After getting the first European patent recently and also the US method patent for the patient hydration method, PLC has further strengthened the barriers to entry for its RenalGuard technology. Now it has several patents in US, and also patents in Europe, Japan & Canada. The US patent is being considered important as it is an important milestone in the long term objective of making the product a commercial success. The company already had method patents covering matched fluid replacement with diuresis for prevention of Contrast Induced Nephropathy (CIN). Other patents include the concept patents which cover “creating and maintaining equilibrium state urine flow to eliminate iodine”. RenalGuard works by maintaining regular urine output, and simultaneously making up for the fluid loss. The Japanese and the Canadian patents are full technology patents. The patents obtained earlier expire between 2026 and 2029. The potential of the product in CIN is immense as this is a serious fallout of various diagnostic and other procedures. PLC Systems is attempting to make RenalGuard the standard of care in prevention of CIN, and hence needs to make faster progress in the trials in US. That will increase the acceptance of the product around the world, and expand the commercial market. Europe is the main commercial market now, and it is expected that it will expand significantly over the next few years. RenalGuard received good reviews from the cardiologists in the European Association of Percutaneous Cardiovascular Interventions (EAPCI) conference in Europe. The sales have shown improvement, and Zacks had given a PT of $0.35 for the stock in its small cap report in March this year. The tremendous potential of RenalGuard was one of the reasons for the company to sell its Heart Laser in February 2011. Faster progress on the trials is required.
As you said we really need some progress in the US trial. Stock is getting demolished with no bad news except for the absence of any news on the US trial. Where is the interim analysis already? Tauscher said shortly two months ago. They need to move this trial along.
If I recall properly, primary completion was originally supposed to be within a year and a half of treatment of the first patient--which puts it roughly now. But a public interim development, determination of the final sample size, was delayed. I believe they announced a while ago that they had the data on which to base that determination--has anything further happened on that front?
Completion was estimated at 18-24 months which puts it to the end of the year.
I don't recall them saying they already had the data for the interim analysis. I do recall Tauscher saying in the Taglich presentation in early May that the interim analysis was coming shortly (whatever shortly means).