By Brian Marckx, CFA
Japan-based Study to Commence
Yesterday (10/16/2013) PLC Systems Inc (PLCSF) announced that the Japanese Ministry of Health, Labor and Welfare approved the clinical trial that PLCSF and Dr. Ichiro Michishita had previously requested approval of.
As a reminder, In January 2012 PLC announced that Dr. Ichiro Michishita had successfully used RenalGuard with two patients for prevention of CIN at Yokohama <_st13a_placename _w3a_st="on">Sakae Kyosai Hospital in <_st13a_city _w3a_st="on">Yokohama, Japan, where Dr. Michishita serves as the Director of the Cardiovascular Division. The plan forward was for Dr. Michishita to meet with the Japanese Ministry of Health (MHLW) and to use this two-patient data as support in outlining a process for regulatory approval of RenalGuard in that country - with the expectation that MHLW would grant approval to move forward on a ~60- patient Japan-based study.
While yesterday's news of approval to commence this 60-patient study comes later than initially anticipated (initially it was thought the trial could start as early as April 2012), it is a significant event as this Japan-based study is expected to provide the requisite proof of efficacy in order for PLC to sell the device in that country.
The study is single-arm and will enroll 60 patients at two sites. It will evaluate RenalGuard in reducing the incidence of contrast induced nephropathy (CIN) in patients undergoing catheterization procedures (such as percutaneous coronary intervention) and compare these results to the expected rate of CIN.
PLC had previously noted that they expected the study could complete in about 8 - 10 months. Assuming positive results, the company will use this to seek approval to sell the device in Japan, which would significantly expand the geographical target market for RenalGuard. RenalGuard is already available in Europe where sales have been ramping fairly aggressively, including an increase of almost 300% through the first 6 months of the current year.
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