QualityStocks would like to highlight PLC Systems, Inc. (OTCBB: PLCSF). PLC Systems, headquartered in Milford, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC's newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain imaging procedures. The Product is CE-marked and is being marketed in Europe and selected countries around the world.
In the company’s news yesterday,
PLC Systems Inc. announced it has inked an agreement with ACIST Medical Systems Inc., a leading developer of innovative and advanced contrast imaging systems for the cardiology and radiology fields, in which ACIST will distribute PLC’s innovative RenalGuard System™ in the EU.
Per the agreement, ACIST will exclusively distribute RenalGuard in France and Germany, significantly expanding PLC’s distribution throughout Europe, where the company has received the CE mark for RenalGuard.
“Today’s news is a critical catalyst to enable PLC to expand the use of RenalGuard in the largest countries in Europe,” Mark R. Tauscher, president and CEO of PLC stated in the press release. “ACIST brings enormous credibility to our effort to increase the number of patients who can access RenalGuard. We’re confident that in partnership with them, we’ll be able to reach many more hospitals and healthcare institutions to allow clinicians to utilize RenalGuard to protect patients.”
Positive results from investigator-sponsored clinical trials of RenalGuard demonstrate the device as superior to current standard of care in the prevention of Contrast-Induced Nephropathy (CIN), a potentially fatal injury to the kidneys in at-risk patients who undergo certain imaging procedures. According to PLC, on an annual, global scale, more than 15 percent of the more than 7 million patients who undergo imaging procedures are considered at-risk of CIN.
PLC already has secured distribution agreements for RenalGuard in Italy, Spain, Portugal, The Netherlands, Austria, Belgium, Croatia, Luxembourg, Monaco and Switzerland in Europe, among other select other countries around the world.
Though RenalGuard has not yet been approved by the U.S. Food and Drug Administration, PLC is preparing to conduct a U.S. pivotal trial of the device, to market and sell RenalGuard in the states.
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