MARIETTA, Ga., Aug. 27, 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, responded today and corrected the multiple inaccuracies in the press release issued by the Musculoskeletal Transplant Foundation ("MTF") regarding the recent rulings from the Patent Trial and Appeal Board ("PTAB").
In April of 2014, MiMedx filed a patent infringement lawsuit in the United States District Court for the Northern District of Georgia against MTF, Liventa Bioscience, Inc., and Medline Industries, Inc. As part of its defense strategy for that lawsuit, MTF petitioned the USPTO's Patent Trial and Appeal Board ("PTAB") to initiate an inter partes review of two asserted MiMedx patents, namely U.S. Patent Nos. 8,323,701 (the '701 patent) and 8,372,437 (the '437 patent). The '701 patent is the MiMedx primary AmnioFix® configuration patent, and the '437 patent is a process patent including aspects of the MiMedx embossment process. In a separate patent infringement lawsuit MiMedx filed in May of 2014 against Transplant Technology, Inc. d/b/a Bone Bank Allograft and Texas Human Biologics Ltd., the Company's primary EpiFix configuration patent was one of two patents for which an IPR was requested by the defendants in that case.
On August 21, 2015, MiMedx issued a press release announcing the PTAB rulings in regard to the IPR requests related to the primary EpiFix configuration and the primary AnmioFix configuration patents. In separate rulings on these primary configuration patents for the Company's flagship products, the PTAB found no basis to challenge either patent and fully rejected both requests for IPR review. Thus, that MiMedx press release was intended to discuss only the two MiMedx primary configuration patents for its flagship products that were submitted for IPR, and not all four of the patents that were submitted for review. While the PTAB granted review on the other two process patents, the grounds for review in both of those proceedings were severely limited.
In the IPR requested by MTF, the PTAB fully denied IPR review on the '701 patent, which means that the Company's primary AmnioFix configuration patent stands as issued, with no modification. "In other words, the PTAB found no reason to even review the validity of the primary configuration patent. While the PTAB may have granted review on the '437 patent, only one of the seven grounds MTF alleged was accepted by the Board. We do not believe this single ground challenge by MTF will prevail," said Parker H. "Pete" Petit, Chairman and CEO.
Bill Taylor, President and COO, stated, "In the MTF press release issued August 25, 2015, MTF asserted that 'the PTAB agrees that MTF has provided sufficient basis to challenge the validity of the primary MiMedx EpiFix configuration patent and has accepted our request for review on the validity of the patent claims.' This is a total misrepresentation of the facts and an inaccurate understanding of the rulings made by the PTAB. Our primary EpiFix configuration patent was not even one of the two patents for which MTF requested the IPR review, and regardless, the IPR requested by Transplant Technology and Texas Human Biologics to review the primary EpiFix configuration patent was rejected, not accepted."
Petit added, "It is important to note that when the primary configuration patents are upheld, others cannot manufacture these products, regardless of the processes they use. As we stated in our August 21st press release, the PTAB ruled in our favor in the IPR requests for both of our primary configuration patents. We are puzzled why MTF would make incorrect statements in its press release regarding the PTAB rulings. We believe it would be appropriate for MTF to issue a retraction and/or correction."
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 are AmnioFix®, EpiFix® and CollaFix™. AmnioFix® and EpiFix® are our tissue technologies processed from human amniotic membrane 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 450,000 allografts to date for application in the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. CollaFix™, our next technology platform 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. CollaFix™ is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness.
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 strength of the MiMedx EpiFix and AmnioFix configuration patents. 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 PTAB rulings declining inter partes review may not necessarily authenticate the strength MiMedx has created to protect the Company's intellectual property, 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. 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.