PURE EP™ was designed to be useful in arrhythmia diagnosis. For example, in atrioventricular reentrant tachycardia (AVRT) & AV nodal reentrant tachycardia (AVNRT), EP physicians often look for a slow pathway potential or accessory pathway potentials that are not easy to detect.
Furthermore, during pacing maneuvers, important diagnostic signals may be buried inside the saturation artifact from the pacing electrode.
The wide dynamic range of the PURE EP™ System may allow for better differentiation of those signals, as there is no system saturation and a quicker recovery to baseline. Cardiac catheter ablation is a procedure that involves delivery of energy through the tip of a catheter that scars or destroys heart tissue to correct heart rhythm disturbances.
In August 2018, the company received 510(k) clearance from the U.S. Food and Drug Administration (the “FDA”) to market their PURE (Precise Uninterrupted Realtime evaluation of Electrograms) EP™ System.
Their initial focus is on improving intracardiac signal acquisition and enhancing diagnostic information for catheter ablation procedures for complex arrhythmias, like ventricular tachycardia (“VT”) and atrial fibrillation, or AFib (“AF”). VT is a fast, abnormal heart rate in the heart’s lower chambers. VT does not give your heart enough time to fill with blood before it contracts again. This can affect blood flow to the rest of your body and is potentially life-threatening. AF is the most common cardiac arrhythmia associated with a fivefold risk of stroke. AF occurs when the upper chambers of the heartbeat irregularly, and do not pump all of the blood to the lower chambers, causing some blood to pool and potentially form clots. If a clot breaks loose, it can travel through the bloodstream to the brain and lead to a stroke. Strokes related to AF are often more severe compared to strokes with other underlying causes.
The company believes that the PURE EP System and its advanced signal processing tools may contribute to improvements in patient outcomes in connection with catheter ablation due to the following advantages over currently available devices on the market:
Less noise: PURE EP’s low-noise proprietary architecture was engineered to enable acquisition of high-fidelity signals in the original, unfiltered format. PURE EP’s Main System Unit (MSU) topology incorporates advanced shielding and very low noise front-end components.
Wider range: PURE EP’s wide dynamic range was developed to retain cardiac signal details and reduce saturation. PURE EP™ combines a low-noise signal architecture with a fixed range up to 500mV, so signals are rarely clipped or limited by quantization noise.
Higher fidelity: PURE EP’s large frequency bandwidth and linear signal acquisition helps to accurately display complex fractionated signals, even at lower amplitudes and higher frequencies. This unique system capability minimizes signal attenuation and maintains original signal amplitude – especially critical for identifying and interpreting complex arrhythmogenic substrates.
Clear, stable unipolar signals: The PURE EP System uses an innovative approach to acquiring unipolar signals. The Wilson Central Terminal (WCT+™) relies on a common front-end circuitry similar to how bi-polar intracardiac signals are acquired. This enables clear, stable unipolar signals, without the need for an internal reference catheter.
Customizable software and filters: PURE EP™ offers software modules and specialty digital filters, so electrophysiologists can customize their interface and optimize signals for mapping, signal interpretation and during therapy delivery.
Seamless integration: PURE EP™ integrates with existing EP labs and workflows. It is compatible and complementary with EP recording systems, mapping systems, robotic equipment, and multi-display panels. We believe that these features may allow physicians to better determine precise ablation targets, strategy, and end point of procedures with the objective of reducing the need for patients to undergo multiple procedures, and to allow for less experienced EP physicians to perform more complex procedures. The PURE EP System is intended to operate in conjunction with the existing EP lab equipment.
Now that you know a bit about the company's lead product, there's several potential catalysts that could fuel BSGM in the near term.
#1. BSGM Potential Catalyst - Achievements Galore: Company Issues Shareholder Letter
BioSig Technologies, Inc. Issues Shareholder Letter with Corporate Update on Recent Achievements
- To date, Company's FDA 510(k) cleared PURE EP(TM) system has completed over 2,200 patient cases with 75 physicians at 17 hospitals across the United States
- The Company adds new executives to accelerate sustained commercial momentum developing a national installed base of the PURE EP systems
BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the "Company"), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today issued a Letter to Shareholders providing highlights on the Company's recent developments and updates.
Recent Company highlights include:
- The growth of its PURE EP(TM) System from its first-in-human surgical procedures in 2019 to completing over 2,200 patient cases with 75 physicians at 17 hospitals across the United States.
- BioSig strengthened its management with a new commercialization team led by industry veteran Gray Fleming, Chief Commercial Officer, who spent 18 years with St. Jude Medical.
- The rollout of a two-phase approach for purchase, lease, or rental options for PURE EP and a new go-to-market strategy for commercialization.
- Launch of its new NOVA-5 software at the Heart Rhythm Society Convention on April 29, 2022. NOVA-5 offers greater customization and smarter workflows with the aim of further driving clinical adoption.
- Recapped the successful completion of its first blinded clinical trial in 2021 and published those results in a leading peer-reviewed journal. Titled "Evaluation of a novel cardiac signal processing system for electrophysiology procedures: The PURE EP 2.0 study," the study was conducted at three leading medical centers across the United States: St. David's Medical Center (TCAI), Mayo Clinic, and Massachusetts General Hospital.
- A snapshot into Biosig's financing included no debt and positioning in a global electrophysiology device market which, according to Grand View Research, could reach $12.2Bn by 2026 and expand at a growth rate of approximately 12%.
"We have made great strides on multiple fronts and felt it was an important time to communicate to our shareholders the strength of our business and the initiatives we are executing that have served as the foundation for our growth trajectory," said Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc. "We strongly believe in the value of our technology and are now supported with both peer-reviewed clinical data and third-party economic data, proving the value of what we have built. We are eager to continue working on our new commercialization strategy, seeing the impact of our new NOVA-5 software has, and all our initiatives we are undertaking to drive shareholder value and expand PURE EP."
Read the full article here.
#2. BSGM Potential Catalyst - New Partnership Agreement With Industry Leader In Equipment Finance And Leasing
BioSig Technologies, Inc. Partners with Summit Blue Capital to Provide Equipment Leasing Services
The leasing and finance program provides a non-recourse financial solution for PURE EP™ to improve purchase flexibility for U.S. hospitals
Westport, CT, March 29, 2022 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced a new partnership agreement with Summit Blue Capital for implementing a leasing and finance program for the Company's PURE EP™ System.
The Minneapolis-based Summit Blue Capital is a leader in equipment finance and leasing. It offers tailored leasing and financing solutions for its partners and clients in industries such as healthcare, manufacturing, hospitality, technology solutions, and more. Most notably, Summit Blue Capital specializes in simplifying the financing experience and finding solutions to advance commercial roll outs in the healthcare industry.
"We believe that partnering with Summit Blue Capital will have considerable benefits to our commercial plans. We intend to take advantage of the Summit team’s expertise, flexibility, and financial solutions as a leasing partner,” said Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “Summit Blue Capital came highly recommended by one of the largest money center U.S. financial institutions. We believe this relationship will help take friction out of the sales cycle and advance our timeline while allowing BioSig to get paid up front per installation. The team at Summit Blue Capital is expected to also help us launch a subscription-based revenue model for our software.”
“The pathway to purchase is always of great consideration in the capital equipment forum. We anticipate that partnering with Summit Blue Capital will impact our ability to expedite PURE EP’s entrance into new electrophysiology labs across the United States,” commented Gray Fleming, Chief Commercial Officer of BioSig Technologies, Inc.
“BioSig has made significant improvements to the EP market, and they have a unique technology offering with their PURE EP,” said Adam Drill, President of Summit Blue Capital. “Summit Blue Capital is excited to partner with BioSig and execute on a strategic financing and leasing program that we believe will benefit their customer roll out and help position them as a leader in medical technology. We look forward to helping each other and building a solid foundation for the future.”
Read the full article here.
#3. BSGM Potential Catalyst - New Feasibility Study With Technion (Leading AI Academic Institution)
BioSig Initiates Artificial Intelligence Development Program with Technion – Israel Institute of Technology
Company partners with the leading academic institution on research and development of AI-driven methods for atrial fibrillation procedures
Westport, CT, Nov. 16, 2021 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company entered into a feasibility study with The Technion Research & Development Foundation Ltd.
Based in Haifa, Israel, Technion – Israel Institute of Technology is a public research university offering degrees in science, engineering, and related fields, such as medicine, industrial management, and education. Over the years, the Technion established itself as a leading academic institution in Artificial Intelligence (AI). It is currently ranked as number one in AI in Europe and 15th in the world, with 100 faculty members engaged in areas across the AI spectrum.
The feasibility program with BioSig will be led by Asst. Prof. Joachim Behar, Head of the Artificial Intelligence in Medicine Laboratory (AIMLab) at the Technion. Under the terms of the program, the ECG signals supplied by the PURE EP(tm) System, the Company’s signal processing technology for arrhythmia care, will be analyzed in the context of developing AI-powered algorithms for atrial fibrillation ablation procedures.
“Artificial Intelligence is promptly becoming an essential tool for increasing efficiency and driving value in many sectors of healthcare, but predictive insights that form the foundation for machine learning solutions are dependant on the high-quality input data. Our clinical work provides us with vast volumes of smaller, often undetectable cardiac signals that hold additional diagnostic information, and we are thrilled to partner with Prof. Behar and his Technion team to take our AI work to the next level. Their expertise in developing deep learning systems for ECG records is invaluable to this program, and we look forward to reporting on the progress of this promising new project,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.
“The laboratory for artificial intelligence in medicine (AIMLab.) at the Technion focuses on the usage of advanced signal processing and machine learning in medicine within the context of physiological time series analysis with a specific focus in cardiology where we have 10 years of expertise in processing and analysing the ECG signal. In particular, in our most recent research we have developed robust deep learning algorithms for AF diagnosis and risk prediction working on large databases - totalling over a million ECG recordings. We look forward to contributing our expertise to support leading industry in the field providing novel clinical ECG analysis tools. Our new partnership with BioSig is aligned with this desire to contribute and impact the medical field through AI powered algorithms to support clinical decision making in cardiology," commented Asst. Prof. Behar.
Read the full article here.
#4. BSGM Potential Catalyst - Another Low Float Profile
According to the Yahoo Finance website, BSGM has a relatively low float.
The website reports this profile to have approximately 35.36Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility.
With so few shares available for trading, other potential catalysts (like big news) could spark a vertical move in the short-term.
BSGM Recap - Key Potential Catalysts To Know Right Now
#1. - Achievements Galore: Company Issues Shareholder Letter
#2. - New Partnership Agreement With Industry Leader In Equipment Finance And Leasing
#3. - New Feasibility Study With Technion (Leading AI Academic Institution)
#4. - Another Low Float Profile
Coverage is officially initiated on BSGM. When you have time later, do this: