BIO 2010: Diagnosis positive for ImpediMed

This feature appeared in the March/April 2010 issue of Australian Life Scientist. To subscribe to the magazine, go here.

In March this year the American Medical Association (AMA) assigned the all important Category III coding to ImpediMed’s bio-impedance spectroscopy (BIS) technology, enabling physicians to be reimbursed for its use in the early detection of lymphedema.

Lymphedema is an all too common condition afflicting cancer and other patients whose lymph nodes have been damaged – in some cases removed – in the course of treatment. Fluids that would otherwise be drained from organs and limbs through the body’s natural process of edema, instead accumulate resulting in painful and unsightly swelling.

While cancer treatment itself has seen significant advances over the last 20 or so years, doctors attending cancer patients had nothing to help them take pre-emptive steps against lymphedema. Unfortunately for most patients, by the time swelling is detected it is usually too late to do anything about it, meaning that they are stuck with it for the rest of their lives.

Bioimpedance refers to the response of a living organism to an externally applied electric current and is a measure of the opposition to the flow of that electric current through the tissues. ImpediMed’s L-Dex technology utilises the characteristics of frequency dependent current flow to quantify changes in extracellular fluid in the patient’s limb.

These changes can assist the surgeon or oncologist in clinically assessing early signs of lymphedema. The L-Dex technology is specific for extracellular fluid and is unaffected by changes in the patient’s weight due to a change in fat mass or muscle mass. As fluid accumulates, the L-Dex value increases on the scale. The L-Dex number provides an instant tool for assisting in the clinical assessment of lymphedema progression as well as an easy way to track change in the patient over time.

Chairman of ImpediMed and long time biotech entrepreneur, Mel Bridges, says that the company has come through the recent economic turmoil in pretty good shape, largely because as he dryly observes “nobody told cancer that there was a global financial crisis.”

Furthermore, the company expects to gain wider exposure to the massive cancer treatment market in the US once the AMA extends its Category III coding to include legs; the announcement in March related only to the treatment of arms.

A substantial percentage of all cancers occur below the waist, leading to vastly more cases of lymphedema affecting the legs, Bridges says, meaning that the next phase of AMA approval will see that the company is soon “off to the races.”

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Based on evidence from tens of thousands of patients, Bridges says that ImpediMed’s technology has resulted in the onset of lymphedema being prevented 100 per cent of the time.

It’s a story investors are certainly warming to. Mid-last year, bang in the middle of the global financial crisis, ImpediMed managed to raise $12 million to help fund its expansion plans, comprising a $5 million placement to the market and a $7 million rights issue. “A lot of companies didn’t get raisings away last year,” Bridges says.

Meanwhile the company’s shares have tracked steadily north over the last six months to reach a high of $0.92 in March. Really the only negative to report for the company is the fact that doctors in Australia aren’t as yet able to be reimbursed for the use of BIS, despite there being several thousand cases of acute lymphedema.

“It’s disappointing that the Australian Government still doesn’t reimburse the use of bioimpedance in lymphedema,” says Bridges. However he stresses that he won sympathetic ears from several key politicians and recently had the opportunity of sitting down with Queensland premier Anna Bligh.

Bridges notes that an arguably worse travesty is the fact that ResMed’s market-leading breathing apparatus for sleep apnoea is also not funded in Australia. Clearly this is an issue that the Australian biotech industry needs to get together and address, especially where Australians are being denied access to technology developed using their own tax dollars.

One horse race It’s unlikely, though, that the key decision makers in Canberra or the states and territories will be able to ignore ImpediMed for long. For one thing, there aren’t many companies that can claim to be the sole player in market potentially worth several billion dollars. “Our only competition is a bucket of water and a tape measure,” says Bridges.

The research underpinning ImpediMed’s technology was initially funded through UniQuest, the commercialisation arm of the University of Queensland. ImpediMed went public in 2005 raising $18 million from the initial IPO.

Testing for the onset of lymphedema is just one of countless healthcare applications for the technology, and its uses have been demonstrated in industries as far removed as boat building.

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The next major frontier ImpediMed is looking to conquer is the kidney dialysis market, where it sees its technology playing an important role in more accurately assessing the fluid status of patients. Currently the only way doctors can do this is by weighing patients, which can only be done before or after the actual dialysis treatment. “Weighing patients is not an accurate measure of fluid status,” says Bridges. By contrast, bio-impedance spectroscopy enables doctors to exactly note the fluid status of dialysis patients.

ImpediMed recently struck a deal with US company Fresenius, one of the world’s leading makers of dialysis machines, with a view to partnering on future product development. The global market for dialysis is estimated to be worth around $US10 billion.

Another important market for ImpediMed is in the area of wound care. Bridges says that the company’s technology could be applied towards determining the rate of healing for wounds without the need to remove dressings. This would have a number of benefits such as reducing the incidences of infection, not to mention patient discomfort while saving hospitals and other health care providers money on bandages and other dressings.

ImpediMed currently brings in around $3 million a year, but Bridges says he expects that will “hockey-stick” over the next few years, in line with an anticipated sharp increase in US sales.

While ImpediMed’s official headquarters are in Brisbane, the San Diego offices are soon expected to handle the lion’s share of the company’s business, especially once the AMA approves reimbursement for the use of bio-impedance in lymphedema resulting from cancers below the waist, and as opportunities open up in the dialysis market.

Last October, ImpediMed announced that it had appointed Metagenics, a global leader in science-based nutraceutical products, medical foods and therapeutic lifestyle change programs, to distribute its technology in the US and Canada. The company is currently looking to recruit a significant number of managed care and physician office representatives to help manage the expected deluge.

ImpediMed’s technology is approved for use throughout much of Western Europe, with demand expected to ramp up especially in the key markets of France and Germany and the UK. In Asia the company says that early signs, especially from Japan are very promising.

Bridges says that while there is clearly a long way to go, he looks forward to the day when ImpediMed can stand alongside the likes of ResMed, Cochlear and CSL in the Australian biotechnology hall of fame, having made a lasting contribution not only to the health and well being of Australians, but for people all around the world.

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Lymphodema The lymphatic system is similar to the blood system and has just as many vessels. However these vessels contain lymph, which is clear and so can only be seen when a suitable dye is injected. A key difference between the blood and lymphatic systems is that while blood circulates throughout the body continually, lymph simply drains from each part.

Lymphatics drain away the excess protein and water which is continually seeping from the blood in small amounts, in addition to certain substances made in the tissues, and any foreign substances which enter them.

Lymphatics begin life as loads of tiny vessels which eventually morph into bigger ones. But should the lymphatic system become damaged or blocked, protein continues to enter the tissues from the blood capillaries in the normal way, and a build-up occurs in the tissues the lymphatics should be draining.

The accumulation of protein in the tissues causes excess fluid to enter them and the tissues to swell. The swelling decreases the oxygenation of the tissues, interferes with their normal functioning, and makes them heal more slowly than normal. The result is a painful, unsightly and sadly permanent condition.

However, if discovered early enough, such as immediately following cancer treatment, it can be treated, effectively preventing swelling from occurring at all.

This feature appeared in the March/April 2010 issue of Australian Life Scientist. To subscribe to the magazine, go here.