BioSig’s Cardiac Ablation Electrophysiology Detects Deadly Arrhythmias
BioSig’s PURE EP™ is a superior electrophysiology (EP) signal recording and processing system to conventional systems, and is positioned to shake-up the EP market when it is launched in 2018. An animal laboratory study utilizing the PURE EP™ system was published in April 2017 in the Journal of Innovations in Cardiac Rhythm Management, showcasing its ability to detect cells that cause deadly arrhythmias. Trials were conducted by a team of cardiologists and electrophysiologists at Mayo Clinic, Harvard’s Brigham & Women’s, and BioSig Technologies, Inc. (BSGM).
A major feature of PURE EP™ is that it can eliminate or reduce the background noise due to the ablation catheter. A significant baseline drift is seen even in high-end catheters (see figure below from the journal publication), which have unbalanced background energy that can push the signal outside the bounds of the device display.
Existing systems compensate for this drift by using front-end filters, whereas PURE EP™ allows the operator to use an alternate window to pin the signal of interest to the baseline to aid with the evaluation of signal changes during the ablation procedure without background noise corrupting the analysis. We bring you an exclusive interview with Founder and Executive Chairman, Ken Londoner.
Alice Ferng, Medgadget: Tell me about yourself and your motivation for founding BioSig.
Ken Londoner, BioSig Technologies, Inc.: Looking at the statistics, 46% of patients that have an ablation relapse and need to have a procedure 4-6 months later. This is what drew me into this field. If we can build a system that we can prove delivers clinical value, then we have something important on our hands. Notably, we don’t have one penny of venture capital money because we did not know in the beginning how long it would take us to get a commercial product to market. There was no visibility on that when we first began since we did not know our timeline. I used to be a VC, so I was aware of this.
Medgadget: What is the PURE EP™ system?
Mr. Londoner: A product that we fashioned using this biomedical signaling platform, called the PURE EP™ system, is both hardware and software that basically is a (electrophysiology) EP information system.
Medgadget: What makes BioSig’s PURE EP™ system superior and unique to the rest?
Mr. Londoner: We are able to provide the surgeon that is doing ablation procedures with additional clinical information that they didn’t have prior. Our ability to take artifact out of the noise in the system allows us to see signals down to 1 microvolt of amplitude. All of the existing mapping and recording systems suffer from interference in their systems from radiofrequency energy being used to deliver the energy to the heart, and from all of the interference from the frequency bands that the ultrasound, MRI, and CT scan and recording systems create. There’s lots of technology in the operating rooms, and when they are all turned on and operating in the same domain, they create a lot of interference. The difference between putting the tip of catheter in the right location to terminate the arrhythmia vs. the wrong location is so minute that we believe our system can provide the best information on location to perform the ablation over other systems. Everybody has been trying for many years and it is a very difficult engineering feat.
Medgadget: What makes PURE EP™ unique and better than the competition?
Mr. Londoner: Basically, it’s a software/hardware combination. We have not seen others file patents or perform clinical studies that show the same level of competency our system provides in this area. 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. We will focus on the leading centers that do these procedures, obtain human data, and then ramp our commercial efforts with the PURE EP™ system. It is like in the early days of mapping — we have had this comparison made to us by some of the pioneers in this space such as J&J — they compare us to this experience where they will get the docs up and running on our technology and produce more bodies of clinical evidence that our system provides value for the procedure. That process will take us through the next 3 years and then we will be international.
Medgadget: Where will the technology go after that?
Mr. Londoner: The total number of the procedures is still very low compared to the total number of incidents since there is only about 6% penetration of the procedure since ablation involves telling a patient you’re going to burn their heart. There is an estimated up to 6.1 million people in the United States that are atrial fibrillation patients, and only 6-7% of these patients elect to have the ablation procedure performed. Even though patients are told that this is minimally invasive, after being told that the procedure involves burning their heart tissue it inevitably freaks them out. If you have the disease, atrial fibrillation can be like cancer where if it progresses to something chronic, then it is very hard to get rid of and it is an important factor causing stroke and death.
19 clinical trials have been performed and there is no meta-analysis showing that there is a real clinical benefit. There may be a little safety benefit, but there is not really an improvement in the outcomes… so there really needs to be a company that breaks through and we think that we are going to be that company.
We have made great strides clinically, all in the pre-clinical domain. Since we are not allowed to have access to human subjects studies until we have 510(k) approval. We believe that our results in animal studies will translate over to clinical studies since the physiological operation of the hearts is very similar. The first version of our hardware and software are actually frozen right now and are being manufactured. Until we do human trials, we don’t know the efficacy. We will have to compare the outcomes between having our system and not having our system, and then follow these patients over time (3, 6, to 12 months).
Medgadget: Who are your main partners moving forward— commercial and clinical partners?
Mr. Londoner: We do a lot of our pre-clinical work with Dr. Kalyanam Shivkumar at the UCLA Cardiac Arrhythmia Center. We are also partnered with leaders in this space, such as Dr. Samuel Asirvatham, director of the Clinical Cardiac Electrophysiology Training Program at the Mayo Clinic in Rochester, Minnesota, and Dr. William Stevenson, director of the Cardiac Arrhythmia Program at Harvard Brigham and Women's. These individuals are some of the greatest minds who really understand the morphology of the signals and waveforms, and how they can influence the outcomes of ablation procedures. There have been 9 pre-clinical studies performed from March of 2015 until today at Mayo on our system. On the clinical side, there is mainly Dr. Asirvatham and Dr. Venkatachalam. On the commercial side, we have selected Minnetronix to get us through development through the FDA, although we have not yet committed to a manufacturer yet.