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September 4, 2013
15:38 EDTMDXGMiMedx disagrees with FDA position, reiterates FY13, FY14 guidance
MiMedx Group confirmed that it is in receipt of an "Untitled Letter" from the Food and Drug Administration. The company further announced that it expressly disagrees with the position in the letter and has been in conversation with the FDA to resolve the matter as quickly as possible. The letter questions the Company's Amnion / Chorion Injectable products' eligibility for marketing solely under Section 361 of the Public Health Service Act. COO Bill Taylor commented, "The Company was surprised by this letter considering the FDA conducted a directed inspection of our facility in July 2012, one of the express purposes of which was to 'determine the status of the [Company's] AmnioFix injectable product.' The inspection report indicated that 'information regarding the [Company's] AmnioFix Injectable product, which was rolled out August 2011, was collected and forwarded to CBER for review. The information collected included advertising, packaging, process procedures and studies conducted related to the product.' Following that inspection, the inspector advised us that CBER had completed its review and had no findings or further questions and, therefore, the inspection was classified as NAI, or No Action Indicated. The formal establishment inspection report confirming the NAI conclusion was issued on December 4, 2012." MiMedx said it proceeded with marketing the injectable product only after receiving advice from outside legal counsel that the product met the criteria for regulation as an HCT/P under Section 361 of the Public Health Service Act. The company said it believes the FDA's conclusion is based on a misunderstanding of the micronization process and is responding to the Untitled Letter and will reiterate its request for a meeting with the FDA. The company reiterated its expected revenue range for 2013 of $54M-$60M and its 2014 goal of $90M-$110M. The revenues from the company's injectable are projected to be approximately 15% of the company's 2014 revenues. CEO Parker "Pete" Petit stated, "Based on other precedents, the Company believes it should be able to continue to sell its injectable products, but even if that not the case, management believes it can refocus its resources to achieve its stated revenue goals."
News For MDXG From The Last 14 Days
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September 2, 2015
09:49 EDTMDXGMiMedx says MTF issued 'second inaccurate' press release
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September 1, 2015
14:35 EDTMDXGMTF 'stands by all statements' made in August 26 press release about PTAB ruling
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August 27, 2015
10:26 EDTMDXGMiMedx says 'inaccuracies' contained in MTF press release on PTAB rulings
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August 26, 2015
09:43 EDTMDXGMiMedx announces publication of study on allografts to regulate diabetic cells
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August 24, 2015
08:56 EDTMDXGMiMedx patent win strengthens IP position, says Brean Capital
Brean Capital noted MiMedx won two Patent Trial and Appeal Board rulings which are involved in the configuration process of two of MiMedx's core products. The firm said the rulings are important wins for the company and strengthens its intellectual properties position. Brean Capital reiterated its Buy rating and $16 price target on MiMedx shares.
August 21, 2015
08:32 EDTMDXGMiMedx patent infringement lawsuits receive rulings from trial and review board
MiMedx announced the Patent Trial and Appeal Board has ruled in favor of the Company's primary EpiFix and AmnioFix patents. In April 2014, MiMedx filed patent infringement lawsuits in the United States District Court for the Northern District of Georgia against Liventa Bioscience, Inc., Medline Industries, Inc. and Musculoskeletal Transplant Foundation, Inc. for permanent injunctive relief and unspecified damages. In May 2014, the Company also filed a separate action against Transplant Technology, Inc. d/b/a Bone Bank Allograft and Texas Human Biologics Ltd. for patent infringement. In both suits, MiMedx asserted that these organizations infringed and continue to infringe at least six MiMedx patents. As part of their defense strategy, two of the four defendants submitted certain of the MiMedx patents to the inter partes review process, which means they are asking the PTAB to review the subject matter covered by the MiMedx patents and decide whether it was proper for the patents to have been granted in the first place. In general, the inter partes review process works as follows: If the PTAB rejects the request for inter partes review, it essentially means that the PTAB found no basis to challenge the patent on obvious or anticipation grounds. If the PTAB grants inter partes review, it means that the PTAB has found that it is worth reviewing the patent, but by no means is it an indication in and of itself that there is something wrong with the subject patent. MiMedx received two recent rulings from the PTAB. One PTAB ruling was made in regard the inter partes review request related to the MiMedx primary EpiFix patent and the other recent PTAB decision was for the inter partes review request related to the MiMedx AmnioFix patent. In both rulings, the PTAB found no basis to challenge these patents and fully rejected the request for review on these patents.

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