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Wall Street Teacher (a pseudonym) worked on Wall Street for several years in the fixed income area and now teaches and writes on financial topics (primarily regulation and markets). Current interests include the psychology of financial markets, the origins of chemistry/physics, synthetic... More
  • Cormedix Gets EU Approval-CC Today 0 comments
    Jul 8, 2013 7:25 AM

    CC Today @ 9AM(info below). Hopefully this little company has turned the corner.

    CorMedix Receives CE Mark for Neutrolin® Catheter Lock Solution

    Drug - Device Shown to Prevent Catheter Related Bloodstream Infections and Maintain Catheter Patency, a Major Health Issue for Patients Requiring Long-term Catheter Use -

    - Company to Hold Investor Conference Call on July 8th at 9 am ET -

    Press Release: CorMedix Inc. - Fri, Jul 5, 2013 11:05 AM EDT

    • BRIDGEWATER, N.J.--(BUSINESS WIRE)--

    CorMedix Inc. (NYSE MKT: CRMD) today announced that it has received CE Mark approval for Neutrolin®, a catheter lock solution, for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease. The Neutrolin solution includes an anti-coagulant and broad-spectrum antimicrobial (antibacterial and antifungal) combination that is active against common microbes including antibiotic-resistant strains, and in addition, inhibits the formation of biofilm. Neutrolin, as a catheter lock solution, has been proven to significantly reduce the incidence of catheter related bloodstream infections (CRBIs) as well as maintain catheter patency by inhibiting thrombosis, thus reducing the need for systemic antibiotics and prolonging central venous catheter life.

    CorMedix received the CE Mark for Neutrolin as a Class III device, which allows the company the ability to market and sell the catheter lock solution in European Union (NYSEARCA:EU) member countries that have adopted the Medical Devices Directive (NYSEARCA:MDD) without being subject to additional national regulations with regard to demonstration of performance and safety (although certain EU member countries may request or require additional performance and/or safety data on a case-by-case basis). The CE mark also permits the sale of Neutrolin in countries that have an MDD Mutual Recognition Agreement with the EU.

    "Receipt of the CE mark for Neutrolin as a Class III device is a significant accomplishment for CorMedix, as this registration required rigorous regulatory review against high clinical and manufacturing standards," said Randy Milby, CorMedix's Chief Executive Officer. "We are well prepared to make this important medical device available to patients with central venous catheters on hemodialysis. We look forward to Neutrolin being widely available in Europe with commercialization efforts led by national sales manager Joachim Petrak and his team at CorMedix Europe GmbH."

    CorMedix Europe GmbH will launch Neutrolin in Germany and Austria initially. The company is in discussions with potential partner companies to market in Europe, the Middle East and Asia. Neutrolin is indicated for the prevention of catheter related bloodstream infections (CRBI) and maintenance of catheter patency in hemodialysis (NYSE:HD) patients. The company has longer term goals to expand its use in oncology patients requiring catheters as well as in additional indications. CorMedix is also now poised to pursue a regulatory strategy for approval of Neutrolin in the United States.

    CorMedix also announced the receipt in late May of funds from two longtime investors Elliott Management and Kingsbrook Partners to further support the commercialization of Neutrolin.

    CorMedix will host a webcast teleconference on July 8, 2013 at 9 am ET to further discuss the significance of the CE Mark designation, the commercial plan for Neutrolin going forward, and other related developments. Please call 866-866-1333 or 404-260-1421 approximately 10-15 minutes before the conference.

    Disclosure: I am long CRMD.

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  • CorMedix: Making Progress In Both EU Commercial And U.S. Regulatory Fronts $CRMD http://seekingalpha.com/a/19v93
    Apr 14, 2014
  • Cormedix: An Interesting Play In The Catheter Care Space $CRMD http://seekingalpha.com/a/1582p
    Dec 31, 2013
  • I'm betting Europe works out. That's bad for the $ but good for gold. I guess the Germans rule the continent without having to fire a shot!
    Jun 4, 2012
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