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A decade ago, during the device industry's first financing crisis, medical device incubators played a crucial role in keeping small start-ups viable. But incubators themselves soon ran into problems, most notably in finding a sustainable financing model for themselves. California-based Intersect Partners has been one of the most successful incubators but it, too, needed to find a new model to make incubation viable.
Despite the best intentions and brightest innovation, start-ups haven't been able to tap into the huge potential presented by the vascular closure market. Ten years after the first generation devices made it to market, the original two leaders still dominate despite the limitations of their devices, while many start-ups have come and gone. A long list of new hopefuls believe they have the solution physicians have desired. Now all they have to do is convince the physicians, who, when it comes to vascular closure devices, are slow to recognize clinical data but quick to embrace a device that feels right to them.
After an initial warm welcome for first-generation femoral artery closure devices--including a few high-profile exits--sales have stalled. Early devices are flawed, indicating the technical challenge is tougher than it looks. A dozen or so start-ups are trying to address the technology problems that have hampered the pioneers. The newcomers face high hurdles as early experience with first generation devices temper clinician and investor enthusiasm. All will have to prove, in large, rigorous clinical trials, that devices are more complication-free and are as easy-to-use as market leader Angio-Seal, and that they're at least as safe, if not safer, than manual compression. But although start-ups face a great of skepticism about particular technologies, they also inherit a $350 million market made up of devices with an average selling price of $200, which is an endorsement of this new device market. At the same time, an enormous opportunity remains in the 75% of the market that remains unpenetrated.
At the top of the industry, consolidation has frozen out much additional M&A; horizontal mergers among large companies have become much more difficult to get through regulatory authorities as the industries themselves have consolidated. In medical devices, M&A is at a 10-year low, reflecting a paucity of high-value small-company opportunities. Perhaps as important, some successful big-company development programs undermine a basic assumption of medical device investing: that big companies must source innovation from small ones, usually through acquisitions. Meanwhile In biotech, the number and value of M&A is down, despite the apparent logic of consolidation and the unprecedented willingness of sellers to accept low valuations. The key problem is that there are few buyers: those without extremely strong balance sheets aren't willing to take on additional burn rates, having seen some acquirers come to grief as their new, apparently stronger companies are unable to raise money in this bear market.