Covidien Acquires CV Ingenuity: Highlights Promise In Drug-Coated Balloons
In late December 2012, Covidien announced a definitive agreement to acquire drug-coated balloon company CV Ingenuity for an undisclosed amount. Covidien joins large cardiovascular device players such as Medtronic, which gained a drug-coated balloon when it acquired Invatec in 2010, and CR Bard, which has the lead in the US market as a result of its acquisition last year of Lutonix Inc. as well as a large number of DCB companies based in Europe.
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The prospective medical device tax, the continuing decline of venture investing, pricing challenges, austerity measures in Europe, and other headwinds continued to push against the medtech industry in 2012. But emerging clinical and geographic markets, along with an active M&A market, provided the industry with some momentum.
German serial entrepreneur Michael Orlowski achieved a successful exit in his first cardiovascular device company, EuroCor, by selling not to a US-based giant, but to an Indian conglomerate, Opto Circuits. His new company, Cardionovum, has developed a next-generation drug-eluting balloon whose novelty rests on a different approach to the coating technology designed to produce better drug-elution. With CE mark in hand, Cardionovum is preparing to launch its products in Europe. The US is a logical next target, but the high cost of clinical trials and the ever-lengthening regulatory approvals process has made the US an even more difficult market to penetrate, forcing companies like Cardionovum to contemplate strategies that bypass or put off a US launch.
Drug-coated balloons were once thought to be an unnecessary innovation because of drug-eluting stents. With DES no longer seen as the panacea for vascular disease, balloons could re-emerge as the next major technology platform, and Lutonix is leading the race to bring them to the US market.