HeartWare International, Inc., a medical device company, develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure. The HeartWare Ventricular Assist System (the HVAD System), which includes a ventricular assist device (VAD) or blood pump, patient accessories and surgical tools, is designed to provide circulatory support for patients in the advanced stage of heart failure. In December 2013, the company acquired CircuLite, Inc. (CircuLite). Solution and Products Proprietary Pump Technology The HeartWare System features the smallest, full-output centrifugal pump designed to be implanted in the chest, directly adjacent to the heart. At the core of its technology platform is its proprietary ‘hybrid’ system for suspending the impeller, which is the only moving part within the pump. The impeller is suspended within the pump housing by the opposing forces of passive magnets and hydrodynamic thrust generated by the pump impeller, which circulates a cushion of blood. Once power is applied to the device and the impeller begins to rotate, there are no points of mechanical contact within the pump, thus providing a completely wearless pumping system. The HeartWare HVAD System The HVAD System comprises the HVAD Pump, a small, permanently implantable VAD, patient accessories and surgical tools. The HVAD Pump is capable of generating up to 10 liters of blood flow per minute. The HVAD Pump is the only approved full-output pump implantable in the pericardial space, directly adjacent to the heart. It is also the only pump designed to be implanted above the diaphragm in all eligible patients. The HVAD System has been approved for sale in Europe. In 2012, the company received approval from the United States Food and Drug Administration (FDA) for the HVAD System as a bridge to heart transplantation in patients with end-stage heart failure. Approximately 5,000 implants have been performed using the HVAD System. The HVAD System has been implanted in patients at approximately 230 health care sites in 37 countries. The HeartWare MVAD System The MVAD System is comprised of similar components, surgical tools and peripherals as the HVAD System, but is differentiated significantly by the MVAD Pump. The MVAD Pump is a miniaturized blood pump intended for chronic heart failure patients. The device is a full-output axial flow pump with a fully suspended rotor and a displacement volume of less than one half of that of the HVAD Pump. The CircuLite SYNERGY Platform The company acquired CircuLite in 2013 and CircuLite’s SYNERGY Circulatory Support System. The CE marked SYNERGY Surgical System is implanted through a right, mini-thoracotomy procedure and does not require a sternotomy or cardiopulmonary bypass. CircuLite’s proprietary micro-pump is then placed in a pacemaker-like pocket and attached to the inflow cannula and outflow graft, which connects to a wearable, external controller and battery pack. The SYNERGY platform offers even less invasive and ultimately interventional options to earlier-stage heart failure patients. Strategy The company’s strategy includes the following elements: expand market penetration outside of the U.S.; expand U.S. market penetration; focus on continuous product development; partner with leading professionals in the fields of cardiovascular surgery around the world; and explore complementary or alternative therapies and technologies. Intellectual Property As of December 31, 2013, the company had 67 issued U.S. patents, 14 issued Australian patents, 11 patents issued patents in Great Britain and France, 10 issued patents in Germany and Japan, as well as patents issued in the Netherlands, Spain, Italy, Austria, Belgium, China, Korea, Canada, Israel and Turkey. The company also has 72 pending U.S. non-provisional patent applications and other international patent applications filed under the Patent Cooperation Treaty, as well as in Japan, Europe, Australia, China, Canada, Hong Kong, India, Korea and Israel. The total patent filings includes 12 issued U.S. patents, 20 pending U.S. non-provisional patent applications, and associated foreign patents and patent applications. HEARTWARE, HVAD, MVAD, PAL, CIRCULITE, SYNERGY and various company logos are the trademarks of the company, in the United States, Europe, Australia and other countries. Research and Development As of December 31, 2013, the company incurred research and development expenses of $102.5 million. Competition The company’s principal competitors in the implantable cardiac assist space include Thoratec Corporation; Jarvik Heart, Inc.; MicroMed Cardiovascular; Berlin Heart GmbH; and Sunshine Heart, Inc.
heartware international inc
500 Old Connecticut Path
Framingham, MA 01701
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