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.
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With a total market potential estimated in the multibillion-dollar range, the drug-coated balloon opportunity is attracting a growing list of competitors, including several leading multinational cardiovascular device companies that have entered the space via recent acquisitions. DCBs still need to prove their worth in large, long-term clinical trials, but the ultimate proving point for DCBs could center on cost: if they can offer an effective treatment option that is significantly less expensive than existing devices, DCBs may provide a compelling economic argument.
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.
The jury is still on the ultimate utility of stenting and atherectomy in the distal periphery; meanwhile, all eyes are now on an extremely promising new technology that could be a game-changer for this arena: drug-eluting balloons. DEBs are basically angioplasty balloons coated with an antirestenosis drug that is delivered directly to the vessel wall at the time of balloon inflation. They offer numerous advantages over drug-eluting stents in the superficial femoral artery and distal vessels since they leave no implant behind in the vessel that can fracture or cause hypersensitivity reactions and they eliminate the worries of in-stent restenosis and late-stent thrombosis.They may also provide more uniform distribution of the antiproliferative drug in the vessel wall than stents.