BSGM: Bringing Clarity to Catheter Ablation
OTC:BSGM
BioSig Technologies (BSGM) was founded in 2009 by former investment portfolio manager Ken Londoner who recognized the compelling opportunity for medical devices in the cardiovascular space. After extensive interaction with electrophysiologists who performed ablative procedures for atrial fibrillation, he realized one of the obstacles that they face is the interference present in electrocardiograms and the complications it presents when trying to accurately conduct their work. In response to this unmet need, Ken launched a company to develop a medical device to minimize interference during electrophysiology studies and ablation. The company’s sole product developed to achieve this end is the Precise Uninterrupted Real-time Evaluation of Electrograms (PURE) Electrophysiology (EP) system.
When conducting heart studies, interference from nearby equipment can distort the quality of reads and generation of data. Readings suffer from baseline wander, noise and artifacts, deteriorating the quality of the signal. The lack of precise data can result in longer procedure duration and the need for additional procedures to address atrial fibrillation (AF) and ventricular tachycardia (VT) given the particular characteristics of these signals. The PURE EP system is intended to improve the fidelity of cardiac readings for ablation procedures in AF and VT. It employs signal processing tools to reduce the interference that plagues current diagnostic and recording catheter systems and also higher sampling rates to more accurately represent the raw wave generated.
Heart Arrhythmia
Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) both represent irregular heart rhythms due to improper electrical signal propagation in the heart. The heart’s rhythm is regulated by the sinoatrial node, which acts as pacemaker. However, in some cases disorganized electrical impulses, usually originating in the pulmonary veins, can lead to irregular conduction and misaligned contraction of the cardiac muscle. For proper function to take place, the contraction of the four chambers of the heart must be synchronized, and not be affected by extraneous electrical impulses.
First line therapy to treat arrhythmia is to prescribe antiarrhythmic drugs (AADs). Sodium channel blockers, calcium channel blockers and beta blockers are commonly used to resume the proper rhythm of the heart. However, these medications do not always work and can in some cases make the arrhythmia worse. Cardioversion is another recognized treatment, however, it is not always durable and the problem frequently returns. If neither of these approaches work, then catheter ablation techniques are considered.
Catheter ablation is a favored approach to treating several types of arrhythmias, especially in middle aged patients without co-morbidities. The ablation technique inserts a catheter into a vein or artery in the groin area and feeds it into the heart chambers. The first steps are to map the heart and identify the abnormal tissue causing the arrhythmia. The physician sends an electrical impulse to different locations in the heart identifying the location of the abnormal tissue, and when discovered, the heated tip of the ablative tool denatures it. Scarring forms in the ablated areas and prevents any electrical impulses from passing through. If successful, the extraneous electrical impulses will be blocked from entering the heart and normal heart rhythm will return. As this is a minimally invasive procedure many patients are able to return home that day or the next.
Catheter ablation is supported with substantial evidence of efficacy for drug resistant AF based on the results of several studies. Ablation resulted in fewer recurrences of AF, and also resulted in better quality of life and improved symptom severity. Serious complications were also much lower in patients where catheter ablation was used.
Despite the advantage of the procedure, half of all patients receiving ablative procedures need a second treatment. The need for some of this rework can be attributed to the quality of the physician’s information. When electrophysiologists are determining where to ablate the tissue in the heart, they use the electrocardiograms and their interpretation of the electrical waves to determine whether or not the proper region was addressed. When the signal is poor or indistinguishable, the electrophysiologist is unable to determine with a high degree of confidence if the unwanted electrical signals have been blocked.
Accuracy is critical for low amplitude and high frequency signals that are characteristic of AF and VT. Without proper accuracy, the ablation may not be complete, and the patient will have to return for a follow-up procedure.
When surgeons and electrophysiologists are interpreting cardiac signals to perform highly complex and precise procedures, interference from equipment in the lab, such as monitors, recording systems, X-rays, fluoroscopes, robotic systems, ablation generators, mapping systems, stimulators and pacing equipment all emit electrical signals that can impact vital imaging work. This raises challenges to overcome. Based on an assessment study by Health Research International, electrophysiologists highlighted signal clarity as essential to the success of ablations. With current technology, these physicians were not able to precisely access lesions, record high-quality unipolar signals or detect small intracardiac signals driving the need for a solution.
PURE EP
BioSig has developed a device to eliminate interference and allow a pure signal to emerge. This permits physicians to judge the success of the ablation during the procedure, decreasing the need for additional work. Successful use of the PURE EP device has the potential to reduce hospital visits and improve outcomes, resulting in healthier patients and lower costs. Other benefits include shorter procedure times and increased confidence in performing complex ablations. The PURE EP device provides improved resolution and a broader dynamic range that can operate alongside other EP systems.
BioSig conducted an independent product assessment for PURE EP and found that electrophysiologists across the United States seek higher quality unipolar signals and the ability to detect small intra-cardiac signals and see these as important for ablative therapy success. Signal clarity, noise reduction and signal accuracy were all highlighted as critical factors. The survey responders felt that the ability to record raw, unfiltered signals, generate greater bandwidth and resolution, supply filter and noise cancellation software and real time visualization were all very helpful in conducting successful ablations.
A Comparison
Relative to GE’s CardioLab and St. Jude’s EP-Workmate, PURE EP boasts a higher bandwidth range, over twice the sampling rate, a 24-bit vs. a 12-bit analog to digital converter and other characteristics which improve both the quality and accuracy of the original signal.
In the exhibit below, we illustrate the difference between a noisy signal and a clean one. Note the sharper distinction and magnitude of oscillation of the wave in red represented in the exhibit.
Existing technology uses amplifiers to enhance the signal, which can have the unintended consequence of amplifying the distortion as well. It also employs filters which may remove a critical portion of the wavelength. Many of these systems must contend with high signal-to-noise ratio outputs, limited dynamic range and representation of only a narrow band of frequencies, all of which contribute to imprecise data. Below we illustrate the schematic of a conventional EP system.
Contrast this with PURE EP’s approach which reduces the steps between the raw signal and the monitor where it is represented. The system has fewer steps and also higher levels of information throughput, which prevents clipping, attenuation and compression. Precision is important to assess in real time the success of the ablative procedure and whether or not the heart rhythm has been restored to its natural pace.
We compare the conventional system above with the PURE EP schematic below, illustrating its relative simplicity.
Development and Regulatory Process
Initial concept validation for PURE EP occurred at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas in 2011. Electrophysiology recordings were imported into the PURE EP system and processed to limit distortions and generate quality signals. Proof of concept for PURE EP took place in the second and third quarters of 2013 at UCLA’s EP Lab. The team generated simulated electrocardiogram and intracardiac data and recorded an identical signal through the proof-of-concept PURE EP device and through GE’s CardioLab system. Based on a visual comparison, the signals on the proof-of-concept unit exhibited less baseline wander, noise and anomalous interference compared to the control system. Independent electrophysiologists also found that the PURE EP system provided improved cardiac signal recording in terms of signal to noise ratio and visualization of juxtaposed signals. The results of this comparison were sufficient to develop the final design of PURE EP in 2014 and conduct in vivo pre-clinical studies.
The first pre-clinical study was undertaken in the first quarter of 2015 at the Mayo Clinic in Rochester, Minnesota, which was subsequently followed by a second and third study over the remainder of 2015 which conducted cardiac mapping and ablation studies. These canine studies mapped several parts of the cardiovascular system, including the atria, ventricles, pulmonary veins and the conduction system. The data from these studies was presented at the Dead Sea Symposium in March 2016 in poster entitled “Enhanced Electrophysiology Recording Improves Signal Acquisition and Differentiation.”
As of August 2017, ten pre-clinical studies have been conducted providing the necessary data to develop a production version of the PURE EP device. In February of 2017, BioSig signed an agreement with Minnetronix to develop a prototype of the PURE EP device.
Since it is not implanted in the body, not life sustaining and represents moderate risk, PURE EP is characterized as a Class II medical device. Class II devices follow the 510(k) clearance process and do not require clinical data to gain FDA approval. Generally, devices are cleared in five to six months.
BioSig is wrapping up 2017 focused on preparing the 510(k) submission for FDA clearance. The company currently plans to deliver its application package to the FDA in 4Q:17 and receive clearance in the first half of 2018.
Outlook for Growth
According to the CDC, NIH National Heart Lung and Blood Institute and the American Heart Association, AF affects from 2.7 to 6 million persons in the United States and results in over 750,000 hospitalizations and 130,000 deaths. 600,000 new cases of AF occur each year. There are also from 300,000 to 450,000 deaths due to VT every year in the United States.
The 2016 HRI Global Opportunities in Medical Devices and Diagnostics report forecasts that the global electrophysiology market will increase revenues and procedure volume at a 10% rate per annum until 2020. Growth in the United States is expected to be slightly higher at 11 to 12% per year. Contributing factors to this rate include aging demographics, rising obesity and improving ability to diagnose arrhythmia. Arrhythmia is more prevalent in individuals over 65 years of age who have previously had a heart attack, cardiac surgery or any other heart condition.
BioSig estimates that there are about 3,000 electrophysiology labs in the U.S. and 1,500 outside the U.S. in 2016. With the increase in ablative procedures anticipated to grow double digits, continued lab growth is also projected.
The incidence of arrhythmia suitable for ablative procedures provides a deep domestic and international market that can benefit from PURE EP’s superior output.
Partners
BioSig has built an impressive reputation through its preclinical and clinical testing of the PURE EP system. They have teamed up with leading cardiac centers for proof of concept testing, development and validation studies and clinical trials including the Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center, U.H. Case Medical Center, William Beaumont Hospital, Mount Sinai Medical Center, and the world renowned Mayo Clinic.
This partnership extends to the company’s scientific advisory board. It includes seven electrophysiologists that hold senior positions at top hospitals across the nation in Florida, Texas, California, New York, Ohio and Michigan. Several board members have also been involved with the testing of the equipment.
On the CMC side, BioSig is collaborating with Minnetronix. In February 2016, it signed an agreement with this company to develop the PURE EP system, pursue FDA clearance and eventually manufacture the device. This medical technology company is focused on electronic and electromechanical devices and has a broad portfolio developed over the company’s near 20 year life. Their regulatory experience with many other products will be an asset for developing PURE EP.
Summary
Founded by an investment manager with an eye for good investments, BioSig has identified an unmet need in the market and is now pursuing FDA clearance for its PURE EP device. PURE EP holds promise to increase the effectiveness of ablative techniques for AF and VT resulting in shorter, more precise procedures and fewer second visits. The device is in its very last stages prior to a 510(k) submission to the FDA and an anticipated 1H:18 clearance by the agency. The market is large and growing for PURE EP with millions of arrhythmia cases that may benefit from ablative techniques and thousands of sites that can bolt-on the system to improve their accuracy and throughput.
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