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 granted the company a second Breakthrough Device Designation – the first was for its interatrial shunt for Heart Failure (HF), and the second, for Pulmonary Arterial Hypertension (PAH). V-Wave is testing a minimally invasive, implanted interatrial shunt device for PAH in a global approved IDE Early Feasibility Study, RELIEVE-PAH. 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
Allergan plc (NYSE: AGN), a leading global pharmaceutical company with a heritage of more than 70 years in eye care, and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and the European Medicines Agency (EMA) has validated a Marketing Authorisation Application (MAA) for Abicipar pegol, a novel, investigational DARPin® therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD).
"Our goal is to find technologies and companies that we believe are among the top three in the world in their field. Two other criteria that are essential: this technology can improve the patient's life and is very economically competitive because health costs are a concern for all. Overall, the global medtech market is growing by 5% per year, but it is a very large sector, which includes both advanced technologies and more common products, such as hospital beds. We focus on sectors and companies that grow by 20% a year or more."
Relievant Medsystems, a privately-held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), has announced the publication of significant and clinically-meaningful outcomes from a prospective, open-label, single-arm, multi-center study in the European Spine Journal.
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 Designation for its interatrial shunt for Heart Failure (HF). V-Wave's minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient pivotal IDE trial called RELIEVE-HF.
Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin® therapies*, announced on 6 August that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) of its strategic partner Allergan for abicipar, a novel DARPin® therapy for the treatment of nAMD.
"Diligence comes down to risk so whether it’s a VC or a strategic doing it, the goal is the same; to assess the level of risk for a transaction. What is different, is how that risk is defined and quantified. My goal in leading diligence was to focus our efforts on the handful of areas that we felt could completely disrupt our deal thesis. You will always miss something in diligence, but it is unacceptable to miss something that fundamentally changes the value of a deal."
"There are 30 million patients in the United States that have chronic low back pain, it’s a massively debilitating condition that affects everything from personal relationships to careers. It is also one of the highest drivers of the national healthcare utilisation system. Our Intracept® Procedure is a minimally invasive outpatient treatment for pain associated with degenerative disc disease. The procedure targets the basivertebral nerve for the relief of chronic low back pain – it is extremely durable, has an excellent safety profile and is supported by an unparalleled portfolio of Level 1 clinical data."
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 during his eight-year tenure at Kyphon, Inc. Paddock also managed successful commercial operations for multiple industry-leading companies, including Stryker, Bausch + Lomb, Inc., and Medtronic, Inc.
"Gynesonics is focused on advancing women’s health by developing uterus-preserving, incision free, transcervical technology.
Currently, we are focused on the treatment of symptomatic uterine fibroids, a condition that affects up to 50% of women and represents a $3-4 billion dollar market globally. When symptomatic, the condition can cause heavy, painful menstrual bleeding and fertility issues, greatly reducing the quality of life for the women affected."