New Guidance Published in The Lancet Recommends Early Intervention and Use of BIS to Reduce Impact of Arm Lymphedema on Breast Cancer Patients

New Guidance Published in The Lancet Recommends Early Intervention and Use of BIS to Reduce Impact of Arm Lymphedema on Breast Cancer Patients

Important Information for Breast Cancer Patients and Survivors in Advance of Lymphedema Awareness Month in March

CARLSBAD, Calif., Feb. 15, 2024 – ImpediMed, a pioneer in the field of medical technology, announced a significant advancement in the fight against breast cancer-related lymphedema, a common but often overlooked condition affecting breast cancer survivors. Leading medical journal eClinicalMedicine, part of The Lancet Discovery Science, recently published new clinical guidance advocating for early detection and prevention strategies, underscoring the validity and efficacy of ImpediMed’s innovative approach.

The newly endorsed guidance, developed by the Multinational Association of Supportive Care in Cancer (MASCC) and made by an independent panel of experts representing 16 countries and 12 disciplines with lymphedema-specific expertise, underscore the importance of regular monitoring for breast cancer-related arm lymphedema (BCRAL), a condition that causes debilitating swelling in the arms of those who've undergone breast cancer treatment. At the center of these recommendations is bioimpedance spectroscopy (BIS), a cutting-edge technology pioneered by ImpediMed, designed to help detect lymphedema in its early stages before it becomes a significant problem.

Lymphedema, a common consequence of cancer treatment, poses significant challenges in healthcare. According to the American Cancer Society 58% of cancer patients diagnosed with breast cancer, melanoma, or pelvic area cancers are at risk for developing limb lymphedema, and over 80% of breast cancer patients are at risk. March is Lymphedema Awareness Month, which is focused on growing awareness and education for patients and healthcare professionals about the impact of lymphedema on patients and advances in care and treatment to improve patients’ quality of life.

ImpediMed has the only FDA-cleared BIS technology for the clinical assessment of lymphedema. The Company’s SOZO^® Digital Health Platform is broadly accepted and recognized for effective and accurate screening of lymphedema.

“This guidance recognizes ImpediMed’s technology as a validated method of building surveillance programs to detect and prevent Breast Cancer Related Lymphedema at the US and global level,” commented Steven Chen, MD, MBA, Chief Medical Officer, ImpediMed. “These recommendations draw on evidence such as the PREVENT trial, which is the largest randomized clinical trial to assess lymphedema detection and prevention. This study provides further evidence of the benefits of BIS technology and prospective model of care.”

The consensus-based recommendation by MASCC, coupled with supportive findings from the large-scale PREVENT trial, underscores the effectiveness of ImpediMed’s technology in preventing the progression of lymphedema. The company's commitment to innovation and patient care is further evidenced by its active role in the medical community, including its participation in upcoming U.S. conferences and contributions to ongoing clinical research.

As ImpediMed continues to champion early lymphedema detection and prevention, its efforts are paving the way for a new standard in breast cancer survivorship care, ensuring that survivors can look forward to healthier, more comfortable futures.

A link to the full manuscript in The Lancet is available here:

https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00020-8/fulltext

About SOZO Digital Health Platform

SOZO, the world’s most advanced, non-invasive 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 lymphoedema, provides fluid status for patients living with heart or renal failure, and can be used to monitor and maintain overall health – all on a single device.

About ImpediMed

ImpediMed is a leading global medical technology company that designs and manufactures medical devices that employ bioimpedance spectroscopy (BIS) technology for use in the noninvasive clinical assessment and monitoring of fluid status and tissue composition in patients. The company consistently drives innovation, directing its primary efforts toward addressing the specific challenges and devastating burden of secondary lymphedema with a focus on breast cancer-related lymphedema (BCRL). With its SOZO® Digital Health Platform and L-Dex®, ImpediMed is the only company to offer an FDA-cleared technology that uses BIS and is setting new standards in early detection and management of BCRL. For more information, please visit www.impedimed.com.