B. Braun's Bet on Balloons
Until now, B. Braun, one of the oldest players in cardiovascular devices, has been comfortable in its niche. B. Braun's cardiovascular business is actually made up of two units, one that makes products for interventional radiologists and surgeons in the peripheral field, the other on a range of devices used in interventional cardiology. But the investment the company is making in a new technology, drug-eluting balloons, could be disruptive, if not to interventional cardiology, at least to the cardiovascular device companies and none more so than B. Braun itself.
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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.
Drug-eluting balloons might someday pick up where drug-eluting stents leave off, promising to solve problems not addressed - and even created - by DES. However, despite what interventional cardiology companies have learned about device and drug combinations, the drug-coated balloon markets aren't as simple as they might at first seem. Device companies will have to get conversant with issues that are more closely akin to the pharmaceutical industry than the device world, namely, how the products perform in terms of pharmacokinetics and drug distribution.