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IMPEDIMED LIMITED — Earnings Release 2018
Apr 18, 2018
65135_rns_2018-04-18_8c6b1e3a-2fef-4948-beed-f10b28164ff8.pdf
Earnings Release
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19 April 2018
ASX ANNOUNCEMENT
Interim Results of PREVENT Trial
Brisbane, Australia - ImpediMed Limited (ASX: IPD) a global provider of medical technology to non-invasively measure, monitor and manage tissue composition and fluid status using bioimpedance spectroscopy (BIS), today released findings of the interim analysis of the PREVENT trial.
The company announced that the PREVENT prospective, randomized trial interim analysis has demonstrated promising results in preventing lymphoedema. The analysis was performed on over 500 patients in two groups, one using the L-Dex BIS system, and the other using traditional tape measurements.
The PREVENT Trial is the largest international multicentre randomised controlled trial undertaken in the prevention of breast cancer-related lymphoedema. The trial commenced in 2014 and is led by Sheila H. Ridner, PhD, RN, FAAN, the Martha Rivers Ingram Professor of Nursing at Vanderbilt University School of Nursing. The objective of the trial is to determine if subclinical detection of increasing extracellular fluid via L-Dex and subsequent early treatment result in a reduction in the rates of progression to chronic lymphoedema as compared to the same intervention when initiated from tape measurement.
As of January 2018, 109 participants have triggered intervention: 68 in the tape measure group, which had 10 patients with lymphoedema progression, and 41 in the BIS group, with only 2 patients with lymphoedema progression. The interim analysis supports continuation of the international study, which has been seamlessly integrated into breast clinics across all study sites.
“I am encouraged by our findings that support the need to continue the study and am delighted there is strong support from all sites to do so,” Ridner said. “These interim results suggest that assessment by this device in post-surgical breast cancer patients can be successfully incorporated into clinical practice. We will begin educational seminars to encourage this incorporation into standard of care for cancer survivors.”
Rick Carreon, Managing Director and CEO of ImpediMed, said, “Achieving this milestone is significant for the company. This demonstrates our technology’s ability to detect very small fluid shifts in the human body that are medically meaningful. This provides clinicians the opportunity to intervene, resulting in improved outcomes and positively impacting the lives of patients.”
Investor Conference Call
Investors are invited to join a conference call with Managing Director and CEO, Richard Carreon, at 10.30am AEST today Thursday 19[th] April.
Conference ID Number: 9497185
Australia Toll Free: Australia Toll: United States Toll Free:
1 800 123 296 +61 2 8038 5221 1855 293 1544
Richard Carreon Managing Director & CEO
Media Contact:
Kyahn Williamson, WE Buchan T: +61 3 9866 4722 E: [email protected]
About ImpediMed
Founded and headquartered in Brisbane, Australia with US and European operations, ImpediMed is the world leader in the design and manufacture of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of tissue composition and fluid status.
ImpediMed produces a family of FDA cleared and CE Marked medical devices, including SOZO[®] for multiple indications including heart failure and lymphoedema, sold in select markets globally.
For more information, visit www.impedimed.com.