BTG Set To Launch First Radiopaque Drug-Eluting Bead In The EU
DC Bead Lumi is designed to be loaded with doxorubicin or irinotecan to treat liver cancer while showing the treating physician where it is to improve control of transarterial chemoembolization procedures.
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The company pleaded guilty to a misdemeanor misbranding charge and agreed to pay $11m in criminal penalties and another $25m to resolve civil False Claims Act allegations. Biocompatibles reportedly marketed its LC Bead product as a drug-delivery product, even though it was cleared only for embolization.
August was another slow month for announcements of medical device approvals outside the US, but the short list of non-US approvals this month includes a broad range of device-types approved, notably a much-awaited expanded indication for Medtronic’s CoreValve Evolut R, in six different territories.
UK-listed BTG PLC is on a route to a major future in interventional medicine, having built solid foundations in licensing and specialty pharma. CEO Louise Makin describes the deal- and decision-making rationale that has allowed a mid-cap player to set billion-dollar plus ambitions in interventional medicine, based on organic and M&A growth.