BioSig Technologies (BSGM) is Transitioning from The Development Stage to Commercialization and Sales of Their PURE EP™ System

Good day everyone,

BioSig Technologies, Inc. (NASDAQ: BSGM) is a medical technology company. Their flagship product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring, and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures.

Current price $2.63/share (+ 9.12% at 10:00 a.m. EST 12-16-21)

After closing the Tuesday session at $2.18/share BSGM shares gained 10.5% in the Wednesday session. BSGM shares added another 9.12% in early trading today.

The current level of pricing for BSGM shares is the lowest I’ve seen since I started watching the company and comes at a time when the company is at its most successful level of progress. I expect that BSGM shares may have a significant near-term gain.

BSGM is in a transition from its development stage to commercialization. Three recent events point toward the transition:

The published clinical data acquired for the PURE EP™ System in a multi-center study in October.

The appointment of Gray Fleming as Chief Commercial Officer earlier this month.

The manufacturing and marketing agreement with Plexus in November.

(I will expand on the above events in our full report)

In news, this morning, the company announced that it is installing a PURE EP™ System for an evaluation at the HCA Healthcare-operated Westside Regional Medical Center in Plantation, FL. Westside Regional Medical Center is a facility of HCA East Florida, the most extensive healthcare system in Eastern Florida and an affiliate of Hospital Corporation of America (HCA). HCA East Florida has 14 hospitals, multiple ambulatory surgery centers, physician practices, free-standing emergency care facilities, and a supply chain center, and an integrated regional lab. To date 73 physicians have completed over 1750 patient cases with the PURE EP™ System.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation (AFIB) is the most common arrhythmia type, affecting over 33 million people worldwide, including over six million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050. According to the CDC, atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year. Cardiac catheter ablation is a procedure performed to correct AFIB and requires high-fidelity cardiac signals to guide the procedure. Without the signal the procedure is not possible and PURE EP™ provides a superior signal.

Stay tuned for our full report on BSGM.

The Team

original report below

BioSig Technologies (BSGM) Starts Sales of Its PURE EP™ System and Presents a Possible Value Opportunity for Investors

Good day everyone,

Current price $2.27/share (at market close 12-13-21)

We reported on BSGM a month ago, but I want to revisit the company for a couple of reasons:

The chart set-up has changed in favor of an upswing.
I want to expand on developments in their flagship product, the PURE EP™ System

Looking at the BSGM stock chart indicates a “dip” has been created since our report on November 16th. We alerted BSGM shares then at $3.26/share and on day one of our coverage they reached a high of $3.70 (+4.4%) and on day two of our coverage the company shares had a high of $3.99 (+22%) and the following day BSGM shares had a high of $4.10/share offering up a potential 25.7% gain for our members.

So, what happened since then? There have been no adverse events at BSGM. In my view, BSGM shares consolidated, like many other small cap companies during the 5.4% selloff in the NASDAQ that occurred in the last two weeks of November. While the NASDAQ index regained some of that loss, its still looking for a stable level. It looks like BSGM fell with the index and just got stuck there.

As I pointed out in our November 16th report, the three times we’ve reported on BSGM this year have resulted in double- or triple-digit gains for our members and I believe that could happen again given the current “dip” price.

BSGM maintains a small share structure with 34.9M shares outstanding and 30.4M shares in the public float. The company’s last reported balance sheet at the end of June 2021, indicated zero debt and cash of $15.5M.

Remember, the PURE EP™ System is already FDA approved. The company just needs to ramp up sales and the pandemic has hampered their efforts. It’s a product that will likely be a $200k upgrade for the clinics that would use it. That’s not too expensive from a hospital/cardiac clinic perspective but sales of machines like PURE EP™ the PURE EP™ System require face to face sales efforts and the availability for those has been hard to come by the past couple of years.

(We’ve included a full description of the PURE EP™ System at the bottom of this report)

That’s why the manufacturing and professional services agreement with Plexus Corp. (PLXS) signed in October is so crucial. Under the terms of the agreement, Plexus will market and manufacture the PURE EP™ System. Plexus is a $2.6B company and a global leader in complex product design with healthcare and life sciences being the company’s largest market sectors.

I believe the agreement with Plexus is the most significant step BSGM has made in their path to generating revenues. Plexus has $3.37B in annual revenues and provides electronic manufacturing services, design and development, supply chain, new product introduction, and manufacturing solutions, as well as aftermarket services, primarily to companies in the healthcare/life sciences,

The company’s most recent 10-Q for the quarter ended September 30th, indicated cash of $17.5M and a nominal long-term debt of only $432K. YTD revenues were at $414K. While the company has curbed their cash burn considerably in 2021, it still runs approximately $8M per quarter indicating the potential for sufficient funding into Q2 2022.

Stay tuned for a full report on BSGM where we will discuss the future of the PURE EP™ System and its potential beyond AFIB.

PURE EP™ is a signal processing platform that combines advanced hardware and software to address known challenges associated to signal acquisition, to enable electrophysiologists to see more signals and analyze them in real-time.

The device aims to minimize noise and artifacts from cardiac recordings and acquire high-fidelity cardiac signals. Improving fidelity of acquired cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and ablation procedures. Our initial focus is on improving intracardiac signal acquisition and enhancing diagnostic information for catheter ablation procedures for complex arrhythmias like ventricular tachycardia (“VT”), a potentially life-threatening arrhythmia, and atrial fibrillation (“AF”), the most common cardiac arrhythmia associated with a fivefold risk of stroke. 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. PURE EP™ is designed to address long-standing limitations that slow and disrupt cardiac catheter ablation procedures, such as environmental lab noise, signal saturation, slow signal recovery, and inaccurate display of fractionated potentials.

We will have an updated report on BSGM out soon.

The Traders News Group

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