17 Dec Positive Signals Abound for BioSig’s Unique Signal Processing Platform
BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company leveraging its signal processing technology platform, has announced the sale of three PURE EP™ Systems to St. David’s HealthCare of Austin, Texas, owned by HCA Healthcare (NYSE: HCA) and the Winner of the Malcolm Baldrige National Quality Award, a presidential honor recognizing performance excellence. The Company installed its first PURE EP™ System at the hospital in November 2019, which was then used on over 200 patients by the Texas Cardiac Arrhythmia Institute (TCAI) as part of its PURE EP 2.0 clinical study named “Novel Cardiac Signal Processing System for Electrophysiology Procedures “.
Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc, commented
“Our first commercial sale to St. David’s HealthCare is an important milestone as we proceed in expanding our installed base nationwide. This installation cements our valued relationship with St. David’s and adds to the traction we are gaining in the electrophysiology (EP) market”.
The PURE EP system uses the Company’s proprietary real-time signal processing platform that can perform a range of function such as enhanced signal acquisition, digital signal processing, and analysis. The system has a novel hardware architecture that facilitates the capturing of unfiltered cardiac analog signals, which are then processed by using advanced signal processing software to offer valuable insights using real time data analysis. The system has been utilized to perform more than 410 patient procedures across six different hospitals in the U.S till date.
BioSig Technologies, Inc. (NASDAQ: BSGM)
Market Cap: $135.82M; Current Share Price: 4.49 USD
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Atrial Fibrallation, commonly known as AF, is irregular heartbeat that can cause serious complications such as stroke, heart failure, and blood clots. This is usually caused by the ineffective beating of the Atria (Upper chamber) and nearly 12.1 million people in the United States will have the condition in 2030 according to the CDC. If the condition is left untreated, it may increase the risk of stroke by 5 times and double the risk of heart-related deaths. The most common causes of AF include uncontrolled high blood pressure, coronary artery disease, prolonged standing or heart surgery.
Electrophysiology Studies (EPS) are undertaken to gain an understanding of arrhythmias (abnormal heart rhythms). The test is administered in a specialized electrophysiology (EP) or catheterization (cath) lab and can determine the cause of arrhythmia, which is crucial for making a decision with respect to the most suitable treatment options for the patients that include surgery, implanting a pacemaker or an implantable cardioverter defibrillator (ICD). The process involves the insertion of electrically sensitive catheters into blood vessels that connect to the heart, which in turn record electrical activity and help in narrowing down the cause of arrhythmia.
The test provides valuable inputs with regards to the efficacy of medicines being used to treat the condition and the most appropriate treatment to treat the condition. According to a report by Markets and Markets, the global electrophysiology market which was valued at USD 6.8 billion in 2020 will grow at a CAGR of 9.1% to reach USD 10.6 billion by 2025. An ageing population, the rise of lifestyle and heart related disorders, technological advancements and, increased research, development and investments will drive the growth in the market.
However, the prohibitive treatment costs and unfavorable reimbursement policies by insurance companies may hamper the growth of the market.
BioSig is seeking to transform the field of bioelectronic medicine by brining innovation to the signal processing solutions through its PURE EP™ System. Since its inception in 2009, the company has achieved significant milestones, be it the development of a novel technology, a 10-year strategic agreement with Mayo Clinic or building an impressive IP portfolio.
The Company received a 510(k) market clearance for PURE EP(tm) from the FDA in 2018 and has already initiated first-in-human clinical trials at three medical centers. The Company intends to release data collected from these trials as well as further extend its technology to increase its clinical footprint.
The Company has built the EP™ System to offer enhanced, clear and detailed signals in various cardiac frequency settings that can be captured in their unfiltered format. It can capture and retain signal details in 24-bit precision and can even display high frequency cardiac signals with accuracy and precision. The systems also provide for up gradation to newer clinical modules and advanced Data-Enabled Software application.
The system can be integrated with pre-existing EP Lab equipment without disrupting current workflow. It allows users to conduct unlimited real-time data analysis and enables magnification of specific components of electro gram.
BioSig has also formed an Alliance for Advancing Bioelectronic Medicine (AABM), a network of leading experts and professional who are passionate about bioelectric medicine and are pioneering innovation in diagnostics and treatments across various diseases.
- BioSig is focused on making strides in the bioelectric medicine industry, which was estimated to be worth over USD 16.1 billion in 2018, according to a report by Grandview Research. The market for these devices is diverse, with possible application of the technology ranging from Parkinson’s, Alzheimer’s, vagus nerve stimulation to even obesity and depression. The Company intends to extend its clinical footprint by exploring areas where its proprietary signaling platform can make a difference.
- In October 2020, the Company’s majority owned subsidiary, ViralClear Pharmaceuticals, Inc. halted the phase 2 trial of merimepodib. BioSig has decided to wind down the operations and reach out to other biotech/ pharmaceutical companies that may want to pursue the program further. The entity will refocus its resources on NeuroClear Neurotechnology Program, which was licensed from the Mayo Clinic in November 2019. It has also received interest from three organizations so far for its merimepodib Program.
- The Company had plans of installing the EP PURE systems in 10 centers by December 2020, however due to the impact of COVID-19; two of its installations have been postponed to Q1, 2021. BioSig has managed to install 8 to 9 systems out of its initial target of 12 to 16 installations. It intends to make up for lost time on account of the pandemic by doubling up its efforts in 2021 and on boarding more people in its sales, marketing, and clinical team functions to handle more centers.
- The electrophysiology market is extremely competitive with players like Johnson & Johnsons (NYSE: JNJ), Boston Scientific (NYSE: BSX), Abbott Laboratories (NYSE: ABT) etc., vying for a majority share of the market. The cost of the devices, budget cuts due to COVID-19, unfavorable reimbursement scenarios may pose further challenges for new entrants in the market.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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