Canadian officials have approved a patent application by PLC Systems Inc., the Franklin, Mass.-based company developing the RenalGuard therapy system to prevent contrast-induced nephropathy.
The decision by the Canadian Intellectual Property Office marks the first patent approval for RenalGuard in any country, according to the company.
The U.S. Food & Drug Administration gave PLC permission to significantly expand testing of the RenalGuard device in November 2008, adding an extra 160 patients to the 246 subjects participating in a clinical trial. Randomized controlled trials are now underway at about 30 U.S. sites.
Contrast-induced nephropathy is a severe reaction in certain patients to iodinated contrast dyes used in diagnostic imaging and interventional procedures such as angiography. It is believed to be the third-most common cause of renal failure in high-risk patients. RenalGuard works by helping the body produce additional urine during procedures and flushing potential toxins out of the body.
PLC posted a $358,000 net loss on about $1.3 million in sales during the three months ended March 31.