Although invented 10 years ago, BioSig’s PURE EP System add-on device has had no published clinical data, only bench and animal studies.
The company said they would present clinical data at the Heart Rhythm Society (HRS) conference, but they did not do it, suggesting the data is below expectations.
Cardiologists we have asked have said that there is no need for this add-on, conventional EP machine signals are already clear enough.
Our research reveals that the PURE EP is unnecessary for the treatment of Atrial Fibrillation (AF), which accounts for over 90% of all heart ablations.
2.15M shares for shareholders just got registered to be sold, and the company needs to raise $10s of millions for their upcoming product launch.
See the full report on Seeking Alpha here.