Cappella: Can a New Twist On An Old Idea Solve the Bifurcation Challenge?

Article preview from IN VIVO-  May, 2010

Device companies large and small have failed repeatedly in efforts to address bifurcations, which remain one of the largest unmet opportunities in cardiology. Cappella thinks it can solve the problem with a device that's a new version of an old idea, reversing current protocol to treat the side branch first.

Cappella: Can a New Twist On An Old Idea Solve the Bifurcation Challenge?

Article preview from IN VIVO-  May, 2010

Innovation in medical devices tends to be more evolutionary than revolutionary, with next-generation products typically featuring subtle advances on existing technology. An exception to that model is when first-generation devices offer less than adequate solutions to clinical needs. In those cases, next-generation devices often represent significantly different approaches in addressing a particular therapeutic challenge, resulting in a major technological shift.

Such a shift is occurring in the treatment of bifurcated coronary lesions. Many companies, large and small, have tried to develop stents to address this significant unmet clinical need, all largely without success. Their efforts have generally shared a common approach, that of focusing primarily on treating the main vessel and then considering whether and how to treat the side branch. Because those approaches yielded largely unsatisfactory results, certain next-generation bifurcation stent companies are taking different approaches, with several of them focusing first on the side branch and developing stents to fit that unique anatomy. The interventional cardiologist is then free to treat the main vessel with traditional workhorse stents, generally drug-eluting.

One of these emerging companies is Galway, Ireland-based Cappella Inc., with its self-expanding Sideguard side-branch stent. This device represents a new twist on two old ideas – a self-expanding stent and one made of nitinol – that both have checkered pasts when it comes to vascular devices. Yet, the company believes this next-generation device is engineered to overcome past problems with previous products and designs, and in the hands of interventionalists, will feel the same as traditional balloon-expandable products.

Cappella is the product of an experienced entrepreneur, physician and management group that has worked together before, and is looking to duplicate that winning combination. The company relies on these experienced device executives, who are located on several continents, to operate a lean, capitally efficient organization that has brought a product to market in Europe in less than five years.

By focusing on developing a device to treat the side branch first, Cappella is betting that cardiologists will be willing to change their practice patterns once they have a dedicated side-branch device, which until now has been lacking. This "if we build it, they will come" approach to product adoption is common among this emerging group of companies looking to come up with an effective side-branch device that will better address this challenging coronary anatomy. This approach relies on interventionalists being perhaps the most eager adopters of new technology of any clinical specialty, so long as there are sufficient clinical data supporting that new device.

Driving adoption ultimately will depend on whether Cappella can demonstrate that the Sideguard provides superior clinical outcomes, and the company is committed to conducting the clinical studies necessary to generate that data. By employing a self-expanding, nitinol stent, as opposed to a traditional balloon-expandable approach, Cappella also must address questions that linger regarding the effectiveness of this type of design for treating coronary disease, based on other companies' previous product disappointments. But Cappella is betting that the FDA and interventionalists will recognize the advancements this device has made over previous self-expanding and nitinol stents, and welcome having a device dedicated to treating these complex cases.

Vexing Clinical Challenge Remains

The problem of treating coronary artery disease occurring at the site of bifurcated vessels – coronary lesions situated where a smaller artery branches off a main vessel – has been a challenge for interventionalists since the inception of angioplasty. Indeed, bifurcations are one of the few remaining billion-dollar market opportunities in interventional cardiology.

While it is difficult to precisely calculate the number of patients with bifurcation disease because of the broad variety of bifurcations and differing views about which of those patients should be treated, cardiologists generally estimate that 20% of all percutaneous coronary intervention (PCI) patients and two-thirds of those with left main coronary disease present with bifurcated lesions, totaling around 500,000 cases annually worldwide. The total global market is estimated at around $1.3 billion, including the $300 million opportunity for left main angioplasty with stenting.

These estimates are appealing to investors, who consider them, in the absence of a dedicated bifurcation stent, to be conservative. As Wolfgang Oster, MD, managing partner with PolyTechnos Venture-Partners, an early investor in Cappella, points out: "If there is no effective treatment or tool for a particular condition, it is typically under-diagnosed, and when a new therapy or device becomes available to physicians, the number of diagnosed patients often increases." For Oster, who is Cappella's chairman, bifurcation disease has three elements that investors look for in device opportunities: unmet clinical need, meaningful market size, and the opportunity to grow the area significantly in the first few years following product commercialization due to creating increased awareness.

-Stephen Levin

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