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Abbott  today announced it has received clearance from the U.S. Food and Drug Administration for the EnSite™ X EP System with EnSite Omnipolar Technology a new cardiac mapping platform available in the U.S. and across Europe that is designed to help physicians better treat abnormal heart rhythms, also known as cardiac arrhythmias. Designed with input from electrophysiologists from around the world, the system ...

- Abbott (NYSE: ABT) today announced it has received clearance from the U.S. Food and Drug Administration for the EnSite™ X EP System with EnSite Omnipolar Technology (OT), a new cardiac mapping platform available in the U.S. and across Europe that is designed to help physicians better treat abnormal heart rhythms, also known as cardiac arrhythmias. Designed with input from electrophysiologists from around the world, the system creates highly detailed three-dimensional maps of the heart to help physicians identify and then treat areas of the heart where abnormal rhythms originate.

"More patients than ever before are benefitting from ablation to treat abnormal heart rhythms, and Abbott's new EnSite X System with EnSite OT, utilizing Advisor HD Grid catheter, embodies the latest innovation available to support the treatment of complex and challenging cardiac arrhythmias," said Amin Al-Ahmad , M.D., a clinical cardiac electrophysiologist with Texas Cardiac Arrhythmia at St. David's Medical Center in Austin, Texas . "To continue improving outcomes for our patients, we need a system with speed, stability and accuracy. Abbott has provided us with a system that not only supports safe and effective treatment, but enhances the accuracy of maps, allowing for a clearer understanding of what is going on in the heart and what areas need to be targeted with ablation to treat arrythmias."

This system includes Abbott's proprietary EnSite OT, which leverages the Advisor HD Grid Catheter to provide true electrograms (EGMs) regardless of how the catheter is oriented within the heart. With the ability to sample EGMs in 360 degrees, the EnSite X EP System with EnSite OT can map 1 million points in the heart and provide more precise location of treatment areas. Offering the best of both unipolar and bipolar measurement principles, the system provides mapping without compromise.

Millions of Americans are affected by abnormal heart rhythms caused by breakdowns in the electrical pathways of the heart. Left untreated, these breakdowns can lead to erratic heartbeats or cause the heart to beat too fast or too slow, which can dramatically impact a patient's health. Atrial fibrillation (AFib), the most common arrhythmia the EnSite X EP System with EnSite OT can help treat, is a condition in which the heart's chambers are out of sync, causing them to beat in a rapid and chaotic fashion. In some cases, untreated arrythmias like AFib may eventually lead to heart failure or stroke.

Increasingly, physicians are turning to cardiac ablation to treat cardiac arrhythmias because –unlike medication – the therapy treats the condition at the source by disrupting the area of the heart generating abnormal heart beats. Cardiac mapping is critical to successful ablation therapy because highly precise, accurate and detailed images of the heart allow physicians to determine the best location to deploy therapy safely and effectively.

"As ablation therapy is increasingly used for patients battling cardiac arrhythmias, new, innovative and advanced cardiac mapping and imaging tools are essential to help physicians provide the best outcomes for their patients," said Mike Pederson , senior vice president, electrophysiology Abbott . "We developed the EnSite X System with EnSite OT to enhance the utility of our unique Advisor HD Grid catheter and allow doctors to quickly and accurately create real-time, stable, three-dimensional models of the heart. These models provide a way to precisely identify areas that are causing problems, so physicians can better treat those abnormal heart rhythms, and preserve healthy tissue."

Reimagining the Potential of Cardiac Mapping
In designing the EnSite X System with EnSite OT, Abbott created the platform to be upgradable via new software, ensuring physicians consistently have access to the latest technology without the need for entirely new systems. In addition, EnSite X EP System with EnSite OT is the first mapping system that allows physicians to choose between two methods of cardiac visualization.

Traditional mapping systems use either unipolar or bipolar measurement principles. While unipolar measurements have multiple advantages, including direction and speed, bipolar measurements provide local signal measuring to pinpoint areas of concern. The EnSite X System with EnSite OT brings the best of both measurement principles together to maximize data collection.

About Cardiac Ablation
When physicians use catheter ablation to treat cardiac arrhythmias, long flexible tools — called catheters — are inserted into the heart to study the arrhythmia and to deliver radio frequency energy. Heat generated from the radio frequency energy disrupts the cells that are creating the abnormal heart rhythm. As a result, this tissue is no longer capable of conducting or sustaining the arrhythmia.

For U.S. important safety information on the EnSite X System with EnSite OT system, visit https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x/indications-safety-warnings.html .

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Cision View original content: https://www.prnewswire.com/news-releases/abbott-receives-us-fda-clearance-for-new-cardiac-mapping-system-to-improve-how-doctors-treat-abnormal-heart-rhythms-301457983.html

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Avisa Diagnostics Appoints Dr. Richard Murray as Chief Medical Officer

Avisa Diagnostics Inc. (CSE:AVBT) (Avisa), a clinical-stage medical device company developing an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of virulent bacterial lung infections, is pleased to announce that the Company has hired Richard K. Murray, M.D., to the newly created position of Chief Medical Officer (CMO).

Dr. Murray has over 25 years of industry experience. He worked at Merck & Co. for many years in positions of increasing responsibility, in a variety of business, medical and scientific areas. His most recent position was Vice President and Deputy Chief Patient Officer. Dr. Murray was also a Fellow at the Advanced Leadership Initiative at Harvard University. He has managed all areas of medical affairs, including outcomes research, medical information, professional and academic affairs, field-based medical physicians, and investigator-initiated trials globally. Prior to his industry career, he was a practicing physician in cardiovascular-pulmonary medicine and an asthma researcher at the Hospital of the University of Pennsylvania. Dr. Murray has an M.D. from Howard University and an M.A. in Chemistry and A.B. in Psychology from Clark University. Dr. Murray currently is Board Chair of the Asthma and Allergy Foundation of America.

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Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
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Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 “long haulers,” who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

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Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 "long haulers," who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

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Aehr Test Systems Receives Orders of Over $2.3 million

Aehr Test Systems (NASDAQ:AEHR) has over 2,500 systems installed over the world that test optical and memory integrated circuits, semiconductors and reliability qualification equipment announced that it received over $2.3 million in orders for test and burn-in services. These orders came from a major manufacturer where Aehr’s services would be implemented for automotive products.

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Cyclacel Reports Fourth Quarter And 2016 Financial Results

Cyclacel Pharmaceuticals (NASDAQ:CYCC) posted its financial results for the fourth quarter and full year 2016.
As quoted in the press release:

The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2016 was $2.9 million and $12.0 million, respectively. As of December 31, 2016, cash and cash equivalents totaled $16.5 million.

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Bloom Health Partners Receives DTC Eligibility

Bloom Health Partners Inc. (CSE: BLMH) (OTCQB: BLMHF) (FSE: D840) ("Bloom" or the "Company"), a global platform for operational health, is pleased to announce that its common shares are now eligible for electronic clearing and settlement through the Depository Trust Company ("DTC"), a subsidiary of the Depository Trust & Clearing Corp. that manages the electronic clearing and settlement of publicly-traded companies in the United States.

The Company's shares will continue to trade in the USA, under the ticker BLMHF on the OTCQB Market. DTC eligibility reduces costs and accelerates the settlement process for investors and brokers allowing the Company's common shares to be traded over a much wider selection of brokerage firms by coming into compliance with their requirements.

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Dr. Yehia Hashad Will Join Bausch + Lomb Corporation as Executive Vice President of Research & Development and Chief Medical Officer

Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health") has announced that Dr. Yehia Hashad will join Bausch + Lomb Corporation ("Bausch + Lomb") as executive vice president of Research & Development (R&D) and chief medical officer (CMO) effective Jan. 31, 2022 .

Dr. Hashad will join Bausch + Lomb from Allergan/AbbVie, where for the past 11 years he held various roles, including leading Allergan's global clinical development program for its eye care portfolio. Prior to that, he was with Novartis Pharma AG for five years, where he focused on ophthalmology, and also with T3A Pharma Group for nearly 10 years.

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Partnerships Key for MedTech in Today's Pandemic World

A recent new partnership in the health technology space has its origins in the COVID-19 pandemic, responding to important patient needs highlighted by the outbreak

Just before the end of last year, Medtronic Canada, a subsidiary of Medtronic (NYSE:MDT), announced plans to expand its outreach to patients via virtual solutions due to the limitations of a world still in a global pandemic.

Medtronic Canada is achieving these “virtual and remote patient monitoring solutions” via a business agreement with Cloud DX (TSXV:CDX,OTCQB:CDXFF), a health technology company. The deal is exclusive to Canada.

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Bloom Health Partners Announces Contract With State of Texas For K-12 Schools

Bloom launches program for K-12 schools for lab-based testing along with supply and management of rapid tests

Bloom Health Partners Inc. (CSE: BLMH) (OTCQB: BLMHF) (FSE: D840) ("Bloom" or the "Company"), a global platform for operational health, announces that it has been awarded a state-wide contract for testing in Texas for K-12 schools for the remainder of the 2022 school year. Bloom's program includes both rapid and lab testing to make up a complete program that covers the needs of schools as they navigate the pandemic. RT-PCR testing will be conducted in Bloom's Dallas based laboratory. Rapid tests are being supplied by Bloom to schools, with results being managed on Bloom's cloud data platform.

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Bausch Health Announces It Is Seeking To Refinance Its Existing Credit Agreement And Conditional Redemption Of Existing Notes - These Steps Will Enable Bausch + Lomb IPO And Facilitate Full Separation

- Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health" or the "Company") announced today that it is seeking to refinance its existing credit agreement (the "Credit Agreement" and such refinancing, the "Credit Agreement Refinancing"). The refinanced Credit Agreement is expected to consist of approximately $2.5 billion of term B loans (the "New Term B Loans") and a $975 million revolving credit facility. The Credit Agreement Refinancing is expected to occur only upon completion of the initial public offering (IPO) of Bausch + Lomb Corporation ("Bausch + Lomb" and such offering, the "Bausch + Lomb IPO") and a related debt financing by Bausch + Lomb (the "Bausch + Lomb Debt Financing"). At the time of the Bausch + Lomb IPO, Bausch + Lomb will initially remain a "restricted" subsidiary subject to the terms of the Credit Agreement covenants, but the Credit Agreement Refinancing is expected to permit Bausch Health to designate Bausch + Lomb as an "unrestricted" subsidiary outside the terms of the Credit Agreement covenants upon achievement of a 7.6x pro forma "Total Leverage Ratio." The Credit Agreement Refinancing is designed to facilitate the separation and distribution of Bausch + Lomb.

The Company also intends, subject to market conditions, to issue approximately $1.0 billion of secured debt securities (the "New Debt Securities"). The proceeds of the New Term B Loans and the offering of the New Debt Securities, along with proceeds from the Bausch + Lomb IPO and from the repayment of an intercompany note owed by Bausch + Lomb (which is expected to be funded by the Bausch + Lomb Debt Financing), are expected to be used to fund the redemption in full of our outstanding 6.125% Senior Notes due 2025 (the "6.125% Notes due 2025"), refinance all of the existing Term B Loans, fund a partial redemption of our outstanding 9.000% Senior Notes due 2025 (the "9.000% Notes due 2025" and, collectively with the 9.000% Notes due 2025, the "Existing Notes") and to pay related fees, premiums and expenses.

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Medtronic announces results showing meaningful pain relief using DTM Spinal Cord Stimulation endurance therapy

DTM™ SCS endurance therapy enables long-lasting recharge-free performance on Vanta™ and 5-minute recharge on Intellis™ neurostimulators

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced three-month results from an on-label, prospective, multi-center study 1 showing meaningful pain relief using DTM™ SCS endurance therapy, a modified, lower-energy variation of the company's Differential Target Multiplexed™ (DTM) Spinal Cord Stimulation (SCS) therapy for chronic overall, back or leg pain. At 3 months, patients treated with DTM SCS endurance therapy reported meaningful pain relief as measured by a 3.9 cm reduction in overall pain on the 10 cm Visual Analog Scale (VAS) 2 . Patients also reported an average 4.3 cm decrease in back pain, and an average 5.0 cm decrease in leg pain.

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