CorMedix Inc. (NYSEMKT:CRMD) announced its lead product, Neutrolin Catheter Lock Solution, has received the Food and Drug Administrations Qualified Infectious Disease Product (QIDP) designation. The product is used for oncology, hemodialysis and ICU patients. It addresses the issue of blood stream infections with catheter wearing patients which can be life-threatening. The product can now attain benefits including a FDA priority review, that could fast-track it to final FDA approval for sales and marketing. The product will also receive a five-year extension of its Hatch-Waxman patent exclusivity.
The product is a result of the combination of taurolidine, citrate and heparin 1000. It creates a solution that decreases the threat of infection by triple the normal rates. It also fights against thrombosis and biofilm to allow the catheter to function safely. It optimizes blood flow within the catheter. The product already has a CE mark approval allowing its use in the European Union and has been approved for phase 3 testing in the US
The company wants to bring the product to market as quickly as possible as it continues to prove its safety and effectiveness in all phases of testing. Catheter infections are a common and serious condition that needs to be addressed and CorMedix Inc. (NYSEMKT:CRMD)’s product will offer positives for both patients and investors in CorMedix.
Treatments and products that receive the QIDP designation need to be proven to focus on a serious or life-threatening infection or condition. They must address qualified pathogens and Neutrolin has shown an ability to produce positive antimicrobial activity against most of these pathogens which include Staphylococcus aureus, Streptococcus and Pseudomonas species, to name a few. Blood-stream infections can be very serious issues for catheter users and are often life-threatening and hard to prevent.
The stock has raced to its 52-week high in the last couple of days and is looking to find a base. The new designation and fast-track status make the possibility of the release of CorMedix Inc. (NYSEMKT:CRMD)’s product imminent and investors are racing in.