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.
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.”
EBR Systems, founded in 2003, has developed a wireless pacing system for heart failure, which has been implanted in 450 patients around the world.
An 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.
EBR 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.
“The data exceeded our pre-specified regulatory primary efficacy and safety endpoints, paving the way for regulatory approval,” he said.
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 company plans to complete its PMA submission to the FDA early next year and hopes for approval in late 2024.
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 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.
“Since I’ve had the device fitted, I’ve been able to wash the cars, mow the lawn and go to the football and walk up all the steps,” Mr Oakley said.
The company listed at $1.08. It is backed by Brandon Capital, M.H. Carnegie & Co, Hostplus, TelstraSuper and HESTA.
Its shares previously closed at 90 cents. The stock had doubled since January in anticipation of the trial results, which ended early due to success. EBR shares were up 10.5 per cent to $1 on Monday afternoon.
“We think we should be well above the listing price, but we have got to earn our way back there, and it looks like we’re on the way to do that,” Mr McCutcheon said.
“The institutional investors have never left us. The ones that came in the IPO and our investors prior to that have been really sticky.”
Pioneer venture capitalist Bill Ferris, chairman of Brandon BioCatalyst and an investor in EBR Systems, described the company as “one of the most exciting healthcare companies in Australia right now”.
“It’s one of a new generation of healthcare companies with the potential to join the greats such as Cochlear and CSL,” he said.
Rather than compete with pacemakers, the WiSE system is designed for patients with heart failure who cannot receive cardiac resynchronisation therapy from existing devices, or are at high risk from conventional upgrades.
Pending regulatory approval, EBR Systems intends to initially target the US, Australia and major European countries.