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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 that two of its peer-reviewed scientific studies have been published in the scientific literature.
The Company's study "Angiogenic Properties of Dehydrated Human Amnion/Chorion Allografts: Therapeutic Potential for Soft Tissue Repair and Regeneration" was published in the May 1, 2014, issue of Vascular Cell. The paper (referred to as the "Angiogenesis Study" throughout the remainder of this press release) was authored by Thomas J. Koob, PhD; William W. Li, MD; Geoffrey Gurtner, MD; Robert Rennert, MD; Nicole Zabek; Michelle Massee; and Jeremy Lim, PhD. The electronic publication can be found here.
The Company's other recently published peer-reviewed article, "Properties of Dehydrated Human Amnion/Chorion Composite Grafts: Implications for Wound Repair and Soft Tissue Regeneration" was electronically published in the Journal of Biomedical Materials Research Part B: Applied Biomaterials. The paper (referred to as the "Bioactivity Study" throughout the remainder of this press release) was authored by Thomas J. Koob, PhD; Nicole Zabek; Michelle Massee; Jeremy Lim, PhD; and Guilhem Denoziere. The hard copy is scheduled to be published in an upcoming edition of the Journal of Biomedical Materials Research. The electronic publication of the study is available in the Wiley Online Library.
In the Angiogenesis Study, MiMedx PURION® Processed dehydrated human amnion/chorion membrane (dHACM) tissue allografts were evaluated for properties to support wound angiogenesis. The creation of new blood vessels, or angiogenesis, is paramount during the late inflammatory and proliferation phases of wound healing since chronic wounds are commonly associated with poor circulation and vascularization. "Chronic wounds will not heal without new vasculature," said Parker H. "Pete" Petit, Chairman and CEO. "The results of this study conclude that MiMedx PURION® Processed dHACM may stimulate angiogenesis when applied to a wound. MiMedx dHACM allografts were confirmed to be a promising wound care therapy with the potential to promote revascularization and tissue healing within poorly vascularized, non-healing wounds."
The Angiogenesis Study examined the angiogenic properties of PURION® Processed dHACM both in vitro with human dermal microvascular endothelial cells and in vivo in a murine ischemic injury model. Numerous angiogenic cytokines are intrinsically present in MiMedx dHACM. Bill Taylor, President and COO, stated, "PURION® Processed dHACM was shown to have a direct effect on human microvasculature endothelial cells. The MiMedx dHACM caused these cells to proliferate in vitro and, significantly, it induced production of over 30 angiogenic factors by these cells, including granulocyte macrophage colony-stimulating factor, angiogenin, and transforming growth factor. The in vitro migration studies showed that MiMedx dHACM is able to recruit endothelial cells."
The presence of angiogenic factors coupled with the direct effect of PURION® Processed dHACM on the production of angiogenic factors by endothelial cells produces a potent local angiogenic environment that revitalizes the resident endothelial cells to regenerate normal vasculature. The effect of MiMedx dHACM is amplified by increasing the number of endothelial cells in the wound and inducing them to produce even more angiogenic factors. "Proof that PURION® Processed dHACM causes vascularization in a wound was obtained in the murine ischemic wound model in which there was a steady increase in microvessels over a four-week period to levels equivalent to healthy and healed skin," commented Petit.
Taken together, the results of the Angiogenesis Study demonstrate that MiMedx dHACM allografts: 1) contain angiogenic growth factors retaining biologic activity; 2) promote amplification of angiogenic cues by inducing endothelial proliferation and migration and by upregulating production of endogenous growth factors by endothelial cells; and 3) support the formation of blood vessels in vivo.
In the Bioactivity Study, MiMedx dHACM tissue allografts were analyzed for the effectiveness of the PURION® Process in retaining composition of the amniotic membrane and preserving bioactivity in the resulting products. MiMedx dHACM was analyzed for extracellular matrix composition through histological staining and for growth factor content. Bioactivity was assessed by evaluating endogenous growth factor production by human dermal fibroblasts in response to MiMedx dHACM.
"An array of 36 cytokines known to regulate processes involved in inflammation and wound healing were identified in the PURION® Processed dHACM. When dermal fibroblasts were treated with extracts of MiMedx dHACM in vitro, bioactivity was demonstrated through an upregulation in biosynthesis of three growth factors involved in wound healing: basic fibroblast growth factor, granulocyte colony-stimulating factor and placental growth factor. MiMedx dHACM induces these cells to produce more wound healing growth factors, which may amplify the regenerative effect of MiMedx dHACM during the proliferative phase," stated Petit.
Inflammation is critical during the early stages of wound repair, but chronic inflammation is a primary cause of refractive healing of wounds. In the healing process, chemokines recruit immune cells to the site of a wound, and cytokines regulate activity of these immune cells. "The Bioactivity Study concluded that PURION® Processed dHACM contains inflammatory cell chemokines and cytokines that regulate the activity of cells derived from the immune system and directly affects inflammatory mechanisms. With MiMedx dHACM, this balance of inflammatory regulators modulates the inflammatory response within refractory wounds, and together with additional wound healing cytokines also retained in MiMedx dHACM, may provide an ideal balance to promote wound healing," added Taylor.
Mr. Pete Petit concluded, "These scientific studies are part of our ever-increasing series of publications that chronicle the compelling scientific foundation of MiMedx PURION® Processed dHACM allografts."