UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

  


 

FORM 8-K

 


 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 


 

Date of Report (Date of earliest event reported):  February 6, 2019

 

BioSig Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

000 - 55473

26-4333375

(State or other jurisdiction

(Commission File Number)

(IRS Employer

of incorporation)

  

Identification No.)

 

12424 Wilshire Blvd ., Suite 745

Los Angeles, California

  

90025

(Address of principal executive offices)

  

(Zip Code)

 

Registrant’s telephone number, including area code: (512)-329-2643

 

(Former name or former address, if changed since last report)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐ Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging Growth Company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

Item 8.01                      Other Events.

 

On February 6, 2019, BioSig Technologies, Inc. mailed a letter to its shareholders from Kenneth L. Londoner, its Chairman and Chief Executive Officer, describing certain business updates, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 9.01                      Financial Statements and Exhibits.

 

(d)           Exhibits

 

Exhibit Number

  

Description

99.1

  

Shareholder Letter, February 2019

 

 

 

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

BIOSIG TECHNOLOGIES, INC.

 

 

Date: February 11, 2019                                    By:   /s/ Kenneth L. Londoner                 

Name: Kenneth L. Londoner 

Title: Chairman and Chief Executive Officer

 

 

 

 

 

 

Exhibit 99.1

 

 

+1 (310) 820-8100

info@biosigtech.com

 

 

LETTER TO SHAREHOLDERS

 

Los Angeles, February 4, 2019

 

Dear Shareholder:

 

2018 was a seminal year for our BioSig Technologies, Inc. (NASDAQ:BSGM). We received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2018, which signalled a green light to bring our technology on the market. Shortly thereafter, on September 21, 2018, we uplisted our shares onto the Nasdaq Capital Market – a major platform for technology companies worldwide and rang the opening bell at Nasdaq on November 13. Also in November, we entered into a new research agreement with Mayo Clinic, which focuses on the development of additional advanced features of our first product, PURE EP TM  System, and to explore applications within a new medical field. We also announced pivotal agreements to commence installations for the first commercial use of our system at two of the leading medical centers in the world: Texas Cardiac Arrhythmia Institute and Mayo Clinic. The achievement of these milestones for our company is just the beginning and gives us a solid foundation as we move into 2019.

 

2019 presents us with many other milestones as potential valuation drivers for BioSig. The launch of First-in-Human studies is a vital step for the Company. This is expected in the first quarter of 2019, and is material advancement towards the targeted commercial launch of our technology, We are honored that we are able to work with some of the most respected institutions worldwide on this phase of our development and are confident that this will position us well in the industry. Preparing for this vital phase has been our biggest priority in the last quarter of 2018, and we look forward to reporting on our progress as the year progresses.

 

A year in review

 

2018 was a challenging one for many national and international investors. Despite markets looking relatively stable in the first half of the year, investment returns for the year as a whole were negative across almost all asset classes. We saw the developing US/China trade war and the impact on global stock markets as a result of the Fed Reserve stance and the partial government shutdown towards the end of the year. In Europe, the markets continued to be affected by the growing political uncertainty around Brexit. Major U.S. indices experienced an average decline of 8%.

 

The medical device sector, to quote Medical Product Outsourcing, has ‘confronted various ghosts of yesteryear’, as a number of high-profile firms ‘instituted layoffs and defended their prior practices’. A majority of emerging medtech companies have shown significant declines in
 

 

 12424 Wilshire Blvd, Suite 745

Los Angeles, CA 90025

www.biosig.com

 

 

 

 

 

 

+1 (310) 820-8100

info@biosigtech.com

 

 

their market valuations, closely following falling performances of major US indices ( see Appendix , table 1 and 2 ) .

 

 

Photography by Libby Greene/Nasdaq, Inc.

 

Despite everything, BioSig shares [NASDAQ:BSGM] delivered 5.96% appreciation in December 2018 alone, and a cumulated 21.30% appreciation in 2018 ( see C hart 1 ) .
 
Building the groundwork on excellence
 
Since the beginning BioSig has build an un impeachable technology and reputation through working with best in class medical institutions. We developed a concept with Texas Cardiac Arrhythmia Institute and have performed 17 pre-clinical studies at the highly regarded Mayo Clinic, Mount Sinai and UCLA medical centers. Mayo Clinic has since become our strategic collaborator, as we agreed to work closely on developing advanced features for our proprietary technology, PURE EP TM  System, and exploring new disease areas and applications, leading to joint IP filings and future licensing opportunities.

 

The growth of the organization led us to opening two additional hubs in Austin, TX and Norwalk, CT. Both locations were chosen carefully for their proximity to major clinical centers and institutional investor base. We now operate out of four locations, including our corporate office in Santa Monica, CA and a rep office in Geneva, Switzerland – a major global medical innovation and financial hub.

 

Growth of broader investor recognition

 

Early December 2018 our shares received a ‘Buy’ rating with $14.00/share price target from ROTH Capital Partners. ROTH analyst, David Solomon, MD, stated a number of reasons for their rating, including the rapidly growing market of electrophysiology and minimized execution risk due to the collective skillset of and validation of technology by BioSig’s leadership.

 

Our team continued to raise our own capital, bringing in $13.5 million of quality capital to finance our operational milestones.

 

Our shareholder base grew by 54% to nearly 3,400 shareholders worldwide, and we thank each and every one of you for your continued support and partnership in our unique organization.

 

Strengthening human talents

 

In March 2018, we formed an Advisory Board to complement our existing Board of Directors and advise the Company leadership on a range of subjects, including financing,

 

 12424 Wilshire Blvd, Suite 745

Los Angeles, CA 90025

www.biosig.com

 

 

 

 

 

 

+1 (310) 820-8100

info@biosigtech.com

 

 

commercialization, government affairs and strategic partnerships. Three prominent leaders in capital markets, clinical and governmental fields joined the Advisory Board last year, and we are working on more high-profile appointments in 2019.

 

We added highly experienced clinical professionals to lead our nationwide physician engagement and first installations for commercial use of our technology. We held our first Clinical Advisory Board meeting with 17 respected physicians, who provided us with valuable feedback on current challenges, which they face in their practices, and key drivers for the effective adoption of new technologies. This feedback will be instrumental in helping us shape our commercial strategy.

 

A year ahead

 

The first thing one sees when one enters our Los Angeles office is a giant ‘Quality First’ sign. It has been there since the first day of our operations and is an important reminder of what matters most to us. As we move into February, we prepare for more strategic hires, first human data and targeted market release through leading medical centers of excellence in our country.

 

This year, for the first time ever, we will actively participate in the largest event in our industry – Heart Rhythm Scientific Sessions. We will be presenting the results from the First-in-Human studies and the early feedback from the use of our PURE EP TM  System to a larger community of physicians, our potential future customers. The HRS convention will be at the famous Moscone Center in downtown San Francisco on May 8 – 11, 2019 and we welcome all of you to see our booth on the floor – a first for the Company.

 

We envisage bringing our technology into at least three more leading centers following the initial First in Human (“FIH”) experience at Mayo Clinic and Texas Cardiac Arrhythmia Institute in the first half of 2019 and then expand the base of users to include many other centers, who are known as the early adopters of new technology. They will be evaluating the features and benefits of our technology, giving us important insight into the first leg of commercialization. Should that process produce expected results, we intend to expand our commercial efforts in the second half of 2019 and prepare for a steeper curve in 2020.

 

Everyone in our Company is a part owner in our business. Our entrepreneurial spirit is a competitive advantage in an age dominated by short-term decisions and uncertainty. As we move into the 11 th year of our operations, we are committed to make this journey a prosperous one for our shareholders and our families.

 

We very much appreciate the importance of trust you place in us. We look forward to the years to come.

 

With best wishes,

 

 

 12424 Wilshire Blvd, Suite 745

Los Angeles, CA 90025

www.biosig.com

 

 

 

 

 

 

+1 (310) 820-8100

info@biosigtech.com

 

 

Ken Londoner
Founder, Chairman and CEO

 

APPENDIX

 

Table 1 : BioSig vs Life Science Companies in 2018

 

Company

Market Cap  

Ticker

2018 Stock Performance

BioTelemetry, Inc

 $ 1.92 billion

BEAT

98.7%

SeaSpine Holdings Corp.

 $ 317.84 mm

SPNE

80.4%

AtriCure Inc.

 $ 1.20 billion

ATRC

67.7%

CONMED Corporation

 $ 1.75 mm

CNMD

25.5%

Crytosorbents Corp

 $ 254.8 mm

CTSO

23.4%

BioSig Technologies

 $ 72.99 mm

BSGM

21.3%

AngioDynamics, Inc.

 $ 798.86 mm

ANGO

20.9%

Cardiovascular Systems, Inc

 $ 1.01 billion

CSII

19.9%

Oxford Immunotec Global PLC

 $ 355.09 mm

OXFD

-8.7%

Avanos Medical, Inc.

 $ 1.89 billion  

AVNS

-16.5%

Corindus Vascular Robotics

 $ 200.89 mm

CVRS

-19.2%

Accuray Incorporated

 $ 297.24 mm

ARAY

-21.6%

AxoGen, Inc.

 $ 824.12 mm

AXGN

-28.3%

Allscripts Healthcare Solutions, Inc

 $ 1.76 billion

MDRX

-33.9%

Castlight Health, Inc

 $ 326.97 mm

CSLT

-42.9%

Pulse Biosciences, Inc.

 $ 256.21 mm

PLSE

-51.9%

Abeona Therapeutics, Inc.

 $ 336.57 mm

ABEO

-55.1%

Accelerate Diagnostics, Inc

 $ 706.21 mm

AXDX

-56.4%

Cutera, Inc.

 $ 235.53 mm

CUTR

-62.9%

ElectroCore, Inc.

 $ 246.2 mm

ECOR

-65.2%

Dermira, Inc.

 $ 299.9 mm

DERM

-74.3%

Invacare Corp

 $ 148.74 mm

IVC

-74.7%

 

Table 2 : BioSig vs Bioelectronic and Emerging Medtech Companies in 2018

 

Company

Market Cap

Ticker

2018 Stock Performance

BioSig Technologies

$ 72.99mm

BSGM

21.30%

SafeSkin

$ 85.7mm

SSKN

126.19%

PulseBiosciences

$ 211mm

PLSE

-45.57%

NeuroNetics

$ 344mm

STIM

-49.53%

ElectroCore

$ 209mm

ECOR

-69.70%

Cutera

$ 222mm 

CUTR

-64.70%

Castlight Health

$ 319mm

CSLT

-39.74%

RTX Medical

$ 230mm

RTXI

-9.76%

iRhythm Technologies

$ 1.61 billion

IRTC

20.41%

PavMED

$ 27.4mm

PAVM

-55.50%

NanoVibronix

$ 24.3mm

NAOV

-19.50%

 

 12424 Wilshire Blvd, Suite 745

Los Angeles, CA 90025

www.biosig.com