UQ technology aids early detection of lymphoedema in cancer patients

A company with origins at The University of Queensland is leading the world in developing bioimpedance spectroscopy devices to improve quality of life for cancer survivors.

Coping with a cancer diagnosis is hard enough, yet every year thousands of cancer patients around the world also face debilitating side-effects brought on by essential medical treatment. One such complication is lymphoedema, where lymph nodes may be removed, damaged or irradiated.

ImpediMed Ltd, a UniQuest start-up company, has developed a technology that is leading the world in the early detection of lymphoedema.

Research beginnings

The ImpediMed bioimpedance technology has its origins in a research collaboration between UQ’s Dr Leigh Ward in the School of Chemistry and Molecular Biosciences and Queensland University of Technology, starting more than 30 years ago in 1988.

The aim of the research partnership was to develop a novel medical device that could accurately measure water content, specifically extracellular fluid, using bioimpedance spectroscopy technology.

Lymphoedema is the abnormal build-up of extracellular fluid due to a damaged lymphatic system. As with most medical conditions, treatment is more effective the earlier it can be administered. Progression of lymphoedema results in irreversible damage that requires lifelong management for patients and impairs their quality of life.

Commercialisation

Dr Ward and his colleagues developed technology that enabled lymphoedema assessment over more than a decade of dedicated research. UniQuest recognised the potential of the technology to improve patient quality of life. In 1999, UniQuest filed a patent application on measuring tissue oedema and ImpediMed Ltd was formed.

Having attracted first round investment from the Parma Corporation in 2000, the Brisbane-based company began operations to commercialise the technology.

With assistance from UniQuest, ImpediMed was successful in its application for a $250,000 Biotechnology Innovation Fund grant from the Australian Government. The grant enabled the company to advance its product development with a regulatory submission and prepare for market launch in Australia.

In 2006, ImpediMed raised an investment of $4.5 million from US healthcare-focussed venture capital firm Versant Ventures and Melbourne-based VC Starfish Ventures.

The following year the company listed on the Australian Stock Exchange to raise a further $18 million. With its bioimpedance devices already selling in Australia, the cash injection helped the company launch its products in the United States and European markets.

Trials, regulators and reimbursement

ImpediMed successfully conducted clinical trials in Australia, US and Europe and planned for a large international post-market approval trial. In 2013, the US Food and Drug Administration (FDA) granted unencumbered clearance for the ImpediMed bioimpedance devices to be used in the clinical assessment of secondary lymphoedema of the arm and leg in women and the leg in men.

In 2013, ImpediMed entered a three-year exclusive agency agreement with 3M to market its bioimpedance products through 3M’s sales representatives in Australia and New Zealand.

In September 2014, the American Medical Association accepted an application from ImpediMed for reimbursement status for bioimpedance spectroscopy for lymphoedema assessment. The code enabled Medicare eligible patients in the US to be reimbursed by the government for services provided and expanded ImpediMed’s addressable market by approximately 940,000 patients in the US alone. ImpediMed was the first company to meet the criteria for this code. To capitalise on this opportunity, the company raised $8.8 million to fund accelerated sales and marketing activities in the US.

In 2017, ImpediMed launched its new flagship product (SOZO®) in Europe and Australia. and was later issued with three 510(k) clearances by the FDA to market SOZO® for unilateral lymphoedema, chronic heart failure and bilateral lymphoedema.

Exclusive agreements

In 2018, ImpediMed and SharpHealthCare entered into a commercial agreement to use ImpediMed’s SOZO® and L-DEX® products within Sharp HealthCare’s Centre of Excellence cancer care program. Under the agreement, multiple systems will be used across several sites to establish best practices and calculate the economic impact of ImpediMed’s bioimpedance technologies.

In 2020, AstraZeneca selected SOZO® to be used in a Phase II trial to measure fluid volume in patients with heart failure and chronic kidney disease, with 175 SOZO®devices leased across 20 countries for the duration of the trial.

With offices in Brisbane and San Diego, ImpediMed is a world-leader in the development and distribution of medical devices employing bioimpedance technologies. It enjoys a reputation as an exciting, rapidly unfolding Australian innovation.