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IMPEDIMED LIMITED — Capital/Financing Update 2013
Jun 6, 2013
65135_rns_2013-06-06_3d0fa0b4-ba16-4eb4-bc6b-ed1956d9bac7.pdf
Capital/Financing Update
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ASX ANNOUNCEMENT
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KEY MILESTONE ACHIEVED - IMPEDIMED RECEIVES 510(k) CLEARANCE
7 June 2013
Brisbane, Australia – ImpediMed Limited (ASX: IPD) (“ImpediMed”) today announced the United States Food and Drug Administration (“FDA”) 510(k) clearance of a revised Indications for Use Statement for its L-Dex[®] U400 device. This revision removes the sentence, “ the device is not intended to diagnose or predict lymphedema of the extremity .” This clarifies the use of the L-Dex U400 as an aid to the clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.
CEO Richard Carreon stated, “We continue to deliver on commitments made to our investors. This clearance removes one of the key roadblocks identified in our recent Investor Presentation. This is an important achievement for the Company allowing us to accelerate our clinical and reimbursement initiatives.”
For further information contact:
Richard Carreon, ImpediMed CEO T: +1 (858) 412-0200
About ImpediMed
ImpediMed Limited is the world leader in the development and distribution of medical devices employing Bioimpedance Spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status. ImpediMed’s primary product range consists of a number of medical devices that aid surgeons, oncologists, therapists and radiation oncologists in the clinical assessment of patients for the potential onset of secondary lymphoedema. Pre-operative clinical assessment in cancer survivors, before the onset of symptoms, may prevent the condition from becoming a lifelong management issue and thus improve the quality of life of the cancer survivor. ImpediMed has the first medical device with an FDA clearance in the United States to aid health care professionals clinically assess secondary unilateral lymphoedema of the arm and leg in women and the leg in men.