LONDON – The EU’s third generation public-private research partnership in health formally got off the ground on Jan. 26, with a promise to invest €2.4 billion (US$2.7 billion) and back 30 large-scale, cross-sector innovation projects by 2030. The Innovative Health Initiative is the successor to the Innovative Medicines Initiatives 1 and 2, which between 2008 – 2020 put €5 billion into precompetitive research to accelerate translation of biomedical research to new drugs.
Smith & Nephew plc added new indications for use of its Pico 7 and Pico 14 single-use negative pressure wound therapy (sNPWT) systems. The FDA cleared the London-based device maker’s systems for reducing the incidence of both deep and superficial incisional surgical sites and dehiscence. Smith & Nephew’s Pico 7Y system, which treats two wounds simultaneously, was also cleared to aid in the reduction of the incidence of superficial incisional SSIs for high-risk patients in class I wounds, post-operative seroma and dehiscence.
The European Council adopted a regulation Jan. 25 giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices during a crisis.
Supply chain issues overshadowed Royal Phillips NV fourth-quarter 2021 results, as the Dutch conglomerate reported sales of $5.5 billion (€4.9 billion), a 10% organic year-on-year decline. Philips management said sales were impacted by several headwinds, including supply chain challenges and postponement of equipment installations in hospitals related to COVID-19. The recall of the Respironics device also caused a double-digit decline in the sleep & respiratory business.
LONDON – The industry is expressing divergent views of changes to how the U.K. health technology assessment agency, the National Institute for Health and Care Excellence (NICE), will in the future select what products to assess and the methods and processes it will use to carry out its evaluations.
Exoskeleton company Wandercraft SAS has landed $45 million in a series C round led by U.S. fund Quadrant Management. The company’s first commercial exoskeleton, Atalante, received CE marking in 2019 and has sold for around $176,000 a piece to European rehabilitation hospitals offering gait re-learning treatment.
PARIS – Robocath SAS has concluded an initial clinical study in Europe to demonstrate the safety and efficacy of robotic coronary angioplasty performed using its R-One platform. Sixty-two patients from six European hospitals participated in the R-Evolution clinical study. The study was aimed at assessing the safety and efficacy of the R-One robotic assistance platform.
Investors have backed Oxford University spin-off ONI Ltd. with $75 million to push commercialization of its nanoimaging technology. The startup’s flagship product Nanoimager is a desktop, super resolution microscope capable of visualizing, tracking, and imaging individual molecules in living cells with 20 nm resolution. The technology is already in use with biomedical companies to aid development of more efficient, targeted therapies.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) unveiled a proposal to overhaul its requirements for clinical trials for drugs and devices, just one of several significant regulatory proposals in recent months. One of the proposed changes would be to require more patient engagement in the design of trials, while another feature would allow sponsors to go through the MHRA process and an ethics review in a single application, thus potentially streamlining the up-front work required for these studies.
Clinisys Inc. has signed a deal to buy laboratory information company Horizon Lab Systems LLC and combine Sunquest Information Systems under the Clinisys brand. The resulting group will be one of the world's largest laboratory informatics organizations. Clinisys and Sunquest share the same parent company – Roper Technologies Inc., which trades on the NYSE stock exchange. The addition of Raleigh, N.C.-based Horizon provides Clinisys with expertise in the public health, environmental, water quality, toxicology and agriculture markets.