We intend to conduct formal animal studies and ini

We intend to conduct formal animal studies and initial human clinical trials using the PURE EP System prototype, using formal protocol and study designs. These formal animal studies and human clinical trials are intended to demonstrate the clinical relevance of the PURE EP System and its advantages as compared to electrophysiology recorders currently on the market, which we believe will demonstrate the value of the PURE EP System to physicians and clinicians. Our objective is to complete all studies by the first quarter of 2015. We have also begun planning and implementing steps for obtaining 510(k) approval from the U.S. Food and Drug Administration for the PURE EP System. We believe that by the second half of 2015, we will have obtained 510(k) marketing clearance from the FDA and will be able to commence marketing and commercialization of the PURE EP System. Our ability to achieve the aforementioned milestones will be principally determined by our ability to obtain necessary financing and regulatory approvals, among other factors.


Animal studies already commenced:

"The Company has already achieved proof of concept validation through UCLA EP & Animal Labs ongoing from May 2013, and is collaborating with several of the nation's most prestigious cardiac arrhythmia centers ranging from UCLA Cardiac Arrhythmia Center to Mayo Clinic in Minnesota."
http://irdirect.net/pr/release/id/1001780

"we plan to build on the initial research we have conducted at the UCLA Cardiac Arrhythmia Center by performing additional animal studies that compare the current state of the art with our PURE EP System. "
http://irdirect.net/pr/release/id/987073