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

MARIETTA, Ga., May 13, 2015 /PRNewswire/ -- 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, Spine, 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 Petit.

The highlights of the study include:

• A biocompatible, biodegradable, braided collagen-fiber based scaffold mimicked fibrous structure and mechanical properties of tendon/ligament.
• Human mesenchymal stem cells were grown on the fibers in vitro and the scaffold was then subjected to cyclic tensile loads comparable to what tendons experience under normal loading conditions. Based on gene expression analyses and extracellular matrix production, cyclic loading of the collagen fibers resulted in differentiation of the mesenchymal stem cells into tendon fibroblasts. Cyclic loading of the collagen scaffold imparted the appropriate mechanical signals to the attached MSCs that caused them to produce regulatory factors and extracellular matrix proteins characteristic of tendon tissue.
• Results conclude that fibrous, braided collagen scaffolds are excellent candidates for use with a cyclic culture bioreactor, both to prime MSCs for cell-based therapies in tendon and ligament repair and for production of tissue-engineered alternatives to current tendon/ligament tissue grafts.

The electronic publication of this peer-reviewed article is available in the Wiley Online Library at http://onlinelibrary.wiley.com/doi/10.1002/term.1880/pdf. The paper was authored by Yongzhi Qui, PhD; Jennifer Lei; Thomas J. Koob, PhD; and Johnna S. Temenoff, PhD. The study was conducted in conjunction with the W. H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University; George W. Woodruff School of Mechanical Engineering, Georgia Institute of Technology; and The Petit Institute for Bioengineering and Bioscience, Georgia Institute of Technology. 

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane.  "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself.  Our biomaterial platform technologies include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through our donor program, a mother delivering via full-term Caesarean section birth can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx® is the leading supplier of amniotic tissue, having supplied over 400,000 allografts to date for application in the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. 

Safe Harbor Statement

This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to,  the potential that CollaFix holds as a tissue-engineered implant to be used in place of traditional treatment for tendon/ligament injuries, that CollaFix will be a disruptive technology and the Company expectations for CollaFix.  These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the Company is not able to commercialize CollaFix as expected or at all; that CollaFix does not gain acceptance within the medical community for use in tendon/ligament repair; that CollaFix does not perform as expected; that the approval of pending patents does not materialize as anticipated; that the issued CollaFix patents do not adequately protect our rights or keep any competitive advantage , and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2014 and its most recent Form 10Q filing. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

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