ImpediMed Limited (ASX: IPD) is engaged in the business of production and designing of medical devices with BIS (Bioimpedance Spectroscopy) technologies to non-invasively measure, manage and monitor tissue composition and fluid status. The company today (as on 3rd May 2019) announced that the ASBrS (American Society of Breast Surgeons) issued a press release and the abstract submitted on the interim results of the PREVENT trial. Dr Julie A. Margenthaler, MD, FACS, Washington University School of Medicine, ASBrS Communications Committee Chair stated that lymphedema suffering patients experienced significant morbidity. BIS can identify early signs of lymphedema, hence interventions can be adopted to prevent progression. These steps are significant from the perspective of improving the lives of breast cancer survivors.
As per the press release issued by ASBrS on the interim results of the PREVENT trial, the surveillance of women at risk for breast cancer-related lymphedema using BIS became more effective in the cure by preventing lymphedema progression as compared to traditional arm circumference measurement, combined with the immediate compression therapy. These were the outcomes of an interim analysis on 508 patients in a large, multi-site, international, randomised controlled trial comparing the discovery of primary lymphatic impairment with this technology which directly weighs extracellular fluid with conventional TM (Tape Measure) calculation.
Lead study author, Sheila Ridner, PhD, RN, FAAN, Vanderbilt University School of Nursing explains that this kind of lymphedema is a chronic, debilitating swelling of the arm likely to be resulted from surgery, radiation or chemotherapy and negatively impact the lymph nodes. Lymphedema lowers quality-of-life and remains a key fear of the breast cancer survivors in a significant manner.
She further added that it was the first trial of such kind to prove the efficacy of BIS over TM valuation to avert further development of lymphedema through early lymphatic impairment detection, with immediate intervention with the help of compression therapy using specially fitted sleeves and gauntlets. Dr Ridner said that the study has revealed BIS as an extremely effective tool for pinpointing patients at risk noting that few females carried on to develop clinical lymphedema when referred for therapy using BIS than TM.
The study took into consideration patients before cancer treatment, undergoing mastectomy and/or a range of lymph node-related breast cancer surgeries and/or radiation. The patients were randomised to either the BIS or TM groups after baseline measurements. Beginning at 90 days after surgery, the patients were under regular assessment and followed for at least 12 months after surgery for this interim analysis.
As per the study, 68 TM patients (28.5%) and 41 BIS patients (15.81%) or 21% of overall patients met the thresholds and triggered interventions. Thresholds pinned mean time was 9.5 months for BIS and 2.8 months for TM. 10 TM triggering patients which is accounted for 14.7% later advanced to clinical lymphedema requiring complex decongestive therapy versus two in the BIS group (4.9%). It represented a relative reduction of 67% with an absolute reduction (p=0.130) of 9.8% with the use of BIS. Clinical lymphedema was defined as a rise of 10% in arm circumference with TM assessment for both the groups.
Dr Ridner also noted that BIS is a comparatively fast and cost-effective non-invasive assessment tool. It enhances patient care significantly as well as may curtail the higher expenses of decongestive physical therapy if later required.
At the time of writing on 3rd May 2019, AEST 2:45 PM, the stock of IPD was trading at $0.265, down 15.873%, with a market cap of $119.63 million.
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