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
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