ImpediMed clears final U.S hurdle for biompedance product

By David Binning
Friday, 25 June, 2010

Brisbane biotech ImpediMed announced today that it has received a Category III coding from the American Medical Association ( AMA ) for the use of its L-Dex U400 bioimpedance spectroscopy ( BIS ) technology in the detection of lymphoedema in limbs, which will take effect on January 1 next year.

The announcement is the culmination of a lengthy approvals process, and paves the way for American physicians to gain reimbursement for the use of the technology, which uses electrical currents to discern the movement of fluid in the body.

Lymphoedema refers to the painful and unsightly accumulation of fluids which can occur following damage to lymph nodes during cancer treatment and is associated with a significant proportion of the costs of cancer. Globally the market for lymphoedema treatment is thought to be worth around $US2.5 billion.

Initially targeted at breast cancer patients, ImpediMed’s technology has already been approved by the FDA for use in detecting lymphoedema in the arms. The company is confident that its application for use on legs will be granted some time this year. The AMA code number granted today allows for reimbursement in treatment of both arms and legs.

ImpediMed is also exploring opportunities to market its technology in the $US10 billion massive kidney dialysis market, having recently entering into an agreement with US company Fresenius, one of the world’s leading makers of dialysis machines, with a view to partnering on future product development.

Speaking from the company’s San Diego offices today, ImpediMed CEO Greg Brown said that the receipt of the all-important Category III Code is expected to have a dramatic impact on the company’s bottom line given expected demand for the technology in the U.S.

Nevertheless, the announcement failed to impress investors today, with ImpediMed’s shares down 6.45 percent to $0.58 amid widespread selling on the local market. ImpediMed’s L-Dex BIS technology is yet to receive approval for medical reimbursement in Australia.