About BioSig

A new advancement in EP information

The PURE EP™ System from BioSig Technologies™ was designed to improve the clinical information for electrophysiology (EP) studies and cardiac catheter ablation – procedures to test the electrical activity of the heart to find where an abnormal heartbeat originates, and then is destroyed. 

Shortcomings for Existing Arrhythmia Treatments

Drug therapies often ineffective

Procedures for ablation need improvement

  • Anatomical for Paroxysmal Atrial Fibrillation (AFib) – not proven sufficient
  • Additional ablation targets needed for Chronic AFib
  • Insufficient signal quality for both AFib and Ventricular Tachycardia (VT) cases 

Poor signal quality may lead to:

  • Long procedure times -
  • 2-8 hours depending on complexity, clinical experience 

Uncertainty in ablation targets

  • Many undergo multiple procedures
Features-Benfits

Proposed Features and Benefits

Feature Benefit
Records raw unfiltered signal Enables operator to focus on specific areas of interest in real-time without loss of information
Double the bandwidth, much greater resolution Enables system to show critical high frequency and low amplitude information which may reduce need for multiple procedures
Filters and noise cancellation in software Allows extraction of useful clinical information in real-time
Real-time visualization May save money by reducing procedure time

PURE EP System Testimonial

"The improved resolution may translate to better ability to pick up specific signals and relate them to specific structure and substrate."

"The dynamic range of the system is larger - likely will translate into better ability to see both large and small (frequency and amplitude) signals with similar resolutions. This is a major problem with present systems, where in order to see smaller signals, we have to amplify the signals, and in doing so, we lose the ability to see larger signals without saturating these signals."

"The display options are also more intuitive and flexible. For example, different filtering can be applied to the same signal and displayed as separate, simultaneous signals. Presently this is not possible with the existing systems to my knowledge."

Samuel J. Asirvatham

M.D. Mayo Clinic

Path to Market

2017

Q2

Submit Abstracts

AF Symposium

HRS Meeting

Phase 2

Detailed Design Engineering Confidence Testing & Beta Build of 8 units

Q3

Phase 3

Design Refinements Verification Test & Iteration

Q4

FDA 510(k) Submission

2018
Q1

Ongoing Market
Development & Clinical Research

Launch Prep & Production Builds

Q2

Soft Launch

Market Intro

Ongoing Market
Development & Clinical Research

FDA 510(k) Clearance

Launch Prep & Production Builds