CARLSBAD, Calif., April 20, 2020 /PRNewswire/ -- ImpediMed Limited, a medical software technology company that non-invasively measures, monitors and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS), today announced the release of its most comprehensive software package to date for the SOZO® digital health platform. This software release, designated as 3.1, adds functionality to SOZO for new applications in heart failure and end stage renal disease patients while building on its current use as the only rapid, noninvasive FDA-cleared tool to aid in the assessment of subclinical lymphedema.
The software package, which is available as a no-cost upgrade to users as part of the ImpediMed SaaS model, includes the separately licensed HF-Dex™ heart failure assessment, a novel monitoring tool for the assessment of fluid overload in heart failure patients that can help provide physicians valuable information to risk-stratify patients as well as to monitor patient condition and response to therapy. It also includes a separately licensed assessment module for patients with end stage renal disease (ESRD) who are undergoing dialysis. For these patients, SOZO provides an accurate, noninvasive, objective way to determine and monitor fluid levels. ImpediMed has achieved CE Mark for the ESRD assessment module as the company works with the FDA for a U.S. clearance.
"These new indications are part of our expansion of BIS technology to bring the benefits of SOZO to new patient populations," said Richard Carreon, Managing Director and CEO of ImpediMed. "Furthermore, they reflect the power of our SaaS model. We can iterate quickly, respond to customer feedback and deliver new features and tools that help healthcare professionals care for their patients. While the SOZO technology has great utility, our primary sales focus today remains on expanding the reach and use of SOZO in cancer centers and surgical practices as part of comprehensive programs to prevent as well as stop the progression of lymphedema."
SOZO helps physicians and care teams to prevent cancer-related lymphedema by calculating a patient's L-Dex® score, a measure of extracellular fluid. One in three at-risk cancer survivors will develop secondary lymphedema related to their cancer treatment. Cancer Centers across the globe are implementing ImpediMed's SOZO technology as part of a Lymphedema Prevention Program. This involves the company's recommended Test, Trigger, Treat™ protocol, which it developed in conjunction with physicians, for early detection and intervention with the goal of ending cancer-related lymphedema.
Founded and headquartered in Brisbane, Australia, with U.S. and European operations, ImpediMed is a medical software technology company that non-invasively measures, monitors and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS).
ImpediMed produces a family of FDA cleared and CE Marked medical devices, including SOZO® for multiple indications including heart failure, protein calorie malnutrition and lymphoedema, sold in select markets globally.
For more information, visit www.impedimed.com.
This announcement contains or may contain forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management.
All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to expand sales and market acceptance in the US and Australia including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialise new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position.
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