Jul 25, 2023
Joe Todisco, CEO of CorMedix, is developing a product that has broad spectrum activity against bacteria and fungus to impact the safety of receiving hemodialysis through a central venous catheter. With the recent acceptance by the FDA of the submission for DefenCath, CorMedix is hopeful of obtaining FDA approval for this therapeutic to prevent bloodstream infections. Since the active ingredient is not an antibiotic, the drug does not further the problem of antibiotic resistance.
Joe explains, "The lead indication for the product is for the reduction in risk associated with catheter-related bloodstream infections in hemodialysis patients undergoing hemodialysis with a central venous catheter, CVC. Catheter-related bloodstream infections, or CRBSIs, are one of the most severe adverse consequences associated with getting hemodialysis through a CVC. The incidence rate in the general population is about 25% to 33%, and they can be fatal up to 25% of the time. So it's a critical unmet medical need. There is no current FDA approved therapeutic for the prevention of bloodstream infection in this patient population or any population, and we're hopeful to obtain FDA approval as a first-in-class therapy."
"DefenCath is what's called a catheter lock solution. As I said, it's investigational. It has not received FDA approval yet. But it is designed to sit in the catheter between dialysis sessions or times that a catheter is accessed. We're pursuing our initial approval for the hemodialysis patient population. Still, the hope is to expand the label post-approval into some other therapeutic areas where patients have high levels of infection and high rates of catheterization. But the product sits in the catheter in between dialysis sessions. It's a combination of heparin, which is an anticoagulant, and our proprietary molecule, Taurolidine. Taurolidine is a molecule with the unique properties of being a non-antibiotic antimicrobial with broad-spectrum activity."
#CorMedix #CRBSI #CLABSI #Dialysis #Infections #BloodstreamInfections #HealthcareInnovation