Corporate Report - Evalve Inc

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Abstract

Evalve├é┬«was incorporated in 1999 to design, develop, manufacture, and market innovative devices to enable percutaneous repair of cardiac valves. Evalve™s senior leadership is drawn from executives with solid experience in product development, research, regulatory affairs, operations, marketing, sales, and finance at leading health and medical device companies. The company™s initial product, the MitraClip├é┬«system, is intended to reduce the risks, trauma, and costs associated with current open, arrested-heart surgical options. The company™s present development and clinical efforts are focused on mitral valve repair.

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A New, Non-Surgical Percutaneous Treatment Alternative for Mitral Regurgitation
The MitraClip system is a novel first-in-class technology, which has shown promise under an investigational device exemption (IDE) phase I feasibility study (EVEREST I) and is now in a phase II pivotal study (EVEREST II). The percutaneous MitraClip procedure is a new non-surgical treatment alternative for patients who suffer from a condition known as mitral regurgitation (MR) where the mitral valve does not close properly, allowing blood to flow backward into the left atrium, decreasing blood flow to the body. MR is the most common type of heart valve insufficiency in the US; it™s the econd most common type of heart valve disease in Europe. It affects millions of people worldwide. A significant issue for patients with MR is that the vast majority are left untreated, leaving their hearts affected by the leak, causing chronic volume overload. This requires the heart to work harder, often leading to heart failure. Many of these patients go untreated because of the significant risks and trauma associated with current open arrested- heart surgery.

On an annual basis in the US alone, there are approximately 250,000 new patients with significant MR diagnosed. Currently, only 20% of these patients are estimated to undergo surgery. MR is an under-treated condition that is often associated with heart failure.
Evalve estimates that approximately two-thirds of the patients who are diagnosed annually with significant MR could potentially benefit from treatment with the MitraClip device. The early data has indicated that patients™ options for mitral valve surgery are preserved after an unsuccessful clip procedure.

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