Gynesonics Announces Full Launch of New Sonata 2 System at 48th AAGL Global Congress 2-year Outcomes Data from the SONATA IDE Pivotal Trial To Be Presented, Demonstrating Significant and Sustained Symptom Relief REDWOOD CITY, Calif. - November 11, 2019 - Gynesonics, a women’s healthcare company focused on the [...]
Allergan and Molecular Partners Present Late-Breaking Data from Phase 3 Studies of Investigational Abicipar pegol in Neovascular Wet Age-Related Macular Degeneration Two-year results from CEDAR and SEQUOIA demonstrate that vision gains observed after one year with every 8-week and every 12-week dosing were maintained in the second year Abicipar [...]
V-Wave Receives Second FDA Breakthrough Device Designation: Interatrial Shunt for Pulmonary Arterial Hypertension V-Wave’s two distinct FDA Breakthrough Device Designations illustrate the company’s dedication to innovation and improving outcomes for two debilitating diseases – Heart Failure and Pulmonary Arterial Hypertension CAESAREA, Israel, September 12, 2019 – V-Wave Ltd., [...]
Allergan & Molecular Partners Announce Acceptance of U.S. FDA Biologics License Application and Validation of EMA Marketing Authorisation The acceptance and authorisation are for Abicipar pegol in patients with neovascular (wet) age-related macular degeneration Filing includes data from two Phase 3 trials which evaluated the safety and efficacy [...]
Relievant Announces Publication of Positive Results from Multi-Center Study of the Intracept® Procedure in Real-world Setting for Patients with Chronic Low Back Pain MINNEAPOLIS – August 27, 2019 – Relievant Medsystems, a privately-held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced the [...]
V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure CAESAREA, Israel, Aug. 15, 2019 — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has just granted the company a Breakthrough Device [...]
Molecular Partners’ strategic partner Allergan announces that EMA has validated the marketing authorisation application for abicipar CAESAREA, Israel, Aug. 15, 2019 — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has just granted [...]
Boston Scientific Announces Agreement to Acquire Vertiflex, Inc. Acquisition of lumbar spinal stenosis treatment to expand portfolio of interventional pain therapies. Vertiflex has raised approximately $160 million in funding from investors including Endeavour Vision, NEA and H.I.G. BioVentures. MARLBOROUGH, Mass., May 9, 2019 / — Boston Scientific (NYSE: [...]
Nuvaira receives french innovation funding for Nuvaira Airflow-3 pivotal trail Acquisition of lumbar spinal stenosis treatment to expand portfolio of interventional pain therapies. Novel program provides reimbursement for TLD therapy in France MINNEAPOLIS, April 28, 2018 – Nuvaira, developer of novel therapeutic strategies to treat obstructive lung diseases, [...]
Relievant announces publication of SMART trial 24-month results Intracept® Procedure Demonstrates Durable Results at 24 Months. MINNEAPOLIS – April 24, 2019 – Relievant Medsystems, a privately-held medical device company developing minimally-invasive solutions for chronic low back pain (CLBP), today announced the publication of 24-month results from the SMART [...]