The PURION® Process

Human amniotic membrane allografts have been used for a variety of reconstructive surgical procedures since the early 1900s. Interest in utilization of amniotic membrane waned in the early 1980’s as a result of communicable diseases such as HIV/AIDS, Hepatitis, etc. In the late 1990s and early 2000s amnion re-appeared in cryopreserved form for the treatment of ophthalmic wounds. In 2007, the use of the amniotic membrane as an allograft accelerated because Surgical Biologics, a MiMedx® company, developed the PURION® Process, which among other things allowed the tissue to be dehydrated and sterilized. This produced an easy to use graft with room temperature storage and a five-year shelf life. To date, over 130,000 allografts have been distributed for human implantation in various surgical applications and to date no adverse events associated with the tissue have been reported. Most recently, amniotic membrane has been utilized as a potent facilitator of wound healing in various fields within medicine including lower extremity ulcers, to treat burns, gynecologic surgery, orthopedics, and a variety of other applications.1,2,3,4,5,6,7

PURION® Processed Amniotic Grafts:

  • AmnioFix®
  • AmnioFix® Sports Med
  • EpiFix®
  • AmnioFix® Injectable
  • AmnioFix® Wrap
  • EpiFix® Micronized

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

Human amniotic membrane comprises the innermost layer of the placenta and lines the amniotic cavity. Processed through the proprietary PURION® Process that combines cleaning, dehydration and sterilization, AmnioFix® is a safe, sterilized tissue that may be stored at room temperature 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 that offers surgeons a clear advantage.

Areas of Use

Spinal surgical barrier applications

 

AmnioFix® Injectable Product Overview

AmnioFix® Injectable is also available and it is supplied in a powder form so the benefits of the tissue may be delivered through an injection. Not only does AmnioFix® Injectable reduce inflammation and reduce scar tissue formation, it enhances the healing of micro-tears in soft tissue.

Areas of Use

Tendon and soft tissue injuries, such as patellar tendon inflammation, tendonitis, tendonosis, plantar fasciitis, tennis elbow

 

AmnioFix® Wrap Product Overview

AmnioFix® Wrap is an amniotic membrane allograft wrap for nerve and tendon protection and to enhance soft tissue healing.

AmnioFix® is a composite structure of amniotic membrane graft layers, uniquely processed to optimize surgical performance and ease of use.

Areas of Use

Nerve and tendon protection and to enhance soft tissue healing

 

Product Offering

AmnioFix®

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

 

AmnioFix® Injectable

Item Number                         Size
AI-5050                                0.5 mL
AI-5125                                1.25 mL
AI-5200                                2.0 mL

 

AmnioFix® 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

 

www.AmnioFix.com/Injectable (AmnioFix Injectable)

AmnioFix

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.

Safety/ Quality Assurance / Regulatory

 

Deploy

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 Line

AmnioFix®, AmnioFix® Injectable, Ambio5, AmbioChoice Plus, AmbioChoice, Amnio1,  AmnioShield , BioArthro, BioXclude, EpiFix®, EpiFix® Injectable, NuShield

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

8,597,587

8,642,092

8,623,421

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

 

 

 SB149.003

 

Epifix-logo

 

Product Overview

EpiFix® is a human amniotic membrane allograft and is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. EpiFix® provides a biologically active matrix and growth factors for cellular ingrowth, and it reduces inflammation and reduces scar tissue formation for enhanced healing. With a variety of sizes available, EpiFix® minimizes graft waste.

Human amniotic membrane comprises the innermost layer of the placenta and lines the amniotic cavity. Processed through the proprietary PURION® Process that combines cleaning, dehydration and sterilization, EpiFix® is a safe, sterilized tissue that may be stored at room temperature for up to 5 years.

EpiFix®Micronized is also available and can be used as a dry powder or mixed with saline to form an injectable.

 

Areas of Use

EpiFix® and EpiFix® Micronized are used in the treatment of chronic and acute partial and full-thickness wounds including, but not limited to, diabetic foot ulcers, venous leg ulcers, arterial ulcers, pressure ulcers, inflammatory ulcers, burns, Mohs, and scar revision.

 

Product Offering

EpiFix®

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
GS-5770                               7 cm x 7 cm              55310003032

 

EpiFix® Micronized

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

 


Click here for more information on EpiFix®

Click here for the Hospital Outpatient and Ambulatory Surgical Center 2014 Final Rule Update

EpiFix

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

 

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