ImpediMed Launches FDA-Cleared SOZO^™ System

CARLSBAD, Calif., Dec. 6, 2017 /PRNewswire/ — ImpediMed Limited (ASX: IPD), a global provider of medical technology to non-invasively measure, monitor and manage tissue composition and fluid status, announced the launch of its new SOZO^® product, which received 510(k) clearance from the U.S. Food and Drug Administration (FDA) this summer.

SOZO readings, using bioimpedance spectroscopy (BIS) and L-Dex^® technology by ImpediMed, are a non-invasive and sensitive method to aid in the clinical assessment and early detection of lymphedema of the limb^1,2,3,4.

Lymphedema is the build-up of extracellular lymph fluid resulting in the swelling of an arm or leg due to impairment in the lymphatic system. This usually occurs after the removal or irradiation of the lymph nodes during cancer-related treatment; lymphedema can lead to pain, infection, reduced mobility and overall impaired function.

SOZO uses ImpediMed’s patented BIS technology to gather and retain thousands of unique data points related to fluid and tissue status. Then, it applies indication-specific algorithms to produce accurate, detailed and actionable results in 20 seconds. SOZO identifies opportunities for early interventions that can prevent certain conditions and slow the progression of others, resulting in better health and quality of life.

“SOZO readings make earlier detection, simpler intervention and better management of lymphedema after cancer treatment possible,” said Richard Carreon, Managing Director and CEO of ImpediMed. “Immediately upon a diagnosis of cancer, medical professionals will be able to easily take baseline measurements for lymphedema and then monitor patients for the disease after cancer treatment. They’ll also have instant access to patient data through SOZO’s interactive web-based platform.”

ImpediMed and its subsidiaries pioneered the use of bioimpedance spectroscopy (BIS), producing the first commercially available BIS devices in 1990. Studies have shown that with ImpediMed’s patented BIS technology, healthcare providers are able to clinically assess a patient and detect lymphedema as much as 4-10 months earlier than other methods.3 ImpediMed’s patented BIS technology in SOZO is clinically proven and measures impedance at 256 different points over a full spectrum of frequencies from 3 kHz to 1000 kHz, allowing precise measurement and analysis of extracellular fluid, intracellular fluid and total body water.

Although other bioimpedance systems do exist, these methods are often a single frequency approach. Such approaches rely on population-specific data to create an estimated reading of the patient’s fluid levels in comparison to a true individual assessment derived through BIS. BIS does not depend on population-specific algorithms, making it a more precise measurement of fluid. Additionally, BIS can replace more traditional means of testing for lymphedema (e.g., circumference measurement [tape measure], water displacement and perometer methods, etc.) as a quantitative measurement that can detect the disease subclinically.

SOZO also includes the following features

• Easy Integration – Does not require gel electrodes, a separate testing room or elaborate instructions, making it easy to incorporate into routine clinic visits or check-ups.
• Quick Results – Application-based software takes a measurement and displays results quickly.
• User Friendly – Interface is built around patients and physicians to ensure information is received in the quickest and easiest way.
• Connectivity – Allows physicians to track and manage patients, easily and efficiently, at any time.

“SOZO’s rapid and non-invasive measurement enables pre-emptive rather than reactive care of cancer-related lymphedema, helping both physicians and patients take control of their health,” says Carreon.

SOZO is currently only available for medical professionals. For more information on SOZO for the early clinical assessment of unilateral lymphedema, patients and physicians may visit www.hellosozo.com or call toll-free 877-247-0111.

References

1. Hayes S, Cornish B, Newman B. Comparison of methods to diagnose lymphedema among breast cancer survivors: 6-month follow up. Breast Cancer Res Treat Feb; 89 (3):221-6,2005
2. Czerniec S, Kilbreath SL, Ward LC, Beith JM, Refshauge KM, Lee MJ, York S. Assessment of lymphedema using measurement tools and self-report. 7th National Lymphedema Network Conference, Nashville, USA, 2006
3. Cornish BH, Chapman M, Hirst C, Mirolo BR, Bunce IH, Ward LC, Thomas BJ. Early Diagnosis of Lymphedema Using Multiple Frequency Bioimpedance. Lymphology 34, 2-11, 2001.
4. Casely-Smith JR, Casely Smith JR. Physical therapy for lymphedema. Med J Aust 15:542-3,1989.

About ImpediMed

Founded and headquartered in Brisbane, Australia with U.S. offices in Carlsbad, Calif. and Bloomington, Minn., and a European office in Thessaloniki, Greece, ImpediMed is the world leader in the design and manufacture of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of tissue composition and fluid status.

ImpediMed was the first company to receive FDA clearance in the U.S. to aid healthcare professionals to clinically assess unilateral lymphedema of the arm and leg in women and the leg in men, for its L-Dex® device. In addition, ImpediMed produces a family of FDA cleared and CE Marked medical devices, including SOZOTM, sold in select markets globally. For additional information, visit www.impedimed.com.