It Believes that Its Catheter Lock Solution is Well Positioned to Unlock Significant Shareholder Value
pennyomega Newsletter
(Mailing list information, including instructions, is located at the end of this message.)
CorMedix Inc. (CRMD)
CRMD 's Neutrolin(R) is a catheter lock solution for the prevention of catheter-related bloodstream infections (CRBI), and maintenance of catheter patency in Hemodialysis patients.
CRMD believes that using Neutrolin as a catheter lock solution will significantly reduce the incidence of CRBIs, thus reducing the need for local and systemic antibiotics while prolonging catheter life.
CRMD reported the progress of on-going discussions with the U.S. Food and Drug Administration (FDA) for a planned pivotal Phase 3 randomized controlled trial for Neutrolin for use in hemodialysis patients with a central venous catheter.
CRMD worked with the FDA to develop the protocol design for the planned trial for a marketing application. Based on FDA input, the planned Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program.
CRMD has earlier submitted detailed information to TUV-SUD for the purpose of advancing its label expansion in the European Union to include oncology, total parenteral nutrition and intensive care patients.
CRMD believes that Neutrolin is well positioned to unlock significant shareholder value.
CRMD 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. CRMD 's first commercial product in Germany is Neutrolin(R), 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.
More about CorMedix Inc. (CRMD) at www.pennyomega.com/disclaimer
pennyomega.com
No related posts.