BioSig Issues Special Letter to Shareholders

Los Angeles, CA / ACCESSWIRE / November 10, 2014 / BioSig Technologies, Inc. (OTCQB: BSGM) today issued the following Special Letter to Shareholders from its Chief Executive Officer, Gregory D. Cash.

Dear Shareholder:

BioSig's recent transition to a publicly traded company was a major milestone for our company. I would like to thank our many long-term shareholders for their support, welcome our new shareholders and take this opportunity to discuss our market position, strategy and goals for the next twelve months.

Following over three years of R&D, and substantial financial investment, we have developed a next-generation Electrophysiology (EP) Information System - the PURE EP^TM System -- that we expect will greatly improve the $3 billion EP marketplace¹.

The PURE EP System acquires and displays high fidelity intracardiac & electrocardiogram (ECG) signals, and provides additional information to assist electrophysiologists in making clinical decisions during cardiac catheter ablation procedures.

The PURE EP System's technology platform has been demonstrated at a number of leading US teaching hospitals and research centers including the Texas Cardiac Arrhythmia Institute, U.H. Case Med Center in Cleveland, UCLA Cardiac Arrhythmia Center and Mount Sinai Med Center in New York City. We are planning to begin its commercial launch in 2016.

The Problem: Heart Disease, Cardiac Arrhythmias and AF & VT
PURE EP is designed to dramatically improve the treatment protocols, and outcomes, for treating cardiac arrhythmias, which are broadly defined as a set of conditions in which the electrical activity of the heart is irregular, or faster or slower than normal. This type of heart disease afflicts 14.4 million Americans, or one in 18 ². Two of the most prevalent and deadly types of arrhythmias today are: Atrial Fibrillation (AF) and Ventricular Tachycardia (VT).

According to the American Heart Association (AHA), AF increases an individual's risk of stroke four to five-fold which is the fourth leading cause of death in the US. It is the most common arrhythmia with 2.7 million cases in 2010, forecast to grow to 5.6 million cases by 2050. In the US alone, this leads to about 600,000 hospitalizations/year with a direct cost of about $6 billion annually and, adding indirect costs, brings the AF total cost to $26 billion ². VT and Ventricular Fibrillation arerapidly fatal if not reversed, and account for over 350,000 sudden cardiac deaths annually (AHA).

At a clinical level, there are two primary classes of treatment for AF, drugs and cardiac catheter ablation. Anti-arrhythmic drug therapies have limited effectiveness, driving demand for catheter ablation.

Cardiac ablation is a procedure performed to correct conduction of electrical impulses in the heart that cause arrhythmias. It requires a board certified cardiac electrophysiologist to obtain highly detailed, real-time intracardiac and ECG signals to pinpoint the location of the malfunctioning heart tissue and then use a heated instrument (catheter), to burn and scar just that tissue to disrupt and halt the abnormal electrical signals affecting the heart rate.  In the US, these ablation procedures range in price from $6,000 to $15,000 each and are routinely insured. The hospital's choice of the cardiac equipment it uses in its EP treatment lab is irrelevant to insurers, so reimbursement is not an issue; however it is a major factor in a hospital's clinical EP results, costs, patient throughput and ability to treat complex cases.

The main clinical problem is high post-ablation recurrence rates ranging from 31% to 46%³ for AF, along with long procedure times of two to eight hours. Current solutions alter the acquired signal morphology rendering it less useful. This is where our PURE EP System adds such high value to the clinicians and their hospitals.

The Solution: PURE EP^TM
The success of cardiac catheter ablation is dependent on the quality of ECG and intracardiac signals. PURE EP is the only system dedicated to improving cardiac signal recordings and providing Confidence Indexes for improved diagnoses and treatments of cardiac arrhythmias. Our PURE EP System is designed to be a true, next generation of technology, one that:

- Preserves morphology of the patient's cardiac signal recordings

- Visualizes crucial information in real-time

- Improves procedure efficiency by eliminating need for manual data validation using PURE EP's Confidence Indexes (CI)

- Uses our Confidence Indexes to assist clinical decision-making for improved ablation outcomes

We will file a 510(k) application with the US FDA for the PURE EP System. Because our system can be considered a next generation of an already, well-established diagnostic device (EP recording system), - greatly enhanced with our proprietary, highly sophisticated software and algorithms added --  we believe it will be classified as a 510(k) regulatory path with no requirement for clinical data vs. the majority of novel cardiac technologies requiring long, expensive Pre Market Approvals. Without speculating on our approval process I can say that, typically it takes five to nine months to receive approval of a 510(k) application.

BioSig Management
As your new CEO, I will briefly describe my background to provide context for why I am so confident in the future of BioSig and our PURE EP System. I have over 30 years of successful executive experience in medical technology, most of it in the cardiac segment. Prior to BioSig, I was CEO of Argent International, a life sciences consulting firm. Previous positions include CEO of NeuroTherm, CEO of HeartSine Technologies, and CEO and a director of Nasdaq-listed Vasomedical. Earlier in my career, I spent five years with Boston Scientific, ultimately as VP, Cardiology Sales and Marketing, Europe.  I began my career at Medtronic serving 14 years in increasingly senior sales and marketing positions.

I know this market sector well, and have led other companies from prototype to successful commercialization. When I first looked at BioSig, met with our Executive Chairman and Co-founder Ken Londoner, I knew from the start that this is a company I had to join and lead into commercialization and sales. BioSig has one of the more accomplished senior management teams and Boards I have ever seen for a company at this stage; I invite you to peruse them at: www.biosigtech.com/about-us.  I am pleased to note that with his long-term track record as a successful Wall Street money manager, Ken has also agreed to serve as our envoy to Wall Street.

Our business plan today provides a capital efficient path to sales and profitability, where we face a large market with pent-up demand.

Fast-Growing, $3B Addressable Market
Analysts forecast the global market for EP devices to more than double from $2.5 billion in 2012, with a 12.1% compound annual rate, and rising to $5.5 billion by 2019¹ - making it one of the fastest growing medical device segments⁵. Just in the US, the number of AF and VT ablations is forecast to grow at 10.5 percent from 2012 to 2017⁴.

12-Month Goals
With a fully functional PURE EP prototype model now ready for initial clinical studies, BioSig's business plan envisions an ambitious agenda for the next twelve months. Our goals include:

- 510(k) FDA Submission. We plan to submit a 510(k) medical device application to the FDA for approval to market. As a next generation of existing cardiac diagnostic technology, historically that process is relatively straightforward, and applications such as ours tend be approved in five to nine months, though that timing cannot be predicted with certainty. 

- Additional Research. To augment our clinical data, we plan to build on the initial research we have conducted at the UCLA Cardiac Arrhythmia Center by performing additional animal studies that compare the current state of the art with our PURE EP System.

- Conduct First In-Human Clinical Studies. We intend to initiate our first in-human trials at a leading cardiac EP laboratory

- Build Intellectual Property (IP) Portfolio. We will continue to advance the medical science, as well as software algorithms and technology, underlying the PURE EP System and add to our IP estate through our own R&D as well as clinical research at leading teaching hospitals.

- Build Management Team. We have an exceptionally senior management team, Board of Directors and Medical Advisory Board. As we progress, we will build the team in R&D, regulatory, clinical, marketing and quality assurance.

- Raise Growth Capital. When the time is right, we will raise capital to fund growth.

-  Communicate Proactively. We are implementing programs to keep our shareholders informed, and to communicate proactively with Wall Street and the media on our progress. 

- Up-list to a Senior Exchange.  We plan to up-list our common stock to a national exchange as soon as possible.

Poised for Success
With over 30 years in med tech, I can confidently state that BioSig today has all the ingredients required for sustainable long term success. In addition to our PURE EP System, they include:

- Proven management team & board of directors
- World-class medical advisory board
- EP devices: A $3B total addressable market, 12.1% CAGR¹
- Large cardiac arrhythmia patient population; ablations growing at 10%+⁴
- Increasing demand for new EP technologies to address:
   - Complex ablation treatments
   - High costs and demand for higher patient throughput, shorter procedure times
   - Unacceptably high recurrence rates (31% - 46%)³
- Our high-growth sector earns an innovation premium, sees aggressive M&A

As a newly public company, we have raised our visibility, lowered our cost of capital and increased our opportunities for growth. It is a privilege to lead your company into what I strongly believe to be an exciting and rewarding future.

Sincerely yours,

Gregory D. Cash
President, CEO and Director