Leading through Disruption: BioSig Technologies, Inc, a Los Angeles-based Medical Device Company, Keeps Pace with EP Advances

Our Vision is to further develop the signal processing technology and clinical effectiveness in PURE EP™ and extend into the growing field of Bioelectronic Medicine: Kenneth L. Londoner

Electrophysiology devices are used in the diagnosis and treatment of those diseases that occur due to abnormal electrical properties of biological cells and tissues.

The market for electrophysiology devices encompasses monitoring as well as treatment devices. These devices enable physicians to understand the nature and origin of abnormal electrical impulses generating in the single ion channel cells to organs such as the heart, and in turn assist with clinical decision making. Globally, the market of electrophysiology is growing due to rising prevalence of cardiovascular diseases that include atrial fibrillation and ventricular tachycardia. Continued product development leads to enhanced digitalization and opening of new EP laboratories worldwide.

BioSig Technologies, Inc. is medical device company, which develops a proprietary biomedical signal processing technology, Precise Uninterrupted Real-time evaluation of Electrograms (PURE) electrophysiology (EP) System. PURE EP™ System a signal acquisition and processing system for both surface and intracardiac signals, which is designed to support cardiac ablation cases for treatments of arrhythmia, or irregular heartbeat.

The company was incorporated in 2009 and is headquartered in Los Angeles, California.

Kenneth L. Londoner, BioSig Technologies, Inc. Founder, CEO and Chairman, spoke exclusively to The Silicon Review. Below is an excerpt.

Why was the company set up? And how did you expand your company and its offerings over the years?

We’ve started the company with a small group of highly experienced biomedical engineers. They have previously developed a number of innovative signal processing systems, and at the time were looking into potentially designing a proprietary platform for electrophysiology-based on the feedback from several KOLs in the field. Given my extensive experience in investing into life science in general and cardiology in particular, this KOL-based approach appealed to me. I’ve invested the first $2.5 million into the company, and we got to work. Those first couple of years were the hardest: to make every dollar count, our small group had to stay extremely focused. Two years later we had a concept developed together with Texas Cardiac Arrhythmia Institute, and in 2013 we ran our first test at UCLA. The results were encouraging, and in 2014 we took our prototype to Mayo Clinic, arguably one of the most innovative centers in our country. I would say that this was a defining moment in the future development of BioSig because Mayo Clinic became our leading pre-clinical facility. Since then, we performed 12 studies with Mayo Clinic, and just over a year ago, in March 2017, we signed a 10-year collaboration agreement with the clinic and Mayo Ventures. Mayo Clinic has been instrumental in providing crucial feedback on the features of our technology, which has helped us define our initial offering and future product pipeline.

“Earning trust and respect of consumers all around the world is through consistent focus on delivering high quality in all of our actions.” How do you interpret this statement?

One of the first things we did in our office in Santa Monica was put up a ‘Quality First’ sign above our white board. Delivering high quality in all actions can be challenging for a young company, however, we were never prepared to compromise on it. We assembled a lean and motivated group of professionals – quality over quantity – and formed a highly impactful, Fortune 500, Board of Directors, consisting of leaders in electrophysiology, wider cardiology, capital markets and intellectual property. In all my years of investing, I have never seen a more engaged Board, and many of its members have been with us since the very early days. To us, high quality begins within the inner circle and translates into everything we do for our shareholders and our future customers. That ‘Quality First’ sign still greets us every day as we walk into the office, as a reminder of what matters most.

Fostering a culture of feedback is crucial to the success of every organization. How is this true with your company?

This is very true in our case. For a small company of 18 employees, timely and constructive feedback is instrumental to ensure those high-quality standards we just discussed. Maintaining a continuous dialogue with our staff, vendors and clinical partners allow us to ensure the most effective allocation of our resources, both human and capital.

Our organizational structure is flat, and every employee is encouraged to think outside the box. If you get a group of talented people together, you must give them an opportunity to be creative, so we are definitely not micro-managers!

What are the factors that make your brand most innovative and why?

First of all, of course, our product: PURE EP™ System. We invested years of research into identifying the largest unmet clinical needs, and the sector of irregular heartbeats stood out for us. If successful, a cardiac ablation can restore a healthy heart rhythm, but at present, majority of patients have to undergo repeat procedures and continue to live with this debilitating disease. Our goal is to take the core expertise of our team –advanced signal processing – and design the technology, which we hope can provide better clinical information due to its higher resolution and broader dynamic range.

Second of all, our approach to financing the company; we have taken on a challenging task of staying in charge of our own fund raising. Four of our staff and three of our Board members came from the investment sector, and under my guidance, we raised over $35 million in small, targeted placements between 2009 and now. Doing it on our own allowed us to select the best capital we could find, and the majority of our shareholder base remained unchanged throughout the years. We made a particular focus on aligning interests of our shareholders and company’s goals, and, similarly to our organizational structure, we maintain an open, inclusive dialogue with our shareholders. Their feedback is important to us, and many of our investors became ambassadors for our company. The need for alignment between capital and vision might not always seem obvious, but is in fact very important.

As a question on sustainability, where do you see your company a couple of years from now?

We want to focus our attention on and raise awareness of the growing field of bioelectronic medicine. Through targeted use of electrical stimulation, bioelectronic therapies use the body’s own natural homeostasis mechanism to restore the physiological functioning of the human body. While the term ‘bioelectronic medicine’ is relatively new, various applications of electrical stimulation have been successfully used for many years, with pacemakers, ICDs and neuromodulation implants among the best-known examples. We are now starting to see more activities in this field, as the growing level of understanding helps to expand the applications into different parts of medicine. We are confident that this is the most innovative field of medicine and one which will lead to some very significant, positive disruptions.

Kenneth L. Londoner: A Dynamic Leader

Mr Kenneth L. Londoner founded BioSig Technologies, Inc. almost a decade ago. He started his investment career at J. & W. Seligman & Co., Inc., a leading institutional money management firm where he became one of the leading medtech investors in the 1990s with $3.5 billion under management. After leaving the firm in 1997, Mr Londoner became an entrepreneur and has since built and took public five innovative companies, four of which were in the life science sector.

Mr Londoner graduated from Lafayette College in 1989 with a degree in economics and finance and received his MBA from NYU’s Stern School of Business in 1994, with a dual major in finance and management.

“The PURE EP™ System was designed to improve the clinical information for electrophysiology (EP) studies and cardiac catheter ablation – procedures to test the electrical activity of the heart to locate and destroy abnormal heartbeat targets.”