MiMedx announces ruling from PTAB on its embossment patent

MARIETTA, Ga., Aug. 11, 2016 /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 today a ruling has been rendered from the Patent Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office with regard to MiMedx's United States Patent No. 8,597,687 related to the embossment of tissues. This embossment is a method for the clinician to determine which side is "up." This patent is not related to the EpiFix® or AmnioFix® patents, other than for the embossment.

Parker H. "Pete" Petit, Chairman and CEO, stated, "The PTAB ruled that the '687 patent was invalid because of prior art rendering it obvious. We believe the finding was wrongly decided. We are disappointed in the PTAB's finding regarding this embossment patent, and we are considering whether we will appeal the decision. It is important to understand that the value of this patent was related to an easy method for the physician to determine which side should be placed 'up' on a wound.  While this embossment is useful, and in my opinion, a novel concept, it is not relevant to the clinical efficacy of our products." 

Notably, the decision does not impact MiMedx's PURION® process, which is embodied in many other of MiMedx's patents, such as the 8,709,494; 8,323,701; 8,642,092; and 8,703,207 patents. The decision also does not impact MiMedx's flagship EpiFix® and AmnioFix® patents, the 8,709,494 and 8,323,701 Patents, respectively, each of which successfully withstood challenges before the PTAB last year.  MiMedx's active district court litigations on those patents against competitors such as Musculoskeletal Transplant Foundation, Inc. ("MTF") and Transplant Technology, Inc. d/b/a Bone Bank Allograft ("Bone Bank") and Texas Human Biologics Ltd. remain pending, and upcoming trials in those matters are unaffected by the Board's ruling on the '687 patent.

Bill Taylor, President and COO, said, "As mentioned in our press releases of August 21 and 27, 2015, and September 1, 2015, our EpiFix and AmnioFix patents have been tested in the inter partes review ("IPR") process. In separate rulings on these patents, the PTAB found no basis to challenge either patent, which means that the PTAB decided that it would not review either patent and that these patents are on solid footing.  MiMedx was not only able to unequivocally defeat challenges to the '494 and '701 patents, but we were able to obtain the extraordinary outcome of having the PTAB deny even instituting a proceeding against these patents in the first place. Such a denial occurs in only a handful of cases and demonstrates the strength of the patents and adds to our confidence that we will prevail."

Petit noted, "We have a very robust patent portfolio with 28 amniotic patents issued and nearly 100 amniotic patents pending with the U.S Patent and Trademark Office. For all of our technologies, we currently have over 200 patents issued and pending."

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues and human skin and bone.  "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself.  The MiMedx allograft product families include our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands; Amniotic Fluid family with OrthoFlo brand; Umbilical family with EpiCord™ and AmnioCord™ brands; Placental Collagen family with CollaFix™ brand; Bone family with Physio® brand; and Skin family with AlloBurn™ brand. AmnioFix, EpiFix, and EpiBurn are our tissue technologies processed from human amniotic membrane; OrthoFlo is an amniotic fluid derived allograft;  EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio is a unique bone grafting material comprised of 100% bone tissue with no added carrier; AlloBurn is a skin product derived from human skin designed for the treatment of burns; and CollaFix, our next brand we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair. 

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 600,000 allografts to date for application in the Wound Care, Burn, 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 Company's belief that the PTAB's finding that the '687 orientation patent is invalid was wrongly decided, the belief that the '687 patent is a novel concept, the fact that both the '494 and '701 patents were upheld in IPR challenges gives the Company confidence that it will fully prevail at the conclusion of the two noted lawsuits this fall. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the fact that the '494 and '701 patents were upheld in IPR challenges does not require that the patents be upheld at trial; if appealed, the PTAB decision on the '687 may still be upheld, despite the Company's belief that the case was wrongly decided and that the patent is a novel concept; the normal risks and uncertainties of litigation, 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, 2015 and its most recent 10Q. 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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