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

Article preview from IN VIVO - May, 2012

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.

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

Article preview from IN VIVO - May, 2012

If there is any industry that can lay claim to a kind of American exceptionalism or American centricity, it’s the medical device industry. Compared even with its sister biopharma industry, the US remains a dominant presence in medical devices, representing not just the largest market in the world but also serving as headquarters to the vast majority of global medical device companies. For years, that prominence, if not dominance, seemed to give US-based giants a presumptive edge in getting to market. When first coronary stents and, soon after, drug-eluting stents came to market, US companies like Johnson & Johnson, Boston Scientific Corp./Guidant and Medtronic Inc./Medtronic CardioVascular quickly took the lion’s share of the stent markets in Europe, despite a fairly large group of native European stent companies, most of which found themselves relegated to a small left-over share of the market, competing on the basis of price.

Today, the US and US-based companies retain their out-sized roles in the medical device industry, in terms of both market opportunity and as a source of innovative technology. But there are signs that the presumptive dominance of the US is being challenged, particularly in one of the industry’s largest segments: cardiovascular devices. A slowdown in the growth rate of PCI procedures in the US, combined with an ever more difficult regulatory environment and a chill in the venture community, has made the US a less robust market, for both big and small companies, than it once was. Indeed, many companies, perhaps most notably Medtronic CoreValve LLC and Ardian Inc., have taken to launching their products outside the US, to gain clinical bona fides and in hopes of attracting a large buyer to avoid having to embark on a full-scale US launch later on – which both CoreValve and Ardian, now both part of Medtronic, did.

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