The European Medicines Agency seems focused on pharmaceuticals to the near exclusion of medical technology, but the agency recently reported the launch of a pilot program for orphan medical devices.

Haemonetics Corp. received CE mark certification for the Savvywire pre-shaped pressure guidewire, a sensor-guided three-in-one guidewire for transcatheter aortic valve implantation. The solution, which is expected to enhance TAVI procedures and improve patient outcomes, is already being used in procedures in European countries.

Levicept Ltd. is scoping the options for phase III development after reporting positive results from its phase II trial of LEVI-04 in the treatment of pain caused by osteoarthritis of the knee. The full data are yet to be published, but the company said the potentially first-in-class neurotrophin-3 inhibitor demonstrated significant differences from placebo, with a mean reduction in pain score from baseline of more than 50%, for the three doses tested.

Immunovia AB significantly increased the accuracy of its test for the early detection of pancreatic cancer, achieving an 85% sensitivity and a specificity of 98%.

The recent €15 million (US$16.3 million) deal that Affluent Medical SAS signed with Edwards Lifesciences Inc. for its heart products does not take away from its ambitions of creating a European med-tech company, Sébastien Ladet, CEO of Affluent Medical, told BioWorld, but was part of the company’s broader strategy to expand the markets for its products.

The U.K. National Institute for Health and Care Excellence endorsed the use of testing for the CYP2C19 genotype for management of clopidogrel usage after ischemic stroke and heart attack, but the agency is specific about the use of tests by Genedrive plc and Genomadix Inc. in point-of-care settings as alternatives to lab testing.

Oxford Nanopore Technologies plc secured £80 million (US$102 million) in an oversubscribed equity raise, with £50 million coming from Novo Holdings.

Noze Inc. breathes a little easier with a new $5 million equity investment from the Bill & Melinda Gates Foundation to support the development of Diagnoze, a breath-based, hand-held diagnostic device. The foundation provided two earlier grants focused on diagnosing tuberculosis in low- and middle-income countries. “We're thrilled to see our partnership with the Bill & Melinda Gates Foundation continue to grow,” Noze CEO Karim Aly told BioWorld.

Protembis GmbH received €20 million (US$21.66 million) in financing from the European Investment Bank to develop its cerebral embolic protection system, Protembo. The intra-aortic filter device deflects embolic material away from arteries leading to the brain during left-sided heart procedures including transcatheter aortic valve replacement.