BioSig Technologies is set to conduct first-in-human studies using the PURE EP System, a biomedical signal processing platform designed for electrophysiology (EP) requirements.
The company has signed an agreement with the Texas Cardiac Arrhythmia Institute (TCAI ) at St. David’s Medical Center to carry out the initiative.
The PURE EP System is designed to procure, filter, measure and display electrocardiographic and intracardiac signals for patients undergoing EP procedures. It is also capable of recording and storing the signals.
BioSig Technologies has developed the device to minimise noise and acquire high-fidelity cardiac signals, thereby enhancing their diagnostic value and improving the efficiency of the EP studies.
Additionally, the device is also expected to facilitate decision-making procedures by helping in the diagnosis of patients with abnormal heart rates and rhythms.
Through the first-in-human studies, the company aims to validate the key value proposition elements of the PURE EP System that was established during the pre-clinical studies.
It is also expected to help the company in commercialising the PURE EP System.
Dr Andrea Natale, executive medical director, TCAI at St. David’s Medical Center will conduct the First-in-Human study.
Dr Natale said: “To better understand complex arrhythmia disease states, the ability to detect the smallest of electrical activity in various clinical situations has been a critical need for our industry.
“I am looking forward to the possibility that the PURE EP System will uncover these signals and advance treatment options so physicians can make more informed decisions for our patients.”
All data including physician experience from the study will be documented. Subsequently, it will be presented in the form of publications and clinical abstracts.
In August this year, BioSig received FDA 510(k) clearance for the PURE EP System.