CardiAQ Valve Technologies Announces New Data, New Board Members

The majority of patients with mitral valve regurgitation (MR) are forced to delay or forego treatment, resulting in a significant unmet clinical need. MR occurs when the heart’s mitral valve doesn’t close properly, allowing blood to leak backward into the atrium. The patient’s heart has to work harder to pump blood. If left untreated, MR can lead to heart failure, other cardiac abnormalities, and ultimately, death. Patients can undergo open-heart surgery to repair or replace the mitral valve, but for patients whose MR is still considered moderate, the risk of such an invasive procedure is difficult to justify.  Unfortunately, by the time the MR becomes severe and symptomatic, many of these patients are too sick to undergo the high-risk procedure. Out of the more than 2 million Americans who have been diagnosed with MR, only about 5 percent are treated each year due to the underlying risks of the existing surgical procedures. 

CardiAQ Valve Technologies (CVT) seeks to help this underserved patient population by offering the first non-surgical option for mitral valve replacement. CVT’s system, currently under development, is the first self-conforming and self-anchoring technology for transcatheter mitral valve implantation (TVMI). The non-invasive implantation procedure is designed to be performed in a catheterization lab and will not require the patient’s heart to be temporarily stopped, thus eliminating one of the major risks associated with cardiac surgery.

With CVT’s system, a catheter carrying the replacement valve is threaded through the femoral vein and up into the heart.  After successful positioning, the replacement valve anchors itself above and below the mitral annulus. Unlike other percutaneous systems being developed today, CVT’s system does not rely on radial force to hold the implant in place. CVT’s system is designed to be self-positioning, self-anchoring, and self-conforming. According to President and CEO Brent Ratz, CVT is the only medical device company looking at truly transcatheter mitral valve implantation. The company has identified a $1 billion market of MR patients who would qualify for TVMI.

The Winchester, Mass.-based device company recently released positive results from an acute in vivo study of the replacement valve. The implant reached five key performance objectives.  Among them, researchers found that the implant successfully sealed the mitral valve, securely anchored itself in the mitral annulus, and did not obstruct blood flow out of the left ventricle. Moving forward, Ratz seeks to make minor refinements to the company’s TVMI system and begin chronic in vivo animal studies to assess the performance of the implant over a 30-day period.

CVT is also looking ahead with two high-profile additions to its board of directors. The company recently announced that serial entrepreneur Nancy Briefs has been appointed as a director. Briefs has over 25 years of experience in medical technology, much of it in the cardiovascular sector. She is president and CEO of Eleme Medical, and has led development at companies such as Vista Medical Technologies, Oximetrix (Abbott), and American Edwards Laboratories. Ratz says that Briefs’ wealth of experience in raising capital and building teams makes her a valuable addition to CVT.

In addition, former CoreValve President and COO Rob Michiels was appointed to CVT’s board of directors. Michiels has over 30 years of industry experience, and is considered a leading figure in the field of transcatheter valve technologies. At CoreValve, Michiels pioneered advances in the percutaneous aortic valve space. CoreValve was acquired by Medtronic in April for $700 million plus milestone payments.

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