Concentric's Clearance Not Likely to Spur Stroke Investment
This article was originally published in Start Up
The FDA's unexpected decision to issue market clearance for the first medical device to treat ischemic stroke, Concentric Medical's Merci retrieval system, is not likely to dramatically increase venture investing in stroke start-ups because of a wide range of challenges facing product development and adoption in this space.
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A decade ago, incuabators were seen as the best medicine for what then ailed the medical device industry, most notably a complex regulatory pathway and a difficult venture financing climate. Perhaps not surprisingly, as both the regulatory path and venture financing grew easier in the mid 2000s, incubators began to struggle, victims of their own financing problems. More recently, two huge acquisitions, Abbott's purchase of Evalve and Medtronic's of Ardian, suggest that at least one incubator, The Foundry, is proving that incubation works.
If the 1990s was the decade of the heart, this was supposed to be the decade of the brain. But the tremendous market for stroke device companies has never quite materialized in part because stroke treatment is so elusive. That elusive nature of therapy has led also to unclear technology solutions, complex regulatory paths, and challenging adoption models. CoAxia is staking its claim with a development and clinical trials strategy that departs from those of other stroke start-ups, aiming to prove clinical efficacy in its complex trials.
Stroke remains a devastating disease that isn't adequately addressed, but the pharmaceutical industry remains wary of the field, having been stung in the past by extremely expensive clinical disappointments. Nevertheless, the opportunity is too enticing for the industry to ignore completely. Two pharma-sponsored major clinical trials are underway for treatment of acute ischemic stroke, foro example. The emerging companies with stroke therapies profiled here, however, are cautiously pushing forward on several fronts, of which the stroke market may or not be the first and foremost application of core technology.