Seeking Better Outcomes for Patients with Complex Arrhythmias
BioSig Technologies, Inc. (web site), a medical device company, is developing a technology platform to minimize noise and artifacts from cardiac recordings during cardiac electrophysiology studies and ablation of cardiac arrhythmias. BioSig products under development include 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 electrocardiograms required during electrophysiology studies and ablation procedures. The company is also developing a library of software tools that are designed to fit the needs of electrophysiologists in various settings and/or for a variety of arrhythmia diagnosis and treatment. BioSig Technologies, Inc. was founded in 2009 and is headquartered in Minneapolis, Minnesota.
Price on 4/13/16: $1.50
52 Wk. High – Low: $4.80 – 0.90
Est. Shares Outstanding: 17.25 million
Market Capitalization: $25.9 million
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Microcap Research (MR) is pleased to present the following interview with the President and CEO of BioSig Technologies, Greg Cash (GC), with this Cautionary Note on Forward-Looking Statements:
Certain statements contained in this interview may be “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and MD&A filed with the United States Securities and Exchange Commission. Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
MR: BioSig Technologies is developing a medical device that addresses specific needs within the electrophysiology (EP) market. What is “electrophysiology” and how fast is the EP market growing?
GC: Cardiac electrophysiology is the science of elucidating, diagnosing, and treating the electrical activities of the heart. Cardiac electrophysiology studies are performed to assess complex cardiac arrhythmias, elucidate symptoms, evaluate abnormal electrocardiograms, assess risk of developing arrhythmias in the future and design treatment. The current market for cardiac electrophysiology devices is approximately $4 billion and is growing at a CAGR of 12.1%.
MR: Would you explain how the Company’s PURE EP™ system addresses a problem/need in this high growth market? What improvement(s) in EP studies and catheter ablation treatment does BioSig Technologies expect to deliver vs. the existing technology?
GC: The PURE EP system is being designed as an electrocardiogram (ECG) and intracardiac recording and analysis system designed to assist electrophysiologists (EPs) 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 electrophysiologists in identifying ablation targets – areas of tissue to treat that create a heart rhythm disturbance (arrhythmia). In the area of complex arrhythmias (atrial fibrillation and ventricular tachyarrhythmias), recording systems designed to address more simple arrhythmias (atrial flutter and supraventricular tachycardias) are being used to address them. Because these systems have limited high fidelity or noise rejection capabilities, anatomical approaches such as pulmonary vein isolation are used to treat arrhythmias like atrial fibrillation (AFib). Patients suffering from persistent or permanent AFib experience a 47% failure rate with ablation procedures. Because PURE EP has been designed from the bottom up to treat complex arrhythmias, we hope to improve upon the ablation success rate.
MR: Electrophysiology labs are a key revenue and profit center at a rapidly increasing number of hospitals globally. How can the Company’s PURE EP™ system affect the bottom line for these hospitals?
GC: In addition to the potential to improve outcomes, the PURE EP system’s real time analysis capabilities and multiple display windows may result in reduced procedure times, which in itself could result in cost savings, and the ability to do additional procedures.
MR: Will the PURE EP™ system from BioSig Technologies compete directly with those from industry giants like Boston Scientific (BSX), St. Jude Medical (STJ), and GE Healthcare (GE), or is PURE EP™ an adjunct system?
GC: The PURE EP system is designed to run alongside existing systems.
MR: BioSig Technologies has clinical and/or advisory relationships with physicians and researchers affiliated with many top cardiac centers in the U.S., including:
• Texas Cardiac Arrhythmia Institute
• UCLA Cardiac Arrhythmia Center
• H. Case Medical Center in Cleveland
• William Beaumont Hospital in Michigan
• Mount Sinai Medical Center in NY
• Mayo Clinic in Minnesota
What milestones have been met to date with the PURE EP™ system, and what’s on the horizon in terms of clinical development and published data?
GC: Initial preclinical work with the proof of concept and prototype systems was conducted at UCLA with Dr. Shivkumar. In 2015 we conducted three studies with Drs. Asirvatham and Venkatchalam at Mayo Clinic in Rochester, Minnesota. The results of these studies was presented at the 13th International Dead Sea Symposium on Innovations in Cardiac Arrhythmias and Device Therapy in Tel Aviv, Israel in early March. A paper on these studies will be submitted to a peer review cardiology journal later this year as well as an engineering paper on the PURE EP system. We have additional preclinical studies planned at Mayo Clinic as well as other institutions this year.
MR: What is the current timeline for FDA submission, when (approximately) do you anticipate approval, and ultimately, when might shareholders see revenue generation start?
GC: We expect to submit our 510(k) application later this year. While PURE EP is considered a Class II device, which does not require human clinical trials and has a relatively straightforward clearance pathway; that being said, the timing of FDA clearance is something beyond our control. It would not be unreasonable to expect commercialization sometime during the first half of 2017.
MR: Earlier this year BioSig Technologies announced a development partnership with Minnetronix Inc. a medical device manufacturing firm. Would you expand on why was Minnetronix chosen for this partnership?
GC: Minnetronix was chosen as a partner after an extensive review of design control development houses. Minnetronix has a long history of successfully partnering with companies in the development of complex medical technologies. We also expect them to be the manufacturer of the PURE EP system, which also made Minnetronix our leading choice.
MR: BioSig Technologies currently trades on the OTC market, with plans to uplist to NASDAQ. The uplisting will obviously bring increased awareness to many more institutional and retail investors. Approximately when do you anticipate the uplisting might take place?
GC: We are aiming to uplist the company to NASDAQ sometime in the second half of 2016. This activity is obviously dependent on a number of factors, including market condition.
MR: Thank you Greg. Best wishes to you and the BioSig team as you continue toward commercialization of PURE EP system.
- Video- Ken Londoner, Executive Chairman of BioSig Technologies, Inc.
- Great, in-depth read on BSGM published 4/12/2016: MedTech Is Outperforming – Here’s A Name To Follow
by Jason Napodano, CFA, BioNap Consulting Inc.
- March 2016 Corporate Presentation
Disclosure: Long BSGM shares bought in open market
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