Healthcare Industry News: Mitral Valve
News Release - April 16, 2014
Cardiac Dimensions(R) Completes $20 Million Equity FinancingFunding Will Enable Initiation of Blinded, Randomized Clinical Trial and Expanded Commercialization of CARILLON® Mitral Contour System®
KIRKLAND, Wash., April 16, 2014 -- (Healthcare Sales & Marketing Network) -- Cardiac Dimensions®, Inc. today announced the completion of a $20 million financing. M. H. Carnegie & Co. and Lumira Capital led the financing as part of an international syndicate of institutional investors from Australia, the U.S. and Canada.
The financing follows the company's completion of TITAN II, its third multi-center study of its CARILLON® Mitral Contour System® and the obtainment of German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1 reimbursement approval across 120 leading hospitals in Germany, which will allow the company to significantly expand its European commercial activities. In addition to commercial expansion, proceeds from the financing will be used to initiate a multi-national, blinded, randomized clinical trial, REDUCE-FMR, involving up to 20 hospitals, with the objective to firmly establish CARILLON as the gold standard therapy in the treatment of functional mitral regurgitation (FMR).
An innovative, minimally-invasive therapy, the CARILLON system is designed to treat heart failure patients suffering from FMR, a condition in which blood flow to the body is reduced due to a poorly functioning heart valve. An estimated 70 percent of the 20 million people worldwide with heart failure suffer from FMR.
"This financing represents a significant leap forward for Cardiac Dimensions," noted Rick Stewart, Chief Executive Officer. "Our financial partners have great confidence in the CARILLON system's ability to address the substantially underserved FMR patient population, based on our completion of three successful multi-center studies with excellent long-term results, and the positive feedback we have received in our early commercial experience. This financing will support expanded global operations throughout Asia Pacific and Europe, as well as support our goal to rapidly expand our commercial, R&D and clinical activities. The company will run REDUCE-FMR while simultaneously focusing on rapid sales growth in key markets. With a deep international financial syndicate and a talented and experienced management team in place, we are well-positioned to achieve our future strategic and financial objectives."
In conjunction with the close of the financing, Cardiac Dimensions is broadening its operations in Germany and opening a new facility in Australia, providing the company with direct access to several markets within the Asia Pacific region and expanded R&D capabilities.
About CARILLON® Mitral Contour System®
Cardiac Dimensions' CARILLON Mitral Contour System combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and a distal anchor connected by a shaping ribbon. Utilizing the heart's natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation (FMR). Rapidly delivered via the venous vasculature, CARILLON has the potential to treat most heart failure patients in a minimally invasive fashion. Clinical data suggests that usage is associated with significant reduction in FMR, and significant improvement in functional capacity and quality of life.
About Functional Mitral Regurgitation
More than 20 million people worldwide have heart failure, most of whom also suffer from functional mitral regurgitation (FMR). FMR typically results from the dilation of the left ventricle, which is the main pumping chamber in the heart. As the left ventricle increases in size, the Mitral Valve also expands. This dimensional increase leads to mitral regurgitation, which significantly reduces the amount of blood flow out of the left ventricle and on to the body and its organs. FMR has been associated with high rates of mortality, reduced functional capacity, poor quality of life and an increase in patient hospitalizations. Current mainstream therapies to address FMR are limited. A majority of patients become refractory to medical therapy, which is the current standard of care and traditional surgical intervention is associated with high rates of operative morbidity and mortality.
About Cardiac Dimensions®, Inc.
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. The company's initial technology platform, the CARILLON Mitral Contour System has been designed to address functional mitral regurgitation, utilizing a novel percutaneous approach. Cardiac Dimensions has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany. For more information, visit the company's web site: http://www.cardiacdimensions.com.
About M.H. Carnegie & Co
M.H. Carnegie & Co. is a venture capital, private equity and alternative asset manager based in Sydney, Australia. Its funds manage direct investments on behalf of institutions, wholesale and high net worth investors with $350 million in committed capital across several funds. For more information, visit the company's web site: http://www.mhcarnegie.com.
About Lumira Capital
Built on a foundation that leverages over 20 years of North American venture capital experience, the Lumira Capital team has substantial experience helping to build transformational health and life science companies. Its goal is to make investments in market leading companies and work in partnership with those companies to develop and implement strategies to build significant businesses that in turn allow us to generate profitable exits that maximize returns within a reasonable time frame. For more information, visit the company's web site: http://www.lumiracapital.com.
Cardiac Dimensions, CARILLON and Mitral Contour System are registered trademarks of Cardiac Dimensions, Inc.
Source: Cardiac Dimensions
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