Intelligent Medicine in Heart Failure Therapeutic Devices Heart failure, which impacts five million Americans each year and more than 30 million worldwide, is a condition in which the heart can’t pump enough blood to the body’s organs. Cardiac Resynchronization Therapy (CRT) is a gold-standard treatment for a significant number of heart failure patients. The Comparison of Medical Therapy Pacing and Defibrillation in Heart Failure (COMPANION) and InSync ICD Randomized Clinical Evaluation (MIRACLE) trials demonstrated significant reductions in mortality for patients with CRT-D (cardiac resynchronization pacing plus defibrillator) as compared to randomized patients treated solely with optimal pharmacologic therapy, in addition to an improvement in NYHA (New York Heart Association) symptom scores at six months. However, both of these studies, as well as others, report that approximately 30 percent of patients fail to show improvement after CRT implantation. Proteus’s first two therapeutic devices leverage the company’s platform technologies to improve heart failure patients’ response rate to CRT, and overall cardiac performance. The first product specifically addresses the clinical issue of extra-cardiac stimulation, a problem that complicates 10-20 percent of CRT implants. The second product utilizes Electric Tomography, a proprietary real-time modality for quantifying cardiac performance, and addresses the need for actionable physiologic feedback to optimize CRT and pharmacologic therapy. Proof of concept feasibility of Electric Tomography has been demonstrated in heart failure patients and in multiple preclinical studies. Additional clinical trials are underway. Pharmaceutical Systems A symptomatic heart failure patient takes multiple drugs daily, with the goal of reducing the heart’s workload and improving quality of life. Mainstays of therapy include angiotensin converting enzyme (ACE) inhibitors, beta-blockers and diuretics. For pharmaceutical therapy to be effective, it is vital that patients adhere to the prescribed regimen, taking required doses at appropriate intervals. Multiple clinical studies demonstrate that more than 50 percent of symptomatic heart failure patients do not receive guideline-recommended therapy, and of those who do, only 40-60 percent adhere to the regimen. Proteus’s Raisin™ System offers the potential to transform the way heart failure and other chronic diseases are managed. The initial application of the Raisin System is for the treatment of patients with heart failure. The system senses and records the precise time a patient takes one or more microchip-enabled drugs, providing physiologic feedback and decision-support to the patient, caregivers and clinicians, thus facilitating a cost-effective pathway to improved patient outcomes through personalized medicine. Raisin System functionality has been demonstrated in multiple preclinical studies. Clinical trials are underway.    Copyright © 2007 Proteus Biomedical, Inc. All Rights Reserved.