The 74-year-old said his cardiologist recommended the device, which is approved for research procedures in Australia, because the left side of his heart did not pump properly. Melbourne-based retiree Brian Oakley said he “improved out of sight” after having the WiSE system implanted over two procedures in July and August last year. The company plans to complete its PMA submission to the FDA early next year and hopes for approval in late 2024. The trial results, presented at Heart Rhythm Society’s annual meeting in New Orleans on Sunday, found patients with EBR’s WiSE device experienced a 16.4 per cent reduction in heart volume, indicating improved heart function, and more than 80.9 per cent of patients were free from device or procedure-related complications. “The data exceeded our pre-specified regulatory primary efficacy and safety endpoints, paving the way for regulatory approval,” he said.īrian Oakley can once again walk up the stairs at the MCG after being fitted with the WiSE device. Micron Technology Inc. Silicon Valley-based EBR Systems listed on the ASX in November 2021, after venture capital heavyweights Mr Ferris, Mr Carnegie and major super funds piled into the business, they predicted would become Australia’s “next Cochlear.”ĮBR Systems, founded in 2003, has developed a wireless pacing system for heart failure, which has been implanted in 450 patients around the world.Īn electrode the size of a cooked grain of rice is placed inside the left ventricle of the heart and powered by a small ultrasound transmitter on the chest.ĮBR Systems chief executive John McCutcheon said the trial results were the most significant milestone in the company’s history and an important step toward gaining pre-market approval (PMA) from the FDA. Micron failed the security tests by Chinese cybersecurity agency. Shares in an ASX-listed medical technology firm backed by investors including Bill Ferris and Mark Carnegie have surged 10.5 per cent on Monday after it revealed positive clinical trial results, which clear the way for US Food and Drug Administration approval for its tiny cardiovascular device.ĮBR Systems chief executive John McCutcheon says the trials are the most significant development for the company so far. On a non-IFRS basis, ECN lost 20.9 million in Q1 2023, 164.6 higher than in the fourth quarter and six times higher than a 4.3 million profit a year ago.
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