Nasdaq GlobeNewswire

BioSig Announces Submission of FDA 510(k) Application for PURE EP(TM) System

Del

SANTA MONICA, Calif., March 28, 2018 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (OTCQB:BSGM) announced that the Company has filed 510(k) application to the U.S. Food and Drug Administration (FDA) for its first product, PURE EP(TM) System.

PURE EP System is a surface electrocardiogram and intracardiac multichannel recording system that acquires, processes and displays high fidelity cardiac recordings required during electrophysiology studies and catheter ablation procedures. The non-invasive PURE EP System is categorized as a Class II medical device according to the FDA and is subject to 510(k) performance standards and regulatory controls. The PURE EP System aims to minimize noise and artifacts and acquire high fidelity cardiac signals, which will potentially increase these signals' diagnostic value, and offer improved accuracy and efficiency of the EP studies and related procedures.

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. The current market of EP is currently estimated at $4.6 billion and growing at 10.5% rate annually.

Between 2015-2018 BioSig has performed eleven pre-clinical studies at Mayo Clinic in Rochester, MN and one study at Mount Sinai Hospital in New York, NY. The results of these studies have been documented in seven peer reviews, including the Journal of Innovations in Cardiac Rhythm Management (JICRM) and the Journal of the American College of Cardiology (JACC).

In October 2017 BioSig announced the results of a nationwide survey of electrophysiologists. Survey respondents rated all six features of the PURE EP System as being 'Very Helpful' for their ablations, emphasizing overall 'noise' reduction and improved signal clarity/accuracy as key benefits.

In November 2017 BioSig engaged California based Sherpa Technology Group as its intellectual property advisors.

"Our Company's mission is to improve the standards of patient care worldwide. Submission of 510(k) application is a major milestone, which, once completed, will allow us to bring the PURE EP System to the EP community. Patient-centred innovation is at the heart of what we do, and we will continue to work rigorously to address unmet clinical needs," commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

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(TM) System.  The technology has been developed to address an unmet need in a large and growing market.

The Company's first product, PURE EP System, is a novel cardiac signal acquisition and display system which 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 deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia.

Contact:

Natasha Russkina
BioSig Technologies, Inc. 
VP Business Development & Corporate Finance 
nrusskina@biosigtech.com
+41 (0) 76 823 7527




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: BioSig Technologies, Inc. via Globenewswire

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Abeona Therapeutics Receives Orphan Drug Designation in the European Union for ABO-202 Gene Therapy Program in Batten Disease20.4.2018 14:15Pressemelding

NEW YORK and CLEVELAND, April 20, 2018 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted Orphan Drug Designation (EMA/OD/013/18) for Abeona's gene therapy program ABO-202 for the treatment of subjects with neuronal ceroid lipofuscinosis, also known as Batten Disease, a fatal lysosomal storage disease that primarily affects the nervous system in children. ABO-202 is an adeno-associated virus developed to introduce a functional copy of the CLN1 gene into cells in order to restore the enzyme activity that is needed to break down certain lipopigment proteins that are deficient in patients with CLN1 disease. "This designation is an important step in our CLN1 program as it encourages us to proceed towards clinical development," st

Taconic Biosciences Licenses Easi-CRISPR Technology from the University of Nebraska20.4.2018 14:00Pressemelding

RENSSELAER, N.Y., April 20, 2018 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered mouse model and service solutions, has been granted a license to the Easi-CRISPR technology from the University of Nebraska. Easi-CRISPR was developed in the laboratories of Drs. Masato Ohtsuka (Tokai University in Japan), and Channabasavaiah Gurumurthy (University of Nebraska). The terms of the agreement include a world-wide, non-exclusive license to the technology, allowing Taconic rights to generate and sell rodent models generated via Easi-CRISPR. When compared to traditional CRISPR, Easi-CRISPR represents a significant advantage, allowing researchers to perform whole genetic insertions versus being limited to point mutations and constitutive knockouts. "Easi-CRISPR is the next progression of the revolutionary CRISPR/Cas technology. Combining the speed of CRISPR with larger genetic insertions allows complex projects typically requiring homologous recombinati

PayByPhone appoints Andreas Gruber as new President and CEO20.4.2018 00:19Pressemelding

VANCOUVER, British Columbia, April 19, 2018 (GLOBE NEWSWIRE) -- PayByPhone, the global leader in mobile parking payments, today announced that it will appoint Andreas Gruber as president and Chief Executive Officer effective June 1st, 2018. Francis Dupuis, the former President and CEO, will take over a position in Germany with parent company Volkswagen Financial Services AG. To provide additional impetus to the PayByPhone board, two new board positions have been created and as a result Maggie Clay (CFO) and Catherine Scott (Legal Counsel) will be appointed effective June 1st, 2018. During his time at PayByPhone, Francis led the business through significant growth and organizational change and leaves the company well positioned for continued success. "We would like to thank Francis for his strong leadership and look forward to building on his experience within Volkswagen Financial Services," Gerd Künne, Vice-President of mobility unit at Volkswagen Financial Services, said. Francis is e

Progress and Potential for Achieving Cleaner Air on a Global Basis20.4.2018 00:09Pressemelding

Adoption of New Generation Diesel Technology Delivers Rapid Clean Air Benefits New understanding of global air quality highlights the need for technologies like new-generation diesel engines, which are capable of accelerating emissions reductions WASHINGTON, April 19, 2018 (GLOBE NEWSWIRE) -- Recent reports highlighting air quality conditions in the United States (State of the Air) and globally (State of Global Air 2018) celebrate the progress made in developed and developing countries, but also emphasize significant disparities in progress toward reducing levels of key pollutants such as particulate matter and ozone. "Achieving continued clean air progress while also sustaining economic growth is possible. Cities and countries must move to proven cleaner engines and fuels," said Allen Schaeffer, executive director of the Diesel Technology Forum. "We can and should bring the tremendous benefits of new technology diesel engines to communities and countries large and small around the wor

SD-WAN for Office 365: Aryaka Helps eLearning company, City & Guilds Group, Improve Office 365 Application Response Time19.4.2018 18:54Pressemelding

Aryaka's Global SD-WAN reduces time for global users to open SharePoint files from 10 to 0.05 seconds; Outlook performance improves 9x worldwide LONDON, April 19, 2018 (GLOBE NEWSWIRE) -- Aryaka®, the leading global SD-WAN provider, announced today its SD-WAN technology has enabled City & Guilds Group, a worldwide leader in workplace skills, eLearning, and executive coaching, to achieve faster Office 365 application response times leading to an increase in productivity and better collaboration between users in Europe and Asia-Pacific. Headquartered in London, the City & Guilds Group works with education providers, governments and major corporations to help shape and support skills development for employers in over 100 countries. Team members of the company are similarly scattered around the world and primarily collaborate using Microsoft Office 365 applications, but many remote users were struggling to access the group's instance of Office 365 hosted in Dublin. For example, it could ta

Canacol Energy Ltd. Announces Private Offering of Senior Notes19.4.2018 16:23Pressemelding

CALGARY, Alberta, April 19, 2018 (GLOBE NEWSWIRE) -- Canacol Energy Ltd. ("Canacol" or the "Corporation") (TSX:CNE) (OTCQX:CNNEF) (BVC:CNEC) is pleased to announce that it intends, subject to market and other conditions, to offer senior unsecured notes (the "Notes") in a private placement to qualified institutional buyers in the United States pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), to non-U.S. persons in transactions outside the United States pursuant to Regulation S under the Securities Act and pursuant to certain prospectus exemptions in Canada (the "Offering"). The Notes will be fully and unconditionally guaranteed by certain subsidiaries of Canacol. The interest rate, redemption prices and other terms of the Notes are to be determined upon pricing of the Offering. Canacol intends to use the net proceeds from the Offering: (i) to repay the outstanding amounts borrowed under its credit facility; (ii) to pay fees and expenses of the O

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom