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| L-Dex device--Courtesy of ImpediMed |
Publicly listed ImpediMed ($IPD) raised AU$75.1 million ($57 million) to back the recent U.S. launch of its technology for early diagnosis of lymphedema in cancer patients and to expand into chronic heart failure.
In January, its L-Dex system won a dedicated CPT Category I reimbursement code from the American Medical Association, identifying it as a procedure consistent with current medical practice that is widely performed. ImpediMed launched the system, which already had gained full FDA clearance in May 2013, in the U.S. shortly thereafter.
"This capital raise further strengthens our balance sheet, and places the company in a strong position as we continue the commercial rollout of L-Dex in the United States, and advance our bioimpedance spectroscopy (BIS) technology applications and clinical trials for the chronic heart failure market," said ImpediMed CEO and Managing Director Richard Carreon in a statement.
The Brisbane, Australia-based small cap sold shares at $0.95 apiece in private placement, which was underwritten by Canaccord Genuity. Shortly after the offering, it was trading at about $0.90 a share.
Its L-Dex system uses bioimpedance spectroscopy (BIS) to noninvasively measure body tissue composition and fluid status. It's intended to enable the identification of lymphedema up to 10 months before there is evidence of limb swelling. Early detection and intervention can help prevent disease progression--or even reverse it.
Lymphedema is a common side effect of cancer treatment caused by the removal of or damage to lymph nodes. It's caused by a blockage in the lymphatic system that prevents lymph fluid from draining adequately and building up. The condition commonly is managed with massage, pneumatic compression and pressure garments.
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| L-Dex device--Courtesy of ImpediMed |
In a clinical trial, L-Dex was found to reduce the clinical lymphedema rate from 4.4% to 36.4%. The technology is in an ongoing trial at 6 major U.S. cancer centers including the Vanderbilt-Ingram Cancer Center, University of Texas MD Anderson Cancer Center, Mayo Clinic, University of Kansas Cancer Center, VCU Massey Cancer Center and Macquarie University. Interim data from that trial are slated to be released in late 2016.
Next up, the company plans to submit a 510(k) filing for the technology in chronic heart failure to complete clinical testing sufficient to launch a CHF product in the U.S. It expects to market L-Dex to treat lymphedema in the U.S. and international markets.
- here is the release