Health Check: Leading ASX heart device plays show they have the ticker to succeed | Stockhead
There's no clowning around with heart health at EBR and Anteris as the companies advance their respective programs. Pic: Getty ImagesEBR Systems reports June quarter uptick in US Wise device implants and. . .
There's no clowning around with heart health at EBR and Anteris as the companies advance their respective programs. Pic: Getty ImagesEBR Systems reports June quarter uptick in US Wise device implants and salesAnteris Technologies’ pivotal heart valve trial is off and runningThe pep-tide is high at ClinuvelEBR 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 choiceWise 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 progressLast 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 we 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 forwardLet’s stick with the rhythm of the cardiac theme. Today, the ASX and Nasdaq-listedAnteris 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 programAmid 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 we suspect that by slipping anti-obesity or anti-ageing into today’s release, the shares would have done better than falling 2% this morning. We’ll make customers ‘appy, says Control BionicsAssistive communications developerControl 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 we 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, we tell it as it is. While EBR is a Stockhead advertiser, the company did not sponsor this article.