This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

MiMedx Responds To Misleading And Inaccurate Media Reports

Stocks in this article: MDXG

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

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs