PLC Systems, a company focused on cardiac and vascular medical device-based technologies, has developed a new strategic plan for its RenalGuard program and is implementing additional cost-saving measures as it continues to seek financing for the company.
The company believes that RenalGuard can be effectively and cost-efficiently manufactured through an external contract manufacturer, because the technology platform is stable. And the manufacturing processes are compliant and the product design has benefited from hundreds of examples of usage to date. The new contract manufacturer selected to build RenalGuard is ISO 13485:2003-registered and FDA-compliant.
The company said that the randomised clinical trials to evaluate the use of RenalGuard in the prevention of Contrast-Induced Nephropathy (CIN) are currently underway in Italy.
The results of one of these, the Mythos trial, continues to reinforce RenalGuard’s efficacy, with rates of CIN in the RenalGuard-protected group dramatically lower, at 3.7%, compared to 15% in the control group, based upon data from 114 of 120 patients.
The Mythos trial has completed its original 120 patient enrollment and analysis of the full data is being finalised. The sponsors, who are international experts on CIN, have determined to expand the trial up to 200 patients to gain even stronger scientific proof of the efficacy of RenalGuard in preventing CIN in affected patients.
Mark Tauscher, chief executive officer of PLC, said: “We believe that our RenalGuard technology has value, and working with our Board, we have developed a strategic plan to explore available opportunities to realize and maximize this value for the benefit of the company and its shareholders.
“We are hopeful that the steps we are taking will help expand RenalGuard’s reach and raise visibility among potential partners who can assist us in bringing our innovative technology to more potential customers.”