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The Evolution of Placental Membrane Allografts

Today the use of amniotic membrane allografts has become common practice, in the USA, in various applications as a wound covering over chronic and acute wounds and a barrier membrane in numerous surgical specialities. Surgical BioFix Ltd is bringing this unique technology from the USA to locally manufacture and offer Australian patients the latest development in regenerative medicine.

 

The human placental membrane is composed of three distinct layers: the amnion, the intermediate layer, and the chorion. Millions of years of evolution have perfected this membrane, making it the ideal barrier to surround and protect a growing fetus.

 

The modern clinical use of the amniotic membrane began in the early 1900s, when physicians experimented with using the tissue as an alternative to xenografts and cadaveric skin grafts. Throughout the 20th century, clinicians and researchers continued exploring the medicinal benefits of amniotic tissue in a wide range of clinical applications, and by the 1990s, amniotic tissue gained broad clinical acceptance in ophthalmic surgery. This single layer, amnion only, graft was the first iteration in a series of advancing placental tissue processing methods.

 

In 2008, Surgical Biologics, founded by Mr John Daniel, developed the first dual layer shelf-stable placental allograft, preserving both the amnion and chorion layers of the native membrane. This breakthrough significantly increased the protein content over single layer placental allografts and enabled broader clinical applications.

 

In 2015, experts at StimLabs LLC, a tissue graft biotechnology company in Atlanta USA also founded by John Daniel, developed the next-generation Clearify process to retain all three layers of the native placental membrane. The Clearify process is optimised to allow the tissues to be cleaned, dehydrated, and terminally sterilised while retaining the jelly-like intermediate layer which naturally lies between the amnion and chorion membranes. The final product, Revita, has a high protein content, excellent handling characteristics, and a five year shelf life at ambient temperatures.

 

Most placenta-based products are processed by removing the intermediate layer and retaining only the amnion and chorion. Manipulating this membrane in such a way diminishes the natural balance of therapeutic components and disrupts the inherent architecture of the tissue. By maintaining the orientation of the native membrane, Revita is 4x thicker than the competitor, providing superior handling characteristics.

 

Preserving all three layers of the placental membrane allows Revita to deliver the maximum concentration of components naturally found in the native tissue and provide a scaffold that mimics the natural architecture of the placental tissue. Revita retains 6.55 times more growth factors and 4.3 times more protein content than the competitor.

Chorion
1990s
Amnion
Single Layer
2000s
Amnion
Dual Layer
 2010s
Amnion
Intermediate Layer
Chorion

In the USA, recent shifts in market dynamics have attracted many new entrants to the amniotic tissue market. This market growth has divided amniotic membrane companies into two different market segments: dual-layer premium products (amnion & chorion), and single-layer commodities (amnion or chorion only). The dual-layer structure and high protein content of the premium products has propelled them to the top of the market.

Such amniotic membrane products have not been available for the treatment of wounds for surgical application in Australia. Surgical BioFix Ltd, founded by Mr Stewart Hemsley, is a Brisbane based biotechnology company that has secured an exclusive license from StimLabs to use the Clearify process to produce and then to market Revita in Australia.