ImpediMed Limited (ASX: IPD), a global provider of medical technology to non-invasively measure, monitor and manage tissue composition and fluid status using bioimpedance spectroscopy (BIS), announces that the first patient has been enrolled in its 200-patient Heart Failure (HF) trial now being conducted at Scripps Memorial Hospital, San Diego, CA.
With the first patient in this at-home HF trial now enrolled, the study will follow patients at-home for 45 days post discharge from a HF-related hospital admission. The study is designed to demonstrate the extent to which changes in SOZO BIS measurements preempt patient-reported symptoms of HF that lead to hospital readmissions. Data has shown 25 percent of patients admitted for HF will be readmitted in <30 days. Earlier identification of fluid overload allows for treatment changes which have resulted in significant reduction of costly re-hospitalization.
A.J. Accardi, M.D. from Scripps Memorial Hospital in San Diego states, We are very excited about enrolling the first patient in this new 200-patient trial with ImpediMed. SOZO has the potential to significantly improve the quality of life for heart failure patients by enabling them to remotely monitor their fluid status so that clinical intervention can take place as soon as possible. This early intervention is critical to helping prevent the occurrence of rehospitalization.
HF is the most common discharge diagnosis among patients age 65+ and the primary cause of readmission within 60 days. Management of HF currently costs the U.S. healthcare system approximately $31 billion in hospitalization costs alone, and the overall global economic toll in 2012 was estimated at $108 billion annually.
Richard Carreon, managing director and CEO of ImpediMed says, We are very pleased to have begun enrollment in this clinical trial, which will further build on the data already being generated in various independent trials of SOZO in heart failure. We believe SOZOs ability to accurately and noninvasively measure and monitor small fluid changes in the human body has the potential to greatly improve these patients lives while also providing tremendous savings to the healthcare system.
SOZO has already received US FDA clearance and a CE Mark for use in heart failure patient monitoring. The data being generated from these trials will support future marketing efforts.
Founded and headquartered in Brisbane, Australia, with U.S. and European operations, ImpediMed is the world leader in the design and manufacture of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of tissue composition and fluid status. ImpediMed produces a family of FDA cleared and CE Marked medical devices, including SOZO for multiple indications, including heart failure and lymphedema, sold in select markets globally. Visit www.impedimed.com.
Laura Carabello, 201.641.1911 x12