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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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#833  Sticky Note 7/25/18 News - Cormedix Inc. Announces Positive Results dshade 08/02/18 10:47:45 AM
#1429   Neutrolin -antibiotic antimicrobial solution designed to prevent costly axelvento 10/22/18 10:19:39 AM
#1428   'Neutrolin has both fast track and QIDP status. axelvento 10/22/18 04:08:02 AM
#1427   'Rap' GLTY this week. A whole lotta' shaking H2004 10/22/18 12:42:44 AM
#1421   YW. Rapture2020 10/21/18 12:24:35 PM
#1420   Tittilator, shhhhhh. Go CRMD! Big week ahead. Watch. Rapture2020 10/21/18 12:01:28 PM
#1419   Big gap up tomorrow. $2 by Friday! rancher64 10/21/18 11:48:07 AM
#1418   It totally could! But could it take a tilator 10/21/18 11:35:31 AM
#1417   Yeah, it is. Of course, I was speaking Rapture2020 10/21/18 11:08:43 AM
#1416   It totally could! But could it take a Rapture2020 10/21/18 11:02:58 AM
#1415   Thanks clay for the update!! Sure tells Bionic Man 10/21/18 09:52:10 AM
#1414   tilator, I appreciate your posts...I hope you will couldbebetter 10/21/18 09:28:34 AM
#1413   it’s not worth wasting my time tilator 10/21/18 03:19:02 AM
#1412   titalating, please just stop posting. You are so Rapture2020 10/20/18 08:18:29 PM
#1411   Here is a direct competitor: tilator 10/20/18 04:21:44 PM
#1410   Lol Impacto 10/19/18 06:10:56 PM
#1409   * * $CRMD Video Chart 10-19-18 * * ClayTrader 10/19/18 04:41:33 PM
#1407   the price will increase axelvento 10/19/18 01:09:38 PM
#1406   I suppose you have read this too: tilator 10/19/18 12:45:17 PM
#1405   next news --- axelvento 10/19/18 11:22:48 AM
#1404   This ticker is really getting CRMD today. Bionic Man 10/19/18 09:50:59 AM
#1403   news fda Q4!!!!! axelvento 10/19/18 09:25:35 AM
#1402   Wow, pre market, shows this tanking. I Bionic Man 10/19/18 09:22:02 AM
#1401   Yeah those call options are looking better and Lazerking40 10/19/18 09:20:12 AM
#1399   Basically, yes. Warrants holders exercised their right Lazerking40 10/19/18 09:13:59 AM
#1397   * * $CRMD Video Chart 10-18-18 * * ClayTrader 10/18/18 05:39:40 PM
#1396   WTH? Supernova12 10/18/18 04:03:05 PM
#1395   So you had to quote her eh tilator? proffetti 10/18/18 03:01:29 PM
#1394   what are we? your DD team? tilator 10/18/18 02:15:34 PM
#1393   what are we? your DD team? janeyH 10/18/18 01:57:52 PM
#1392   Does this mean, they have some 15M$ more tilator 10/18/18 12:51:15 PM
#1391   Can ya say volatile? $CRMD Good things await here.. Supernova12 10/18/18 11:58:55 AM
#1390   nice . bouncer$$$$$$ ; On October 15, axelvento 10/18/18 08:44:18 AM
#1389   Straight from their website: "No new shares are janeyH 10/18/18 08:44:17 AM
#1388   Great update on website, re: no dilution w/those Rapture2020 10/18/18 08:30:42 AM
#1387   Center of the 30day bullish channel is $2. proffetti 10/17/18 04:04:43 PM
#1386   same. Added yesterday. janeyH 10/17/18 12:43:42 PM
#1385   This is holding well. axelvento 10/17/18 09:34:57 AM
#1384   Added to my position yesterday at the close. Market LasNubes 10/17/18 08:52:32 AM
#1383   Still rebounding nicely in aftermarket trading Supernova12 10/16/18 05:36:11 PM
#1382   It’s held up well. Hope it’s a strong Rapture2020 10/16/18 03:09:26 PM
#1381   $CRMD Supernova12 10/16/18 01:24:32 PM
#1380   .75 - 1.15 - 1.45 - 1.85 proffetti 10/16/18 01:03:09 PM
#1379   Fell right back to the top of the proffetti 10/16/18 12:56:13 PM
#1378   Yay! Go back to StockTwits and congratulate yourself. Rapture2020 10/16/18 10:03:44 AM
#1377   Lazer, I agree with your #3. Some entity Idunno 10/16/18 09:53:42 AM
#1376   perfect exit!!!! always sell above bands!! TrendTrade2016 10/16/18 09:32:12 AM
#1375   Sweet! Glad to hear from you. Volatility is Rapture2020 10/16/18 09:25:09 AM
#1374   Hey guys - Haven't posted for a while Lazerking40 10/16/18 09:07:10 AM
#1373   Picked up some shares at real bargain prices Supernova12 10/16/18 08:41:12 AM
#1372   Good analysis. Too bad this can’t be summed Rapture2020 10/16/18 08:40:00 AM
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