Lutonix: Back To The Future With Drug-Coated Balloons
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.
You may also be interested in...
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.
Medical device companies raised $800 million in the fourth quarter of 2011, and venture capital represented half of that amount. Just over $4 billion was spent to acquire medical device companies, down 50% from Q3’s $8 billion. In vitro diagnostics/research financings were well above the previous quarter, raking in a total of $269 million, with late-stage rounds again bringing in most of the Q4 money. Only five M&A deals were completed, totalling $915 million – way down from Q3’s $2.8 billion for the same number of deals.
Following a four-year effort with FDA, Minneapolis start-up Lutonix recently met its goal to become the first company to gain an investigational device exemption for a drug-coated balloon.