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Hijacking the Restenosis Market

This article was originally published in Start Up

Executive Summary

Innovative device companies have always had to contend with the Sword of Damocles of unexpected technological obsolescence, but for would-be developers of interventional devices for the prevention of restenosis, the sword is dangling perilously close. In the RAVEL trial, a 238-patient clinical trial on a drug eluting stent, treated patients experienced 0% restenosis compared to 26% in the control group. Now, device developers with alternatives to stents reposition themselves to sustain businesses in the face of potentially shrinking target markets. Many argue that they will serve certain applications better than stents; others hope to work with drug-coated stents to enhance performance, many believe that economics will leave room for alternative approaches, and still others are getting out of the coronary business entirely.

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World Congress of Cardiology: DES Safety Dominates Discussions

While the greater efficacy of drug-eluting stents (DES) compared to bare-metal stents is widely accepted, over the past year, data has continued to build showing that first-generation DES also have a higher late-stage in-stent thrombosis risk, a complication that can cause death 30% of the time, according to some estimates. The findings of these studies had some physicians at this year's World Congress of Cardiology calling for "an immediate halt to DES overuse." However, most conceded that additional randomized trials will be needed to fully understand the potential risks associated with these devices.

Fair Winds or Foul in Treating Total Occlusions?

The company that did the largest private financing last years was, surprisingly, Wilmington, MA-based OmniSonics Medical Technologies. The company is developing an innovative technology that uses acoustical energy to break up clots, plaques, and other occlusions wherever they occur in the human vasculature. OmniSonics' Series C financing will ultimately wind up raising a total of $44 million. The company's first approval, expected later this year, will come in treating peripheral disease, but the golden ring is clearly coronary arteries and that includes chronic total occlusions, a challenge that has been particularly vexing for both interventional cardiologists and medical device developers. Indeed, the recent news that CTO start-up Lumend Inc. is significantly scaling back its operations is a case in point.

Medical Acquisitions: No Icebreaker in Sight

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.

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