MINNEAPOLIS, MN--(Marketwired - Dec 9, 2015) - BioSig Technologies, Inc. (
BioSig recently turned one year of age as a public company. We would like to thank our long-term shareholders for their investment, engagement, and support of our efforts to bring innovation and strong products to the electrophysiology marketplace, first in the U.S. and then worldwide.
2015 has been a year of many achievements; and, we end the year well positioned for a break out year in 2016. We would like to review our progress by segment of the company:
Technology and Clinical Development
We completed development of the PURE EP™ System prototype in order to test its performance and obtain pre-clinical data.
We conducted a series of pre-clinical studies at Mayo Clinic in Rochester, Minnesota under the leadership of Dr. Samuel Asirvatham, and, several engineering studies at UCLA under the leadership of Drs. Kalyanam Shivkumar and Jason Bradfield. The main objective of these studies has been to demonstrate the clinical potential of PURE EP (not currently obtainable with present recording systems). Earlier in the year, we reviewed the results with our Scientific Advisory Board and received enthusiastic comments from the group. We intend to publish the results of these studies at industry conferences and peer reviewed journals early in 2016.
We plan to transition from pre-clinical evaluation of the PURE EP to product development utilizing a local design firm highly experienced in developing and manufacturing medical diagnostic devices. We expect to employ a 510(k) approval process and fully develop a Quality Management System.
Corporate and Organizational Development
BioSig has added significant strength and talent to its already strong team in 2015. Jay Millerhagen joined us in March to lead clinical research for BioSig. Jay led the clinical team in the Afib division of St. Jude Medical (STJ) for five years, and prior to that was at Boston Scientific/Guidant (BSX) for eighteen years, including leading the heart failure product and market development efforts. His grasp, understanding, and experience will prove invaluable as BioSig expands its clinical efforts in 2016. Brian McLaughlin joined in April to lead corporate finance and investor relations. He brings over 15 years of experience from leading buy side healthcare focused investment firms and has already built a solid foundation for us to leverage in 2016 in developing new investor relationships. Charlotte Gasperin recently joined us to lead regulatory and quality management. Charlotte comes to us from Magellan Consulting where she was Director of Regulatory and Quality Affairs. Previously, she was at Medtronic (MDT) as well as St. Jude Medical and started her career as a nurse in cardiac catheterization and electrophysiology laboratories.
2015 has been a banner year in strengthening our already leading Board of Directors. Dr. Jerome Zeldis, current Chief Medical Officer of Celgene, Inc. (CELG), joined in April and leads the Governance Committee. David Weild, IV, former Vice Chairman of NASDAQ (NDAQ), joined in May and heads up the Audit Committee. Donald Foley, former Chairman and CEO of Wilmington Trust, joined in October and recently made a significant investment into BioSig. All bring extensive capital markets experience to complement the industry-related experience that has been on the Board for several years.
In 2016, expect to see the company add resources in marketing, business development, sales, technology, clinical operations, field engineering, and finance. Management is actively preparing for the commercial launch of PURE EP™.
BioSig raised $4.1 million in common stock and warrants at the end of March and over $1 million thus far in the fourth quarter. These funds have allowed the Company to vigorously pursue its operating plan for 2015. Management and the Board of Directors have recently invested in the company to continue our expansion. In April, BioSig hired Donohoe Advisory Associates to assist with the uplisting of the Company to NASDAQ. We expect to commence trading on a national exchange in 2016, positioning BioSig for growth and expansion of its shareholder base. Senior management invested significant time in investor relations; visiting over 21 cities from Minneapolis to Philadelphia, from Dallas to Atlanta, from Seattle to Las Vegas, and from Boston to Tampa.
2016 Goals and Objectives
Our key objectives in 2016 are:
510(k) Submission. We plan to submit our 510(k) medical device application to the FDA for approval to market PURE EP during the second half of 2016. We view this process as relatively straightforward and will have an expanded team in place to drive this initiative.
Advanced Clinical Initiative. Given the clinical experience of 2015, we will be significantly expanding our clinical activities and team for 2016 to include additional pre-clinical studies to further define and evaluate the clinical efficacy of the PURE EP System. This will enable us to further develop clinical observations noted in earlier studies.
Uplist to a Senior Exchange. We plan to uplist our common stock to a national exchange in the first half of 2016.
Expand our IP Portfolio. We expect to file at least two additional patents in 2016. Management believes significant potential exists to continue to strengthen our intellectual property position beyond 2016.
Expand our ability to communicate with our shareholders. In 2015, BioSig made the strategic decision to bring investor relations management in-house. We believe strongly in proactive shareholder education and communications. Expect to see us expand this team in 2016, increasing our ability to attend leading investor conferences. In addition, we will strive to achieve sell side research coverage. Management will also travel the U.S. to meet investors in the communities in which they reside. It is important to educate the marketplace of the virtues of investing in BioSig Technologies, Inc. (
Build a Go-to-Market Plan and Strategy. BioSig will develop a full go-to-market plan and strategy for the commercialization of PURE EP. It is difficult to say with certainty when we will launch our first commercial product, as regulatory approval is always hard to predict. With that said, we are preparing for a launch in early 2017 and will do everything possible to drive timelines as aggressively as possible without compromising quality and regulatory rigor.
POISED FOR SUCCESS. To reiterate what we stated in our letter to Shareholders one year ago, we can say with confidence that BioSig has all of the ingredients required for sustainable long-term success and value creation in our stock. We have:
- A proven and expanding management team and a world-class and enhanced Board of Directors, many of whom have continued to invest their own cash into the Company.
- A world-class Scientific Advisory Board.
- A large and growing $3.5 billion addressable cardiac electrophysiology market with a 12.1% compound annual growth rate.
- Increasing demand in the field for new technologies to treat complex arrhythmias and a shortage of innovators to deliver it. This supply/demand imbalance will be to the benefit of our shareholders, long-term.
- Valuation premiums established by significant merger and acquisition activity in a high-growth sector. There were three major acquisitions made in the past 12 months of innovators by strategic medical device companies; Abbott (ABT) bought Topera for $350 million, Medtronic (MDT) bought CardioInsight for $272 million; AtriCure (ATRC) bought nContact for $149 million.
On behalf of our Board of Directors and management team, we thank you for your investment in our Company and your continued interest in our collective future together.
We are striving to deliver for all of our shareholders in 2016 and look forward to many accomplishments.
Kenneth L. Londoner
President and Chief Executive Officer
About BioSig Technologies
BioSig Technologies is a medical device company that is developing a proprietary technology platform designed to improve the $3 billion electrophysiology (EP) marketplace(1) (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig Technologies is preparing to commercialize its PURE EP System.
PURE EP System is a surface electrocardiogram and intracardiac multichannel recording and analysis system designed to assist electrophysiologists in making clinical decisions in real-time by acquiring and displaying high-fidelity cardiac signal recordings and providing clarity of data which may be used to guide the EPs in identifying ablation targets - areas of tissue to treat that otherwise create a heart rhythm disturbance (arrhythmia).
Analysts forecast the global market for EP devices will grow at a 12.1 percent compound annual growth rate, from $2.5 billion in 2012 to $5.5 billion by 2019(1) -- making it one of the fastest growing medical device segments. Just in the US, the number of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) arrhythmia ablations is forecast to grow at 10.5 percent from 2012 to 2017(2).
BioSig intends to seek FDA 510(k) clearance for the PURE EP System. The Company has achieved proof of concept validation through UCLA labs, and has performed preclinical studies at the Mayo Clinic in Minnesota. The Company is collaborating with several of the nation's most prestigious cardiac arrhythmia centers including Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center, and Mayo Clinic.
(1) Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019
(2) HRI 2013 "Global Opportunities in Medical Devices & Diagnostics" report; triangulation of multiple sources; *AF includes left atrial tachycardia, left WPW, left atrial flutter.