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MiMedx Announces Publication On CollaFix™, The Company's Next Technology Platform To Be Commercialized

MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spinal, Sports Medicine, Ophthalmic and Dental sectors of healthcare, announced that the publication of its peer-reviewed scientific study, "Cyclic Tension Promotes Fibroblastic Differentiation of Human MSCs Cultured on Collagen-Fibre Scaffolds", electronically published in the Journal of Tissue Engineering and Regenerative Medicine, proves the link between the mechanical properties of the proprietary CollaFix™ fibers and induction of tendon regeneration.

Tendon and ligament injuries caused by trauma or continuous overuse are a common clinical problem. After rupture, many of these patients require tendon/ligament replacements to recover normal activity levels. The traditional replacement materials used for tendon/ligament surgeries have inevitable shortcomings such as donor site morbidity, risk of disease transmission and high long-term failure rate. A very promising therapeutic approach that holds great potential as alternative tissue grafts for these applications is tissue-engineered implants with strong and stiff biocompatible scaffolds. In addition, mesenchymal stem cells (MSCs) have been prominently suggested as a potential cell source for tendon/ligament tissue engineering. This scientific study was established to confirm these beliefs.

Parker H. Petit, Chairman and CEO, said, "Our CollaFix fiber braids were developed to be strong enough to carry loads right after surgery and to have the right mechanical properties, those equivalent to tendons, so that repair cells would receive the correct signals to regenerate tendon tissue. The significance of this peer-reviewed study article is that it proves the link between the mechanical properties of the fibers and induction of tendon regeneration. We believe that our CollaFix platform will be our second truly disruptive technology and we look forward to commercializing it. "

"Our proprietary patent-protected CollaFix, collagen-fiber scaffold was created by wet spinning sub-millimeter fibers from purified soluble collagen and crosslinking these fibers. The study established that the CollaFix collagen fiber scaffold with its superior mechanical properties not only mimicked the mechanical cues provided by the individual fibers in tendon/ligament tissues, but also may act as an ideal tissue-engineered scaffold for mechanical substitution or augmentation for tendon/ligament repair," continued Petit.

Bill Taylor, President and COO, stated, "The study demonstrated that the MiMedx collagen fiber-based scaffolds with high tensile strength, combined with cyclic tensile culture, promoted fibroblastic differentiation of MSCs as well as substantial extra-cellular matrix production; and therefore, represent a promising approach to fabrication of tissue-engineered tendon and ligament grafts. Basically, this means that because the strength and stiffness of CollaFix matches that of native tendons and ligaments, the repair can be exercised very early in rehabilitation. This greatly enhances the engagement of tendon cells and reduces the formation of scar tissue. Thus, a much stronger repair occurs. "

The Company also announced an updated status report on its issued and pending patents at the United States Patent and Trademark Office and with various international patenting agencies related to its CollaFix technology. Worldwide, the Company's CollaFix technologies are protected with 24 issued patents. Additionally, in the U.S. and internationally, there are over 30 patent applications pending covering the Company's CollaFix technology. "We already have an issued patent wherein we pre-load CollaFix braids with cells, cyclically load the cells (MSCs) to turn them into tendon fibroblasts, then implant the construct as a tendon augment or replacement," added Taylor.

"In all of our technologies, we have substantial expertise and have made extensive investments of time, effort and financial resources to bring new regenerative biomaterial products and implants to the market. The importance of obtaining and maintaining patent protection for significant new technologies, products and processes cannot be underestimated. We are committed to sustaining this approach to protecting the intellectual property of our next commercialized technology, CollaFix, as well as our PURION® Processed amniotic technologies, EpiFix and AmnioFix," concluded Mr. Pete Petit.

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