The PURE EP System is a novel platform designed to obtain and display important clinical data during electrophysiology procedures – Precise, Uninterrupted, Real-time evaluations of Electrograms.
Significant Milestones Achieved to Date
- Established clinical and/or advisory relationships for both technology development and prototype studies with physicians and researchers affiliated with the following medical centers:
- Texas Cardiac Arrhythmia Institute
- UCLA Cardiac Arrhythmia Center
- H. Case Medical Center in Cleveland
- William Beaumont Hospital in Michigan
- Mount Sinai Medical Center in NY
- Mayo Clinic in Minnesota
- Tested initial system concept in collaboration with physicians at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas in June 2011.
- Evaluated present electrophysiology recording technology by performing a detailed analysis of the methods currently used to reduce noise and artifacts – especially studied the effect of signal processing on spatiotemporal characteristics of electrocardiograms and intracardiac electrograms.
- Compared the signal quality (amplitude, morphology and duration) obtained by the PURE EP System software with different conventional electrophysiology recording systems presently used in the EP Lab by using a custom built electrocardiogram/intracardiac simulator with a database of various electrophysiology signals.
- The electrocardiogram and intracardiac signals acquired with the PURE EP System contained less baseline wander, noise and artifacts compared to the conventional recording systems.
- Developed visualization tools to assist electrophysiologists in further differentiating true signals from noise.
- Obtained proof of concept testing at UCLA’s EP and Animal labs in 2013.
- Developed the PURE EP System’s proof of concept unit (POC) to demonstrate that the system’s hardware and software have the ability to faithfully record small cardiac signals in an electrophysiology laboratory, and to obtain initial performance results.
- Our proof of concept unit performed well compared to the conventional recording system, in that the electrocardiogram and intracardiac signals displayed on our POC unit showed less baseline wander, noise and artifacts compared to signals displayed on the other recording system.
- Assembled the PURE EP System prototype and have begun testing.
- After analyzing the results obtained with our proof of concept unit, we developed the PURE EP System prototype.
- Performed initial testing in September 2014 at the UCLA Animal lab.
- Conducted a series of preclinical studies in 2015 at Mayo Clinic in Rochester, Minnesota under the leadership of Dr. Samuel Asirvatham, and, several engineering studies at UCLA under the leadership of Drs. Kalyanam Shivkumar and Jason Bradfield. The main objective of these studies has been to demonstrate the clinical potential of PURE EP (not currently obtainable with present recording systems). We intend to publish the results of these studies at industry conferences and peer reviewed journals early in 2016.
We plan to significantly expand our clinical activities and team in 2016 to include additional preclinical studies to further define and evaluate the clinical efficacy of the PURE EP System. This will further enable us to further develop clinical observation noted in earlier studies. We also plan to transition the PURE EP to product development utilizing a local design firm highly experienced in developing and manufacturing medical diagnostic devices. We expect to employ a 510(k) approval process and fully develop a Quality Management System in order to achieve clearance to market from the Food and Drug Administration in the United States.