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ASX:EBR

11 stories mentioning ASX:EBRUpdated 8d ago

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Asia

EBR Systems Says Death of Patient During Post-Implant Echocardiograms 'Isolated Event' Related to Disclosed Risk; Shares Climb 4%

EBR Systems (ASX:EBR) completed its internal review into an incident where a patient implanted with the Wireless Stimulation Endocardially (WiSE) system died during post-implant echocardiograms, concluding that this was an "isolated event" related to a disclosed risk that can be mitigated when following recommended imaging procedures per the device labelling and training, according to a Friday Australian bourse filing.Two patients at one site implanted with the WiSE system separately developed ventricular fibrillation during next-day, post-implant, transthoracic echocardiograms, the company said. One patient went into cardiac arrest, could not be resuscitated, and died.There have been no previous reports of patient death due to this complication, it noted. To date, the only occurrences in the commercial experience have been the two that occurred at one site on the same day.The company's shares climbed nearly 4% in recent trading on Friday.

ASX:EBR
Asia

EBR Systems Advances Cardiac Pacing Device Rollout With 46 Commercial Implants in Q2

EBR Systems (ASX:EBR) reported 46 commercial implants of its WiSE cardiac pacing device for heart failure in the second quarter, bringing total implants across the pilot phase and limited market release to 117, according to a Thursday filing with the Australian bourse.The company said it signed an additional 17 purchasing contracts during the quarter, taking overall purchasing contracts signed to 52.It added that 90 physicians at 30 sites are now trained to implant the WiSE system, with 26 of them trained during the second quarter.Additionally, EBR Systems expects second-quarter revenue in the range of $2.5 million to $2.6 million. It sees "encouraging numbers" of patients being identified and scheduled for WiSE implants in the second half of the year.

ASX:EBR
Asia

EBR Systems Says US FDA Reviewing Incident Where Patient Implanted with WiSE System Died During Post-Implant Echocardiogram, Shares Reach Four-Year Low

EBR Systems (ASX:EBR) said the US Food and Drug Administration (FDA) is reviewing an incident where, during post-implant echocardiograms, two patients at one site, implanted with the Wireless Stimulation Endocardially (WiSE) system, separately developed ventricular fibrillation, and one patient went into cardiac arrest, could not be resuscitated, and died, according to a Friday Australian bourse filing.Noting online speculation, the firm said the complications suffered by the two patients were not related to the procedure or the effective functioning of the system and were a result of the use of external echocardiography for imaging. It will provide a detailed risk assessment with its conclusion as part of the US FDA process.Its internal assessment is that this is an isolated event related to a disclosed risk that is mitigated when following the recommended echocardiography procedures. It added that it provides clear echocardiography guidelines and imaging procedures for patients implanted with the system.Its shares plunged past 9% in recent trading on Friday, reaching their lowest point in over four years.

ASX:EBR
Asia

EBR Systems Completes Placement, Entitlement Offer; Shares Hit Near 18-Year Low

EBR Systems (ASX:EBR) completed the fully underwritten placement and institutional component of its 1-for-2 accelerated non-renounceable entitlement offer of new Chess depositary interests, according to a Friday filing with the Australian bourse.The placement raised roughly AU$64.4 million, comprising AU$29.4 million to be raised under tranche one and AU$35 million to be raised under tranche two, subject to security holder approval, the filing said.The institutional entitlement offer raised gross proceeds of AU$42 million, with a take-up of AU$8.4 million by eligible institutional security holders. The remainder of the institutional entitlements being AU$33.6 million were placed to eligible institutional and sophisticated investors as part of the bookbuild.The retail entitlement offer to raise a further AU$43.6 million will open on June 11, per the filing.Shares fell 18% in morning trade Friday and earlier hit their lowest since July 2008.

ASX:EBR
Asia

EBR Systems to Raise AU$150 Million Via Institutional Placement, Entitlement Offer

EBR Systems (ASX:EBR) is undertaking a fully underwritten institutional placement and entitlement offer to raise AU$150 million, comprising a AU$64.4 million institutional placement and a fully underwritten one-for-two pro rata accelerated non-renounceable entitlement offer to raise about AU$85.6 million, according to a Thursday Australian bourse filing.The company said the institutional placement comprises a AU$29.4 million tranche one placement and a AU$35 million conditional tranche two placement to certain existing securityholders, subject to securityholder approval.Funds advised by Brandon Capital Partners, which are existing securityholders, have committed to take up to AU$46.65 million in aggregate, including AU$35 million via the tranche two placement and sub-underwriting the retail component of the entitlement offer to AU$11.65 million, the filing added.Proceeds will be used to support sales and marketing expansion, manufacturing scale-up, research and development, clinical activities, and working capital, with EBR expecting a pro forma cash balance of about AU$185.3 million following completion and intending to fund the company through to cashflow breakeven, per the filing.

ASX:EBR
Asia

EBR Systems Enters Cardiac Device Purchasing Deal With US Hospital Network

EBR Systems (ASX:EBR) entered a three-year purchasing agreement with US hospital network Christus Health to advance the commercial rollout of its WiSE CRT System, according to a Wednesday filing with the Australian bourse.The agreement establishes a purchasing pathway for the implantable cardiac device across a network of 66 hospitals, the company said.

ASX:EBR
Asia

EBR Systems Secures Purchasing Agreement With Advocate Health; Shares Hit Over Three-Year Low

EBR Systems (ASX:EBR) has signed a purchasing agreement with Advocate Health, enabling access for its WiSE wireless cardiac pacing system across Advocate Health's network as part of its expanding US commercial rollout, according to a Monday Australian bourse filing.The agreement includes 69 hospitals across a footprint spanning eight states, including Alabama, Georgia, Illinois, Indiana, Michigan, North Carolina, South Carolina, and Wisconsin, the filing added.The company's shares fell 8% in recent Monday trade, hitting their lowest level since January 2023.

ASX:EBR
Asia

EBR Systems Secures Purchasing Agreement With HCA Healthcare; Shares Up 10%

EBR Systems (ASX:EBR) signed a purchasing agreement with HCA Healthcare, marking a key step in the commercial rollout of its WiSE cardiac resynchronization therapy system, according to a Wednesday Australian bourse filing.The agreement facilitates wider deployment by simplifying procurement and contracting across HCA's hospital network, making it easier for clinicians and administrators to access the system, per the filing.The company already operates at several HCA sites in Texas, and the partnership is expected to accelerate adoption and US commercial expansion, the filing added.The company's shares rose 10% in recent Wednesday trade.

ASX:EBR
Asia

EBR Systems Reports $2.4 Million Revenue In March Quarter, Shares Fall 5%

EBR Systems (ASX:EBR) reported March quarter revenue of $2.4 million, compared to $935,000 in the previous quarter, according to a Monday Australian bourse filing.Its WiSE heart pacing system was implanted in 41 commercial patients during the three months, increasing total commercial implants across the pilot phase and limited market release to 71.It signed an additional 16 purchase agreements with target centres during the quarter, adding to the 21 signed in previous quarters.Its shares fell 5% in recent trading on Tuesday.

ASX:EBR
Asia

EBR Systems Receives Priority Review Determination From Therapeutic Goods Administration; Shares Up 7%

EBR Systems (ASX:EBR) received priority review determination from the Therapeutic Goods Administration for the WiSE System, according to a Friday filing with the Australian bourse.The WiSE System is a cardiac device capable of pacing the heart without a lead.The determination provides an accelerated pathway for the device to be included on the Australian Register of Therapeutic Goods, the filing said.Shares rose 7% in morning trade on Friday.

ASX:EBR
Asia

EBR Systems Reports Contained Cyber Incident Affecting Limited Network Data

EBR Systems (ASX:EBR) has reported a contained data security incident in February involving unauthorized access to limited network data following a temporary disruption, according to a Wednesday Australian bourse filing.The company said it detected the disruption, promptly secured its systems, and launched an investigation with external forensic specialists to determine the scope and nature of the event, per the filing.The company noted that a small amount of personal health information may have been affected, with no material impact on operations, and confirmed its cyber insurance will cover all related costs, the filing added.The company's shares fell 1% in recent Wednesday trade.

ASX:EBR

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