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Sept. 25, 2013 /PRNewswire/ --
MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, commented today on various recent media reports concerning certain of the Company's tissue products and the amniotic tissue industry.
While MiMedx's allografts have been in the market for over six years and over 170,000 units have been shipped, the Company's recent rapid growth in the advanced wound care market has placed it in a leadership role and that has attracted attention from numerous sources.
Parker H. Petit, Chairman and CEO commented, "When a company takes a leadership role with a new and promising healthcare technology, it deserves scrutiny from regulatory authorities, patients, physicians, and shareholders. Naturally some media reports will follow. Ideally, the scrutiny and the media reports would be fair and objective and accomplished with integrity. In our case, we believe that some of this scrutiny and the resultant media coverage may be prompted by competitors from which we have taken significant market share and who may seek to discredit our products or from short sellers who stand to profit from creating confusion in the stock market. That being the case, there is likely to be more misinformation being disseminated than usual. This type of misinformation does not serve our patients, their prescribing physicians, MiMedx or even the FDA very well. "
Petit continued, "Our goals are to help all of our constituents thoroughly understand this promising new medical technology and the various regulatory pathways, and clear up all the misinformation and misunderstandings created by various media reports. We also want to reiterate our goal of maintaining strict compliance with the regulations."
September 4, 2013, MiMedx issued a press release regarding the recent "Untitled Letter" it received from the FDA, which raised an issue regarding the proper regulatory pathway for the Company's micronized product line. As stated in that press release, the micronized product line represents approximately 15% of the Company's projected 2014 revenues and the Company believed that it would be able to achieve its published revenue goals for the balance of 2013, as well as 2014, even without the micronized product. Further, as the Company announced on
September 12, 2013, the Company has scheduled a meeting with the FDA on
October 16, 2013, to discuss the Untitled Letter and seek resolution of the issue raised.
First and foremost, it is important to understand that the majority of the Company's products are not impacted by the FDA's Untitled Letter. MiMedx processes two general types of amniotic membrane allografts: one type is in the form of sheet allografts and the other is a micronized version of these same sheet allografts. The sheet allografts make up approximately 85 percent of the Company's projected 2014 revenues, and the regulatory status of this product category has not been questioned.