Last year, Medgadget spoke with BioSig Technologies about the company’s PURE EP System for detection of cells that cause arrhythmias. PURE EP is a surface electrocardiogram and intracardiac multichannel recording system that acquires, processes, and displays high fidelity cardiac recordings required during electrophysiology studies and catheter ablation procedures. A nationwide survey of electrophysiologists in 2017 highlighted the noise reduction and overall signal clarity and accuracy as differentiating factors setting PURE EP apart from other electrophysiology signal recording and processing systems.
Mayo Clinic’s Dr. Samuel J. Asirvatham, a BioSig Scientific Advisory Board member has stated that, “The dynamic range of the system is larger – likely will translate into better ability to see both large and small (frequency and amplitude) signals with similar resolution. This is a major problem with present systems, where in order to see smaller signals, we have to amplify the signals, and in doing so, we lose the ability to see larger signals without saturating these signals.” Dr. Asirvatham has also highlighted the “improved resolution” and “intuitive and flexible” display options as other distinguishing factors of the PURE EP System.
When Medgadget spoke with BioSig last year, the company had just published the successful results of an animal study along with cardiologists and electrophysiologists from Mayo Clinic and Harvard’s Brigham and Women’s. At the time, BioSig Founder and Executive Chairman Ken Londoner projected that, “The PURE EP System will be rolled out to the leading centers in the United States starting next year , since we expect FDA clearance towards the end of this year or early next year.”
At the end of last month, BioSig submitted a 510(k) application to the FDA for approval of the PURE EP System. The submission identified BioSig’s technology as a Class II medical device. Medgadget had a chance to catch up with BioSig to learn about progress the company has made in the last year and what the recent FDA submission means for the company.
Michael Batista, Medgadget: What are some important milestones BioSig has achieved since you spoke with Medgadget last summer?
Ken Londoner: We have reached a number of important milestones since the last time we spoke:
- BioSig filed for FDA 510(k) approval on the 26th March.
- BioSig completed a 2-year nationwide market assessment project in collaboration with Health Research International. Survey respondents rated all six features of the PURE EP System as being ‘Very Helpful’ for their ablations, emphasizing overall ‘noise’ reduction and improved signal clarity/accuracy as key benefits. The research has concluded strong future demand for PURE EP System and suggested robust pricing points at market launch.
- BioSig engaged Sherpa Technology Group as our IP advisors. Sherpa is a leading advisory in Silicon Valley with a deep understanding of medical technology. Sherpa has been working on helping us assemble a robust patent portfolio around our core technology and solidifying our 10-year working relationship with Mayo Clinic.
- BioSig expanded its team by appointing Joe Rafferty, Chief Commercialization Officer (CCO). Joe has more than 30 years of experience in bringing medical technology to market. BioSig also partnered with Chuck Austin, former Corporate Vice President, Global Supply Chain, and Management Committee member at Johnson & Johnson. Chuck has joined us on a consultancy basis to scale up our manufacturing and global business development efforts ahead of commercialization.
- BioSig performed its 11th pre-clinical study at Mayo Clinic.
- BioSig was once again featured in the The Journal of Innovations in Cardiac Rhythm Management. Their ‘Innovations in Clinical Cardiac Electrophysiology: Challenges and Upcoming Solutions in 2018 and Beyond’ article features PURE EP System in the section dedicated to the novel ablation targets for the treatments of ventricular arrhythmias. The ‘Purkinje Fibers’ section of the article talks about the importance of consistent visualization of Purkinje signals during the ablation procedures, which can be achieved through the use of high-pass filters of an advanced signal processing technology of PURE EP System.
- BioSig opened an operational office in Austin, TX – a key location for med-tech companies.
- BioSig raised approximately $9 million in premium-to-market equity investment in 2017. Continuing to raise capital without intermediaries allows the company to maintain appropriate alignment of interests between the business and our shareholders.
Medgadget: With FDA approval on the horizon, what are some of the next for commercializing BioSig’s technology?
Londoner: Our PURE EP System is expected to launch in the United States in the first half of 2019 and be followed up with a foray into European markets. Joe Rafferty, our CCO, has a proven strategy of bringing cardiology devices to market. Upon receiving FDA clearance, we will start with a small number of highly strategic medical centers of excellence – the ‘early adopters’ of our technology. These centers will provide the perfect base for collecting our first-in-man clinical data. We expect to expand our commercial efforts nationwide later in 2019.
Medgadget: What is the value for physicians and patients that BioSig is striving to achieve as the PURE EP System becomes available for human use?
Londoner: The PURE EP System has been developed together with the leading electrophysiologists in our country, who are not only outstanding surgeons, but also exceptional innovators. Our technology has been designed to address a very pressing, unmet clinical need. During the market assessment study that we completed last year, all of the surveyed electrophysiologists have agreed that the signal clarity is paramount to the success of ablation procedures. If we can improve the quality of clinical information that the surgeons receive in real time, they will be able to make better decisions for the patients. Over the years we have encountered many Afib (atrial fibrillation) patients. Afib is a very debilitating condition, which significantly affects the quality of life of those who suffer from it, and those who are indirectly affected by it, such as families and friends. Many of the people who shared their experience with us had to undergo 2-3 ablations, which did not improve their condition. As a result, many patients refuse further treatments. It is our goal to address that by giving better tools to the doctors.
Medgadget: Given the news that BioSig is bringing an innovative EP system to market, are you seeing any changes in your incumbent competitors or new players?
Londoner: Bringing medical technology to the market is a highly complex and lengthy process. Our own path to market has taken over 9 years, which isn’t that long in comparison to many life science companies. In our years of experience, we have seen many companies entering the market. The key question is, however, how to sustain the market presence? To do so, a company must address a defined clinical need, have a large global market, have the support of key opinion leaders in their chosen space, develop a robust IP strategy, and be extremely diligent with their financing. That last point in particular can make all the difference between success and failure and is often overlooked by the founders. As an innovative company charting a long-term growth strategy, we always welcome the news about positive developments on the market – healthcare is everyone’s utmost priority, and if in the future we can partner with an excellent company to take our efforts to the next level, it will only be a good news for both the patients and the medical community.
Medgadget: You mentioned the low 6% penetration of ablation procedures in your last interview with Medgadget’s. Is one of BioSig’s goals to move the needle on this number and increase the number of patients who feel comfortable with and elect to have the potentially life saving procedure? If so, how do you accomplish that?
Londoner: Absolutely. It is our goal to improve the standards of care in electrophysiology and increase the number of patients, who can have their condition successfully treated during the first procedure. The key to this, as I’ve said above, begins with giving better tools to the surgeons. To quote one of our longstanding Scientific Advisory Board members, “electrophysiologists constantly need to choose between efficacy and safety.” We will strive to raise the level of confidence while performing complex ablation procedures, which in turn should result in better clinical outcomes, shorter procedures and, ultimately, more patients seeking appropriate treatment.
Medgadget: Thank you for the update! Anything else to share?
Londoner: We strongly believe that the future of the market lies in the rapidly emerging field of bioelectronic medicine. As a company with a core competency in advanced signal processing technologies, we will strive to gain a market leadership position in this field over the next several years. The global bioelectronic medicine market is expected to reach $25.2 billion by 2021 from $17.2 billion in 2016, growing at a CAGR of 7.9% from 2016. We believe that our combination of skill, capital market expertise and global industry relationships will allow us to successfully navigate this rapidly evolving field.
Link: BioSig Technologies…