BioSig's Targets Enormous A-Fib Market With Game-Changing Device

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BioSig Technologies, Inc. (BSGM) is a Minnesota-based medical device company developing a proprietary technology platform designed to improve the rapidly growing $4 billion dollar electrophysiology (EP) marketplace. The company’s leading product is PURE EP™, a novel surface electrocardiogram (EKG) and intracardiac multichannel recording and analysis system designed to assist electrophysiologists during catheter ablation procedures to treat cardiac arrhythmia.

Below is a "Mock Q&A" designed to help investors understand cardiac arrhythmia and atrial fibrillation, the PURE EP system and what the recently published impressive data mean, how and why PURE EP could be a game-changer for electrophysiologists, and what BioSig might be worth if management is successful at bringing PURE EP to market in the next year.

What Is Electrophysiology?

Electrophysiology is the study of the electrical activity of the heart. An electrophysiology study (EPS) is a diagnostic procedure performed by a specialized cardiologist, called an electrophysiologist, with the intent to help understand the nature of an abnormal heart rhythm. The results of an EPS facilitate the assessment of complex arrhythmias, elucidate symptoms, evaluate abnormal EKGs, assess the risk of developing arrhythmias in the future, and design treatment options, which may include pharmaceutical therapy or the surgical implantation of a cardiac defibrillator, pacemaker, or a cardiac ablation procedure. An EPS takes place in an electrophysiology or catheterization (cath) lab, usually under mild sedation.

What Do Electrophysiologist Hope To Learn From An EPS?

The primary diagnostic output of an EPS is an electrogram or intracardiac signal. In essence, an EPS is like an EKG performed from inside the heart through the use of specialized catheters inserted into the femoral artery or vein through small incisions in the inner thigh and guided by x-ray videography into the heart. Small electric pulses through these catheters make the heart beat at different speeds. Electrical signals produced by the heart are picked up by the catheters and recorded. An EPS can last several hours, during which time an immense amount of information is recorded and analyzed. This is called cardiac mapping, and the procedure allows the electrophysiologist to locate where arrhythmias are coming from within the heart or aorta.

What Is Cardiac Arrhythmia?

An arrhythmia is an abnormal heartbeat or a change from the normal sequence of electrical impulses that control the beating (contraction) of the heart. The beating of the heart is caused by an electrical impulse that begins in the sinoatrial node (also called the SA node or sinus node). This is the heart's natural pacemaker. The impulses move in a coordinated way from the right atrium throughout the atria to the atrioventricular (AV) node. From the AV node, electrical impulses travel down a group of specialized fibers called the His-Purkinje system to all parts of the ventricles. This is the exact route that must be followed for the heart to pump in a synchronous matter causing blood to flow through the valves in the proper direction. As long as the electrical impulse is transmitted normally, the heart pumps and beats at a regular pace, sending blood into the pulmonary and systemic circulation.

An arrhythmia occurs when the heart beats outside of a normal coordinated pace, which may include beating too fast or too slow, or in an irregular fashion. There are three main types of arrhythmia:

  • Tachycardia – An abnormally fast heartbeat (usually above 100 beats per minute) at resting rate.
  • Bradycardia – An abnormally slow heartbeat (usually less than 40 beats per minute) at resting rate.
  • Fibrillation – An irregular beat of the heart that may include tachycardia or bradycardia, or the heart beating in a chaotic or quivering fashion.

Atrial fibrillation (AF) is the most common form of arrhythmia. In AF, the electrical impulses do not originate in the SA node. Instead, they come from different parts of the atrium or in the nearby pulmonary veins. The abnormal firing of electrical impulses causes the atria to quiver or beat in a chaotic (irregular and rapid) fashion, which causes the ventricles to pump the blood ineffectively throughout the body. Ineffective pumping may result in blood pooling in atrial appendages that may lead to clot formation.

How Big Is The AF Market?

According to the American Heart Association (AHA), an estimated 2.7 million Americans are living with AF. Untreated AF doubles the risk of cardiovascular-related death and causes a 4-5-fold increase in the risk of stroke due to the potential for clot formation originating from inside the heart or the atrial appendages. According to the U.S. Center for Disease Control and Prevention (CDC), more than 750,000 hospitalizations and 130,000 deaths occur each year in the U.S. because of AF. AF is the underlying cause for 15-20% of ischemic strokes and costs the U.S. an estimated $6 billion in direct medical expense each year.

What Is The Primary Treatment Option For AF?

The primary treatment options for AF include procedures designed to control the heart’s rhythm and rate, medications to reduce the workload of the heart, and/or medications to prevent the formation of clots to reduce the risk of stroke. Electrical cardioversion is a medical procedure where an electrical shock is delivered to the heart through paddles or patches placed on the chest that shock-stop the heart momentarily in hopes that when it resumes at a normal rhythm. Pharmaceutical options for the treatment of AF include antiarrhythmic drugs, calcium channel blockers, beta-blockers, and antiplatelet and/or anticoagulant medications to thin the blood and reduce the risk of clot formation.

For many patients, pharmaceutical options are not sufficient to control the arrhythmia. In these patients, pacemakers or cardiac defibrillators may be surgically implanted to provide low-energy pulses to the heart to restore rhythm and monitor the heart to prevent sudden cardiac arrest. In the U.S., over 225,000 pacemakers and 135,000 cardiac defibrillators are implanted each year.

What If Pharmaceuticals and Cardioversion Fail?

Medications and cardioversion to control atrial fibrillation are not always effective. In these cases, a cardiologist may perform a procedure to ablate the area of heart tissue that's causing the erratic electrical signals in an effort to restore the heart to a normal rhythm. This is done by the use of specialized catheters that deliver radiofrequency energy, extreme cold (cryotherapy), or heat to ablate small areas of the heart, either by isolating or destroying the tissue causing the asynchronous signal. This corrects the arrhythmia without the need for medications or implantable devices.

However, determining the exact tissue to isolate that is causing the erratic electrical signals is paramount to a successful catheter ablation procedure, hence the importance of the cardiac mapping and real-time information noted above during the electrophysiology study. A surgeon looking to remove a cancerous tumor must remove the entire tumor or the risk of recurrence is high. The concept is similar during an ablation procedure. The entire area responsible for asynchronous signal must be isolated or destroyed or fibrillation will remain. That being said, electrophysiologists clearly do not want to over-ablate heart tissue in fear of excess scar formation or loss of heart function. It's a delicate balance.

What Type of High-Tech Equipment Is Necessary For Cardiac Ablation?

Highly fidelity 3D cardiac mapping can only be obtained through the use of a cutting-edge diagnostic software and hardware system employed by the electrophysiologist during the EPS. The system helps the electrophysiologist in locating the defective tissue and in monitoring target ablation sites in real-time.

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