The Power of SOZO

A SOZO reading provides a detailed and individualized assessment of a patient’s extracellular fluid, intracellular fluid and total body water through bioimpedance spectroscopy in less than 30 seconds.

A single, powerful SOZO reading allows for individualized, proactive care across multiple specialties for improved clinical outcomes, including breast cancer-related lymphedema.

News

ImpediMed launches SOZO at San Antonio Breast Cancer Symposium™; a non-invasive SOZO reading transforms patient care.

About SOZO

SOZO uses ImpediMed’s patented bioimpedance spectroscopy technology to gather and retain thousands of data points.

Clinical Research

Two new key studies show that breast cancer-related lymphedema is now highly preventable.hi

News

CARLSBAD, Calif., December 6, 2017 – 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.

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About SOZO

What is bioimpedance spectroscopy?

Bioimpedance refers to the process of sending a painless electrical current, typically at one or more frequencies, through the body. Measuring the body’s resistance and reactance in response to this electrical current provides easy access to detailed information regarding fluid and tissue status without the need for an invasive procedure.

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.1 ImpediMed’s patented BIS technology 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.

Breast Cancer-Related Lymphedema

Breast Cancer-Related Lymphedema (BCRL) occurs when the lymph system is damaged or blocked due to “disrupted flow of lymph fluid through the draining lymphatic vessels and lymph nodes, usually as a consequence of surgery and/or radiation therapy.”2 The National Cancer Institute calls lymphedema one of the most poorly understood, relatively underestimated, and least researched complications of cancer or its treatment.”3

Clinical Research

Studies have shown that with ImpediMed’s patented BIS technology, healthcare providers are able to clinically assess a patient and diagnose lymphedema as much as 4-10 months earlier than other methods.

Two Key Studies Using Biompedance Spectroscopy Recently Released

Pat Whitworth, M.D., of the Nashville Breast Center, followed breast cancer patients at risk for the development of lymphedema from April 2010 to November 2016.6 ImpediMed’s bioimpedance spectroscopy technology was utilized in a prospective surveillance model to identify patients with early/subclinical indications for the development of breast cancer-related lymphedema (BCRL). The six-year study of nearly 600 breast cancer survivors showed a demonstrable reduction in patients with BCRL for those who received a pre-surgical baseline bioimpedance spectroscopy test with ImpediMed’s L-Dex® U400, a precursor to its new SOZO™ system, and subsequent monitoring throughout their treatment. Positively, only 18 of the 596 patients (3 percent) developed BCRL – as compared to the 20-65 percent of patients who could have developed lymphedema, as prior published studies have suggested.

David I. Kaufman, M.D., F.A.C.S, Chief of Breast Surgery St. Joseph Hospital, Bethpage, NY, Assistant Professor of Surgery, Hofstra Northwell School of Medicine, Hempstead, NY, conducted a retrospective analysis beginning in 2010 of 264 patients prospectively surveilled for the development of BCRL using ImpediMed’s bioimpedance spectroscopy technology.7 All patients had a baseline assessment and a minimum of two post-operative follow-up assessments, at which time 28 patients (10.6%) had elevated L-Dex scores and underwent a 4-week compression sleeve treatment. After treatment, only 4 patients had persistently elevated L-Dex scores, yet remained asymptomatic.

1Cornish BH, Chapman M, Hirst C, Mirolo BR, Bunce IH, Ward LC, THomas BJ. Early Diagnosis of Lymphedema Using Multiple Frequency Biompedance. Lymphology 34, 2-11, 200.

2Lawenda, B.D., T.E. Mondry, and P.A. Johnstone, Lymphedema: a primer on the identification and management of a chronic condition in oncologic treatment. CA Cancer J Clin, 2009. 59(1): p. 8-24.

3Supportive, P.D.Q. and B. Palliative Care Editorial, Lymphedema (PDQ(R)): Health Professional Version, in PDQ Cancer Information Summaries. 2015, National Cancer Institute (US): Bethesda (MD).

4SEER – Surveillance, E., and End Results Program (www.seer.cancer.gov) Cancer Stat Facts: Female Breast Cancer. SEER Cancer Statistics Review, 1975-2014, 2016.

5Shah, C. and F.A. Vicini, Breast cancer-related arm lymphedema: incidence rates, diagnostic techniques, optimal management and risk reduction strategies. Int J Radiat Oncol Biol Phys, 2011. 81(4): p. 907-14.

6Langbecker, D., et al., Treatment for upper-limb and lower-limb lymphedema by professionals specializing in lymphedema care. Eur J Cancer Care (Engl), 2008.

7Voss, R.K., et al., The long-term risk of upper-extremity lymphedema is two-fold higher in breast cancer patients than in melanoma patients. J Surg Oncol, 2015. 112(8): p. 834-40.

8Herd-Smith, A., et al., Prognostic factors for lymphedema after primary treatment of breast carcinoma. Cancer, 2001. 92(7): p. 1783-7.

9Mortimer, P.S., et al., The prevalence of arm oedema following treatment for breast cancer. Q J Med, 1996. 89(5): p. 377-380.

10Soran, A., et al., The importance of detection of subclinical lymphedema for the prevention of breast cancer-related clinical lymphedema after axillary lymph node dissection; a prospective observational study. Lymphat Res Biol, 2014. 12(4): p. 289-94.