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 - Bullish Technical Indicators Throughout Short, Medium, And Long Term
Do not discount BSGM's bullish technical indicators.
At close on Thursday, BSGM was displaying several triggered technical indicators across the short, medium term, and long term.
Barchart was reporting these as triggered:
Short Term Indicators
- 20 Day Moving Average
- 20 - 50 Day MACD Oscillator
- 20 - 100 Day MACD Oscillator
- 20 - 200 Day MACD Oscillator
Medium Term Indicators
- 50 Day Moving Average
- 50 - 100 Day MACD Oscillator
Long Term Indicators
- 100 Day Moving Average
- 150 Day Moving Average
- 200 Day Moving Average
The website also shares its all-important "Trend Seeker" composite indicator is triggered.
Watch these technicals closely this week.
#2. BSGM Potential Catalyst - Company CEO Made Major (BSGM) Share Purchases In 2022
Wow. To say BSGM CEO, Kenneth Londoner, went "hard in the paint" in 2022 might be an understatement.
Since the beginning of last May, the company's CEO has purchased thousands of shares.
In fact, after a quick count it looks to be somewhere in the neighbor of 200k+ shares.
What does he know that we don't? Could something big be right around the corner in 2023?
Check out his buying spree here.
#3. BSGM Potential Catalyst - A List Of Recent Company Milestones Signals The Potential For A Bright (BSGM) Future
BioSig Issues Shareholder Update to Highlight Recent Achievements and Ongoing Developments
Westport, CT, Jan. 19, 2023 (GLOBE NEWSWIRE) --
To date, the Company's FDA 510(k)-cleared PURE EP™ System has been used in approximately 3,000 patient cases across the United States
The Company has built a robust pipeline of commercial sale prospects and expects multiple closings in first half of 2023
New supporting clinical data to be published
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today issued an update to shareholders highlighting recent milestones and ongoing company developments.
Despite the difficult operating environment, there were several positives that came out of the year for the Company, our customers, and our shareholders. Most recently, we successfully raised approximately $3.8 mm in private placements of common st-ock and warrants at what we believe were relatively attractive terms. We will continue to try to find shareholder-friendly ways to fund the Company as we work to grow revenue and expand our value proposition through the ongoing development of our technology. We also received a letter from Nasdaq notifying us that the Company has been granted an additional 180-day period, or until May 22, 2023, to regain compliance with the St-ockholders’ Equity Requirement. Management believes that this is sufficient time to regain compliance.
Below is a list of examples that we believe demonstrate BioSig’s unique position within the Medtech industry and the growing interest in our disruptive technology, the PURE EP™ System.
- On January 10, 2023, we announced that Bellin Health entered into an agreement to acquire a PURE EP™ System. Through a formal evaluation, Bellin reported that clear cardiac signals positively impacted procedural efficiency resulting in cost savings per procedure.
- Over 3,000 procedures have been performed using the PURE EP™ System with more than 80 physicians at 21 hospitals across the United States.
- The PURE EP™ System was featured in an abstract presentation at the 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session in Singapore. Results from the randomized study revealed the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablation procedures.
- BioSig’s PURE EP™ System was highlighted in a peer-reviewed case report by the Journal of Atrial Fibrillation & Electrophysiology (JAFIB-EP). This clinical abstract detailed the value of PURE EP™ and its groundbreaking High Frequency Algorithm (HFA) during pulmonary vein isolation.
- A Master Research Agreement was signed with the Cleveland Clinic to explore expanded applications for its digital signal processing technology.
- A purchase agreement was signed with San Antonio Methodist Hospital.
- Launched PURE EP™ software Version 6 with ACCUVIZ™ Module highlighting the proprietary High Frequency Algorithm (HFA), a novel feature that identifies the key frequency components of cardiac data that can be difficult to identify within the traditional waveform presentation.
- Cleveland Clinic, a leading Medical Center of Excellence, agreed to evaluate the PURE EP System, and a short time later requested a second system for evaluation.
- A purchase agreement was signed with Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center.
- The PURE EP™ System was featured at numerous conferences including Kansas City Heart Rhythm Symposium 2022, the 17th Edition Venice Arrhythmias 2022 Congress, and EPLive 2022.
Although 2022 was a difficult year, we have the fortitude and laser focus to build on the progress we have made and are energized for what the new year brings us. We will continue to advance our commercialization strategy and look to add more hospitals and centers of excellence to our portfolio of PURE EP™ adopters. We are fortunate to operate in a growing sector as the global EP market is expected to reach $16Bn by 2028, an estimated 11.2% compound annual growth rate. With the number of annual catheter ablation procedures expected to grow, we believe that our PURE EP™ technology is well-positioned to set a new standard in intracardiac visualization.
As physician advocates, we are dedicated to developing technology that provides greater clarity and opens doors to ingenious treatment solutions for the most challenging arrhythmias. Collaborating with equal parts respect and humility, we are advancing science and technology, furthering the field of electrophysiology, and helping to solve healthcare’s greatest challenges.
Read the full article here.
#4. BSGM Potential Catalyst - Another Milestone Achieved As Wisconsin Healthcare System Signs Agreement To Acquire PURE EP™ System
BioSig Executes Agreement with Bellin Health for the Acquisition of its PURE EP™ Technology
Westport, CT, Jan. 10, 2023 (GLOBE NEWSWIRE) --
Leading Midwest healthcare system reports significant cost savings and noise reduction following evaluation of the PURE EP™ System
Medical center signs agreement to acquire the Company’s digital signal processing technology for arrhythmia care
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that Bellin Health System in Green Bay, Wisconsin has signed an agreement to acquire the Company’s PURE EP™ System.
The agreement follows a 60-day formal evaluation of the PURE EP™ System at Bellin Health. The hospital reported that the PURE EP™ demonstrated a significant cost savings per case as well as a substantial reduction in noise and signal interference compared to the use of conventional systems only.
The agreement grants Bellin Health full autonomy with respect to its operation of the PURE EP™ System, and BioSig will not be required to provide an on-site clinical account manager following the new system install.
The PURE EP™ System is a combination of hardware and software that enables the real-time acquisition of raw signal data—absent of unnecessary noise or interference—allowing physicians to make informed clinical decisions based on clear and precise data. With the heightened visualization of active signals, the PURE EP™ System is facilitating personalized patient care and innovations in the field of electrophysiology.
“Bellin has observed, first-hand, that clear cardiac signals provide more information that can impact procedural efficiency without driving up procedural costs,” commented Gray Fleming, Chief Commercial Officer, BioSig Technologies. “The terms of this agreement represent a new milestone for the PURE EP™ System—expanding the accessibility and automaticity of our novel digital signal processing technology.”
Bellin Health recently announced plans to combine operations with Gundersen Health System, a physician-led, nonprofit, integrated healthcare network headquartered in La Crosse, Wisconsin. The hospital serves 22 counties in western Wisconsin, southeastern Minnesota, and northeast Iowa. The merger allows the health systems to offer access to more resources and a broader network of top-tier clinical services, shared provider expertise, state-of-the-art technology and digital healthcare tools that bring virtual care options into homes and workplaces.
Read the full article here.
#5. BSGM Potential Catalyst - Clinical Evidence Continues To Grow Validating The PURE EP™ System
BioSig’s PURE EP™ System Highlighted in the Journal of Atrial Fibrillation & Electrophysiology
Clinical abstract focuses on value of PURE EP™’s and its groundbreaking High Frequency Algorithm (HFA) during pulmonary vein isolation
Westport, CT, Dec. 06, 2022 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that a peer-reviewed case report titled, “Confirmation of Acute Pulmonary Vein Reconnection with The Utilization of PURE EP’s High-Frequency Algorithm (HFA)” has been published in the Journal of Atrial Fibrillation & Electrophysiology. The publication is available electronically via the JAFIB-EP open access digital journal.
Co-authored by Roy Chung, MD, Clinical Cardiac Electrophysiologist at Cleveland Clinic and Zachary Koch, CCDS, CEPS, Clinical Director at BioSig Technologies, Inc., the case report describes a 65-year-old patient with a medical history of symptomatic and persistent atrial fibrillation undergoing pulmonary vein isolation (PVI). PURE EP™’s HFA signal analysis was observed alongside the simultaneous signal anno New Primary Logo New Primary Logotation produced by a 3D mapping system. PURE EP™’s real-time HFA identified early local activation, providing a clear and precise location that served as the primary target for ablation therapy during the procedure. Results from the case study support the efficacy of PURE EP™’s HFA in identification of the pulmonary vein gap compared to the inferior annotation produced by the 3D mapping system.1
“This case study adds to the growing pipeline of clinical evidence validating the PURE EP™ System as an essential and valuable technology for today’s EP lab—particularly for challenging cases,” commented Gray Fleming, Chief Commercial Officer, BioSig Technologies, Inc. “We believe that these findings, along with other clinical applications we continue to explore in collaboration with the Cleveland Clinic, demonstrate PURE EP™’s ability to set new standards in the field of electrophysiology.”
Read the full article here.
BSGM Recap - Key Potential Catalysts To Know Right Now
#1. - Bullish Technical Indicators Throughout Short, Medium, And Long Term
#2. - Company CEO Made Major (BSGM) Share Purchases In 2022
#3. - A List Of Recent Company Milestones Signals The Potential For A Bright (BSGM) Future
#4. - Another Milestone Achieved As Wisconsin Healthcare System Signs Agreement To Acquire PURE EP™ System
#5. - Clinical Evidence Continues To Grow Validating The PURE EP™ System
Coverage is officially reinitiated on BSGM. When you have time later, do this: