Neutrolin -antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters.
FDA Fast Track status and is designated as a Qualified Infectious Disease Product.
10.5 years of market exclusivity.
PHASE 3 STOPPED FOR EFFICACY
LOCK-IT-100, is a multicenter, randomized, double-blind, active control trial aiming to demonstrate efficacy / safety of Neutrolin in preventing CRBSIs, in subjects receiving hemodialysis therapy as treatment for end stage renal disease.
In July 2018, DSMB recommended to stop the study for efficacy and had no safety concerns, at the Interim Review.
****FDA meeting planned Q4 2018 to agree on next steps to complete Neutrolin development plan.
SIGNIFICANT MARKET OPPORTUNITY
More than 400m vials of catheter lock solutions consumed in the U.S. for all indications every year.
Approved in Europe via CE Mark for use in multiple indications requiring use of central venous catheters.
TAUROLIDINE TECHNOLOGY PLATFORM
Developing a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels.
Developing pipeline for oncology as taurolidine may enhance activity of oncologic agents.
KEY BENEFITS OF NEUTROLIN®
Prevents and reduces bloodstream infection. Bacteria and fungi, Antibiotic- resistant strains, No reported resistance in a clinical setting
Neutrolin ® is used to fill catheter lumens when they are not in use, keeping them sterile and preventing microbial colonization and biofilm formation
CORMEDIX
Inhibits peptide crosslinking in microbial cell walls
Neutralizes endotoxins, exotoxins, and lipopolysaccharides released by bacteria
Reduces thrombosis; optimizes catheter patency and reduces expensive catheter complications
CRBSI is Life-Threatening
MULTIDOLLAR$$$$$$$
