BioSig Technologies, Inc. (web site) is a medical device company with proprietary, patent-pending technology which addresses a well-documented, yet unsolved problem in the rapidly growing $3 billion electrophysiology (EP) marketplace. The company has a unique platform to minimize noise and artifacts from cardiac recordings during electrophysiology studies and ablation. Its product under development includes PURE (Precise Uninterrupted Real-time evaluation of Electrograms) EP system, a surface electrocardiogram and intracardiac multichannel recording and analysis system that acquires, processes, and displays electrocardiogram and electrograms required during electrophysiology studies and ablation procedures. The company is also developing a library of software tools that are designed to be configured to fit the needs of electrophysiologists in various settings and/or for arrhythmia treatments.
BioSig Technologies was founded in 2009 and is headquartered in Minneapolis, Minnesota.
Shares outstanding: 17 million
Recent price: $1.29
Market cap: $ 21.9 million
Insider ownership: 50%
Float: 6 million
With a novel product nearing commercialization which addresses a need in the global cardiology market, BioSig Technologies became public by filing an S-1 registration statement for an IPO, and began trading in November of 2014. Insiders have been buying shares regularly, (see recent transactions), and the process of uplisting to NASDAQ has begun. Uplisting to NASDAQ is projected to be completed in “early 2016“.
The Electrophysiology Market
Cardiac arrhythmias (abnormal heart rhythms) are a common problem. It’s estimated that between 3 and 6 million patients in the U.S. alone have atrial fibrillation, the most frequently seen cardiac arrhythmia. If left untreated, atrial fibrillation can cause chronic fatigue, heart failure, or even a stroke. More than 750,000 hospitalizations occur each year because of atrial fibrillation and the condition contributes to an estimated 130,000 deaths annually. Unfortunately, the death rate from this abnormal heart rhythm as the primary or a contributing cause of death has been rising for more than two decades according to the CDC. Atrial fibrillation costs the United States about $6 billion each year, and the medical costs for people who have the rhythm disturbance are about $8,705/year. Other, more serious cardiac arrhythmias include ventricular tachycardia and ventricular fibrillation, where the lower heart chambers just quiver and the heart doesn’t pump any blood, causing cardiac arrest and sudden death.
An electrophysiology study (or EP study) is a diagnostic procedure performed to locate and map out where an arrhythmia such as atrial fibrillation is coming from within the heart’s conduction system. Cardiologists who specialize in heart rhythm abnormalities are called electrophysiologists, and they use EP studies to determine if a patient needs medicine, a pacemaker, cardiac ablation surgery, or an implanted cardioverter defibrillator.
The addressable market also includes cardiac ablation, an invasive procedure performed to correct abnormal heart rhythms by terminating a faulty electrical pathway(s) from microscopic sections of the heart. Cardiac ablation is used when pharmaceutical options to treat rhythm problems have failed and has a 90% success rate of curing cardiac rhythm abnormalities according to The American Heart Association.
Still in its infancy, the EP device market is seeing significant growth as more physicians become experienced in EP study and cardiac ablation techniques, increasing numbers of hospitals purchase supportive equipment, and patient outcomes improve.
The global EP market is estimated to grow at a significant CAGR of 10.3% from 2014 to 2019, making it one of the fastest growing medical device segments. Once found in only large metropolitan areas, EP labs are becoming commonplace in small and mid-sized cities throughout the U.S. as America’s baby boomers continue to age. While about half of the EP labs in the world are currently located in the U.S., hospitals in Canada, South America, Europe and Asia are rapidly adopting the technology.
The product BioSig Technologies is on the verge of commercializing addresses both the EP study (electrical mapping and diagnostic) branch of the market, and the cardiac ablation (definitive treatment) branch of the market.
The Problem of Noise and Artifact in EP Studies and Cardiac Ablations
Prior to my investing career, I was directly involved in EP studies and cardiac ablations as the manager of a coronary care unit and later as director of intensive care in a large hospital system in Florida. I can speak with firsthand knowledge that a persistent challenge in EP studies and cardiac ablation procedures is the presence of what is called “noise” or “artifact” encountered while recording the electrical activity of the heart. This signal noise can be caused by electrical interference coming from other equipment in the room, the patient’s own minute, involuntary muscle contractions, offset signals produced by the electrodes themselves, and artifact signals produced by the interaction of body fluids and the electrode gel.
To date there is no complete solution for eliminating noise and artifact, and signal processing in the EP lab remains a challenge. This is where BioSig Technologies comes in, with what may be the perfect solution for dealing with noise and artifact in the EP lab.
The Solution from BioSig Technologies
With 7.5 years of development, BioSig has a system unlike anything else on the market to correct the problem of noise and artifact in the EP lab. The PURE ( Precise, Uninterrupted, Real-time evaluations of Electrograms) EP System was developed using proprietary technology that (among other advances) converts the analog to digital signal at 2-3X the sampling rate of the most precise and advanced EP equipment now available. During proof of concept testing, the electrocardiogram and intracardiac signals produced by the PURE EP System were shown to have less baseline wander, noise and artifacts compared to signals displayed on other recording systems.
BioSig conducted a series of preclinical studies in 2015 at the Mayo Clinic in Rochester, Minnesota and engineering studies at UCLA. The main objective of the studies was to demonstrate the superior clinical potential of PURE EP which is not currently obtainable with present recording systems. BioSig will publish the results of these studies at industry conferences and peer reviewed journals early this year.
The PURE EP System gives electrophysiologists information and data that is unobtainable from any other EP device today, including:
- proprietary hardware and dramatically improved signal processing capabilities
- ability to open multiple review windows
- assisting in clinical decision making in real-time
- maximizing ablation efficacy & minimizing need for repeat procedures
- shorter and & simplified EP procedures
Today’s health care system is extremely focused on improving patient outcomes, minimizing complications and repeat procedures, (which in turn decreases length of stay). Management believes that the PURE EP System will contribute to an increase in the number of successful ablation procedures performed in each electrophysiology lab thereby substantially raising the value of the platform among EP labs.
The length of time to perform an ablation can vary widely, but is typically 3-6 hours. In addition to the patient’s particular rhythm disturbance, ablation procedure time is dependent upon how quickly and thoroughly the electrophysiologist can reproduce the rhythm disturbance in the lab, and then to “ablate”, or destroy the offending electrical pathway that is causing the rhythm disturbance. To eliminate the atrial fibrillation for example, a typical patient requires between 150 and 250 different micro areas to be cauterized! The PURE EP System shortens the “reset” time between each micro-cauterization by more rapidly acquiring a clean rhythm signal with zero noise or artifact. With a reduction in ablation procedure times, EP lab efficiency and turnover are improved, thereby driving demand from hospitals and electrophysiologists.
In the near term, BioSig plans to file with the FDA for 510(k) clearance, (new medical device premarket notification), which management believes will be granted in 2016. In a December shareholder letter Kenneth Londoner, (Chairman), and Greg Cash (President and CEO) stated:
“Management is actively preparing for the commercial launch of PURE EP…and will do everything possible to drive timelines as aggressively as possible without compromising quality and regulatory rigor.”
Full scale commercialization is projected for early 2017.
Proven Management Team Collaborating With World–Renowned Testing Centers
BioSig Technologies is collaborating with several of the nation’s most prestigious cardiac arrhythmia centers including:
BioSig Technologies has multiple upcoming catalysts that will increase awareness of the company in the medical and investor communities. These catalysts include:
- Q2 2016 NASDAQ Uplisting
- Mayo Clinic Peer Review Cardiology Journal Q2 2016
- Engineering Journal Feb/March 2016
- Heart Rhythm Society May 2016
- Sell Side Research/Conferences
- FDA 510(k) Submission Q4 2016
The company has a proprietary, patent pending device that addresses an unmet need in the high growth electrophysiology market.
With the stock market off to such a rough start in 2016, many individual investors along with institutions will be looking for defensive positions in health care and medical device stocks.
A near-term uplisting to NASDAQ should drive increased investor awareness and institutional participation.
As a result we believe taking a position in BSGM shares soon is the “Buy Low” part of the buy low/sell high equation.
See also: February 2016 Investor Presentation
Disclosure: receipt of of $20,000 from Star Media LLC.