CorMedix Inc (CRMD)

[rmgillis]

Heparin is purely for patency. It has no effect on Catheter related bloodstream infections (CRSBIs). Defencath (formerly Neutrolin) includes heparin as one of its main constituent. Taurodoline is the anti-infective component in Defencath- it uniquely prevents biofilm which allows infections to gain a foothold in the bloodstream.. . In Europe TauroPharm (German company) sells a virtually identical catheter lock they call TauroLock. It was originally licensed to them by the predecessor company of Cormedix, BioLink. Because the catheter lock solution is deemed a "device" and not a drug in Europe as it is in the USA (courtesy of the FDA) it didn't have to go through the arduous FDA approval process. Cormedix was unable to stop TauroLock from continuing to sell their product without permission or royalty in the German courts. There are a number of copycats in Europe where the market entry barriers are much lower.

Now that CRMD has the exclusive FDA approval for the only catheter lock solution approved in the US, they will enjoy many years without competition. Once they have enough revenue they will commence an Oncology trial which has many times the market potential of the diabetes catheter lock solution market -- which is essentially new diabetes patients starting dialysis while they wait for maturation of an AV graft that will result in a fistula for further dialysis access. There are also always ESRD (end stage renal disease) patients who are not fistula candidates who must remain on catheters for all of their dialysis sessions - these unfortunate patients will need Defencath to protect their indwelling catheters from infection and biofilm for their remaining lifetimes. Life expectancy and quality of life with Defencath should be much better for these patients.