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IMPEDIMED LIMITED — Capital/Financing Update 2017
Mar 6, 2017
65135_rns_2017-03-06_c96320b0-5821-46b4-9191-faf892021f9a.pdf
Capital/Financing Update
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7 March 2017
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ASX ANNOUNCEMENT
First SOZO[TM] Device Placed at Scripps Health for CHF Study
Brisbane, Australia, Carlsbad, Calif., and Bloomington, Minn. - ImpediMed Limited (ASX: IPD) a global provider of medical technology to measure, monitor and manage fluid status and body composition, is pleased to announce that SOZO[TM] has successfully cleared all safety testing, as well as system performance testing for device readings and transmission of data, enabling the placement of the first SOZO[TM] unit at Scripps Health.
The site will use SOZO[TM] in the initial study for monitoring patients with chronic heart failure in a clinical setting, in order to provide real-world data. This data is expected to be generated by mid-year, and will form the basis of the design of the larger scale trial expected to be initiated by mid CY 2017.
Concurrently with this study, and with the successful completion of safety and performance testing of SOZO[TM] , the Company is well on track to be filing its application for 510(k) clearance of SOZO[TM] in mid CY 2017. Similarly, the completion of safety and performance testing has the Company well placed in its aim of obtaining CE Mark for SOZO[TM] in the coming months and initiating the European launch of SOZO[TM] in key commercial sites in 2H CY 2017.
“We are very excited to start collecting clinical data from SOZO[TM] for future marketing to the CHF practitioners. Enrolment in the study will commence shortly, and we aim for the data set from this initial study and the subsequent larger trial to provide us with compelling materials as the foundations of our marketing into the US and international CHF markets,” stated Richard Carreon, Managing Director & CEO of ImpediMed.
The initial study is designed to use SOZO[TM] to measure fluid levels in Class III CHF patients. If successful, SOZO[TM] will provide an early warning system for cardiac decompensation with the potential to optimise patient care and significantly reduce hospital readmissions.
CHF is among the most expensive diseases for Medicare in the US. An estimated 5.7 million people in the US suffer from heart failure, with more than 850,000 new patients diagnosed each year. Heart failure currently costs the US an estimated $31 billion per year, and is estimated to increase to $70 billion by 2030. 80% of the current costs are spent on hospitalisations.
Richard Carreon Managing Director & CEO
For further information, contact: Richard Carreon, ImpediMed Managing Director & CEO Morten Vigeland, ImpediMed CFO
T: +1 (760) 585-2100
Media Contact:
Kyahn Williamson, WE Buchan T: +61 3 9866 4722 E: [email protected]
About ImpediMed
Founded and headquartered in Brisbane, Australia with U.S. offices in Carlsbad, Calif. and Bloomington, Minn., ImpediMed 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 in patients. ImpediMed has the first medical device with FDA clearance in the U.S. to aid healthcare professionals to clinically assess unilateral lymphoedema of the arm and leg in women and the leg in men. For more information, visit www.impedimed.com.