SAN DIEGO, June 27, 2012 /PRNewswire/ -- Excelsior Medical Corporation has agreed to distribute a statement correcting false claims it made to the market in September of 2011, false statements that prompted Ivera Medical Corporation to file suit against Excelsior for false advertising and unfair competition.
Ivera manufactures, markets, and sells the Curos® Port Protector, a device that disinfects luer-activated needleless IV valves, killing the organisms associated with catheter-related bloodstream infections. Excelsior sells a directly competitive product, SwabCap®, throughout the United States.
On September 19, 2011, Ivera learned that Excelsior was using a "MAUDE Adverse Event Report" filed with the U.S. Food and Drug Administration by a California hospital to orchestrate a mis-information campaign about Curvos. Although a subsequent investigation definitively cleared Curos of any role in the events that precipitated the MAUDE filing, Excelsior's sales representatives used the report to create a false concern that use of Curos caps could present an infection risk to patients. The suit sought an injunction prohibiting Excelsior from making these false and misleading statements.
Under the settlement, Excelsior agreed to cease making false statements about Ivera's products. In addition, Excelsior agreed to issue the following statement regarding its earlier claims relating to the MAUDE report to all parties that had received the misleading information:
"Last Fall Excelsior informed you about a MAUDE report that mentioned Ivera Medical Corporation's Curos product. From that report we incorrectly inferred that Curos was the source of the infections at that facility. We have since learned that Curos was not the source of the infections at that facility, and there is no evidence relating or linking Curos to any increased risk of infection."
This case marks the second time Ivera has sued Excelsior for making false statements to customers and potential customers. In both cases, Excelsior has agreed to issue corrections of its false statements regarding Ivera and its Curos products.
"Disinfection caps are a rapidly emerging market and the clinical and economic benefits to our customers are enormous," said Bob Rogers, Ivera Medical CEO. "We believe in educating the market to enable users to make the best decisions for their practice and patients. It is unfortunate when mis-information serves to slow the adoption of a technology that has been proven to kill the organisms associated with catheter-related bloodstream infections. In this marketplace, we believe superior design and education will win the business."
About Ivera Medical
Ivera Medical Corporation is focused on the design, development, manufacture, marketing and sale of products that help healthcare providers reduce facility-acquired patient infections. Curos, manufactured in Carlsbad, CA, is the first disinfecting cap to be marketed in the U.S. and has received FDA's 510(k) market clearance. For more information about Curos and Ivera Medical, visit the website at www.curos.com.
Chief Executive Officer
Ivera Medical Corp.
SOURCE Ivera Medical Corporation