This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

MiMedx Responds To Misleading And Inaccurate Media Reports

MARIETTA, Ga., 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." 

On 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.

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 17,689.86 -56.12 -0.32%
S&P 500 2,103.84 -4.79 -0.23%
NASDAQ 5,128.2810 -0.5040 -0.01%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs