PARIS – Robocath SAS, of Rouen, France, has secured a new $43 million funding round to boost roll-out of its R-One robotic system for treating vascular disease. This series C funding was led by Hong Kong-based Microport Scientific Corp.
LONDON – Base Genomics Ltd. has raised $11 million in an oversubscribed seed round to commercialize a new liquid biopsy technology for detecting DNA methylation, invented in the U.K. at the Ludwig Institute for Cancer Research at Oxford University.
PARIS – Uromems SAS, of Grenoble, France, reported the completion of a series B round of $17.5 million to advance development of its implantable mechatronic device for treating stress urinary incontinence.
The implementation date for the EU’s new med-tech regulatory framework has been pushed back a year, giving device makers much-needed breathing room for compliance work. At the same time, the International Organization for Standardization (ISO) has not fulfilled the planned May update of its device clinical investigations standard, ISO 14155.
LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.
PARIS – Carmat SA, which is based in Vélizy Villacoublay, France, reported the first implantation of its bioprosthetic artificial heart at the Heart Center of the Rigshospitalet in Copenhagen, Denmark.
PARIS – Fineheart SA, of Bordeaux, France, reported the success of a seven-day preclinical study to evaluate its Implantable Cardiac Output Management System (ICOMS), the first fully Intra-Ventricular Flow Accelerator synchronized to the native heartbeat to restore natural heart pumping capacity.
Like many other med-tech companies, Medtronic plc, of Dublin, saw COVID-19 affect its financial results for its fourth quarter and fiscal year 2020, as procedures were deferred in the wake of the pandemic. Quarterly worldwide revenue came in at $5.998 billion, representing a decrease of 26% as reported and 25% on an organic basis.
LONDON – Astrazeneca plc is to get up to $1.2 billion from the new U.S. COVID-19 vaccines program, Operation Warp Speed, to support further development and manufacturing of a vaccine developed at Oxford University’s Jenner Institute. The company said it will begin to ship the product in September 2020, with the U.K. and U.S. first in line for deliveries.
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.