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Clogged Plumbing

Executive Summary

Two years ago, OmniSonics, a small medical device firm with a promising application in BPH, ran into a brick wall in discussions with investors; some of that was due to dot-com mania, but investors also evinced distaste for the urology and gynecology markets. A poor industry track record, compounded by reimbursement troubles, cautious physician adopters, and patients sometimes reluctant to seek treatment, had left earlier investors in the space feeling burned. But there's reason to hope that investor skittishness will begin to fade. Not only is the market driven by strong demographics, but also social and cultural taboos are coming down. For all its problems, for many device companies, particularly for large ones, the opportunity in urology and gynecology may soon become too attractive to turn down.

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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.

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.

Hijacking the Restenosis Market

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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