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."
Boston Scientific today announced that it has entered into a definitive agreement to acquire Vertiflex, Inc., a privately-held company which has developed and commercialized the Superion® Indirect Decompression System, a minimally-invasive device used to improve physical function and reduce pain in patients with lumbar spinal stenosis (LSS). The procedure – primarily performed by physicians who treat chronic pain patients with therapies including spinal cord stimulation and radiofrequency ablation – is expected to reach $60 million in sales in 2019. The transaction consists of $465 million in upfront cash and additional payments contingent on commercial milestones for the next three years.
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 French health technology assessment agency) into its Forfait Innovation program. The program is designed to fast-track novel medical devices with significant potential to improve clinical outcomes, with the objective of expediting access to important new therapies.
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 total of 106 of the 128 treatment arm patients in the SMART trial completed 24-month follow up. Data at 3 months and 12 months from the Level I SMART trial, a randomized, multi-center trial comparing the Intracept Procedure to sham, was previously published.
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 characterizes all types of genomic alterations in 42 clinically relevant genes associated with a range of solid tumors such as lung, colorectal, skin and brain cancers.
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 T. Abraham, MD, is joining V-Wave as Chief Medical Officer. Dr. Abraham makes this move to V-Wave after more than 16 years as Director of the Division of Cardiovascular Medicine at the Ohio State University.