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EBR aligns with FDA on WiSE cardiac pacing labelling. * EBR Systems moves to update commercial labelling for its WiSE wireless cardiac pacing system following discussions with US FDA * Update aims to increase visibility of echo-induced pacing risk and its mitigations with submissions for change set for Q4 CY26 * FDA initiates pre-approval inspection of EBR's new manufacturing facility in Santa Clara, California Special Report: EBR Systems is taking proactive steps to update commercial labelling for its WiSE wireless cardiac pacing system to increase the visibility of echo-induced pacing risk and the measures used for mitigation. The company plans to submit a Changes Being Effected (CBE) Premarket Approval (PMA) supplement to the US Food and Drug Administration (FDA) in Q4 CY26. EBR Systems (ASX:EBR) said the update was designed to elevate the visibility and prominence of mitigation strategies to prevent known complications within the device labelling. This follows a meeting with FDA to discuss plans to proactively update labelling to increase the visibility of echo-induced pacing risk and its mitigations. During that meeting, EBR addressed FDA questions and FDA was aligned with the path forward. The CBE PMA provides a streamlined regulatory pathway for labelling improvements, allowing safety enhancements to be implemented without requiring prior FDA approval. Aligned with FDA on patient safety. WiSE holds the distinction of being the only leadless left ventricular endocardial pacing device for cardiac resynchronisation therapy (CRT). A receiver electrode about the size of a cooked grain of rice is implanted inside the heart's left ventricle and remotely powered by ultrasound. The device received FDA approval in April 2025 and is designed for patients whose left and right ventricles aren't beating in synchronisation. It is currently in pilot and limited market release phase in the US, with a broader national rollout planned for later this year. EBR said it was pleased with the collaborative FDA interaction and was aligned with FDA on ensuring patient safety. At the end of Q2 CY26 EBR reported 117 patients had been implanted with WiSE and 90 physicians trained across US 30 sites "As the commercial adoption of the WiSE System gathers momentum across the US, our paramount commitment remains patient safety and procedural success," CEO John McCutcheon said. "This proactive labelling update ensures that the clinical mitigations we have developed are clearly visible and top-of-mind for implanters." FDA initiates pre-approval inspection of manufacturing facility. The FDA has also initiated its pre-approval inspection of EBR's new manufacturing facility in Santa Clara, California. The company expects FDA approval of the new facility by year end. The company expects its move to the new facility will improve manufacturing efficiency and increase production capacity by ~500%, supporting its focus on cost reduction, yield improvement and production scale-up as commercial demand for WiSE grows. Increasing EBR's manufacturing footprint, the new facility is expected to support higher overall production capacity as demand for WiSE System grows. EBR announced earlier this month that the facility had achieved ISO 13485 certification following an assessment by global standards and certification body the British Standards Institution (BSI). This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Investor Guide: Health & Biotech 2026 featuring Tim Boreham

New EBR manufacturing facility in US clears quality milestone. * EBR's new Santa Clara manufacturing facility achieves ISO certification following assessment by British Standards Institution * New automated assembly equipment is being installed, expected to lift WiSE System production capacity by ~500% * FDA pre-approval Inspection scheduled for September, with approval by regulator of the facility expected by year end Special Report: Securing a key quality management certification for EBR Systems' new US manufacturing facility marks an important milestone as the company prepares to transition medical device production into the expanded site. EBR Systems (ASX: EBR) said the facility in Santa Clara, California had achieved ISO 13485 certification following an assessment by global standards and certification body the British Standards Institution (BSI). ISO 13485 is the internationally recognised quality management standard for medical device manufacturing. The certification supports EBR's move to an expanded manufacturing facility with increased capacity for continued US commercial rollout of its WiSE wireless cardiac pacing system for heart failure. The US Food and Drug Administration (FDA) pre-approval inspection of the new facility is expected to take place in September. Following the inspection and any remediation of potential observations, EBR expects the facility to receive FDA approval by year end. Automated assembly to improve efficiency. EBR is continuing to install additional manufacturing equipment at the new facility, including automated assembly machinery. Once FDA approval is received, EBR will start transitioning the WiSE System assembly process from manual to automated assembly. The company expects the move to improve manufacturing efficiency and increase production capacity by ~500%, supporting its focus on cost reduction, yield improvement and production scale-up as commercial demand for WiSE grows. Increasing EBR's manufacturing footprint, the new facility is expected to support higher overall production capacity as demand for WiSE System grows. In a recent trading update EBR announced it had achieved the 100th implant of WiSE during the June quarter as its limited US market release and pilot launch phase gained momentum. Supporting scalable manufacturing. EBR CEO John McCutcheon said achieving ISO certification for its new Santa Clara facility was an "important milestone in its manufacturing scale-up strategy." "The certification, together with the move-in of additional manufacturing equipment including new, automated assembly machinery, supports our transition to a larger, more scalable manufacturing platform," he said. "This expanded capability is an important part of EBR's broader commercial execution strategy as we continue the US commercial rollout of the WiSE System." This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Investor Guide: Health & Biotech 2026 featuring Tim Boreham

Health Check: Leading ASX heart device plays show they have the ticker to succeed. There's no clowning around with heart health at EBR and Anteris as the companies advance their respective programs. Pic: Getty Images * EBR Systems reports June quarter uptick in US Wise device implants and sales * Anteris Technologies' pivotal heart valve trial is off and running * The pep-tide is high at Clinuvel EBR Systems' (ASX:EBR) June quarter report shows that the US rollout of its Wise leadless pacemaker device is gaining momentum, even though the process has not been without its challenges. In a US filing, EBR reported net sales revenue of US$2.64 million in the stanza, compared with a mere US$170,000 a year previously. In April last year the company won US Food & Drug Administration (FDA) approval for Wise and launched it shortly thereafter. As a guide to a stiffening usage run rate, surgeons completed 46 implants during the quarter, across 23 hospitals. In the June half, patients underwent 87 implants at 29 houses of healing, for sales of US$5 million. EBR reported a US$17.4 million loss for the quarter. Still, as of June end EBR held cash and equivalents of US$86.9 million ($130m). This included the first two tranches of a fully underwritten, $150 million capital raise, with the final $35 million yet to be banked. Wise choice. Wise stands for 'wireless stimulation endocardially'. The device is the world's only wireless, endocardial (inside the heart) pacing system, for stimulating the heart's left ventricle. "This has long been a goal of cardiac pacing companies, since internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location," the company said. Wise is for patients whose left and right ventricles aren't beating in synchronisation. A transmitter picks up the groove of the right ventricle and sends a signal to the Wise electrode, which converts ultrasound energy to electrical energy to stimulate the left ventricle. The unit is powered by a subcutaneous battery. Share swoon defies solid progress. Last month, EBR CEO John McCutcheon said management was "thrilled" with progress of the US rollout. "The cases are going well, the doctors are really happy, and the patients are doing great. "We're getting repeat business and we're getting those contracts signed." But as noted, it hasn't been all plain sailing. EBR today said it had completed an internal investigation of two reported complications, which confirmed the incidents "were not related to the effective functioning of the device". The device labelling on Wise "provides guidance to mitigate the risk of these types of complications". The incidents did not impact the implant rate at other sites, the company said. Sadly, EBR shares have lost around three-quarters of their value since the post-FDA approval euphoria. Yesterday Stockhead referenced the Lassonde Curve: a famed chart that tracks how a junior explorer's share value rises and falls as the company moves from discovery to production. There's a Lassonde lesson for biotechs as well: shares tend to spike post approval and then sag, but then take off like the Clapham omnibus when revenue (and earnings) gain momentum. Anteris shifts Paradigm trial forward. Let's stick with the rhythm of the cardiac theme. Today, the ASX and Nasdaq-listed Anteris Technologies (ASX:AVR) reported June quarter cash outflows of US$20.8 million, as the company ramps up its pivotal Paradigm trial. Paradigm tests the safety and efficacy of the company's DurAVR transcatheter heart valve, relative to commercially-available replacements. Artificial valves treat aortic stenosis - a potentially life-threatening condition resulting from narrowing aortic valves. This head-to-head study is a biggie: it will enroll around 1000 patients, randomised equally between DurAVR and the standard devices. The study needs to prove the 'non-inferiority' of DurAVR. This is measured by mortality from all causes, fewer strokes and lower cardiac-related hospitalisation one-year post procedure. The balloon-expandable DurAVR is the first artificial valve shaped to mimic the performance of a healthy human aortic valve. During the quarter, Anteris secured US Medicare reimbursement for Paradigm. The agency pays for procedures done at eligible US sites. Paradigm enrolled and treated its first patients in May. The company is "actively recruiting" in the US, Denmark and the Netherlands. The company is also rolling out Australian sites. While DurAVR is not approved - hence the trial - the FDA has cleared the device's underlying anti-calcification tissue, known as Adapt. In fact, clinicians have used Adapt for more than a decade, in more than 55,000 patients. Clinuvel peps up peptide program. Amid the current interest in peptides spurred by GLP-1 fat-busting drugs, Clinuvel Pharmaceuticals (ASX:CUV) reports promising developments with its work on improved peptide delivery. Clinuvel has selected the first candidates for further preclinical studies of its controlled-release injectable liquid peptide platform, VLRX-L. The program has identified the flexible liquid dose formulations showing "the greatest potential for further development". The company is carrying out the work in Singapore, with further preclinical studies planned in the current quarter. By delivering peptide drugs in flexible, controlled release doses, VLRX-L enables more individualised patient dosing. "One candidate formulation demonstrated a superior release profile over the targeted peptide delivery window, with lower peak plasma levels and drug detected over the delivery period," the company said. Whether legal or obtained illicitly, injectable peptides are all the rage with the body beautiful brigade and social media influencers. Given Clinuvel is a skin diseases house, its program aptly focuses on melanocortins. But Stockhead suspect that by slipping anti-obesity or anti-ageing into today's release, the shares would have done better than falling 2% this morning. Stockhead'll make customers 'appy, says Control Bionics. Assistive communications developer Control Bionics (ASX:CBL) has launched its Neurostrip app on the "world's biggest software shopfronts": the App Store, the Mac App Store and the Microsoft Store. Indeed - that just about covers the western world as Stockhead know it. Neurostrip is a wearable sensor platform that reads the muscles' electrical signals via surface electromyography. In effect it's a miniaturised version of the company's Neuronode tech. Neuronode helps people with disabilities - such as those wheel-bound with motor neurone disease - to communicate. However, Neurostrip covers the more capacious markets of elite sports performance, clinical rehabilitation and research. While Neurostrip works on a software-as-a-service revenue model, the app itself is free. "Our customers can now find and use our software the same way they access everything else on their devices," says CEO Jeremy Steele. "It opens the platform to a far wider audience than we could reach through direct distribution alone." At Stockhead, Stockhead tell it as it is. While EBR is a Stockhead advertiser, the company did not sponsor this article. Investor Guide: Health & Biotech 2026 featuring Tim Boreham