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 - Company CEO Makes Major BSGM Share Purchases
Wow. To say BSGM CEO, Kenneth Londoner, went "hard in the paint" last week might be an understatement.
Over the span of 3 days, the company's CEO purchased thousands of shares.
What does he know that we don't? Could something big be right around the corner?
Check out his spending spree:
#1. 8/16/22 (25,100 shares)
#2. 8/17/22 (13,100 shares)
#3. 8/19/22 (10,000 shares)
All I'm going to say is, "Hmmmm."
#2. BSGM Potential Catalyst - Positive Momentum Spotted In Company's Sales Pipeline Growth
BioSig Sees Positive Momentum from Sales Pipeline Growth
Westport, CT, Aug. 16, 2022 (GLOBE NEWSWIRE) --
- Company sees increase in medical centers entering into 60-day evaluation agreements
- Existing customers seeing positive results from PURE EP™ System expected to increase number of units purchased
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 announced that it is seeing positive momentum from the growth of its sales pipeline, and expects to see an increase in enterprise adoption of its PURE EP™ System in the coming months.
Since BioSig’s national commercial launch of its PURE EP™ System on July 1st, 2022, the Company’s commercial pipeline has experienced a steady increase in advanced leads and technology adoption across several key regions and centers of excellence...
“The demand for minimally invasive catheter-based ablation procedures continues to grow. We believe that market demand is high, and expect to see an acceleration of commercial activity in our quarterly results going forward,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.
BioSig’s commercial momentum is supported by its recent decision to streamline the PURE EP™ System evaluation period from 180-360 days to 60-days. The Company has also implemented a new leasing program to help expedite the acquisition of Pure EP’s superior signal processing capabilities and shortens the sales cycle. Consistent with its stated commercial strategy, BioSig is prioritizing the growth of its robust sales team, including the recent appointment of a new sales leader who will cover the COLT states (Colorado, Oklahoma, Louisiana, and Texas).
“By shortening our evaluation period and providing flexible paths to purchase, we are meeting the demands of physicians and supply chain management, ensuring that superior signal processing technology is within reach. We’re pleased to be exploring opportunities for repeat business and additional unit placement with many of our existing accounts,” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.
Read the full article here.
#3. BSGM Potential Catalyst - Milestone Achievement Reached With New Purchase Agreement
BioSig Announces Purchase Agreement with Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center
Westport, CT, July 07, 2022 (GLOBE NEWSWIRE) --
- OPRMC marks our first leasing agreement under new program
- Company also inks national master agreement with one of the largest U.S. healthcare 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 announced that Kansas City Heart Institute at Overland Park Regional Medical Center in Kansas City, U.S. has signed a purchase agreement to acquire its PURE EP(T.M.) System.
Following its evaluation of BioSig's PURE EP(T.M.) System, Overland Park Regional Medical Center (OPRMC) has signed an agreement to purchase the technology under the terms of the Company's new program. The agreement represents BioSig's first commercial adoption since it announced the national launch of its PURE EP ™ System, supported by The Company's new commercial structure and clinical support teams. The agreement also represents The Company's first national purchasing agreement.
"Establishing a contract with a leading national hospital network is a milestone achievement for BioSig Technologies," commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. "A leasing option provides a cost-effective and efficient pathway for hospitals to acquire our technology. As a Company that prioritizes physician experience and throughput, we believe a leasing program supports the clinical evolution of PURE EP as we continue upgrading and enhancing our technology based on physician feedback."
Read the full article here.
#4. BSGM Potential Catalyst - Company Enters Into Key Evaluation Agreement With The Cleveland Clinic
BioSig Announces New Evaluation Agreement for its PURE EP System with Cleveland Clinic
Leading Center of Excellence will participate in a 60-day evaluation of The Company’s signal processing technology
Westport, CT, June 22, 2022 (GLOBE NEWSWIRE) -- 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 announced it has entered an evaluation agreement for its PURE EP(TM) System with the Cleveland Clinic.
The evaluation agreement marks the first since BioSig inducted a new commercialization team. Consistent with The Company’s stated national rollout strategy, Cleveland Clinic will participate in a 60-day evaluation of BioSig’s PURE EP(TM) System. The Company recently announced that is has restructured its clinical support and installation teams to streamline and accelerate the pathway from product evaluation to adoption.
“We are excited to include Cleveland Clinic as an evaluation center for the Pure EP System. We look forward to working alongside their physicians to demonstrate the superior signal quality that can be achieved on even the most difficult arrhythmias,” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.
Read the full article here.
#5. 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 40.02Mn 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. - Company CEO Makes Major BSGM Share Purchases
#2. - Positive Momentum Spotted In Company's Sales Pipeline Growth
#3. - Milestone Achievement Reached With New Purchase Agreement
#4. - Company Enters Into Key Evaluation Agreement With The Cleveland Clinic
#5. - Another Low Float Profile
Coverage is officially initiated on BSGM. When you have time later, do this: