Zurich-Schlieren, Switzerland, December 27, 2019. Molecular Partners AG (SIX:MOLN), a clinical stage biotech company pioneering the use of DARPin® therapeutics to treat serious diseases, announces the receipt of Orphan Drug Designation by the US Food and Drug Administration (FDA) for its novel therapeutic, MP0250, for the treatment of Multiple [...]
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 development of minimally-invasive solutions for symptomatic uterine fibroids, announced today the full launch of the [...]
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 sustained vision gains in year two with quarterly injections compared to monthly ranibizumab Reductions in central retinal thickness were lower in [...]
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., [...]
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: [...]