                         Size
APS-5160                             16 mm disk
APS-5230                             2 cm x 3 cm
AAS-5330                             3 x 3 cm
APS-5440                             4 x 4 cm
AAS-5460                             4 x 6 cm

 

Particulate

Item Number                         Size
AI-5050                                40 mg
AI-5125                                100 mg
AI-5200                                160 mg

 

Wrap

Item Number                         Size
TN-5220                               2 cm x 2 cm
TN-5240                               2 cm x 4 cm
TN-460                                 4 cm x 6 cm
 

Safety/ Quality Assurance / Regulatory

 

AmnioFix® 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.

Epifix-logo                     

EpiFix

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
  • Reduces 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.

EpiFix®:

Sheet/Membrane

Item Number                         Size                         UPC
GS-5140                               14 mm disk               55310003087
GS-5160                               16 mm disk               55310003001
GS-5230                               2 cm x 3 cm              55310003018
GS-5440                               4 cm x 4 cm              55310003025
GS-5560                               5 cm x 6 cm              55310003124

 

Particulate

Item Number                         Size                         UPC
EI-5050                                 40 mg                       855310003377         
EI-5125                                 100 mg                     855310003360
EI-5200                                 160 mg                     855310003353

 

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

 

 

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

8,642,092

8,623,421

8,703,206

8,703,207

8,709,493

8,709,494

Additional patent applications pending


Patents associated with the COLLAFIXTechnologies

6,565,960

6,821,530

7,901,455

8,177,839

8,367,148

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

Additional patent applications pending

 

 

 SB149.005

 

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

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