MiMedx Group, Inc. 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."
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in