BioSig Technologies, Inc. (OTCQB: BSGM) Breaking News  - August 15, 2018

BioSig Technologies Announces FDA 510(k) Clearance for PURE EP System
 

Santa Monica, CA, August 15, 2018 - BioSig Technologies, Inc. (OTCQB: BSGM), announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the U.S. Food and Drug Administration (FDA).

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 accuracy and efficiency of the EP studies and related procedures.

To date, BioSig has performed twelve pre-clinical studies at Mayo Clinic in Rochester, MN, three at UCLA Medical Center in Los Angeles, CA, and one at Mount Sinai Hospital in New York, NY. BioSig signed a 10-year collaboration agreement with Mayo Clinic in 2017 that will enable the Company to advance the platform and expand its capabilities into other areas of clinical importance. The Journal of Innovations in Cardiac Rhythm Management published several years of pre-clinical data (https://www.biosigtech.com/technology/publications) conducted at Mayo Clinic.

Minnetronix, BioSig’s manufacturing partner in St. Paul, MN, has produced initial systems that will allow the Company to enter the market in the U.S. with selected sites.

“Our PURE EP System is the culmination of many years of scientific research and business development efforts. It is our goal to provide tangible benefits to electrophysiologists and improve the current standards of EP procedures in the clinical setting. We are excited to bring the advanced platform to the U.S. market,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

One of the most common reasons for an EP procedure is the diagnosis and treatment of atrial fibrillation. Atrial fibrillation is the most common arrhythmia currently affecting 33.5 million people worldwide, with 6.1 million people in the U.S. Atrial fibrillation increases the risk of stroke by 4 to 5 times and contributes to ca. 750,000 hospitalizations per year. According to the 2016 HRI Global Opportunities in Medical Devices & Diagnostics report, the current market of EP is estimated at $4.6 billion and growing at 10.5% rate annually.

On August 1, 2018 the Company announced its intention to uplist to the Nasdaq exchange. The Company expects to be trading on Nasdaq in 2018.

The Company recently filed an omnibus patent with the leading patent law firm, Sterne Kessler Goldstein & Fox in Washington, DC that thoroughly protects the Company’s technology.

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com).  Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.

The Company’s first FDA cleared product, PURE EP™ System, is a novel cardiac signal acquisition and display system that is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to ultimately deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward initial commercial distribution of the PURE EP™ System.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contact:

Natasha Russkina
BioSig Technologies, Inc.
VP Business Development & Corporate Finance
12600 Hill Country Blvd R-275
Austin, TX 78738
nrusskina@biosigtech.com
512-329-2643

SOURCE Biostage, Inc.
 

Biostage to Host Conference Call to Discuss Second Quarter 2018 Financial Results and Operations
 

Conference Call with Live Audio Webcast on Tuesday, August 14th at 9:00 AM ET

Minneapolis, MN, - August. 09, 2018 - BioSig Technologies, Inc. (OTCQB: BSGM), a biotechnology company developing bioengineered organ implants to treat life-threatening conditions of the esophagus, bronchus and trachea, announced today that it will report its financial results for the three and six months ended June 30, 2018 in a press release that will be issued pre-market on Tuesday August 14, 2018. Biostage management also announced that it will host a conference call with a live audio webcast that same day at 9:00 AM ET to review its operational progress and financial report.

To participate in the call, please dial (877) 407-8293 (domestic) or (201) 689-8349 (international). The live webcast will be accessible on the Events page of the Investors section on the Company's website at www.biostage.com, and will be archived for 60 days. An audio webcast will be available for one week following the call and can be accessed during that period by dialing (877) 660-6853 (domestic) or (201) 612-7415 (international) with Conference ID #: 13682407.

About Biostage, Inc.

Biostage is a biotechnology company developing bioengineered organ implants based on the Company's Cellframe™ technology which combines a proprietary biocompatible scaffold with a patient's own stem cells to create Cellspan organ implants. Cellspan implants are being developed to treat life-threatening conditions of the esophagus, bronchus or trachea with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its technology.

For more information, please visit www.biostage.com and connect with the Company on Twitter and LinkedIn.

Forward-Looking Statements:
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to development expectations and regulatory approval of any of the Company's products, including those utilizing its Cellframe technology, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of the Company's products, including those utilizing its Cellframe technology, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the Company's ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading "Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2017 or described in the Company's other public filings. The Company's results may also be affected by factors of which the Company is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Investor Relations Contacts:
Tom McNaughton
Chief Financial Officer
774-233-7300
tmcnaughton@biostage.com

SOURCE Biostage, Inc.


Hong Yu Appointed President of Biostage
 

Minneapolis, MN, - May 31, 2018 - BioSig Technologies, Inc. (OTCQB: BSGM), a biotechnology company developing bioengineered organ implants to treat life-threatening conditions of the esophagus, bronchus and trachea, has elected Hong Yu as President, effective May 29, 2018. Mr. Yu brings a depth of experience in cross-border business development to the Company. Over the past several months, Mr. Yu has assisted in sourcing several private placement investments for the Company. He will report to CEO Jim McGorry and be responsible for raising capital to advance our Cellframe™ technology from pre-clinical studies to clinical trials, in addition to leading development for China expansion.

Mr. Yu is a seasoned executive with extensive knowledge in strategic analytics, wealth management, and investment research. Prior to Biostage, Mr. Yu was most recently a Senior Vice President responsible for strategic analytics at Bank of America, where he was employed for nearly 20 years. During his career, Mr. Yu has built strong business connections in various industries, including biotech/healthcare, financial services, and robotics/artificial intelligence. He developed an expertise in matching emerging companies with cross-border investors, often providing U.S. companies with market access to the vast capital supply in China. Mr. Yu graduated from Huanggang High School (Hubei, China) in 1990 and obtained a B.S. in Biophysics from Peking University (Beijing, China), and M.S. in Biostatistics from School of Public Health, University of Illinois (Chicago, IL). Mr. Yu is a charterholder of Chartered Financial Analyst (CFA). Mr. Yu commented, "I am excited to join Biostage as the company advances its technology to improve the solutions and outcomes for esophageal cancer patients and children suffering from esophageal atresia. I will continue my efforts toward raising cross-border investments to enhance Biostage's ability to advance our Cellframe technology and I look forward to helping lead the company's market expansion into China, which has half of the new esophageal cancer patients worldwide every year."

Biostage CEO Jim McGorry commented, "I am pleased to welcome Hong to Biostage as President. Hong has been essential regarding connecting new investors to the Company which has enabled us to extend our operational runway and advance our esophageal implant product candidates towards Investigational New Drug applications, which we anticipate to occur in 2019. His experience building relationships between investors, companies, and other stakeholders will be instrumental as we advance our products and expand into China."

About Biostage, Inc.

Biostage is a biotechnology company developing bioengineered organ implants based on the Company's Cellframe™ technology which combines a proprietary biocompatible scaffold with a patient's own stem cells to create Cellspan organ implants. Cellspan implants are being developed to treat life-threatening conditions of the esophagus, bronchus or trachea with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its technology.

For more information, please visit www.biostage.com and connect with the Company on Twitter and LinkedIn.

Forward-Looking Statements:
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to development expectations and regulatory approval of any of Biostage's products, including those utilizing its Cellframe™ technology, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of Biostage's products, including those utilizing its Cellframe™ technology, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, Biostage's ability to obtain and maintain regulatory approval for its products; Biostage's ability to expand into foreign markets, including China; plus other factors described under the heading "Item 1A. Risk Factors" in Biostage's Annual Report on Form 10-K for the fiscal year ended December 31, 2017 or described in its other public filings. Biostage's results may also be affected by factors of which Biostage is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Biostage expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Investor Relations Contact:
Tom McNaughton
Chief Financial Officer
774-233-7300
tmcnaughton@biostage.com

SOURCE Biostage, Inc.

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About BioSig Technologies, Inc.:

LABOUT BIOSIG
A NEW ADVANCEMENT IN EP INFORMATION

The PURE EP™ System from BioSig Technologies™ was designed to improve the clinical information for electrophysiology (EP) studies and cardiac catheter ablation – procedures to test the electrical activity of the heart to find where an abnormal heartbeat originates, and then is destroyed.

Shortcomings for Existing Arrhythmia Treatments

Drug therapies often ineffective

Procedures for ablation need improvement

Anatomical for Paroxysmal Atrial Fibrillation (AFib) – not proven sufficient
Additional ablation targets needed for Chronic AFib
Insufficient signal quality for both AFib and Ventricular Tachycardia (VT) cases
Poor signal quality may lead to:

Long procedure times -
2-8 hours depending on complexity, clinical experience
Uncertainty in ablation targets
Many undergo multiple procedures

VISION
BioSig's Vision is to further develop the signal processing technology and clinical effectiveness in PURE EP, and extend into the growing field of Bioelectric Medicine

Bioelectric Medical Revolution: The Internet of the Body

Bioelectric medicine is an emerging medical practice that uses miniature implantable devices to modify electrical signals to the body's nervous system. This scientific breakthrough has the potential to become a paradigm-shifting market disrupter in the healthcare marketplace.

For generations, physicians and scientists alike have been intrigued by leveraging the power of electrical impulses in the human body for therapeutic benefits. Throughout the last several decades, the practice has undergone significant growth and technological advancements.

Launched in 1980, Implantable Cardioverter Defibrillators (ICDs) became useful in preventing sudden death in patients with known, sustained ventricular tachycardia or fibrillation. Studies have shown ICDs to have a role in preventing cardiac arrest in high-risk patients who haven't had, but are at risk for, life-threatening ventricular arrhythmias. The market will grow from $2 billion 2015 to $2.5 billion in 2020.

First utilized in 1958, the pacemaker was a medical marvel. Today, the global pacemaker market size was valued at $4.9 billion in 2015 and is expected to grow at a CAGR of 9.2% over the forecast period. In 2025, the market is projected at $12.3 billion.

According to a market research study from Neurotech Reports, the worldwide neuromodulation device industry is expected to grow from approximately $6 billion in 2014 to more than $10 billion in 2018, with the market for implanted spinal stimulators for treatment of chronic pain alone valued at $1.8 billion worldwide in 2014, and growing to $2.88 billion in 2018. Industry observers predict a double-digit compound annual industry growth rate overall.

The size and scope of this market can be easily recognized when we understand the magnitude of the potential treatment population. Afflictions such as epilepsy, migraines, spinal cord injuries, Parkinson's disease and urinary incontinence affect more than 40 million people in the United States alone.

The National Institutes of Health announced that it had awarded nearly $31 million in fiscal year 2014 to develop new approaches to engage researchers. The group's goal is to conduct research that leads to new ways to treat cardiovascular disease by targeting nerves in the heart's nervous system.

Researchers believe that modulating cardiac electrical signals holds promise as a way to treat heart failure and other common cardiovascular problems.

BioSig sees three categories of opportunity in this space: signal capabilities, therapeutic tools, and procedures.

MANAGEMENT TEAM
Kenneth L. Londoner, MBA
Co-Founder, Chief Executive Officer, Chairman and Director

Mr. Londoner co-founded BioSig Technologies, Inc. in February 2009. Mr. Londoner is the Managing Partner of Endicott Management Partners, LLC, a firm dedicated to assisting emerging growth companies in their corporate development and investing needs since 2004. From April 2007 to October 2009, Mr. Londoner was the executive vice president of NewCardio, Inc., a silicon valley based cardiac software company. Mr. Londoner also served as a Director and the architect for the turnaround at Alliqua BioMedical, Inc. (Nasdaq: ALQA) from May 2012 to March 2014. Mr. Londoner is a co-founder of Safe Ports Holdings, LLC, in Charleston, South Carolina, a port security and logistics company. Started in July 2005, the company built and sold an inland port development project to Dubai Ports World. The sale, in the fall of 2007, was for almost six times what investors had invested. Mr. Londoner is a member of Safe Ports Board of Directors. Mr. Londoner was the founder and managing partner of Red Coat Capital Management in New York. Founded in late 1996, the hedge fund (long/short equity strategy) grew from its initial base of $ 2 million in assets to a peak of $ 1.1 billion. Mr. Londoner started his investment career at J. & W. Seligman & Co., Inc., a leading institutional money management firm where he rose from research analyst to managing $3.5 billion in mutual funds, pension funds, and international assets. He joined Seligman in 1991 and left in 1997. Mr. Londoner graduated from Lafayette College in 1989 with a degree in economics and finance and received his MBA from NYU's Stern School of Business in 1994, with a dual major in finance and management. Mr. Londoner just celebrated his 25th wedding anniversary and has four children. Mr. Londoner has been working with Lafayette College to develop and expand a summer internship program designed to provide undergraduate students with high value summer employment in leading growth industries in the U.S.

Jay Millerhagen
Vice President, Clinical Affairs

Jay Millerhagen, Vice President of Clinical Affairs, has over 25 years of experience developing, evaluating and launching new medical technologies and therapies. Most recently, Mr. Millerhagen served as Vice President, Clinical Affairs and Market Development for Respicardia, Inc., in Minnetonka, MN. At Respicardia, he led clinical operations, staffing and site management leading to the pivotal IDE trial of the fully implantable remedē System for the treatment of Central Sleep Apnea.

Prior to joining RESPICARDIA, Mr. Millerhagen served in positions of increasing responsibility at St. Jude Medical in St. Paul, MN. From 2011 to 2012, as Vice President, Clinical Affairs, he led a team of 20 in-house clinical personnel and a team of 22 field clinical engineers to execute a series of clinical studies targeted at addressing cardiac arrhythmias. He oversaw the team that completed enrollment in five major IDE (investigational device exemption) trials most of which were completed several months ahead of schedule. From 2007 to 2010, Mr. Millerhagen served as Senior Director, Clinical Affairs. His team was the first to design, submit and secure approval of an IDE from the FDA for a novel open irrigated ablation catheter based indication for Atrial Fibrillation.

From 1989 to 2007, Mr. Millerhagen held senior positions at Boston Scientific Corporation. Joining the company as a Manager of New Product Planning, he co-authored a patent on a pacemaker based on hemodynamic performance. Promoted to Director, he oversaw Brady Marketing, Heart Failure Research and Development, Heart Failure Marketing and from 2004 to 2007, he served as Director, Business Alliance Marketing with industry giants Johnson & Johnson and GE Healthcare. During his tenure at Boston Scientific he directed numerous areas of cardiovascular health.

Mr. Millerhagen received his MBA from the University of St. Thomas, St. Paul, MN, earned an MS in Exercise Physiology from St. Cloud State University, St. Cloud, MN, and a BA in Physiology and Psychology from Concordia College, Moorhead, MN. He has been member of the Heart Rhythm Society (NASPE), the Heart Failure Society of America, and the American College of Sports Medicine.

Steve Chaussy
Chief Financial Officer

Mr. Chaussy has served as our chief financial officer since May 2011. Since 2001, Mr. Chaussy has acted as a consultant for small publicly traded entities with a special emphasis towards SEC reporting and compliance; Mr. Chaussy provides consulting services both directly and through his wholly-owned entity, Anna & Co., Inc. Prior to 2001, Mr. Chaussy served as chief financial officer for a large private distribution and wholesaling company, where he gained international experience. Mr. Chaussy is a graduate of Virginia Polytechnic Institute and State University and is a licensed certified public accountant in Virginia, California and Florida.

Natasha Russkina
Vice President, Business Development and Corporate Finance

Natasha Russkina is a well-established finance professional. She is the founder and director of Augeous Consulting in Geneva, Switzerland, a firm that provides various levels of business development capabilities to companies in the life science sector. Ms. Russkina has over 13 years of experience in international business development, including over 9 years at IG Group PLC, a British FTSE 250 company and a global leader in online trading. During this time, she was responsible for the Group’s global business development successfully delivering a number of high level projects from opening new international branches to global rebranding, and providing all initial and ongoing business support to 12 international offices in Europe, South Africa and Australia, a business sector, which accounted for 40% of the Group’s revenue. During her career, she had been appointed by the Board of Directors to open a new IT development office in Eastern Europe and was responsible for all parts of operations. During this assignment, the office grew from 14 inherited members of staff to over 135.

Lora Mikolaitis
Co-Founder, Director of Administration

Ms. Mikolaitis co-founded BioSig Technologies, Inc. in February 2009. As Director of Administration, her role encompasses a wide range of duties that started out with co-writing the business plan to now co-writing all marketing materials and SEC filings. She supports all departments of the Company including accounting and finance, legal, marketing, investor relations, public relations, human resources, and research and development. Ms. Mikolaitis is also President of Miko Consulting Group, Inc., a firm that provides marketing research and administrative support to life science companies.

Joseph W. Rafferty
Chief Commercialization Officer

Mr. Rafferty brings to BioSig over 30 years of leadership experience with traditional corporate and emerging growth companies. Having functioned as CEO, GM, VP Global Sales-Marketing, VP Physician Training, VP Sales Training and Director for National Contracts, Mr. Rafferty has created a legacy of building and leading highly successful teams with industry leaders like Pathway Medical, Avinger, ACS/Guidant, CR Bard Vascular/Cardiovascular, Synthes Spine, Sterilox, J&J's Ethicon Mechanical Products (Endo) and, most recently, as CEO of National Medical Sales, LLC.

ECHNOLOGY
GAIN A BETTER UNDERSTANDING OF
THE SPACE AND PROBLEMS BIOSIG IS FOCUSING ON

Atrial Fibrillation (AFib) Background

- Electrical signals travel from the hearts pacemaker called an SA node across and down the heart muscle.
- Everyone over 40 has a 1 in 4 lifetime risk; Afib affects a population of approximately 6 million in the US.
- This condition increases stroke risk more than 4 times, which is the 5th leading cause of death in the U.S.
- Catheter ablation is now a recommended procedure; depending on the severity of the disease, multiple procedures are oftentimes necessary for effective results.
- Current technology in the electrophysiology lab has limitations in precisely locating the tissue to ablate that is the source of the abnormality.

- The current treatment process starts with an Electrocardiogram taken from the surface of the skin.
- Doctors read the results and determine if medication and/or ablation is indicated.
- If ablation is indicated, an EP study is performed.
- A catheter is inserted into the heart via the patients’ neck or groin and the electrical activity of the heart is recorded.
- Based on this EP study, ablation is done on the area(s) of the heart they suspect is causing the abnormal heart rhythms.

The current most recommended solution for AFib is ablation.
- An ablation catheter is inserted in the patient's blood vessel and guided to the site of the tissue that is causing the abnormal electrical current in the heart.
- In the diagram on the left you see the catheter entering from the bottom of the heart and winding into the left atrium.
-The catheter will use either heat or cold to scar the tissue, reducing its ability to transmit abnormal electrical impulses which eliminates the abnormal heart rhythm.
- Our goal is to give doctors the tools to solve the problem in less visits greatly reducing these costs and the discomfort to the patient.

- Besides AFib already discussed, our solution is also designed to improve outcomes for the even more serious Ventricular Tachycardia or VT.
- Electrical signals travel from the heart's pacemaker called an SA node across and down the heart muscle.
- You can see the heart beats are evenly spaced. On the right, we see that VT happens when the electrical signals in the ventricles, or lower chambers of the heart,get disorganized, overriding the heart's normal rate and rhythm.
- This is rapidly fatal if not reversed; there are approximately 450,000 sudden deaths a year in the US from ventricular arrhythmias.
- Like AFib, VT is also treated by using ablation to scar the areas of tissue sending the abnormal electrical impulses.
In determining where to ablate, doctors rely on looking for tiny changes on these charts that are often filtered out or get lost in the noise with current technologies. This results in more treatments being required until the appropriate areas are found and ablated.

SOURCE: https://www.biosigtech.com/

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