New Data Show ImpediMed's Lymphedema Prevention Program Reduces Incidence of Chronic Lymphedema in Breast Cancer Patients and Survivors

CARLSBAD, Calif. and BRISBANE, Australia, Dec. 1, 2020 /PRNewswire/ -- ImpediMed Limited (ASX: IPD), a global medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to improve patient health, today announced the publication of a new study demonstrating that the company's Lymphedema Prevention Program reduces the incidence of chronic breast cancer-related lymphedema in breast cancer patients and survivors. Published in Breast Cancer Research and Treatment, the meta-analysis involving 50 studies and more than 67,000 breast cancer patients confirms that routine monitoring for early detection of lymphedema using ImpediMed's L-Dex^® technology, combined with early intervention, cuts the relative rate of chronic breast cancer-related lymphedema by as much as 81%.

The publication is available online here: https://link.springer.com/article/10.1007/s10549-020-05988-6.

"The results of this analysis confirm the utility of L-Dex as part of breast cancer-related lymphedema screening in reducing rates of chronic breast cancer-related lymphedema as compared to circumference measures (i.e., tape measure) or no monitoring," said Chirag Shah, MD, Radiation Oncologist, Director of Clinical Research and Director of Breast Radiation Oncology in the Department of Radiation Oncology at the Cleveland Clinic and primary author of the study. "What is striking is the reduction with L-Dex surveillance and intervention that showed an 81% relative decrease in breast cancer-related lymphedema as compared to circumference measures. The fact that the analysis is both statistically and clinically significant stresses the need for widespread prospective surveillance of breast cancer patients and survivors with L-Dex."

Breast cancer-related lymphedema occurs when the lymphatic system is damaged by surgical, radiation or chemotherapy treatments for breast cancer. The risk of developing lymphedema ranges from 6% to 42% depending on the treatment approach. Patients suffering from lymphedema commonly experience swelling in their arms and hands that can interfere with activities of daily life and work. Treatments, including compression garments and therapy, can be costly to patients. On average, breast cancer survivors with lymphedema spend an extra $3,325 per year on medical care and productivity losses as compared to survivors without lymphedema. If left untreated, lymphedema can lead to infection and become a chronic lifelong condition.

In 2019, ImpediMed introduced a comprehensive Lymphedema Prevention Program to help educate healthcare providers and patients that with proper protocols in place, subclinical lymphedema can be detected and managed before it becomes a debilitating, chronic condition. This program utilizes ImpediMed's Test, Trigger, Treat™ protocol for early detection and intervention of cancer-related lymphedema. Routine lymphedema testing of cancer survivors uses the company's FDA-cleared SOZO® device with BIS (L-Dex) technology, which measures extracellular fluid. A significant increase in a patient's L-Dex score is a trigger to evaluate the patient and initiate intervention.

"These findings are an important step forward in our goal to eliminate breast cancer-related lymphedema," said Richard Carreon, Managing Director and CEO of ImpediMed. "The meta-analysis demonstrates the effectiveness of early detection with L-Dex and intervention in reducing breast cancer-related lymphedema. This Level 1 evidence is a key step in making L-Dex the standard of care for all patients at risk of developing breast cancer-related lymphedema."

ImpediMed's PREVENT Trial demonstrated that routine monitoring with L-Dex combined with at-home intervention resulted in a 95% reduction in lymphedema progression at one year. Today, L-Dex is the only non-invasive, reliable, validated tool to help clinicians identify subclinical lymphedema. The company's SOZO digital health platform can measure a patient's L-Dex score with a simple, painless 30-second scan. Monitoring L-Dex scores allows clinicians across multiple specialties to provide individualized, proactive care that can help improve patient outcomes.

To view the meta-analysis, visit https://link.springer.com/article/10.1007/s10549-020-05988-6.

About ImpediMed

Founded in Brisbane, Australia, with U.S. headquarters and European operations, ImpediMed is a global medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to maximize patient health. ImpediMed produces a family of FDA cleared and CE Marked medical devices, including SOZO^® for multiple indications, including heart failure, lymphedema, and protein calorie malnutrition sold in select markets globally. Visit www.impedimed.com.

About SOZO Digital Health Platform

SOZO, the world's most advanced, noninvasive bioimpedance spectroscopy (BIS) device, delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds. Using ImpediMed's BIS technology, SOZO measures 256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz. Results are available immediately online for easy data access and sharing across an entire healthcare system. The FDA-cleared, CE-marked and ARTG-listed digital health platform aids in the early detection of secondary lymphedema, provides fluid status for patients living with heart failure, and can be used to monitor and maintain overall health – all on a single device.

For more information, visit: https://www.impedimed.com/products/sozo/

About SOZO Fluid Analysis for Lymphedema

The SOZO fluid analysis for lymphedema provides the L-Dex score to measure fluid build-up in a limb at risk for lymphedema. By identifying the patient's baseline L-Dex score before cancer treatment and then measuring it at regular intervals post-surgery, healthcare professionals can accurately monitor patient progress and offer appropriate education and intervention to prevent the progression of lymphedema. One-year interim results from the PREVENT Trial showed that this early detection combined with at-home intervention using standard compression therapy can reduce the progression of lymphedema by 95%. Use of L-Dex and BIS for the clinical assessment of lymphedema is recommended in multiple clinical practice guidelines, including the American Physical Therapy Association, National Lymphedema Network, and Lymphatic Education & Research Network Centers of Excellence program.

For more information, visit: https://www.impedimed.com/healthcare/cancer-related-lymphedema/

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SOURCE ImpediMed Limited

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https://www.impedimed.com