US-based CorMedix has secured CE Mark for its Neutrolin, a catheter lock solution designed for patients with central venous catheters on hemodialysis.
Neutrolin has been approved as a Class III device. With the approval, the company can now sell the catheter lock solution in the EU markets.
The Neutrolin solution consists of an anti-coagulant and a broad-spectrum antimicrobial (antibacterial and antifungal), which actively work on common microbes such as antibiotic-resistant strains. In addition, it controls the formation of biofilm.
This device is claimed to considerably minimize the rate of catheter related bloodstream infections (CRBIs) and maintain catheter patency by inhibiting thrombosis, thus minimizing the need for systemic antibiotics and prolonging the life of central venous catheter.
CorMedix CEO Randy Milby said that the receipt of the CE mark for Neutrolin as a Class III device is a significant accomplishment for the company, as this registration required regulatory review against high clinical and manufacturing standards.
"We are well prepared to make this important medical device available to patients with central venous catheters on hemodialysis. We look forward to Neutrolin being widely available in Europe with commercialization efforts led by national sales manager Joachim Petrak and his team at CorMedix Europe GmbH," Milby added.
CorMedix Europe is planning to initially launch Neutrolin in Germany and Austria.
The company is planning to expand the use of Neutrolin in oncology patients who are in need of catheters as well as for additional indications.
CorMedix also received funds from two longtime investors Elliott Management and Kingsbrook Partners in late May, supporting the commercialization of Neutrolin.