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 of Abicipar quarterly dosing regimen Approvals in the United States and Europe are anticipated in 2020 DUBLIN, IRELAND – [...]
MINNEAPOLIS – August 27, 2019 – Relievant Medsystems, a privately-held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced the publication of significant and clinically-meaningful outcomes from a prospective, open-label, single-arm, multi-center study in the European Spine Journal. This study follows previous publication of [...]
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 [...]
Zurich-Schlieren, Switzerland, August 06, 2019. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies*, today announced that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) of its strategic partner Allergan for abicipar, a [...]
Medical Device Veteran Has 23-Year Record of Successful Commercial and Organizational Leadership MARLBOROUGH, Mass., June 5, 2019 — CeQur® announced that the company has appointed Bradley Paddock as chief executive officer, effective today. Paddock brings a track record of commercial medtech successes, notably leading sales up to $600 million [...]
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: [...]
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, has received acceptance from the Haute Autorité de Santé (HAS, the [...]
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 trial in the International Journal of Spine Surgery. A [...]
for its Solid Tumor Solution for accurate cancer detection. Lausanne, SWITZERLAND – 11 April 2019: SOPHiA GENETICS, global leader in Data-Driven Medicine, announced today the CE-IVD marking of its Solid Tumor Solution (STS), a new step in the fight against cancer. This standardized molecular diagnostic application precisely detects and [...]
William T. Abraham, Md Joins V-wave as Chief Medical Officer CAESAREA, Israel, March 11, 2019 – V-Wave Ltd., an early stage medtech company, developing an implantable interatrial shunt device for treating advanced heart failure (HF) and pulmonary arterial hypertension (PAH), announced today that renowned heart failure cardiologist, William [...]