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Neutrolin® granted FDA Fast Track status and is designated as a Qualified Infectious Disease Product

Harnessing taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases

Neutrolin® a novel, non-antibiotic antimicrobial solution in Phase 3 development for the prevention of costly and dangerous bloodstream infections associated with the use of central venous catheters

Neutrolin® granted FDA Fast Track status and is designated as a Qualified Infectious Disease Product

Harnessing taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases

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CorMedix Inc. is a commercial-stage pharmaceutical company focused on harnessing its taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases.

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© 2016 CorMedix Inc. All rights reserved.

400 Connell Drive, 5th Floor
Suite 5000
Berkeley Heights, NJ 07922




CorMedix Inc. is a pharmaceutical company that develops and seeks to commercialize therapeutic products for the treatment of cardiac and renal dysfunction, also known as Cardiorenal disease. Specifically, our goal is to treat kidney disease by reducing the commonly associated cardiovascular and metabolic complications - in effect, "Treating the kidney to treat the heart.

Our therapeutic candidates for cardiorenal disease may be small molecules, biologicals, devices and/or diagnostics (tests) that enable therapy.
 

Cormedix Inc. Announces Positive Results Of Its Neutrolin(R) Phase 3 Lock-It-100 Study Based On Recommendation By Independent Data Safety Monitoring Board

News Provided by Accesswire2018-07-25
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MAJOR DEVELOPMENTS

Statistical Significance Achieved at Interim Analysis

BERKELEY HEIGHTS, NJ / ACCESSWIRE / July 25, 2018 / CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of the data from the currently ongoing Phase 3 LOCK-IT-100 study for Neutrolin®. Because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB recommended the study be terminated early. No safety concerns were reported by the DSMB based on the interim analysis. The company will submit the results of the interim analysis to the U.S. Food and Drug Administration for its review.

"We are thrilled to have received the DSMB's recommendation that efficacy has been demonstrated. Once we have submitted the interim analysis results and DSMB's recommendation to the FDA, we will begin the dialogue on the appropriate next steps," said Khoso Baluch, Chief Executive Officer of CorMedix. "We have invested a significant amount of the Company's resources over the last 2 ½ years in this study, and it is gratifying to have achieved this result based on the interim analysis. We believe Neutrolin has great potential to save lives of patients receiving hemodialysis therapy as a treatment for end-stage renal disease and to lower overall healthcare costs due to reducing the risk of catheter-related blood stream infections (CRBSI)."

The primary endpoint of the Phase 3 LOCK-IT-100 study is reducing the risk of occurrence of CRBSI by Neutrolin relative to the active control of heparin. The secondary endpoints are catheter patency, which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction, and catheter removal for any reason.

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, in a Phase 3 clinical trial enrolling patients undergoing chronic hemodialysis that will be terminated early for efficacy. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels. The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information, visit: www.cormedix.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the LOCK-IT-100 trial, 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, financing plans, 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: the resources needed to terminate the Phase 3 trial and the costs and time needed to submit a new drug application to the FDA; risks related to obtaining FDA approval of the new drug application for Neutrolin; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; relying on preclinical results that may not be indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. 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.

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors
617-535-7746

SOURCE: CorMedix, Inc.

 

© 2018 Accesswire. All Rights Reserved.

Listen to what key opinion leaders have to say.
 
Click here  to listen to what a key opinion leader has to say about contrast induced acute kidney injury and the role catalytic iron and oxidative stress play in cardiovascular disease:
CormedixPeter McCullough, MD, MPH Consultant Cardiologist, Chief Academic and Scientific Officer with St. John Providence CormedixHealth System

Click here to listen to what a key opinion leader has to say about chronic kidney disease and catalytic iron:
CormedixSudir Shah, MD, Professor of Medicine, Director of Nephrology University of Arkansas College of Medicine, Little CormedixRock, AR

Click here to listen to a key opinion leader commenting on catheter related bloodstream infections, how they affect the dialysis patient population and current treatments available:
CormedixMichael Allon, MD, University of Alabama Birmingham, Birmingham Alabama

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CRMD News: Statement of Changes in Beneficial Ownership (4) 05/17/2019 09:25:14 AM
CRMD News: CorMedix Inc. to Present at the 20th Annual B. Riley FBR Institutional Investor Conference 05/16/2019 08:45:00 AM
CRMD News: Quarterly Report (10-q) 05/13/2019 04:47:30 PM
CRMD News: Current Report Filing (8-k) 05/13/2019 04:22:03 PM
CRMD News: CorMedix Inc. Reports First Quarter 2019 Financial Results and Provides Business Update 05/13/2019 04:05:00 PM
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#2222   glacial janeyH 05/19/19 10:43:46 AM
#2221   Nice move the other day. This one is KC01905 05/19/19 07:42:40 AM
#2220   I’m going to look at a few other morserep 05/17/19 01:22:24 PM
#2219   Sad to say I'd almost be averaging down KC01905 05/16/19 09:40:41 PM
#2218   I'm almost afraid to at this point lol. KC01905 05/16/19 06:50:35 PM
#2217   And divide by five janeyH 05/16/19 11:57:32 AM
#2216   6.66 ... what a price lol. Sign of KC01905 05/16/19 08:10:58 AM
#2215   I find that with a lot of biotechs KC01905 05/14/19 09:02:08 AM
#2214   Yup. Khoso and Chew are jokers. They were Rapture2020 05/14/19 08:39:21 AM
#2213   Makes me wish I snagged some profits post KC01905 05/14/19 07:58:01 AM
#2212   ATM for $15M in Q1?!?!?!?! Rapture2020 05/14/19 12:53:08 AM
#2211   Has anyone heard of SOLY yet? The board RichardSawars 05/11/19 11:16:28 AM
#2210   Dud. This won’t move CRMD. Rapture2020 05/11/19 10:49:08 AM
#2209   The published results were from a Boston conference KC01905 05/11/19 06:30:13 AM
#2208   why? janeyH 05/11/19 12:05:15 AM
#2207   So are we expecting a premarket explosion come Monday?!? KC01905 05/10/19 11:02:08 PM
#2206   https://www.biospace.com/article/releases/ground-breaking-studies-presented-to-a Xzano 05/10/19 11:36:25 AM
#2205   https://casehippo.com/Symposium/national-kidney-foundation-2019-spring-clinical- axelvento 05/10/19 09:11:43 AM
#2204   https://s.flashalert.me/C5r7A Xzano 05/10/19 08:31:44 AM
#2203   should get more detail on that new rat experiment proffetti 05/08/19 05:58:05 PM
#2202   Likely a stinker. Khoso will tell us how Rapture2020 05/08/19 04:19:55 PM
#2201   Maybe, but quarterlies are usually pretty mundane and desarcmo 05/08/19 03:24:14 PM
#2200   NEWS Maybe this will be everything and more of rawsteel 05/08/19 10:54:37 AM
#2199   the latest drop from 10 has been done janeyH 05/06/19 08:14:44 PM
#2198   This thing took a beating since the R/S. KC01905 05/06/19 04:37:05 PM
#2197   continued beat down - WTF janeyH 05/06/19 01:22:52 PM
#2196   Ah PR. Got it. Maybe they announce partnership Rapture2020 05/06/19 09:46:58 AM
#2195   what do you mean? janeyH 05/06/19 09:45:32 AM
#2194   What is May 13? Rapture2020 05/06/19 09:45:25 AM
#2193   what do you mean? janeyH 05/06/19 09:41:43 AM
#2192   What happened? Rapture2020 05/06/19 09:40:41 AM
#2191   May 13 report date, you ready for that? janeyH 05/06/19 08:40:30 AM
#2189   Yup. Thanks chew and Khoso for your BS Rapture2020 05/03/19 12:50:54 PM
#2188   getting pummeled janeyH 05/03/19 10:30:03 AM
#2187   CRMD buy 7.87 stocktrademan 04/30/19 10:42:56 AM
#2186   Upcoming Presentation axelvento 04/29/19 11:44:50 PM
#2185   I agree with you completely in regards to morserep 04/29/19 08:21:50 AM
#2184   when we get good news from our less-than-stalwart janeyH 04/26/19 07:18:49 PM
#2183   chill out y’all. let’s not eat our janeyH 04/26/19 07:16:54 PM
#2182   Pre split were at $1.60. What’s the point? Rapture2020 04/26/19 12:21:28 PM
#2181   That's great lol. But we are a far KC01905 04/26/19 11:26:43 AM
#2180   I’ve been here since $.27 so what’s your point? Rapture2020 04/26/19 11:22:16 AM
#2179   I bet you never thought we'd be here KC01905 04/26/19 11:03:45 AM
#2178   https://casehippo.com/Symposium/national-kidney-foundation-2019-spring-clinical- Xzano 04/25/19 03:29:19 PM
#2177   https://casehippo.com/Symposium/national-kidney-foundation-2019-spring-clinical- Xzano 04/25/19 03:29:03 PM
#2176   https://casehippo.com/Symposium/national-kidney-foundation-2019-spring-clinical- Xzano 04/25/19 03:28:33 PM
#2175   https://casehippo.com/Symposium/national-kidney-foundation-2019-spring-clinical- Xzano 04/25/19 03:28:30 PM
#2174   This thing is going down like the Titanic KC01905 04/24/19 02:00:27 PM
#2173   News: $CRMD CorMedix Announces Online Pre-Clinical Abstract at whytestocks 04/22/19 03:31:31 PM
#2172   https://ih.advfn.com/stock-market/AMEX/cormedix-CRMD/stock-news/79736142/cormedi Xzano 04/22/19 09:58:35 AM
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