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Lutonix: Back To The Future With Drug-Coated Balloons

Executive Summary

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.

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Cardionovum: As DEBs Heat Up, Who Needs The US Market?

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.

Device and Diagnostics Dealmaking Quarterly Statistics, Q4 2011

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.

First Drug-Coated Balloon IDE: A Conversation With Lutonix CEO Dennis Wahr

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.

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