This NASDAQ is Cardiac Worthy: Patent Protected Signal Processing Advancements for Cardiac Arrhythmia Nearing Commercialization: BioSig Technologies (NASDAQ: BSGM)

– Developing Advanced Medical Technology to Improve Signal Fidelity and Uncover ECG and Intra-Cardiac Signals.
– Completed New Share Offering to Finance Full Product Commercialization.
– US Patent Claims Awarded for PURE EP(TM) Noise-Filtering Technology.
– Total of 49 Issued or Allowed Worldwide Patents Covering BSGM Tech.
– 30 Year Bio Industry Veteran John Sieckhaus Appointed as COO.
– Access Strategy to Enhance Market Access Strategy and Expand Installation Base.
– Product installed at a Leading HCA Healthcare-Operated Facility in Florida.

Breaking News:

The leasing and finance program for BSGM provides a non-recourse financial solution for PURE EP(TM) to improve purchase flexibility for U.S. hospitals

BioSig Technologies, Inc. (Nasdaq: BSGM) a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced a new partnership agreement with Summit Blue Capital for implementing a leasing and finance program for the Company’s PURE EP(TM) System.

The Minneapolis-based Summit Blue Capital is a leader in equipment finance and leasing. It offers tailored leasing and financing solutions for its partners and clients in industries such as healthcare, manufacturing, hospitality, technology solutions, and more. Most notably, Summit Blue Capital specializes in simplifying the financing experience and finding solutions to advance commercial roll outs in the healthcare industry.

“We believe that partnering with Summit Blue Capital will have considerable benefits to our commercial plans. We intend to take advantage of the Summit team’s expertise, flexibility, and financial solutions as a leasing partner,” said Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “Summit Blue Capital came highly recommended by one of the largest money center U.S. financial institutions. We believe this relationship will help take friction out of the sales cycle and advance our timeline while allowing BioSig to get paid up front per installation. The team at Summit Blue Capital is expected to also help us launch a subscription-based revenue model for our software.”

“The pathway to purchase is always of great consideration in the capital equipment forum. We anticipate that partnering with Summit Blue Capital will impact our ability to expedite PURE EP’s entrance into new electrophysiology labs across the United States,” commented Gray Fleming, Chief Commercial Officer of BioSig Technologies, Inc.

BSGM has made significant improvements to the EP market, and they have a unique technology offering with their PURE EP,” said Adam Drill, President of Summit Blue Capital. “Summit Blue Capital is excited to partner with BioSig and execute on a strategic financing and leasing program that we believe will benefit their customer roll out and help position them as a leader in medical technology. We look forward to helping each other and building a solid foundation for the future.”

The PURE EP(TM) is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, 75 physicians have completed more than 2,150 patient cases with the PURE EP(TM) System.

Clinical data acquired by the PURE EP(TM) System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(TM) signals over conventional sources.

About Summit Blue Capital

Summit Blue Capital is a national commercial finance business based in Minnesota. The Company specializes in custom vendor programs and lease lines-of-credit for companies across the United States. Summit Blue is a privately owned and independently operated finance company that serves all industries

About BioSig Technologies

BioSig Technologies (NASDAQ: BSGM) is a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals.

The first BGSM product, PURE EP(TM) 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. BSGM is working to develop and deliver the advanced signal processing solutions that will unlock the future of bioelectronic medicine, starting with the PURE EP(TM) System.

The BSGM vision is a strong commitment to research, a world-class leadership team, and a network of expert partners. BSGM is now achieving important milestones as the company prepares to enter the fast-growing electrophysiology market.

– Public Offering of BGDM Common Stock to Fund Full Activities for Commercialization of the PURE EP(TM) System.

On March 23rd BSGM announced the completion of an underwritten public offering for 2,611,739 shares of its common stock, $0.001 par value per share, at a price to the public of $1.15 per share. This offering was lead by a family office that has deep expertise in small cap emerging growth investing.

The proceeds to BSGM from this offering were $3 million. BSGM also issued a cash warrant at $1.40. Fully exercised BSGM will receive another $3m of cash proceeds.  This funding and its existing capital should provide sufficient operating capital for BSGM to execute its current business plan. BSGM intends to use the net proceeds from the offering for the continuation of full commercialization activities related to the PURE EP(TM) System.

– BSGM Appoints John Sieckhaus as Chief Operating Officer

On March 16th BSGM announced the appointment of John Sieckhaus as its new Chief Operating Officer.

Mr. Sieckhaus brings to BGSM 30 years in the healthcare industry, including 21 years at St. Jude Medical and Abbott Laboratories [NYSE: ABT]. During his tenure with St. Jude Medical, Mr. Sieckhaus held commercial leadership positions of rising responsibility, including U.S. National Sales Leader, Senior Vice President & General Manager when he led sales and customer relationship management activities in the United States across all cardiovascular product lines. Mr. Sieckhaus’s experience in building and leading high-performance teams, in addition to integrating multiple new and novel technologies and introducing them commercially, led to significant revenue growth for St. Jude Medical over his career. Most recently, Mr. Sieckhaus held the position of Vice President – Field Clinical Affairs for Abbott for the United States and CALA, where he created a world-class field clinical and monitoring team to support clinical trials across multiple business units within Abbott’s Cardiovascular portfolio. Mr. Sieckhaus holds a Bachelor of Science degree in Biomedical Engineering from Johns Hopkins University.

“I am very excited to join this team and look forward to building upon the foundation of the PURE EP(TM) system and its capabilities. Focusing in the area of electrophysiology by providing better solutions in identifying and treating complex arrhythmias for our clinical customers and patients will be extremely rewarding,” commented Mr. Sieckhaus

The BSGM PURE EP(TM) is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, 75 physicians have completed more than 2150 patient cases with the PURE EP(TM) System.

Clinical data acquired by the BSGM PURE EP(TM) System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting BSGM PURE EP(TM) signals over conventional sources.

– US Patent Claims Awarded for PURE EP(TM) Noise-Filtering Technology
– Claims address computer-implemented systems and methods for filtering noise from input cardiac signals using its PURE EP(TM) technology.
– BSGM now has 49 issued or allowed worldwide patents covering its novel technology for arrhythmia care.

On January 26th BSGM announced that the US Patent Office had allowed a utility patent covering its PURE EP(TM) noise-filtering technology. The recently allowed patent application number 17/091,357 entitled “Universal Notch Filter” was filed on November 6, 2020. The patent describes and claims computer-implemented methods for filtering noise from an input signal.

Generally, some current electrophysiology (EP) recording systems can effectively support the treatment of arrhythmias such as atrial flutter and supraventricular tachycardia, which show up as large-amplitude, low-frequency signals. However, more complex and prevalent arrhythmias, such as atrial fibrillation and ventricular tachycardia, which are characterized by low-amplitude, high-frequency signals, have not found an effective evaluation of all relevant signals.

This signal detection, acquisition, and isolation can be further complicated by equipment line noise and pacing signals. Current EP recorders use low-pass, high-pass, and notch filters to remove noise and artifacts from the various electrical signal information. Unfortunately, conventional filtering techniques can alter signals and make it difficult or impossible to see low-amplitude, high-frequency signals that can be inherent in cardiac monitoring, the visualization of which signals could help treat atrial fibrillation and ventricular tachycardia. It has been recently recognized that the assurance of waveform integrity, such as for the noise-free acquisition of IC and ECG signals in an EP environment, had not been previously accomplished due to contamination of various signals by artifacts and noise.

The patented BSGM PURE EP(TM) System can record raw (unaltered) cardiac and other physiologic signals with multiple display options, low noise, and a large input signal dynamic range. This is achieved using a low-noise amplifier topology with minimal filtering to band-limit the signal and a high-resolution A/D converter. In addition, the BDGM PURE EP(TM) System can provide large-signal (e.g., from a defibrillator) input protection and radio frequency (RF) signal (e.g., from ablation) noise suppression. There is no need for gain switching in this architecture, and the full range of input signals is digitized with high resolution.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 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 Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually.

– Access Strategy Partners to Accelerate Commercial Sales

On December 21st BSGM announced that it appointed Access Strategy Partners, Inc. to advise on the next phase of the commercial roll-out.

Led by medical device sales experts, Boston-based Access Strategy Partners brings to BSGM deep expertise in commercialization, contract management, execution, and value proposition optimization. The company’s Co-Founder and President, Jim Walker, is a healthcare executive with more than 30 years of experience in sales, marketing, sales operations, and national accounts management in some of the leading companies in the medical device sector, including Boston Scientific Corporation (BSC) and Johnson & Johnson. His experience spans domestic and international responsibilities, focusing on strategic market development and key customer management. During his 18-year career with Boston Scientific Corporation, Mr. Walker established the organization as a recognized leader with Group Purchasing Organizations. He created a world-class Corporate Sales organization that represented the full BSC portfolio to supply chain executives across every level of market aggregation, including group purchasing organizations (GPOs), national and regional integrated delivery networks (IDNs), and National and Regional Purchasing Alliances. Mr. Walker was the company’s lead strategic pricing advisor and gained the support of the executive management team to invest in and develop an enterprise-wide contract management system that provides global pricing intelligence and profitability analysis capabilities.

“ASPI was founded to provide strategic relationship management for emerging medical device companies,” said Jim Walker. “Our sales conversations are all about delivering excellent clinical and economic value. BioSig and its breakthrough PURE EP(TM) product bring meaningful benefits to physicians and patients that we are thrilled to introduce to healthcare providers.”

Under the terms of the new collaboration, Access Strategy Partners will advise BioSig on all aspects of commercial strategy, including economic value modeling, hospital administration engagement, and contracting.

– BSGM Expands Its Clinical Footprint in Florida

On December 16th BSGM announced that it is installing a PURE EP(TM) System for an evaluation at the HCA Healthcare-operated Westside Regional Medical Center in Plantation, FL.

Westside Regional Medical Center is an award-winning 250-bed hospital recognized for providing a wide array of services to the residents of Broward County, South Florida, and visitors from around the world. The hospital’s electrophysiology program is one of the most frequented in Broward County, offering advanced diagnostic services and multiple modalities for diagnosing and treating arrhythmia. In addition to its comprehensive cardiovascular services, Westside Regional Medical Center is certified as a Comprehensive Stroke Center by the Agency for Health Care Administration (ACHA). 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.

For more information on BioSig Technologies (BSGM) visit:  http://www.biosig.com

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