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BioSig Makes A “Smart” Move, Partners with Vuzix®Corp

15 Jan BioSig Makes A “Smart” Move, Partners with Vuzix®Corp

BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device Company leveraging its signal processing technology platform, announced its partnership with Vuzix® Corporation (NASDAQ: VUZI), to deploy Vuzix’s M400 Smart Glasses for remote servicing, installations, upgrades and training of its  PURE EP™ System, to support a nationwide planned rolled out.

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.

A “Smart” Move!
Kenneth L. Londoner, Chairman & CEO of BioSig Technologies, Inc. commented,

“We are thrilled to work with Vuzix to deploy its outstanding smart glasses solution and enhance our technology offering as we work to accelerate commercialization of our PURE EP™ System nationwide. The Vuzix M400s are the powerful enterprise smart glasses and have compelling clinical applications for digital healthcare. The addition of AR technology to our PURE EP™ System solution should give us an even greater opportunity to elevate the standard of care in the electrophysiology market.”

Vuzix’s product offerings include personal display and wearable computing devices that also find application in areas such as enterprise, medicine, first responders, security solutions and retail markets. Vuzix enables the streaming of high quality video/audio, and real-life projections to be made, through the use of its smart glasses. M400, the next generation of Vuzix M-Series smart glasses comprises the new Qualcomm® Snapdragon(TM) XR1 platform., the first purpose built, dedicated XR platform from Qualcomm  (NASDAQ: QCOM)  and offers complete navigation through a combination of voice and touchpad navigation.

The M400 will not only provide quick remote access to technical experts for easy servicing of the hardware architecture and digital modality, but also eliminate the need for on-site visits, thereby improving costs and saving time. Furthermore the glasses will be used to deliver customer training and offer line-of-sight visualization of intracardiac signals during ablation procedures performed by physicians.

BioSig Technologies (NASDAQ: BSGM)

Market Cap: $162.20M; Current Share Price: 5.28 USDChart
Data by YCharts

PURE EP Makes it to the EP Lab Digest
BioSig’s PURE EP System has been featured in the latest issue of EP lab digest as a novel system that addresses the unmet needs for better EGM signal fidelity that can overcome limitations such as signal saturation and inadequate signal-to-noise ratio during critical procedures. This marks the latest editorial in several industry-leading media publications which highlight the systems unique capabilities.

Pushing its Boundaries
In December 2020, the Company’s NeuroClear Technologies division entered into a research agreement with the University of Minnesota, to develop novel therapies for the treatment of nervous system diseases. The program is likely to commence in Q4, 2020 and intends to develop new hardware, software, and algorithmic solutions in conjunction with a tier 1 US-based manufacturing partner to help navigate through FDA approval, manufacturing, and commercialization as per the Company.

Barry Keenan, Ph.D., Vice President of Engineering of BioSig Technologies, Inc. commented,

“University of Minnesota is at the forefront of autonomic neuromodulation research. We believe that with their expertise, resources and collaboration, we can accelerate product development of new novel bioelectronic medicine devices.” 

The Company’s NeuroClear division was found in 2018 to focus on targeting nerve stimulation and closed feedback loop system to address the needs in the cognitive disorders, nephrology and several other markets that could benefit from BioSig’s core competency in intracardiac, surface ECG and neuronal signal analyzing. The Company’s Neurotechnology Program was licensed from the Mayo Clinic in November 2019.

The Company had previously raised $3.7 million in an initial seed round, the proceeds from which will be used for pre-clinical development and studies, intellectual property portfolio and operational purposes.

Atrial Fibrillation, 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 heat-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 bringing 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.

Image Source: Company

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.

BioSig has also formed 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 is 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.

Key Takeaways

  • The Company will be unblinding the clinical data from its PURE EP Study in 2021. The study claims to have demonstrated that in 5% of samples, the reviewers selected PURE EP™ data because “more signal components were visible. The system seems to offer more reliable and high-quality signals compared to conventional systems. The Company landed its first commercial contract in Q4, 2020 at a customer center that is ranked number one in volume in the U.S and is focused on growing its customer base three fold in 2021.
  • BioSig has its sight on expansion and is working on acquiring a CE mark approval and consequently an entry into the European Market by Q4, 2021.
  • 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. 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 (US) (NYSE: BSX), Abbott Laboratories (US) (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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