BAROSTIM NEO™ provides effective treatment for heart failure patients HACKENSACK, N.J., Feb. 3, 2020 /PRNewswire/ — Hackensack Meridian Hackensack University Medical Center announced today that it is the first hospital in the nation to successfully implant the world’s first heart failure neuromodulation device, BAROSTIM NEO™. This innovative technology is an effective alternative for […]
Author: Ken Dropiewski
Resverlogix Receives US FDA Breakthrough Therapy Designation for Apabetalone
CALGARY, Alberta, Feb. 03, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX: RVX) is pleased to announce the U.S. Food & Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for apabetalone in combination with top standard of care, including high-intensity statins, for the secondary prevention of major […]
Mesoblast Submits Completed Biologics License Application for Ryoncil™ to US FDA
NEW YORK, Feb. 03, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that it has submitted its completed Biologics License Application (BLA) to the United States Food and Drug Administration (US FDA) for Ryoncil™ (remestemcel-L), its lead allogeneic cell therapy […]
Lantheus Announces Topline Results for BENEFIT 1 LVEF Clinical Trial
NORTH BILLERICA, Mass.–(BUSINESS WIRE)–Lantheus Holdings, Inc. (NASDAQ: LNTH) (“Lantheus” or the “Company”), parent company of Lantheus Medical Imaging, Inc. (“LMI”), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced topline results for the BENEFIT 1 Left Ventricular Ejection Fraction (“LVEF”) clinical trial. […]
Ancora Heart Announces Expansion of U.S. Early Feasibility Study
CorCinch HFrEF Study Evaluating Safety of AccuCinch Ventricular Repair System in Heart Failure Patients SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of enrollment in its CorCinch HFrEF […]
Endologix Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX) (the “Company”), a developer and marketer of innovative treatments for aortic disorders, announced today the grant of an inducement equity award to a newly hired employee (the “Awardee”). The award was approved by the Company’s Compensation Committee, which is comprised of independent directors, on […]
MedAlliance Receives CE Mark Approval for SELUTION SLR™ Sirolimus Drug Eluting Balloon for Endovascular Applications
3 February 2020 – MedAlliance has announced the award of its first CE Mark approval: for SELUTION SLR™, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of peripheral arterial disease. This approval applies to sizes from 2.0 x 20mm to 7.0 x 150mm. This award was supported by two-year […]
Neovasc Announces Renewal of German Reimbursement NUB Status 1 Designation for Neovasc Reducer for Treatment of Refractory Angina
VANCOUVER, Jan. 31, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that the Institut für […]
Itamar™ Medical Announces Upsizing and Pricing of Public Offering of American Depositary Shares
CAESAREA, Israel, Jan. 30, 2020 (GLOBE NEWSWIRE) — Itamar Medical Ltd. (Nasdaq: ITMR) (TASE: ITMR), a medical technology company focused on the development and commercialization of non-invasive medical devices to aid in the diagnosis of respiratory sleep disorders, today announced the upsizing and pricing of its public offering of 2,545,450 American Depositary […]
Edwards Lifesciences Reports Fourth Quarter Results
IRVINE, Calif., Jan. 30, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today reported financial results for the quarter ended December 31, 2019. Fourth Quarter Results and Outlook Q4 sales grew 20% to $1.2 billion; underlying1 sales grew 19% Q4 TAVR sales grew […]



