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Bellerophon Therapeutics Inc. has selected Flextronics International Ltd. as its manufacturing partner for the INOpulse Mark2, the company's next-generation pulsatile nitric oxide delivery device. Bellerophon and Flextronics have entered into an agreement under which Flextronics will manufacture, repair and service the Mark2 devices to be used in Bellerophon's INOpulse clinical development programs.
Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, noted, "We are pleased to work with Flextronics, an established, global leader, for the manufacturing of our next-generation device. This new device is significantly smaller, lighter and more user friendly than the previous version, which we believe will help patients to be more compliant with their therapy. Flextronics' experience with manufacturing medical devices, including portable drug delivery systems, was important to us, and we look forward to working with them to have devices ready for our upcoming Phase 3 trials for the treatment of pulmonary arterial hypertension (PAH) which we expect to commence in the second half of 2015."
"Flextronics is proud to collaborate and provide innovative manufacturing solutions to Bellerophon for its next-generation, nitric oxide delivery device--INOpulse Mark2," said Mark Kemp, President of Flextronics Medical. "We are thrilled to provide supply chain solutions that support Bellerophon's efforts to further advance therapies for PAH, a rare and progressive lung disease."
Flextronics will produce the INOpulse Mark2 for Bellerophon at its facility in Dallas, Texas.
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary and cardiac diseases. Two of the company's product candidates are based on its proprietary pulsatile nitric oxide delivery device, INOpulse, one for the treatment of pulmonary arterial hypertension (PAH) and a second for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). Bellerophon's other program is bioabsorbable cardiac matrix, or BCM, which is being developed for the prevention of cardiac remodeling and subsequent chronic heart failure following acute myocardial infarction, commonly known as a heart attack. For more information, visit www.bellerophon.com.
Bellerophon's INOpulse is a drug-device combination system that is targeted to reducing pulmonary hypertension in patients with this condition including those with PAH and PH-COPD. The INOpulse system is designed to deliver pulsed doses of pharmaceutical-grade nitric oxide, a molecule naturally produced in the endothelial lining of blood vessels that plays a significant role in vasodilation, or opening of the arteries, including arteries in the lung. INOpulse is also designed to be portable for chronic at home use and is programmed to automatically adjust based on patients' breathing patterns to deliver a consistent dose to patients. The next-generation Mark2 device is significantly smaller and lighter than the predecessor prototype device, having approximately the same dimensions as a paperback book and weighing about 2.5 pounds. It incorporates a simple, intuitive user interface and an estimated battery life of 24 hours when recharged.
Flextronics is a leading end-to-end supply chain solutions company that delivers innovative design, engineering, manufacturing and logistics services to a range of industries and end-markets, including data networking, telecom, enterprise computing and storage, industrial, capital equipment, appliances, automation, medical, automotive, aerospace and defense, energy, mobile, computing and other electronic product categories. Flextronics is an industry leader with $26 billion in sales, generated from helping customers design, build, ship, and service their products through a network of facilities and innovation centers in approximately 30 countries and across four continents. Flextronics service offerings and vertically integrated component technologies optimize customer supply chains by lowering costs, increasing flexibility, and reducing time-to-market. For more information, visit www.flextronics.com.