Navigation Links
CorMedix Receives Minutes from Neutrolin Pre-IND Meeting with FDA
Date:12/23/2013

BRIDGEWATER, N.J., Dec. 23, 2013 /PRNewswire/ -- CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardio-renal and infectious disease, today announced receipt of the official minutes from the Nov. 14, 2013 Pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA).  The minutes confirmed the guidance received from the FDA concerning the development of Neutrolin. CorMedix intends to work with the FDA to finalize a clinical protocol and file an IND to support activities required to commercialize Neutrolin in the U.S.

"Commercializing Neutrolin in the U.S. is an important long-term goal for CorMedix, and is one that we plan to pursue in tandem with several, more immediate, key objectives," said Randy Milby, CorMedix Chief Executive Officer.  "We recently began shipping Neutrolin to our first hemodialysis customers in Germany.  As we enter 2014, we will be keenly focused on expansion into other targeted EU countries as well as non-European markets that recognize the CE Mark."

About CorMedix

CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product  is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients. Please see the company's website at www.cormedix.com for additional information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: risks of launch and market acceptance of our products; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; CorMedix's ability to maintain its listing on the NYSE MKT; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's ability to enter into and maintain collaborations with third parties for its development programs; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

(Logo: http://photos.prnewswire.com/prnh/20130715/NY47431LOGO)

 


'/>"/>
SOURCE CorMedix Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. CorMedix to Report Third Quarter Financial Results on November 19, 2013
2. CorMedix Inc. Closes $3,000,000 Preferred Stock Offerings
3. CorMedix Reports Receipt of European Patent Office Decision to Allow Prosl Patent to Proceed in European Union
4. CorMedix Reports Second Quarter 2013 Results
5. CorMedix Granted Extension of NYSE MKT Listing
6. Philips receives FDA clearance for First-Ever Spectral Breast Density Measurement Application
7. Caris Life Sciences Receives Tumor Profiling Industrys First ISO 15189 Medical Laboratory Accreditation
8. Synapse Biomedical Receives $2.4 Million
9. Cell Therapeutics Receives Remaining $5 million Under Existing Loan Financing Agreement
10. Mobius Imaging Receives ISO 13485 Certification
11. Oramed Receives Allowance on its Core Oral GLP-1 Technology Patent in Israel
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical Systems ... "Company"), which develops, markets and sells medical devices and ... , signed a strategic cooperation agreement with Hongyuan Supply ... Supply Chain") on June 20, 2016, to develop Dehaier,s ... strategic cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 27, 2016 , ... A revolution is underway. Brooklyn-based ... experience for the millions of people who require these medical transport services annually. ... through the use of technology. Now, SmartEMS has put forth an industry-changing app ...
(Date:6/26/2016)... PLAINSBORO, N.J. (PRWEB) , ... June 27, 2016 , ... ... same sources, yet in many ways they remain in the eye of the beholder, ... Oncology (EBO), a publication of The American Journal of Managed Care. For the full ...
(Date:6/26/2016)... ... , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect ... a whole new perspective by using the title layers in ProSlice Levels to ... ProSlice Levels contains over 30 Different presets to choose from. FCPX users ...
(Date:6/26/2016)... , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal ... personalized through a fitness app. The fitness app plans to fix the two major problems ... offer a one size fits all type program , They don’t eliminate all ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
Breaking Medicine News(10 mins):