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MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today the publication of another peer-reviewed scientific study in the scientific literature.
The Company's peer-reviewed article, "Cytokines in Single Layer Amnion/Chorion Allografts Compared to Multi-Layer Amnion/Chorion Allografts for Wound Healing," was electronically published in the Journal of Biomedical Materials Research Part B: Applied Biomaterials, on August 30, 2014. The paper was authored by Thomas J. Koob, PhD; Jeremy J. Lim, PhD; Nicole Zabek; and Michelle Massee. The electronic publication of the study in the Journal of Biomedical Materials Research is now available in the Wiley Online Library at http://onlinelibrary.wiley.com/doi/10.1002/jbm.b.33265/pdf
The Company's previously published analyses have determined that over 50 growth factors, chemokines, cytokines, and regulatory factors are contained in PURION® Processed dehydrated human amnion/chorion membrane (dHACM) tissue allografts, specifically EpiFix®, a bilayer laminated graft containing both amnion and chorion. The scientific study was conducted to determine the relative contribution of each layer to the overall growth factor and cytokine content, as well as biological activity in the allograft. The study compared the results to the growth factor content in five representative commercially available single layer amnion grafts.
Study Highlights include:
· MiMedx's multilayer amnion/chorion grafts (EpiFix® and AmnioFix®) contain approximately 20 times more growth factors and cytokines than the competitive single layer amnion grafts evaluated in the study.
· AmbioDry2®, the MiMedx PURION® Processed single layer amnion, contains four to five times greater amounts of growth factors than the competitive single layer amnion products (DryFlex®, AmnioExCel®, SteriShield™, and SteriShield II™) that were evaluated in the study.
· EpiFix® contains four to five times the growth factors in AmbioDry2®.
· All single layer amnion grafts that were tested contained substantially fewer growth factors and cytokines, and therefore, will deliver significantly less growth factors and cytokines than MiMedx's amnion/chorion multilayer grafts with the same surface area.
· When calculated per surface area of tissue applied to a wound, the evaluated PURION® Processed amnion contained on average only 25% of the growth factor content contained in the PURION® Processed chorion.
· The chorion layer in the MiMedx multi-layered allografts is four to five times thicker than the amnion layer, and therefore, contributes disproportionately to the growth factor content in amnion/chorion grafts. Chorion contributes on average 82% of the growth factors in EpiFix®.
"Recently, there has been misinformation in the market making the generalization that all amniotic membrane grafts are similar, regardless of whether they are single layer amnion or multi-layer allografts," said Mr. Pete Petit, Chairman and CEO. "This study confirms that there is a substantial differentiation between multi-layer allografts with both amnion and chorion versus the single layer amnion allografts tested. This scientific study clearly demonstrates that PURION® Processed allografts with both amnion and chorion have a multiple of approximately 20 times more cytokines than the competitive single layer amnion allografts evaluated in the study."
To examine the role of tissue processing technique in cytokine retention, cytokine contents in representative dehydrated single layer wound care products (DryFlex®, AmnioExCel®, SteriShield™ Single Layer, and SteriShield II™ Dual Layer) were measured. The results demonstrated that cytokine content varied significantly among the allografts tested, and that PURION® Processed single layer amnion grafts, AmbioDry2®, contained significantly more cytokines than the other single layer products that were evaluated in the study. "AmbioDry2® is the single layer wound care product MiMedx processes for its ophthalmic partner, IOP Ophthalmics, Inc. These results suggest that, as compared to other methods of tissue processing, the proprietary PURION® Processing contributes to greater cytokine retention and the delivery of substantially more growth factors, which are known to be critically important in wound repair and tissue regeneration," commented Bill Taylor, President and COO.
The publication suggests that the retention of biologically active growth factors during processing of amniotic tissues is critically important in preserving the bioactivity of the native tissues for wound care. "The abundance of growth factors that results from combining amnion and chorion in the MiMedx dHACM allografts may contribute to these allografts being a more effective treatment in promoting the healing of refractive wounds," stated Taylor.
The ability to induce fibroblast proliferation was studied, and it was determined that both the amnion and chorion caused dermal fibroblasts to proliferate. However, the chorion per square cm was on average five times more effective at inducing proliferation. "The study determined that the predominant basis for the bioactivity is derived from the chorion. This is a clear indication that the biological activity in EpiFix® that induces fibroblast proliferation is a result of both our proprietary processing technique and the graft's multi-layer configuration with both amnion and chorion," concluded Mr. Pete Petit.
DryFlex®and AmnioExCel® are registered trademarks, and SteriShield™ and SteriShield II™ are trademarks of their respective owners. AmbioDry2® is private labeled for, and is a registered trademark of, IOP Ophthalmics, Inc.