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BioSig Technologies - Bringing Next Gen EP Device to Market

BioSig Technologies – Bringing Next Gen Electrophysiology (EP)  Device to Market

Overview

BioSig Technologies (OTCQB:BSGM) is a medical device company that has developed a proprietary technology platform targeting the growing electrophysiology (EP) device market. EP devices are used in the treatment of cardiac arrhythmias, which can lead to stroke or even death. The current standard of care is cardiac catheter ablation which has a low efficacy rate.

BioSig Technologies’ goal is to bring to market technology that can provide better treatment outcomes for patients with cardiac arrhythmias. The company is working to commercialize its PURE EPTM System which is designed to improve the clarity of clinical signals available for EP studies and ablation procedures.

BioSig Technologies is led by a management team and a board of directors with a long track record of success in health and business. The board of directors includes Jay Millerhagen (St. Judes, Boston Scientific, Johnson & Johnson, and GE); David Weild (Former Vice Chairman of NASDAQ); Dr. Jerome Zeldis (CEO, Celgene Global Health and CMO, Celgene Corporation); Jeff O’Donnell (2005 LifeSciences CEO of the Year by Price Waterhouse Coopers), and Seth Fischer (Johnson & Johnson).The company has also put together a world-class advisory board consisting of the top authorities in electrophysiology from the leading cardiac arrhythmia centres in the United States.

In 2016, BioSig Technologies expects a significant amount of market-moving news flow. “This year we will be putting a lot of clinical data into the marketplace, and another huge catalyst for BioSig will be our uplisting to the NASDAQ which will allow us more exposure to institutional investors,” stated Ken Londoner, BioSig Technologies Founder and Executive Chairman. “We are applying for FDA 510(k) clearance this year and are planning our go-to-market strategy for the launch of our product. We are right at the precipice of some really good things happening.”

BioSig Technologies recently signed a manufacturing agreement for production of the PURE EPTM system with industry leader Minnetronix.

Investment Highlights

  • $3.5 billion global market for EP devices has a 12.1 percent compound annual growth rate.
  • World-class management team, Fortune 100 board of independent directors and scientific advisory board composed of key opinion leaders.
  • Supply/demand imbalance: increasing demand for new technologies to treat complex arrhythmias and a shortage of innovators.
  • Pre-clinical data to be released in first half of 2016.
  • Signed manufacturing agreement with Minnetronix
  • Aggressive M&A in a high growth sector.
  • Quality support from eight of the top ten leading hospitals.

2016 Catalysts

  • Uplisting to NASDAQ in Q2 2016
  • Release of Mayo Clinic and UCLA 2015 pre-clinical data in 1H 2016
  • FDA 510(K) Clearance in Q4 2016/Q1 2017

EP Devices Market: Global Growth and Room for Innovation

Cardiac arrhythmia afflicts 14.4 million Americans today. The two most prevalent and deadly types of this disease are atrial fibrillation and ventricular tachycardia. Atrial fibrillation is the most common type and the most likely to lead to a stroke—the fourth leading cause of death in the United States. The number of atrial fibrillation cases in the United States is expected to grow from 2.7 million cases in 2010 to 5.6 million cases by 2050.

The global market for EP devices is currently worth $3.5 billion and analysts considered it one of the fastest growing medical device segments with a projected value of $5.5 billion by 2019. Today’s market is dominated by three major players: GE (50 percent of market share); St. Judes (35 percent); and Boston Scientific (15 percent). However, BioSig Technologies Founder Ken Londoner is confident there is room in this space, “All of their technology is decades old. No one in this market has the technology we have.”

The EP devices market is also a hot space for M&A activity with several major players as viable takeover candidates.

Top takeover candidates in order of probability:
1 Boston Scientific (NYSE: BSX, market cap $ 24 billion)
2 St. Jude Medical (NYSE: STJ, market cap $ 23 billion)
3 Abbott Labs (NYSE: ABT, market cap $ 61 billion)
4 Johnson & Johnson (NYSE: JNJ; market cap $ 212 billion)
5 General Electric (NYSE: GE, market cap $ 256 billion)
6 Phillips, NV
7 Siemens, AG
8 Atricure (Nasdaq: ATRC, market cap $ 660 million)
9 Cardinal Health (NYSE: CAH, market cap $ 126 billion)

 

BioSig Technologies now has the support of 8 of the top 10 medical centers in our industry from Harvard to the Mayo Clinic to UCLA to Cleveland Clinic.

Key Product: PURE EPTM System

Solving treatment challenges to improve patient outcomes

BioSig Technologies’ PURE EPTM System is a surface electrocardiogram and intracardiac multichannel signal acquisition and analysis system. It’s designed to address the challenges posed by today’s standard treatments for cardiac arrhythmias—cardiac catheter ablation. During this EP procedure a catheter is advanced through the groin and toward the heart through a patient’s vessels and then placed on ablation targets—areas of cardiac tissue believed to be the source of the arrhythmia.

BioSig Technologies - Bringing Next Gen EP Device to Market

The various sophisticated equipment in today’s electrophysiology lab creates a significant amount of background noise which interferes with the detection and recording of the electrophysiological signals needed to pinpoint these ablation targets. Often, the EP equipment on the market today is not at all effective in silencing the background signals from other electronic devices in the lab. This interferes with the ability to correctly pinpoint the best targets. The result is that treatment is only effective in one out of every two patients meaning many patients must undergo multiple procedures.

In order for the treatment to be effective, electrophysiologists need high-quality, precise information. “The machines in the surgery room can cause interference, distorting signals that show the doctors where to place the wire which translates into a lot of guessing and burning in multiple places in hopes of getting the right spot,” explains Londoner. “Our PURE EPTM technology is a clinically significant information system which eliminates the noise of all the other signals from the lab equipment and processes digital signals. It provides doctors with clean information so that they can clearly identify ablation targets in real-time.”

The PURE EPTM system differs from the current technology in that its proprietary hardware and signal processing provides electrophysiologists with enhanced real-time information. The system improves the clarity of acquired cardiac data even at very low, previously undetectable signal levels. “The dynamic range of the system is larger and likely will translate into better ability to see both large and small (frequency and amplitude) signals with similar resolution,” stated Mayo Clinic’s Dr. Sameul Asirvatham.

BioSig Technologies - Bringing Next Gen EP Device to Market

Several other benefits of this technology place it far and above current technologies in this market space including:

  • Provides critical information that is unobtainable from any other EP device
  • Signal processing capabilities
  • Ability to open multiple review windows
  • Assists in clinical decision-making in real-time
  • Maximizes ablation efficacy and minimizes need for repeat procedures
  • Shortens and simplifies EP procedures

Developed by leading cardiac arrhythmia and electrophysiology experts

The concept for the PURE EPTM system was first developed with the help of Texas Cardiac Arrhytmia Institute in 2011. BioSig Technologies achieved proof of concept for the system through UCLA EP & Animal Labs.

BioSig Technologies has the support of eight of the top ten medical centers in the industry from Harvard to the Mayo Clinic to UCLA to Cleveland Clinic.

Pre-clinical trials completed

A series of preclinical studies of the PURE EPTM system were completed at the Minnesota-based Mayo Clinic in 2015 under the leadership of Dr. Samuel Asirvatham. The results of these studies will be published at industry conferences and in peer reviewed journals throughout the first half of 2016.

“These important pre-clinical data characterize the PURE EPTM System’s ability to improve acquisition and visualization of high fidelity cardiac signals, and is an important milestone for the company,” stated Greg Cash, President and CEO. “We have been very pleased with our collaboration with Dr. Samuel Asirvatham and his team and look forward to continuing this work at the Mayo Clinic.”

Advancing toward commercialization

Having completed its pre-clinical evaluation of the PURE EPTM system, BioSig Technologies is now ready to move on to the product development stage.

BioSig Technologies - Bringing Next Gen EP Device to Market

BioSig Technologies announced in February 2016 that it has signed an agreement with award-winning medical technology development and manufacturing firm Minnetronix to initiate development of the system. “Minnetronix has developed numerous technologies in the electrophysiology field, including mapping and ablation, which positions us well to bring leading-edge technologies like the PURE EPTM System to the market quickly,” said Jeremy Maniak, Minnetronix Chief Operating Officer.

“This is a major milestone for us that says to the world we have completed our technology and are ready to bring it to market,” stated Londoner who also explained that the pre-production process will take about 9 months.

Because the Pure EPTM System qualifies as a Class II device in the United States, extensive clinical work is not required. Sales and marketing in the United States does require 510(k) Clearance from the Food and Drug Administration (FDA). BioSig Technologies expects to complete the FDA 510(K) medical device application in late 2016 or early 2017 and is preparing to launch in the second quarter of 2017. The company is developing a full go-to-market plan for the commercialization of the product first in the United States, then Europe followed by Asia and Latin America.

Management

Gregory D. Cash — President, CEO and Director

Greg Cash is a seasoned industry veteran with over 30 years of business experience. He has held executive and director positions in several life science-based companies including Argent International, NeuroTherm, HeartSine Technologies, Sorin Group, Vasomedical (a NASDAQ traded public company), Datascope Corporation and its subsidiary, InterVascular, Eminent Technology Partners and its subsidiary, Eminent Research Systems, U.S. Surgical Corporation, and Boston Scientific Corporation. He began his career at Medtronic where he served 14 years in increasingly senior sales and marketing positions.

Kenneth L. Londoner, MBA — Executive Chairman and Director

Ken Londoner founded BioSig Technologies in February 2009. He is the Managing Partner of Endicott Management Partners, a firm dedicated to assisting emerging growth companies in their corporate development and investing needs since 2004. From April 2007 to October 2009, Londoner was the executive vice president of NewCardio, a silicon valley based cardiac software company. He also served as a director and the architect for the turnaround at Alliqua BioMedical. He is a co-founder of Safe Ports Holdings, in Charleston, South Carolina, a port security and logistics company sold for almost six times what investors had invested within two years of its founding. He was the founder and managing partner of Red Coat Capital Management, a hedge fund in New York which grew from its initial base of $ 2 million in assets to a peak of $ 1.1 billion.

Jay Millerhagen — Vice President, Clinical Affairs

Jay Millerhagen has over 25 years of experience developing, evaluating and launching new medical technologies and therapies. Most recently, he served as Vice President, Clinical Affairs and Market Development for RESPICARDI where he led clinical operations, staffing and site management leading to the pivotal IDE trial of the fully implantable ReMed System for the treatment of Central Sleep Apnea. He has served as Vice President, Clinical Affairs at St. Jude Medical in St. Paul where he led a series of clinical studies targeted at addressing cardiac arrhythmias. His team was the first to design, submit and secure approval of an IDE from the FDA for a novel open irrigated ablation catheter based indication for Atrial Fibrillation. He has also held senior positions at Boston Scientific Corporation. Millerhagen co-authored a patent on a pacemaker based on hemodynamic performance. He also served as Director, Business Alliance Marketing with industry giants Johnson & Johnson and GE Healthcare.

Asher Holzer, Ph.D. — Chief Scientific Officer

Dr. Asher Holzer brings to the company his more than 25 years of experience in advanced medical devices, as well as expertise covering a wide range of activities, including product development, clinical studies, regulatory affairs, market introduction and the financial aspects of the advanced medical device business. Dr. Holzer co-founded InspireMD Ltd., the predecessor and later wholly-owned subsidiary of InspireMD, Inc. Previously, Dr. Holzer founded Adar Medical, an investment firm specializing in medical device startups.  Dr. Holzer founded TheraCoat (now called UroGen), an Israeli company developing a novel way to treat bladder cancer. Dr. Holzer currently serves on the board of directors of Adar Medical, O.S.H.-IL The Israeli Society of Occupational Safety and Health, 2to3D, and Magnetecs Corp. He is also an inventor and holder of numerous patents.

Brian McLaughlin — Vice President, Corporate Finance and Investor Relations

With over 19 years of financial experience, Brian McLaughlin is a seasoned Wall Street veteran specializing in healthcare investments. During his tenure in the money management industry, McLaughlin held senior roles with some of the leading U.S. hedge funds. In that capacity, he built an extensive network of relationships that will bring tremendous value to BioSig. McLaughlin held senior executive positions in the hedge fund industry for over 13 years at Sigma Capital Mgt., SAC Capital Mgt., and the investment bank, JP Morgan & Co. At Ridgeback Capital, McLaughlin was president and chief operating officer managing over a billion dollars, specifically investing in the healthcare industry.

David Weild IV — Director

David Weild is founder, chairman and CEO of Weild & Co. which was launched in 2014 to improve capital markets outcomes for corporations while continuing to support policymakers as they strive to improve equity markets in ways that will drive economic and job growth. He was a former vice chairman of NASDAQ and head of corporate finance and equity capital markets at a major Wall Street firm. Weild’s work has been discussed, presented or referred to in the U.S. Congress, the U.S. Securities and Exchange Commission, the White House, the European Commission, the Organization of Economic Cooperation and Development, the Federation of European Securities Exchanges, the G-20 in Istanbul in April 2015 and by regulators throughout the world.

Jerome B. Zeldis, M.D., Ph.D. — Director

Dr. Jerome Zeldis brings his extensive background in the healthcare industry, as well as his experience in emerging growth companies. Dr. Zeldis is the Chief Executive Officer of Celgene Global Health and the Chief Medical Officer of Celgene Corporation. He has worked at Sandoz Research Institute and Janssen Research Institute in both clinical research and medical development. He is currently on the boards of the Semorex Corporation, Bionor Pharma, Mali Health and PTC Corporation and serves as the chairman of the board of directors of Alliqua BioMedical. He was Assistant Professor of Medicine at the Harvard Medical School, Associate Professor of Medicine at University of California, Davis, Clinical Associate Professor of Medicine at Cornell Medical School and Professor of Clinical Medicine at the Robert Wood Johnson Medical School in New Brunswick, New Jersey. Dr. Zeldis has published 122 peer reviewed articles and 24 reviews, book chapters, and editorials.

Jeffrey F. O’Donnell, Sr. — Director

Jeff O’Donnell has extensive experience in the healthcare industry. He brings more than 20 years of Board and CEO experience running emerging medical device firms. Businesses under his direct leadership have achieved over $1.5 Billion in value creation from initial public offering of stock or mergers and acquisitions. Currently, O’Donnell is the President and CEO of Trice Medical, an emerging growth medical device company developing optical needles used by orthopedic surgeons to diagnose soft tissue damage of joints. In 2008, he started and ran Embrella Cardiovascular, a medical device startup company, which was sold in 2011 to Edwards Lifesciences. He has served as President and CEO of PhotoMedex and Cardiovascular Dynamics (CCVD).  His team took CCVD public on the NASDAQ in June of 1996 and purchased Radiance Medical Systems and Endologix. He has held the position of President and CEO of Kensey Nash Corporation as well as several senior sales and marketing management positions at Boston Scientific Corporation, Guidant Corporation and with Johnson & Johnson’s Orthopedic Division. In 2005, O’Donnell was named LifeSciences CEO of the Year by Price Waterhouse Coopers. In 2011, he was named the Greater Philadelphia Emerging Entrepreneur Of The Year by Ernst & Young.

Patrick J. Gallagher MBA, CFA — Director

Patrick Gallagher is an accomplished capital markets executive, advisor and investor with a distinguished record of success in both the public and private markets. He has nearly 20 years of experience on Wall Street and extensive expertise in alternative investments, capital markets, and marketing. He serves as a strategic consultant for Kinex Pharmaceuticals. In November 2010, he was appointed by broker Concept Capital, a division of Sanders Morris Harris, as a Managing Director and the head of institutional sales. In 2001, Gallagher co-founded BDR Research Group, an independent sell-side research firm specializing in healthcare investing, financing and operations, and served as its chief executive officer until November 2010. He has held various sales positions at investment and research firms Kidder Peabody, PaineWebber and New Vernon Associates.

Donald E. Foley — Director

Donald Foley brings extensive financial, economic, capital markets, executive leadership expertise to BioSig. He was elected chief executive officer and chairman of Wilmington Trust in July 2010 and joined the Board of Directors in July 2006. Foley served as senior vice president, treasurer and director of the ITT Corporation, a supplier of advanced technology products and services. He was assistant treasurer for International Paper Company and held a progression of capital market, treasury, and tax-related assignments at Mobil Corporation. He began his career at General Electric. In addition to his experience in leading global companies, Foley has also been both a member and chairman of the Board of Trustees of Burke Rehabilitation Hospital in Westchester County, New York since 2005.

Roy T. Tanaka — Director

Roy Tanaka brings broad experience in executive leadership in the medical device field. His operational expertise and knowledge of the regulatory environment, both in the U.S. and globally, also bring a valuable perspective. He served as the worldwide president of Biosense Webster, a Johnson & Johnson company, a market and technology leader in the field of electrophysiology. He joined Biosense Webster as its U.S. president in 1997. Previously he held a variety of senior management positions at Sorin Biomedical and leadership roles at CooperVision Surgical and Shiley, a division of Pfizer. He currently serves on the boards of directors of Volcano Corporation, Coherex Medical, Advanced Cardiac Therapeutics, a company using electrophysiology to develop technology to measure the temperature in a lesion during cardiac ablation procedures, and VytronUS. In addition, Tanaka served as a director of Tomo Therapy until its acquisition in June 2011.

Seth H. Z. Fischer — Director

Seth Fischer is the CEO and director of Vivus, a biopharmaceutical company focusing on the treatment of obesity, sleep apnea, diabetes and sexual health. Prior to that, he served in positions of increasing responsibility with Johnson & Johnson until 2012. Most recently, Fischer served as Company Group Chairman Johnson & Johnson, and Worldwide Franchise Chairman Cordis Corporation from 2008 to 2012, which included responsibility for Cordis and Biosense Webster. Previously, he served as Company Group Chairman North America Pharmaceuticals with responsibilities for Ortho-McNeil Pharmaceuticals, Janssen and Scios. Fischer also serves on the board of directors of Trius Therapeutics.

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