HeartWare International, Inc., a medical device company, develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices (VADs), to treat patients suffering from advanced heart failure. Solution and Products Proprietary Pump Technology The HeartWare Ventricular Assist System (the HVAD System), which includes a VAD or blood pump, patient accessories and surgical tools, is designed to provide circulatory support for patients in the advanced stage of heart failure. The HVAD System features the smallest, full-output centrifugal pump designed to be implanted in the chest, directly adjacent to the heart. At the core of the company’s 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 wearless pumping system. The company’s hybrid suspension technology also establishes a miniaturization path. The HeartWare HVAD System The first product in the company’s portfolio, the HVAD System, consists of 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. With a displaced volume of only 50 cubic centimeters and a mass of 140 grams, the HVAD pump is the only approved full-output pump implantable in the pericardial space, directly adjacent to the heart. The HeartWare MVAD System The MVAD System consists 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 an axial flow pump with a fully suspended rotor and a displacement volume of less than one half of that of the HVAD pump. The MVAD pump is designed for pericardial implantation and initial human clinical trials are expected to commence in 2015. The CircuLite SYNERGY System The SYNERGY Surgical System is designed to be implanted through a right, mini-thoracotomy procedure and does not require a sternotomy or cardiopulmonary bypass. In January 2015, the company discontinued development of CircuLite’s proprietary micropump and focused its efforts on a version of its MVAD pump for its partial-assist program. The company’s HVAD and MVAD Systems offer minimally invasive treatment to end-stage heart failure patients, the SYNERGY Circulatory Support System offers even less invasive and ultimately interventional options to earlier-stage heart failure patients. Enhanced Quality of Life with Implantable Devices The HVAD System and all commercially available VADs are powered by a controller, batteries and other power sources carried external to the body. The company is working to develop an implantable system utilizing transcutaneous energy transfer or wireless power that would eliminate the need for a percutaneous driveline. A transcutaneous energy transfer system contains a wearable power management system that is inductively coupled to an implanted pump controller and electronics that includes a rechargeable battery. Business Strategy The key elements of the company’s strategy include expanding market penetration outside of the U.S.; expanding U.S. market penetration; focusing on continuous product development; partnering with professionals in the fields of cardiovascular surgery around the world; and exploring complementary or alternative therapies and technologies. Sales and Marketing The company sells its products primarily to large hospitals and distributors. Globally, approximately 7,000 implants have been performed using the HVAD System. The HVAD System has been implanted in patients at approximately 270 health care sites in 41 countries. Intellectual Property As of December 31, 2014, the company had 86 U.S. patents, 24 Australian patents, 23 Japanese patents, 11 patents issued in each of Great Britain, Germany, and France, as well as patents issued in the Italy, Netherlands, Spain, Austria, Belgium, China, Korea, Canada, Israel, Hong Kong and Turkey. The company also had 97 pending U.S. non-provisional patent applications and various international patent applications filed with various national and regional patent offices including the Patent Cooperation Treaty, Japan, Europe, Australia, China, Canada, Hong Kong, India, Korea and Israel. Trademarks HEARTWARE, HVAD, MVAD, Pal, CIRCULITE, SYNERGY and various company logos are the trademarks of the company. Research and Development For the year ended December 31, 2014, the company incurred research and development expenses of $122.4 million. Competition The company’s principal competitors in the implantable cardiac assist space include Thoratec Corporation; Jarvik Heart, Inc.; ReliantHeart Inc.; Berlin Heart GmbH; and Sunshine Heart, Inc. Government Regulation The company’s products are regulated by the United States Food and Drug Administration as a Class III medical device under the U.S. Food, Drug, and Cosmetic Act.
heartware international inc
500 Old Connecticut Path
Framingham, MA 01701
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