CorMedix, Inc. (NYSE MKT: CRMD) is a commercial-stage biopharmaceutical company seeking to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. The company’s first commercial product, Neutrolin®, is currently marketed in Europe as a catheter lock solution for the prevention of catheter-related bloodstream infections in hemodialysis, oncology and critical care patients. In the coming months, CorMedix plans to expand commercial distribution of Neutrolin into the United States, Asia, the Middle East, South America and Africa following appropriate regulatory approval.
In June, CorMedix took a significant step toward the eventual commercialization of its innovative product in the United States when it received positive feedback from the FDA regarding a second pivotal clinical trial protocol. This protocol is designed to assess Neutrolin as a catheter lock solution in oncology patients who require total parental nutrition. Previously, the FDA also reviewed the company’s phase III clinical trial protocol to evaluate the use of Neutrolin in hemodialysis patients. With this feedback received, CorMedix expects to initiate the corresponding clinical trials in the fourth quarter of this year. Since the company’s product received fast track designation earlier this year, these trials will be eligible for priority review of FDA submissions and accelerated clinical results in the future.
“CorMedix is thankful for the valuable feedback provided by the FDA, and we are encouraged by their continued enthusiasm and support of Neutrolin,” Randy Milby, chief executive officer of CorMedix, stated in a news release. “We are optimistic that this trial will further our efforts to bring Neutrolin to market in the United States so that more patients can benefit from its use.”
Following FDA approval, Neutrolin will provide CorMedix with access to an underserved market within the biopharmaceutical industry. According to the company’s data, central venous catheters are the most frequent cause of healthcare-associated bloodstream infections, accounting for approximately 25 percent of the 1.7 million recorded hospital infections each year. Among these infections, approximately 20 percent are fatal, further demonstrated the immense market potential of the company’s product.
For prospective shareholders, CorMedix’s continued progress toward commercialization of Neutrolin in the United States could foreshadow an opportunity for the company to realize strong financial growth in the months to come. Look for CorMedix to continue preparing for the initiation of two phase III clinical trials moving forward.
For more information, visit www.cormedix.com
