MiMedx Says Working with FDA to Resolve Issue with Amnion/Chorion Injection; Reiterates FY13-14 Outlook
MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, confirmed today that it is in receipt of an "Untitled Letter" from the Food and Drug Administration ("FDA"). 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.
As explained on the FDA's website, an "Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of regulatory significance for a Warning Letter."
Bill Taylor, the Company's President and COO, 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." The establishment report is posted on the Company's website at www.mimedx.com.
MiMedx is very focused on regulatory compliance and 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 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 $54 million to $60 million and its 2014 goal of $90 million to $110 million. The revenues from the Company's injectable are projected to be approximately 15% of the Company's 2014 revenues.
Parker H. "Pete" Petit, the Company's Chairman & CEO, 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."
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