Knowles Pushes Into High-Growth Markets With Strategic Cornell Dubilier Acquisition

Knowles Corporation is aggressively transforming into an industrial technology powerhouse. The components supplier announced it will acquire capacitor manufacturer Cornell Dubilier in a $263 million all-cash deal. This strategic purchase provides Knowles with expanded exposure to highly attractive end markets including medtech, defense, and industrial electrification.

Privately-held Cornell Dubilier, based in South Carolina, is a leader in film, electrolytic and mica capacitors used in demanding applications. Its capacitors are found in sectors like aerospace, automation, and critical care medical devices. The company generates over $135 million in revenue annually.

The acquisition brings new state-of-the-art capacitor technology into Knowles’ portfolio. This allows Knowles to offer more innovative solutions and cross-selling opportunities to customers. Cornell Dubilier’s offerings create a compelling combined value proposition for Knowles in the industrials space.

Knowles CEO Jeffrey Niew stated the purchase will help Knowles “grow with new and existing customers as we work to generate stronger earnings and cash flow and create shareholder value.” The deal is expected to contribute positively to Knowles’ earnings per share (EPS) beginning in 2024.

Specifically, the acquisition provides three key benefits:

Expands Knowles’ addressable market – Cornell Dubilier significantly expands Knowles’ serviceable available market through its broad capacitor capabilities and presence in diverse sectors including medtech, defense, aerospace, and industrial automation.

Take a moment to take a look at Kratos Defense & Security Solutions Inc., a company specializing in unmanned systems, satellite communications, missile defense, and hypersonic systems.

Diversifies product portfolio – Combined with Knowles’ existing precision devices like RF filters and ceramic capacitors, the deal delivers a wider range of capacitor products and solutions including film, electrolytic, and mica capacitors.

Boosts profitability – Knowles expects the acquisition to be accretive to earnings per share starting in 2024. The purchase is forecast to contribute to the bottom line while Knowles maintains balance sheet flexibility through its capital deployment strategy.

For investors, the strategic deal offers exposure to higher growth markets as Knowles pivots towards attractive areas with strong tailwinds. The companies noted defense spending increases, healthcare application growth, and industrial automation advances are driving demand.

The announced $263 million price consists of $140 million upfront and $123 million in seller notes due over the next two years. Knowles expects to finance the deal through cash, existing credit, and the deferred paper. The total fair value transferred is estimated at 9.6x Cornell Dubilier’s trailing EBITDA including synergies.

The acquisition caps off a transformative year for Knowles as it shifts towards high value industrial technology. Knowles recently restructured divisions to optimize its focus areas. It is also reviewing strategic options for its consumer microphones segment.

Together, these moves aim to reshape Knowles into a higher growth, higher margin technology supplier. The company is working to leverage megatrends like IoT, EVs, and 5G adoption. Knowles is strengthening its industrial roots to drive value for shareholders.

The Cornell Dubilier deal provides Knowles with an expanded presence in crucial growth industries. It also refocuses the company towards participating in rising opportunities like defense, medtech, and automation. For investors, the transformative purchase plants Knowles firmly in key sectors, unlocking value over the long-term.

Why Small Medical Device Stocks Could Become Very Rewarding this Year

JNJ Admits M&A Appetite in Medtech Space

While pharmaceuticals and biotech get much of the attention in the life sciences field, investors in medical device manufacturers got confirmation last week that the high growth projections in sales is on track. Of added interest to those invested in smaller companies in the medtech space, large key players are looking to increase market share through mergers and acquisitions (M&A). This was emphasized in Johnson and Johnson’s (JNJ) Q2 reporting released last week.

Consumer health giant Johnson & Johnson said it has a “pretty voracious” appetite for medical device M&A going forward, as it expects further rebounds in surgery volume, post-pandemic, to continue funneling cash into the company for the rest of the 2023. Projections for the global medical device market size, according to Fortune Business Insights, was valued at $512.29 billion in 2022 & is projected to grow from $536.12 billion in 2023 to $799.67 billion by 2030.

Even after the demand from patients who put off procedures, while labor shortages in hospitals became less of a problem, device sales that are helping fulfill delayed procedures have a much brighter future even after the pandemic-related surge in needs.

Driving demand is an aging and sedentary population, with a growing prevalence of chronic disorders like diabetes, cancer, heart disease, etc. There is also an increased demand for ophthalmic and orthopedic procedures as the population experiences more joint fractures and debilitating vision issues.  

Source: Fortune Business Insights

Johnson and Johnson’s admitted during its quarterly reporting that it will continue actively looking for situations to acquire medtech companies. The company’s medtech businesses produced $7.79 billion in global revenue during the second quarter, totaling 14.7% growth compared to the $6.90 billion brought in during the same three-month period in 2022.

Last year JNJ bought a miniature heart pump maker Abiomed, for $16.6 billion. Business from this acquisition accounted for 4.8%, or nearly a third of the Q2 gains, with $331 million in worldwide revenue for the quarter. JNJ’s acquiring Abiomed was one of the largest medtech deals of 2022; as of the end of the second quarter, it has added $655 million to J&J MedTech’s bottom line since the acquisition was closed last December.

Source: JNJ, July 20, 2023

“Everything is moving well and according to plan in Abiomed’s integration, and we are increasingly convinced that this is going to be a key component in our medtech strategy of becoming a leader in heart recovery,” J&J CEO Joaquin Duato said on the company’s investor call.

“When it comes to M&A, we continue to look for opportunities,” Duato said. “And when it comes to medtech … we look forward to growing in areas that are close to where we are today: vision, cardiovascular, surgery, and also high-growth segments in orthopedics.”

Abiomed wasn’t the only contributor in JNJ’s growing medtech businesses. Much of the growth was driven by a 25.9% year-over-year boost in electrophysiology sales, pushing the segment past the billion-dollar mark. The company also saw increases in trauma orthopedics, wound closure kits and biosurgery products, as well as in contact lenses.

Take Away

Medical device companies are helping to fulfill a need as the population ages and new technology, including AI and robotics, are able to provide new solutions to old problems. The announcement by JNJ that they are hungry for medtech companies that fit their criteria ought to cause life sciences investors to pay even more attention to the space.

Late in 2022 Channelchek asked our Med Device & Services analyst to discuss his “shopping list” in the medical device arena, the video is helpful for investors to discover more about this space.

Paul Hoffman

Managing Editor, Channelchek

Release – BioSig’s PURE EP™ System Demonstrates Potential Time and Cost Savings at the 15th APHRS Scientific Session in Singapore

Research, News, and Market Data on BSGM

December 14, 2022

Abstract highlights promising results from PURE EP™ study at premier Asia-Pacific Heart Rhythm Society Conference

Westport, CT, Dec. 14, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that its PURE EP™ System was featured in an abstract presentation during the 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session in Singapore.

Results from the randomized study reveal the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablations. The study enrolled 29 patients with non-paroxysmal AF with post-ablation arrhythmia recurrence (“redo AF”). The primary objective was to determine the difference in procedural times when comparing ablations guided by PURE EP™’s electrocardiogram (EGM) visualization to the conventional ECG recording system. Study results demonstrated that the PURE EP™ System led to a mean procedure time reduction of 11.3 minutes. Given that the mean cost of operating room time is approximately $37 per minute1, the procedural time savings demonstrated by the PURE EP™ System suggest potential cost savings of approximately $418.10 per procedure. While this suggests that PURE EP™ might promote shorter procedural times, further studies are underway. 

The abstract titled, Reduced Time of Redo Atrial Fibrillation Ablation Procedures with PURE EP™ Recording System for ECG/EGM Visualization: A Randomized Study,” was presented as a poster presentation by Dr. G. Joseph Gallinghouse, Cardiac Electrophysiologist at St. David’s Medical Center in Austin, TX.

 “With over 75,000 AF ablations performed in the US each year2 the ability to demonstrate that PURE EP™ may reduce procedure times resulting in potential healthcare cost savings is a landmark milestone for the overarching value proposition of our technology,” said Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. “We believe a hospital can generate a meaningful return on investment in the first year of ownership of a PURE EP™ System. Additional studies demonstrating compelling clinical and economic value of the PURE EP™ System are in motion and we are looking forward to sharing these insights with the EP and healthcare community in the near future.”  

APHRS 2022 represents the Company’s first abstract presentation at an international conference. It also marks the first physician-sponsored presentation unveiling clinical data from the Company’s REDO AF Sub Study, initiated in July 2021. [ClinicalTrials.gov Identifier: NCT04964440]. 

About APHRS  
The APHRS is a leading non-profit organization that represents medical, allied health, and science professionals specializing in cardiac rhythm disorders in the Asia-Pacific region. The annual Asia Pacific Heart Rhythm Society (APHRS) is a premier event featuring industry workshops and a core scientific program delivered by international and regional speakers.  

About BioSig Technologies 
BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives. 
The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. 
The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating. 
The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.


  
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) market conditions and the Company’s intended use of proceeds; (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed; (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and 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. 

1. Kawasaki K. Megan, Cleary J. David, Correa de Sa D. Daniel, Calame R. Susan, Dillon M. Christopher, Tsai H. Mitchell, (2019) Abstract 9552: Understanding the Costs Associated with Cardiac Ablations. Circulation, 2019;140:A9552. www.ahajournals.org/doi/10.1161/circ.140.suppl_1.9552

2. “Late-Breaking Clinical Trials II: Innovation Boulevard: Pulsed AF: First Human Experience and Acute Procedural Outcomes Using A Novel Pulsed Field Ablation System” [Friday, May 8, 2020 at 11:00 a.m. EST]

3.  Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 

Source: BioSig Technologies, Inc.

Released December 14, 2022

Release – BioSig’s PURE EP™ System Highlighted in the Journal of Atrial Fibrillation & Electrophysiology

Research, News, and Market Data on BSGM

December 06, 2022

Clinical abstract focuses on value of PURE EP™’s and its groundbreaking High Frequency Algorithm (HFA) during pulmonary vein isolation

Westport, CT, Dec. 06, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that a peer-reviewed case report titled, “Confirmation of Acute Pulmonary Vein Reconnection with The Utilization of PURE EP’s High-Frequency Algorithm (HFA)” has been published in the Journal of Atrial Fibrillation & Electrophysiology. The publication is available electronically via the JAFIB-EP open access digital journal.

Co-authored by Roy Chung, MD, Clinical Cardiac Electrophysiologist at Cleveland Clinic and Zachary Koch, CCDS, CEPS, Clinical Director at BioSig Technologies, Inc., the case report describes a 65-year-old patient with a medical history of symptomatic and persistent atrial fibrillation undergoing pulmonary vein isolation (PVI). PURE EP™’s HFA signal analysis was observed alongside the simultaneous signal anno New Primary Logo New Primary Logotation produced by a 3D mapping system. PURE EP™’s real-time HFA identified early local activation, providing a clear and precise location that served as the primary target for ablation therapy during the procedure. Results from the case study support the efficacy of PURE EP™’s HFA in identification of the pulmonary vein gap compared to the inferior annotation produced by the 3D mapping system.

“This case study adds to the growing pipeline of clinical evidence validating the PURE EP™ System as an essential and valuable technology for today’s EP lab—particularly for challenging cases,” commented Gray Fleming, Chief Commercial Officer, BioSig Technologies, Inc. “We believe that these findings, along with other clinical applications we continue to explore in collaboration with the Cleveland Clinic, demonstrate PURE EP™’s ability to set new standards in the field of electrophysiology.”

In October, the Company signed a master research agreement with Cleveland Clinic to explore expanded applications for its digital signal processing technology.

The proprietary High Frequency Algorithm (HFA)—a proprietary feature found only in the PURE EP™ System—reclaims the specificity lost within the blended data of the traditional bipolar wave. HFA enables electrophysiologists to apply specific near-field frequency data to the treatment of even the most complex arrhythmias. By removing unnecessary distractions, the PURE EP™ System with HFA preserves the value of cardiac signals and delivers clear, actionable insights to today’s electrophysiologist.

About BioSig Technologies
BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives.

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating.

The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.2

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) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and 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.

1 Koch W. Zachary; Chung, Roy (2022), Confirmation of Acute Pulmonary Vein Reconnection with Case Report: The Utilization of PURE EP’s High-Frequency Algorithm (HFA), Journal of Atrial Fibrillation & Electrophysiology, Volume 15, Issue 6, Nov 2022. https://jafib-ep.com/journal/volume-15-issue-6-nov-2022/confirmation-of-acute-pulmonary-vein-reconnection-with-the-utilization-of-pure-eps-high-frequency-algorithm-hfa/

2 Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 
 

Source: BioSig Technologies, Inc.

Released December 6, 2022

Release – BioSig Invited to Attend and Sponsor Venice Arrhythmias 2022

Research, News, and Market Data on BSGM

October 12, 2022

Company to introduce its novel digital signal processing technology to the European EP community at world-renown international congress

Westport, CT, Oct. 12, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that it has been invited to attend the 17th Edition Venice Arrhythmias 2022 Congress—a Heart Rhythm Society sponsored program taking place from October 13-15, 2022 in Venice, Italy.

During the event, BioSig’s leadership and commerical teams will introduce the PURE EP™ System to the European EP (electrophysiology) market for the first time. Following the recent launch of PURE EP™ Software Version 6 with ACCUVIZ™ Module, the Company will be showcasing the highly differentiated features of its digital signal processing technology, which includes advanced signal processing automation, elevated visualization of clear cardiac signal information, and TRUSOURCE™, a comprehensive procedural analysis and report.

“It is an honor to be interacting with many talented physicians who are breaking new ground in electrophysiology science. Their research is impacting technological advancement in the industry,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.  “I could not be more excited to demonstrate how the PURE EP™ System can provide deeper clinical insights and simplify procedural workflows to this science-based community. As a company, we celebrate their clinical legacy and embody their investment in this critical field of healthcare.”

About Venice Arrhythmias 2022

Venice Arrhythmias 2022 is a world-renown congress that convenes global experts and innovators in the field of heart rhythm disorders to discuss the latest scientific advances and cutting-edge technologies in cardiac electrophysiology, pacing, and clinical arrhythmology. This year’s—17th edition— program will be led by course directors and presidents of the Venice Arrhythmias Congress: Andrea Natale, MD, FHRS, Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas; Sakis Themistoclakis, MD, PhD, Director of Cardiology of Dell’Angelo Hospital in Venice-Mestre, Italy; and Antonio Raviele, MD, FHRS, President of the Alliance to Fight Atrial Fibrillation (ALFA).

About BioSig Technologies

BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives.

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating.

The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.1

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) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and 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.

1 Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
  

Source: BioSig Technologies, Inc.

Released October 12, 2022

Release – BioSig Executes Purchase Agreement with Methodist Hospital, San Antonio and Expands Customer Base

Research, News, and Market Data on BSGM

October 07, 2022

Leading medical center in San Antonio acquires BioSig’s novel digital signal processing technology for arrhythmia care

Westport, CT, Oct. 07, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that San Antonio Methodist Hospital has acquired the PURE EP™ System.

The acquisition, one of many in the pipeline, reaffirms the continued expansion of BioSig’s U.S. footprint and customer base.

“As we continue to advance the national commercial rollout of the PURE EP™ System, we are thrilled to introduce our technology to Methodist Hospital in San Antonio,” said Gray Fleming, Chief Commercial Officer, BioSig Technologies, Inc. “We believe that the PURE EP™ System enhances EP lab infrastructure by integrating with existing workflows and delivers critical signals of interest that are not visible on conventional systems.”

“PURE EP™ delivers great value to our lab across many different types of ablations. By uncovering new levels of clarity of intracardiac signals, PURE EP™ opens doors to the benefits of signal processing in the digital domain,” commented David N. Pederson, MD, Clinical Cardiac Electrophysiologist, Methodist Hospital, San Antonio, TX.

About Methodist Healthcare

Methodist Healthcare is recognized as a leading healthcare provider in South Texas, offering an outstanding selection of doctors, healthcare professionals, equipment and health services. The hospital belongs to a network of hospitals in the greater San Antonio area, including nine acute care facilities: Methodist Hospital, Methodist Children’s Hospital, Methodist Hospital Metropolitan, Methodist Hospital Northeast, Methodist Hospital Atascosa, Methodist Hospital Specialty and Transplant, Methodist Hospital Stone Oak and Methodist Hospital Texsan. 

About BioSig Technologies

BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives.

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating.The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.1

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) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and 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.

1 Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

Released October 7, 2022