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MiMedx Addresses FDA Untitled Letter And Reiterates 2013 And 2014 Guidance
Date:9/4/2013

cember 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."

About the Company
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 the device technologies HydroFix® and CollaFix™, and our tissue technologies, AmnioFix® and EpiFix®. Our tissue technologies are processed from human amniotic membrane that is derived from the donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lie
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SOURCE MiMedx Group, Inc.
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