ImpediMed

Founded in 1999, ImpediMed Limited is a medical technology company that develops, manufactures, and distributes devices using bioimpedance spectroscopy (BIS) to non-invasively assess and monitor fluid status and tissue composition. Originating in Brisbane, Australia, the company also has operations in the United States and Europe and is listed on the Australian stock exchange. The majority of its revenue is generated in North America.

ImpediMed's business model transitioned in 2018 from a focus on capital equipment and consumables to a Software-as-a-Service (SaaS) subscription model. Revenue is generated from the sale of their SOZO devices and recurring software subscription services, supplemented by sales of legacy devices and consumables and income from research contracts. The company primarily serves hospitals, clinics, and medical professionals such as surgeons, oncologists, and therapists.

The company’s core offering is the SOZO® Digital Health Platform, which uses patented BIS technology. In less than 30 seconds, the device performs a scan applying a low-level electrical current at 256 different frequencies to measure extracellular fluid, intracellular fluid, and total body water. This provides a detailed analysis of a patient's fluid and tissue composition. The key application is the early detection of secondary lymphedema, a chronic swelling that can result from cancer treatments. The platform's L-Dex® analysis can detect fluid shifts equivalent to as little as 2.5 tablespoons, enabling clinicians to identify subclinical lymphedema up to 10 months before physical symptoms appear. This early detection allows for intervention that may prevent the condition from progressing.

The SOZO platform has received multiple 510(k) clearances from the U.S. Food and Drug Administration (FDA). Its indications have expanded beyond lymphedema to include providing fluid status for patients with heart failure and aiding in the assessment of protein-calorie malnutrition. Furthermore, the SOZO platform has been granted FDA Breakthrough Device Designation for monitoring fluid volume in renal failure patients undergoing dialysis. The technology's importance is underscored by its reference in the NCCN Clinical Practice Guidelines in Oncology for screening at-risk cancer patients for lymphedema. Keywords: bioimpedance spectroscopy, lymphedema prevention, SOZO Digital Health Platform, fluid status monitoring, medical SaaS, tissue composition analysis, non-invasive medical devices, cancer survivor care, L-Dex technology, FDA cleared medical device, heart failure monitoring, protein calorie malnutrition assessment, medical technology, oncology solutions, body composition analysis, chronic disease management, digital health platform, clinical assessment tools, MedTech, healthcare analytics