BioSig Technologies, Inc. (OTCQB: BSGM) is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace. BioSig Technologies is preparing to commercialize its PURE EP(TM) System. The technology has been developed to address an unmet need in a large and growing market. The device is designed to record, analyze and display electrocardiogram and Electrograms used in electrophysiology studies and catheter ablation studies.
In the recent past, the company has made noticeable progress in all areas of its business and financial risk profile and hit a critical inflection point that positions it for significant momentum and growth in 2018 and beyond. More recently, the company’ stock has seen strong momentum building up after it announced that the Company had received 510(k) clearances for its first product, PURE EP System, from the U.S. Food and Drug Administration. As per management, Initial systems have been produced that will support a limited rollout. Also, the company plans to up list to Nasdaq this year.
From a liquidity standpoint, on August 17th, the company announced that it had received final proceeds from an oversubscribed capital raise, totaling approximately $6,000,000. BioSig has now raised approximately $12.5 million in 2018 and received 510(k) clearances from the U.S. Food and Drug Administration for its PURE EP System.
In fact, the oversubscription of funds positions the company well for its strategic growth plan. In addition to strengthening its balance sheet, the finances will assist in moving through the Nasdaq listing process the company began in July, while also providing it with capital to commercialize and launch its PURE EP System that recently received 510(k) FDA clearance.
Key investment highlights and strategic achievements which are instrumental in supporting the timely launch and expansion of the PURE EP™ System in late 2018:
- Announced FDA 510(k) Clearance for PURE EP System
- Submitted Application to Uplist to Nasdaq
- Added to the LD Micro Index
- Ranked Top 50 for The Silicon Review’s Innovative Companies to Watch in 2018
- Long-Term Collaboration with Mayo Clinic
- Core competency in Basic Science, Capital Markets, and Capital Architecture
- Operates Within Rapidly Emerging Field of Bioelectronic Medicine
- High-Growth Sector Earns Innovation Premium, Aggressive M&A
Upcoming Catalysts: Analysts tracking to stock believe that BSGM’ significant milestones are right on its doorstep. Also, the company’ experienced management stacks up extremely against potential competition. With multiple catalysts over the near term including FDA approval, Nasdaq up-listing, potential strategic deals, and support from high-quality healthcare institutional investors, BSGM is now at a critical inflection point and is well poised for significant value unlocking for its shareholder value.
Upcoming presentation: The company is selected to present at the third annual MicroCap Leadership Summit, hosted by MicroCapClub, on Friday, September 28, 2018, at the Westin Chicago Northwest Hotel in Itasca, Illinois.
About the PURE EP System: The non-invasive PURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. The PURE EP System aims to minimize noise and artifacts and acquire high-fidelity cardiac signals. Improving cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving the accuracy and efficiency of the EP studies and related procedures.
Key demand and offtake drivers: PURE EP has the potential to be one of the most significant complementary product to an existing installed base that is dominated by industry leaders. From a growth perspective, the most recent MD&D report shows the global Electrophysiology (EP) market revenues will grow more than 10% annually, from currently just over $4.6 billion to approximately $6 billion by 2020. The Company operates within the rapidly emerging field of bioelectronic medicine, estimated at $3.75 billion in 2017 with the projected annual growth of 14.2%.
BioSig is collaborating with leading EPs from:
Financial results for Three Months Ended June 30, 2018, Compared to Three Months Ended June 30, 2017:
- Revenues and gross profit: The company had no revenues or cost of goods sold during the three months ended June 2018 and 2017.
- Net loss: As a result of the foregoing, net loss available to common shareholders for the three months ended June 30, 2018, was $6,047,590 compared to a net loss of $3,101,425 for the three months ended June 30, 2017.
- Liquidity and financial flexibility – As per management, the company is well capitalized to commercialize and launch its PURE EP System that recently received 510(k) FDA clearance.
Key risk factors and potential stock drivers:
- Timely DA approval of PURE EP™ technology in late Q2 or early Q3 of 2018 would be a key catalyst over the near term.
- The company’ business is still at a nascent stage. Even though the company has arranged for the capital to commercialize the PURE EP™. However, timely completion of the project without any time and cost overruns would remain a critical stock sensitivity factor.
- They may need to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements.
- On Wednesday, August 29th, 2018, BSGM was at $2.08, with a volume of 175K shares exchanging hands. Market capitalization is $84.874 million. The current RSI is trending at 38.87
- At $2.08, shares of BSGM are trading below its 50-day moving average (MA) at $2.36 and above its 200-day moving average (MA) at $1.77.
- The present support and resistance levels for the stock are at $2.11 & $2.29 respectively.
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