ImpediMed announced that it will present new results from a breast cancer-related lymphedema study during a poster session at the American Society of Breast Surgeons (ASBrS) Annual Meeting in Orlando, FL on April 12, 2024. The study, titled "Timing of Breast Cancer-related Lymphedema Development Over Three Years: Observations from a Large, Prospective Randomized Screening Trial," revealed that patients at risk of developing breast cancer related lymphedema (BRCL) should continue to be monitored for three years following the completion of cancer treatment, as patients could trigger at any time over this period. The results are part of PREVENT, the largest randomized control trial to assess lymphedema prevention, in 1200 women, which monitored progression to BCRL following intervention for BCRL assessed by both bioimpedance spectroscopy (BIS) and a tape measure, demonstrating lower progression to chronic lymphedema with early detection using BIS and intervention versus using tape measure.

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. 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, with US payors now providing coverage for over 140 million covered lives. The PREVENT trial is a pivotal study and the largest randomized controlled trial to assess lymphedema prevention. The study enrolled 1,200 patients across 10 trial sites in the US and Australia, involving 13 hospitals, including Vanderbilt University, Mayo Clinic and MD Anderson.

The trial was conducted over six and a half years and patients were followed for up to three years, with the primary aim to determine if early intervention in patients with subclinical detection of extracellular fluid accumulation via bioimpedance spectroscopy results in a lower rate of lymphedema progression versus the rate when tape measure is used for subclinical detection. The manuscript is published in Lymphatic Research and Biology. The results of the trial demonstrated that patients with early detection with L-Dex?

technology and at-home intervention with compression garments resulted in a 7.9% rate of chronic lymphedema compared to a 19.2% rate of chronic lymphedema using tape measure. The difference is statistically significant (p=0.016) as well as being clinically significant for patients and clinicians. This represents an absolute reduction of 11.3% and relative reduction of 59% in lymphedema progression at three years.