Boston Scientific Corp. reported the controlled launch of its Acurate Neo2 aortic valve system in Europe. The next-generation transcatheter aortic valve implantation (TAVI) technology extends the clinical performance of the original Acurate Neo platform and includes an expanded indication for patients with aortic stenosis.
Wellington Life Sciences general partner Regina Hodits, during a talk with CBT Advisors CEO Steve Dickman at the recent Biopharm America meeting, said the disaster scenario feared for European investments when COVID-19 struck “turned out very different. We never have a lot of time off in summer, not as much as we would want to, but this year we certainly had no time off,” as portfolio firms found money and Wellington tapped new opportunities.
Scientists long have puzzled over what goes wrong in people with cardiovascular disease. Now, they have created a cellular and molecular map of the healthy human heart, with an eye toward preventing some of the 17.9 million deaths from cardiovascular disease that occur each year.
LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week.
According to the Swiss association for medical technology companies, Swiss Medtech, introducing the new European regulations for medical devices (MDR) and in vitro diagnostics (IVDR) is going to have serious consequences for the sector in Switzerland. This Swiss trade association has just published its biannual survey as part of the 2020 sector study on the Swiss medical technology industry (SMTI).
LONDON – Sleep disorder specialist Nyxoah SA hit the top end of its price range of €17 per share, raising €84.75 million (US$100) million in its initial public offering. Assuming full exercise of the over-allotment option, the company will have a market capitalization of €375.26 million. The shares began trading on Euronext Brussels (EBR:NYXH) on Sept. 18, and had a good first day, closing up 14.7%, at €19.50.
PARIS – Soon, a machine, as quick and simple as a breathalyzer, could be used to detect COVID-19 from molecules present in exhaled air. The research team from Institut de recherches sur la catalyse et l’environnement de Lyon (IRCELYON – Lyon Institute for Research on Catalysis and the Environment) is investigating the analysis of volatile organic compounds (VOCs) found in exhaled breath for COVID-19 detection.
LONDON – After years of progressing at snail’s pace, COVID-19 has forced through a rapid adoption of digital tools across the spectrum of health in the U.K., from general practitioner appointments, to hospital referrals, elderly care homes and community nursing. “At game changing speed” the health and care system, “has gone from one extreme to another,” said Harpreet Sood, a general practitioner in inner city London and board member of Digitalhealth London.
LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said.
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