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Orqis® Medical Reaches MOMENTUM Pivotal Trial Mid-Point with 100th Patient Enrollment Study Assessing Use of Cancion® System in Patients Hospitalized with Heart Failure Lake Forest, Calif., Nov. 20, 2006 – Orqis® Medical Corporation, a clinical-stage company developing devices for the treatment of congestive heart failure (CHF), announced today that the company achieved its mid-point milestone in the MOMENTUM Pivotal Trial by enrolling the 100th patient in the 200 patient study of the company’s percutaneous Cancion® System. The novel Cancion System is designed to treat patients hospitalized with acutely decompensated chronic heart failure who respond poorly to medical therapy. The MOMENTUM Pivotal Trial is assessing the safety and effectiveness of the Cancion System across 40 U.S. clinical sites in preparation for a U.S. Food and Drug Administration PMA filing. The device is CE marked and available in select overseas markets. "Enrollment in the MOMENTUM Trial continues to accelerate as we reach the 100-patient milestone," said Barry Greenberg, M.D., the Principal Investigator for the trial and the Director of the Advanced Heart Failure Treatment Program at the University of California-San Diego School of Medicine. "The MOMENTUM Trial is one of the only active randomized controlled device trials focused on acutely decompensated patients with chronic heart failure. We look forward to completing our study on this potentially breakthrough device as physicians who care for this patient population are very interested in finding new and effective treatments for this patient population." Orqis Medical’s feasibility study for the Cancion System, published last year in the journal, Circulation, found that the therapy led to improvement in vascular, renal and cardiac measures. The MOMENTUM Pivotal Trial was designed to help confirm those benefits. The Cancion System works by continuously augmenting blood flow in the descending aorta throughout the cardiac cycle. More than 200,000 heart failure patients a year respond poorly to medications during an acute decompensation event requiring hospitalization, leaving them with few options and a poor prognosis. "Although we’ve made significant headway in identifying drug and device therapies that improve clinical outcomes in patients with heart failure, many patients progress to a phase where current therapeutic options are limited and morbidity and mortality rates remain high." said Marvin A. Konstam, M.D., Chief of Cardiology at New England Medical Center, and the company’s medical director. "By addressing the causes of underlying disease progression and offering the potential for clinical improvement, we believe the Cancion System could provide an important advance in the care of these patients." About Heart Failure Almost 5 million Americans – and 14 million worldwide – suffer from heart failure, a condition in which the heart becomes weakened and cannot pump blood efficiently. Heart failure is caused by coronary artery disease, past myocardial infarctions, cardiomyopathy and other underlying cardiovascular disorders, and it is characterized by shortness of breath, functional impairment, and edema. In the U.S., heart failure results in over 1 million hospitalizations annually and is responsible for over $29 billion in direct and indirect costs to the U.S. healthcare system each year. About Orqis Medical Corporation Orqis Medical Corporation is a privately held, clinical-stage medical device company seeking to redefine heart failure therapy by developing products that prevent or reverse the underlying disease progression and provide new treatment options to the clinical community to improve patient outcomes and quality of life. The company's percutaneous Cancion System, for the treatment of acutely decompensated heart failure, is CE marked and is currently under an investigational device exemption (IDE) investigation in the United States in the MOMENTUM Pivotal Trial. The company's implantable Exeleras® System utilizes a pump about the size of an implantable cardioverter defibrillator (ICD) and is intended to treat mid- to late-stage chronic heart failure patients. First clinical use of this system is planned in 2007. For more information on Orqis Medical, please visit http://www.orqis.com and for the MOMENTUM Trial, please visit: http://www.momentumtrial.com. # # # Orqis® Medical Receives 13th U.S. Patent Lake Forest, Calif., Nov. 16, 2006 – Orqis® Medical Corporation announced today that the U.S. Patent and Trademark Office has granted the company its 13th patent, "Implantable Heart Assist System and Method of Applying the Same." The patent covers the miniaturization of the company’s Cancion® and Exeleras® Systems for direct placement of a pump, blood flow conduits and pump control electronics directly into the vasculature of congestive heart failure patients. Issuance of the patent provides a proprietary right that protects a means to treat acute and chronic heart failure that is not currently available which involves supplementing blood flow in the descending aorta with a system that can be inserted percutaneously and totally contained within the patient’s vasculature without coming into direct contact with the heart. The Cancion System is currently being studied in the MOMENTUM Pivotal Trial. The first clinical use of the Exeleras System is expected next year. The feasibility study of the Cancion System, published last year in Circulation, found treatment with the device was associated with improvement in vascular, renal and cardiac function. "This patent continues to solidify the intellectual property surrounding our novel and promising treatment for heart failure," said Ken Charhut, President and Chief Executive Officer of Orqis Medical. "In addition, the patent also serves as the basis of the development platform for future generations of both the Cancion and Exeleras Systems." About Heart Failure Almost 5 million Americans – and 14 million worldwide – suffer from heart failure, a condition in which the heart becomes weakened and cannot pump blood efficiently. Heart failure is caused by coronary artery disease, past myocardial infarctions, cardiomyopathy and other underlying cardiovascular disorders, and it is characterized by shortness of breath, wheezing and edema. In the U.S., heart failure results in over 1 million hospitalizations annually and is responsible for over $29 billion in direct and indirect costs to the U.S. healthcare system each year. About Orqis Medical Corporation Orqis Medical Corporation is a privately held, clinical-stage medical device company seeking to redefine heart failure therapy by developing products that prevent or reverse the underlying disease progression and provide new treatment options to the clinical community to improve patient outcomes and quality of life. The company's percutaneous Cancion System, for the treatment of acutely decompensated heart failure, is CE marked and is currently under an investigational device exemption (IDE) investigation in the United States in the MOMENTUM Pivotal Trial. The company's implantable Exeleras System pump, about the size of an implantable cardioverter defibrillator (ICD), is designed to treat mid- to late-stage chronic heart failure patients. First clinical use of this system is planned in 2007. For more information on Orqis Medical, please visit http://www.orqis.com and for the MOMENTUM Trial, please visit: http://www.momentumtrial.com. |