Using bioimpedance spectroscopy (BIS), ImpediMed's proprietary technology sends 256 unique frequencies through the body to assess both intra- and extracellular fluid.
By detecting small amounts of fluid changes, it can help health care providers better detect and manage chronic disease in patients and give individuals information to better manage their health.
The BIS technology is available for an oncology indication in Australia and in the United States for aid in the early assessment of secondary unilateral lymphedema of the arm and leg in women and the leg in men.
Under the agreement with Mayo Clinic, clinical trials will be conducted at multiple U.S. locations and will explore future indications for the BIS technology, potentially including cardiology, nephrology, wellness and fitness.
"Changes in body fluid give an early indication that an intervention may be necessary, especially when caring for patients with heart failure. With precise, repeatable, and non-invasive application, a goal for this technology and clinical research would be to offer health care providers the data needed to make evidence-based decisions," said Paul Friedman, MD, Vice Chair, Department of Cardiovascular Medicine and Medical Director, Remote Monitoring at Mayo Clinic.
The master clinical trial agreement is the next phase of an existing relationship between Mayo Clinic and ImpediMed. Since 2015, the Mayo Clinic Hospital in Jacksonville, Fla., has been one of six cancer centers participating in a randomized controlled study analyzing the BIS technology’s effectiveness in the early identification of lymphedema.
Interim results are expected to be released in late 2016.
"We are pleased to continue our clinical relationship with an institution as prestigious as Mayo Clinic," said Richard Carreon, Managing Director and CEO of ImpediMed.
"The master clinical trial agreement expands our opportunity to scientifically explore applications for our BIS technology, and its potential impact on reducing healthcare costs and improving quality of care and outcomes."
Founded and headquartered in Brisbane, Australia with U.S. offices in Carlsbad, Calif., ImpediMed is the world leader in the development and distribution of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status in patients.
ImpediMed has the first medical device with FDA clearance in the U.S. to aid healthcare professionals to clinically assess secondary unilateral lymphedema of the arm and leg in women and the leg in men.