MARIETTA, Ga., April 22, 2014 /PRNewswire/ -- 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 it has filed a patent infringement lawsuit against Liventa Bioscience, Inc. ("Liventa"), Medline Industries, Inc. ("Medline") and Musculoskeletal Transplant Foundation, Inc. ("MTF") for permanent injunctive relief and unspecified damages. In addition to the allegations of infringement of MiMedx's patents, the lawsuit asserts that Liventa and Medline knowingly and willfully made false and misleading representations about their respective products to providers, patients and in some cases, prospective investors. The suit was filed in the United States District Court for the Northern District of Georgia.
In the suit, MiMedx asserts that Liventa (formerly known as AFCell Medical, Inc.), Medline and MTF infringed and continue to infringe at least four MiMedx patents:
1. US 8,323,701 – Placental Tissue Grafts.
2. US 8,642,092 – Placental Tissue Grafts.
3. US 8,372,437 - Placental Tissue Grafts.
4. US 8,597,687 – Methods for Determining the Orientation of a Placental Tissue Graft.
The patents at issue relate to the MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts. MTF is the processor and Liventa and Medline are the distributors of the allegedly infringing products.
Over the last six years, MiMedx has shipped over 225,000 of its dHACM allografts. In addition to the 11 patents already issued to MiMedx, the Company has filed 53 other patent applications related to its amnion technology and MiMedx expects some of these to be issued shortly.
Parker H. "Pete" Petit, Chairman and CEO, said, "MiMedx has a portfolio of valuable and innovative regenerative medicine patents. The amniotic membrane, when processed with our proprietary Purion® Process, retains the vast majority of the growth factors and cytokines that are inherent in the amniotic membrane itself. Developing the processes that allow this critical retention to occur and create dHACM allografts with superior healing and regenerative properties has taken years of research and development. MiMedx has established itself as the leader in biomaterials produced from human amniotic membrane. We have a responsibility to the prescribing physicians and their patients to safeguard our technology. Also, we have responsibilities to our shareholders and employees to protect the investments we have made in our technology and patents."
"Most egregious among the alleged false and misleading representations are statements suggesting that the clinical results from the use of products processed using MiMedx's Purion® Process are the results of clinical tests on products processed by MTF and marketed by Liventa and Medline," stated Bill Taylor, President and COO. "These misrepresentations also must be stopped. MiMedx has spent millions of dollars on product development, and the clinical effectiveness of our allografts is supported by numerous clinical and scientific peer-reviewed published studies. Since our allografts are the only tissue products on the market processed using our patented and proven Purion® Process, it is misleading for Liventa and Medline to suggest that the clinical effectiveness of their products is the same as ours."
MiMedx® is an integrated developer, manufacturer 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, mothers delivering full-term Caesarean section births 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 225,000 allografts to date for application in the Wound Care, Surgical, 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, express or implied statements about the Company's ability to maintain and enforce patent and other intellectual property protection for its product portfolio and to succeed in its claims relative to false advertising, unfair trade practices and unfair competition. 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 the 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, 2013. 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.