These first-in-human studies are aimed at validating the safety and efficacy of the PURE EP System during mapping and ablation procedures in the cardiac EP lab. Mayo Clinic has conducted 12 pre-clinical studies to date using the PURE EP System, results of which have been published in a number of journals, including The Journal of Innovations in Cardiac Rhythm Management. Collected data and physician experience arising from this non-randomized first-in-human study will be documented and presented in the form of publications and lay the foundation for future larger clinical trials.
The Mayo Clinic becomes the second center to launch pilot first-in-human studies ahead of BioSig’s targeted commercial launch of its first product, PURE EP System in 2019. BioSig announced on Nov. 28, 2018, that it began installations of the first systems at Texas Cardiac Arrhythmia Institute in Austin, Texas. BioSig signed a 10-year collaboration agreement with the Mayo Clinic in March 2017 and announced a new research agreement focusing on development of additional advanced features and potential new applications of the PURE EP System late last fall.
The study will be conducted under leadership of K. L. Venkatachalam, M.D., and Samuel J. Asirvatham, M.D., medical director of the Electrophysiology Laboratory.
“We are extremely proud to be working with Dr. Venkatachalam and Dr. Asirvatham on collection of the first-in-human data. Our continued collaboration with Mayo Clinic remains one of our biggest assets, and we couldn’t wish for a better team to launch this new clinical milestone, which is essential to unlocking better treatments for all arrhythmia patients and creating shareholder value for everyone who continues to support our company,” commented Kenneth L. Londoner, chairman and CEO of BioSig Technologies.
The PURE EP System aims to minimize noise and artifacts and acquire high-fidelity cardiac signals. Improving fidelity of acquired cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures. The PURE EP System takes advantage of improvements in hardware design as well as signal processing software to produce better quality signals to distinguish scar from healthy tissue, and also use tissue properties to estimate the force being applied to tissue. These advantages could improve safety and efficacy of ablation procedures. Initial pre-clinical studies have shown the benefits of this approach.
The Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace. Led by a management team and a veteran, independent Board of Directors, Los Angeles, Calif.-based BioSig Technologies is preparing to commercialize its PURE EP System. The technology has been developed to address an unmet need in a large and growing market.
The company’s first product, PURE EP System, is a cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, atrial fibrillation and ventricular tachycardia. BioSig has partnered with Minnetronix on technology development and has received U.S. Food and Drug Administration 510(k) clearance for the PURE EP System in August 2018.