Stentys' Shifting Focus: Moving Beyond Bifurcations, Stenting for AMI

Article preview reprinted from IN VIVO - November/December, 2009  

Launched to develop a better bifurcated stent, Stentys discovered its device appears to be effective in treating a larger unmet clinical need: AMI. This strategy shift holds great promise, but the company must convince physicians that its self-expanding stent will succeed where others have failed, and that it is superior to traditional stents from the major CV players.
Launched to develop a better bifurcated stent, Stentys discovered its device appears to be effective in treating a larger unmet clinical need: AMI. This strategy shift holds great promise, but the company must convince physicians that its self-expanding stent will succeed where others have failed, and that it is superior to traditional stents from the major CV players. Read more...

Stentys' Shifting Focus: Moving Beyond Bifurcations, Stenting for AMI

Article preview reprinted from IN VIVO - November/December, 2009  

**Stentys was founded to develop an innovative self-expanding nitinol stent designed by surgeon Jacques Seguin initially to treat bifurcated lesions.

**The company has recently shifted its focus from bifurcations to treating AMI—a much larger market—because recent clinical data indicate that its self-expanding stent may be more effective than balloon-expandable stents in treating AMI patients due to better stent apposition.

**But Stentys must overcome physicians' concerns about self-expanding stents, which have a checkered history in treating coronary disease.

**The company must also overcome interventionalists' reliance on balloon-expandable stents from the major CV players, which it hopes to do through superior clinical data, although AMI trials are costly and complex, presenting a significant challenge to a start-up company.
It is not at all uncommon for a medical device start-up company to begin by focusing on a particular clinical area only to find that its technology doesn't work and is better suited to another therapeutic space. In that case, the decision to change the company's clinical focus is an obvious and easy call.

Such a decision is much harder, however, when a start-up's technology proves effective in the company's original area of concentration, and subsequently also turns out to be viable in treating another clinical condition that may also serve a larger market. Since most start-ups, even those that are well-funded, need to be keenly focused on a single clinical application—at least initially—deciding whether to shift the company's strategic direction, even to what appears to be a more promising opportunity, carries considerable risk, particularly in tough economic times when any added risk is frowned upon by investors and is a greater burden for CEOs.

That is the decision that Paris-based Stentys SAS faced earlier this year. The company ultimately decided to shift its focus from developing self-expanding stents that treat bifurcated lesions to that of a much larger market: stents for patients who have suffered acute myocardial infarctions (AMIs).

Perhaps the biggest risk from this kind of move is that it may implicitly raise questions about the effectiveness of the company's underlying technology since the most common reason start-ups shift focus is that their device didn't work as it was originally intended. "I didn't want anybody to think that the real reason we were putting bifurcations on the back burner was because our device didn't work, when nothing could be further from the truth," says Gonzague Issenmann, Stentys' co-founder and CEO. "As a start-up, we just couldn't afford to run programs in both areas."

- Stephen Levin

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Companies mentioned in this article:

Boston Scientific Corp.

Cappella Inc.

Devax Inc.

Invatec SRL

Johnson & Johnson

Cordis Corp.

Medtronic Inc.

Medtronic CoreValve LLC

Minvasys

Prescient Medical Inc.

Stentys SAS

Trireme Medical Inc.

Tryton Medical Inc.

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