Sleep study patients' records leaked in ransomware hack
The personal details of more than 2000 patients who took part in a sleep study with a public hospital have been breached in a ransomware attack.
The attack on Compumedics, an ASX-listed medical diagnostics company, compromised the third-party data of 2254 patients at the Women's and Children's Hospital in Adelaide.
SA Health chief executive Robyn Lawrence said her department was notified on April 17 by the medical company, which had experienced a critical breach in late March.
Those affected were patients who used the inpatient sleep service at the 295-bed hospital since 2018, the department said.
"As soon as Compumedics revealed the initial national ransomware attack we took immediate action to suspend access to the Compumedics software and related devices from our network," Dr Lawrence said in a statement on Thursday.
"All Compumedics devices and software were disconnected from SA Health systems and an external cyber security organisation was engaged to help verify the safety of our systems."
She reassured patients that SA Health's IT systems were not affected, with the data stored in the third party's servers.
The medical firm told SA Health no financial information, Medicare numbers or bank account details had been taken, but names, addresses, phone numbers and dates of birth and limited clinical information were accessed.
"Compumedics has advised that identity theft and potential scams are the biggest risk to patients impacted," SA Health said.
AAP has sought comment from Compumedics.
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News.com.au
4 hours ago
- News.com.au
Scott Power: ASX stocks fall as investors hear mixed news from Cochlear
ASX heath sector falls 1.1% over past five days, while broader markets flat as Middle East tensions flare Cochlear downgrades full-year profit expectations but launches a world first Monash IVF head Michael Knaap resigns after another embryo mix-up Healthcare and life sciences expert Scott Power, who has been a senior analyst with Morgans Financial for 27 years, gives his take on the ASX healthcare sector for the week and his 'Powerplay' stock pick. It was a big week of news for the ASX healthcare sector with the bourse's fourth largest biotech Cochlear (ASX:COH) downgrading its FY25 net earnings ~4% to $390-400 million, compared with prior guidance in February of $410-430m, on "slower-than-expected sales growth over the last few months". Morgans' healthcare analyst Derek Jellinek wrote in a note to clients consensus for the hearing tech company sat at $411m with Morgans at $412m. While Cochlear continues to expect implant units to grow ~10% in FY25, growth will be weighted to emerging markets as developed market growth has been impacted by slower-than expected market growth and a "small loss" of market share in a few countries. Cochlear now expects services revenue to decline by low double-digits compared to prior expectations for a single-digit decline. "COH believes ongoing work to identify and connect with recipients who could benefit from the latest sound processing technology, combined with the introduction of the new off-the-ear Nucleus Kanso 3 sound processor, which is expected to launch in EU and APAC mid-Jun-25, should lift services revenue in FY26," Jellinek wrote. Following a disappointing H1 FY25 result, Morgans highlighted risks in the services segment (around 25% of sales), driven by slower-than-expected uptake of the Nucleus 8 sound processor, which was launched in FY23, and cost-of-living pressures delaying device replacements. But in some positive news, Cochlear also announced the launch of Nucleus Nexa, the world's first and only smart cochlear implant system, saying it was the "outcome of a 20 year investment in R&D". "A couple of key features include upgraded firmwear, the smallest sound processor and internal memory so that has actually countered the profit downgrade they've announced," Power said. Morgans has a hold rating on Cochlear with a 12-month target price of $285.55. Monash chief quits following another embryo mixup A new acting CEO has been appointed to steer the troubled Monash IVF Group (ASX:MVF), which fell ~27% on Tuesday after reporting another embryo implant bungle. Monash announced on Thursday CEO and managing director Michael Knaap had resigned with CFO and company secretary Malik Jainudeen appointed acting CEO. In the latest incident a patient's own embryo was mistakenly transferred to them, rather than their partner's embryo as specified in the treatment plan at Monash's Clayton laboratory in Melbourne on June 5. Monash said it was conducting an internal investigation to determine the cause of the incident and notified the relevant assisted reproductive technology (ART) regulators, the Victorian health regulator and its insurers. It comes after Monash revealed in April a woman had given birth to a baby that was not hers after receiving the wrong embryo at a Brisbane clinic. An independent review by Fiona McLeod AO SC regarding that incident is currently ongoing and has been extended, with the findings yet to be disclosed. Monash confirmed that its updated profit guidance, issued on May 20, remains unchanged, projecting an underlying NPAT of $27.5 million. Morgans maintains a speculative buy on Monash with a 12-month target price of $1. Israel strikes on Iran add to market uncertainty At 1.45pm on Friday the S&P/ASX 200 Health Care index was down 1.1% for the past five days, while the benchmark ASX 200 was flat for the same period. Markets took a tumble on Friday after reports of Israel strikes against Iran's nuclear sites with the Middle East bracing for retaliation. Power said the escalating conflict adds further complexity to global equity markets still very much being driven by macroeconomic factors and geopolitical tensions. "Markets are still very much broader macro driven including with US President Donald Trump's trade and regulatory policies," Power said. "Investors will now be closely monitoring the escalating tensions in the Middle East." Power's Powerplay: EBR completes raise, starts US rollout EBR Systems (ASX:EBR) is Power's stock of the week after announcing completion of a share purchase plan (SPP) and that the first US commercial patients have been implanted with its WiSE CRT System, the world's only wireless solution for pacing the left side of the heart. The procedures took place at St David's Medical Centre and the Cleveland Clinic, two of several leading US institutions participating in this pilot release of the WiSE CRT System, which was approved by the FDA in April. EBR said the cases represented two of the main indications for WiSE. "Clearly, the first commercial patients implanted with WiSE is a key milestone, as EBR has officially transitioned from a pure R&D focus to a commercial entity," Jellinek wrote in a note to clients. He said importantly, the implants were done in advance of reimbursement and the limited market release of WiSE, which remained on track for October, showcasing the unmet medical need in the initial US$3.6m total addressable market and belief in use of the device. "As this device is a novel treatment option requiring physician education, we view the LMR, targeting key heart failure centres in the US, as an appropriate strategic way to build familiarity and experience, prior to full market release," he wrote. "We see sales surpassing US$80m into CY29. "While certainly not a 'hockey stick', we believe it is a methodical, stage-gated rollout to build strong physician support and closely monitor clinical outcomes, helping to pique interest from any would-be suitor." The company also announced today it had finished its SPP raising $xxm and adding to a fully underwritten Institutional Placement raising $55.9m completed in May. Proceeds from the capital raise will be used to advance its US commercialisation strategy for WiSE. Morgans has a buy rating and 12-month target price of $2.86. Two positive studies for Avita Wounds management company Avita Medical (ASX:AVH) has announced the first clinical publication of its Cohealyx product, which is a collagen-based dermal matrix, in the Journal of Surgery. The publication includes two positive case reports on patients with complex hand wounds treated with Cohealyx. In both instances, the patients sustained full-thickness burns following syncopal episode (temporary loss of consciousness due to a drop in blood flow to the brain). The study showed significant acceleration of wound bed vascularisation and autograft readiness, achieving readiness within five to 10 days compared to the typical two to four weeks. "Clearly, a small sample size and this publication represents the first clinical validation of AVH's preclinical findings but it's a strong start and likely the first of many case-studies to come," Morgans' healthcare analyst Iain Wilkie wrote in a note to clients Avita also announced a new study of its flagship spray-on skin treatment Recell showed it reduced hospital stays by 36% compared to traditional skin grafts. Presented at the British Burn Association's annual meeting, the US-based study analysed outcomes for more than 6,300 patients treated with Recell between 2019 and 2024. All patients had burns covering less than 30% of their total body surface area. The findings showed Recell patients spent on average 6.2 fewer days in hospital, delivering an estimated $300m in healthcare savings over the five-year period. Wilkie wrote that the share price had continued to remain weak following series of missed guidance expectations and dwindling cash reserves. "The point with Avita is they've expanded their product range to treat more of the wound complex and what the market is concerned about is do they need to raise additional funds," Power said. "They've told the market they can see a pathway through to profitability or breakeven by the fourth quarter of this calendar year so as each quarter rolls on we will get more confident that they're able to achieve that." Morgans has a speculative buy rating on Avita and 12-month target price of $3.76. Imricor gets CE Mark for NorthStar Mapping System Imricor Medical Systems (ASX:IMR) has received CE mark (European) certification for its NorthStar Mapping system under the new, more stringent European Union Medical Device Regulations (MDR). NorthStar has been approved as a Class IIa medical device with the certification received ahead of schedule. Imricor is advancing technology for real-time interventional cardiac magnetic resonance (iCMR) ablations, enabling cardiac ablation procedures to be guided by live MRI imaging instead of traditional x-ray fluoroscopy. NorthStar is a key component of its product offering. The certifications follows on from recent European approvals received for its Advantage-MR EP Recorder/Stimulator (Advantage-MR), and its second generation Vision-MR Ablation Catheter. "Imricor will now phase out first generation products approved under the old EU regulations, replacing them with new MDR approved devices," Power said. "We expect sales momentum to steadily build over coming quarters." Power said next catalysts to watch for include additional sales orders in Europe and Middle East and US FDA approval for NorthStar. Imricor is also undertaking its Vision-MR Ablation of Atrial Flutter (VISABL-AFL) pivotal clinical trial to support FDA approval of its products, which it hopes to achieve in 2025. In Europe, where Imricor has already received regulatory approval for atrial flutter, the company has started a pivotal VISABL-VT clinical trial for its second indication, ventricular tachycardia (VT). Morgans has a speculative buy on Monash and 12-month $2.28 target price. The views, information, or opinions expressed in the interview in this article are solely those of the interviewee and do not represent the views of Stockhead. Stockhead has not provided, endorsed or otherwise assumed responsibility for any financial product advice contained in this article.
News.com.au
a day ago
- News.com.au
Health Check: Cochlear's ear-nings downgrade is not what investors wanted to hear
Cochlear downgrades full-year profit expectations, citing sluggish sound processor sales Mesoblast eyes second US drug approval sooner rather than later Who's for a bargain biotech … or three? Cochlear (ASX:COH) is banking on the rollout of new hearing devices to bolster earnings after today downgrading its full-year earnings expectations. The fourth biggest ASX-listed biotech, Cochlear now expects underlying net earnings of $390-400 million, compared with February's guidance at the 'lower end' of $410-430 million. Let's call it a 5% downgrade. Management had expected a single-digit decline in its services revenue – sound processors and the like – but now expects a fall in the high-single digit territory. The problem is that Nucleus 8 sound processor sales grew strongly post launch, but the buzz has abated. Users are unwilling to upgrade to tweaked variants such as the Kanso 'off the ear' processor. 'We continue to work on identifying and connecting with recipients who could benefit from the latest sound processing technology,' the company says. 'These initiatives, combined with the introduction of are expected to lift services revenue in the 2025-26 year.' Meanwhile, sales of the Cochlear implants remain robust and should increase by 10 per in the current year. But growth is weighted to emerging markets. 'Growth in the higher value developed markets has been impacted by slower-than-expected market growth and a small loss of market share in a few countries.' Smart implant launch dulls the pain Not all Cochlear's news was negative. Also today, Cochlear launched its Nucleus Nexa System, 'the world's first and only smart cochlear implant'. The device enables users to upgrade the firmware for both the implant and the related Nucleus 8 Nexa sound processor. Cochlear CEO Dig Howitt says Nexa results from 20 years of research and development. 'Similar to smartphones, the implant firmware can be updated to enable new features and access to future innovations.' After dipping 8% in early trade, Cochlear shares by noon were slightly higher ... so go figure. Buoyant Bioxyne bolsters revenue Bioxyne (ASX:BXN) this morning had a more encouraging update, upping full-year revenue expectations from $25 to $28 million. That's a 200% jump on last year's run rate. Bioxyne sells consumer health products – notably cannabis derived ones such as medicinal 'gummies'. Through its subsidiary, Breathe Life Sciences, Bioxyne is expanding into producing psychedelic compounds for therapeutic use. The company was granted Australia's first Good Manufacturing Practice licence to produce psilocybin and MDMA ('molly', or ecstasy) Management cites Australian pharmaceutical manufacturing and supply as the key growth driver. "The company is making significant progress in Germany and the UK and will provide a market update shortly." Telix launches second imaging product Telix Pharmaceuticals (ASX:TLX) has launched its second commercial product in the US, also for prostate cancer. The tool, Gozellix, is a kit for preparing an injection of gallium-68 (gozetotide) to detect the tell-tale prostate-specific membrane antigen. The agent is relevant for prostate cancer patients suspected metastases and are candidates for initial definitive therapy. It is also intended for patients with suspected recurrence of prostate cancer based on an elevated serum prostate-specific antigen level. The US Food and Drug Administration (FDA) approved Gozellix in March 2025. The company says Gozellix has a shelf life of up to six hours, which makes it more flexible to use than other products based on the gallium-68 isotope. The company also claims Gozellix is 90% accurate in detecting metastases at the initial stage. In December 2021 the FDA approved Telix's first product, Illucix, which is also gallium-68 based. In calendar 2024 Telix reaped $783 million of revenue from Illucix, 70% higher. US Mesoblast-off for second product? Stem cell therapy developer Mesoblast (ASX:MSB) is confident the FDA will allow accelerated approval of its heart disease drug candidate, Revascor. The agency last December approved Mesoblast's Ryoncil for childhood graft-versus-host disease. That entrenches Ryoncil in the Biotech Hall of Fame as the first and only FDA-approved mesenchymal stromal stem cell product for any indication. Revascor is intended for the much larger market of patients with ischemic chronic heart failure, reduced ejection fraction and inflammation. In the first week of June, Mesoblast held a Type B meeting with FDA to discuss components of a potential filing for marketing approval. 'There was general alignment on items regarding chemistry, manufacturing and controls, potency assays for commercial product release and proposed design and primary endpoint for the confirmatory trial post-approval,' Mesoblast says. 'The company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing.' What's in the brokers' bargain bin? Investors are undervaluing at least three ASX biotech, according to broking analysts. Bell Potter rates Radiopharm Theranostics (ASX:RAD) a buy, citing an 'exceptionally positive outlook'. This follows yesterday's announcement of US Food and Drug Administration fast track approval for its metastatic brain cancer radiotherapy, RAD101. Radiopharm is trialling RAD101 in a 30 patient, phase II effort across five eastern Australian sites. Headline results are due in late 2025 – 'earlier than anticipated'. Bell Potter values the stock at 2.6 cents, compared with yesterday's close of half a cent. Macquarie Equities opines the Monash IVF Group (ASX:MVF) share sell off has been overdone following a second embryo mix-up 'incident'. In a note titled 'bargain hunting' – there's a clue – the firm values the stock at $1.30 a share, implying 100% upside. This is despite the shares recovering 10% this morning after CEO Michael Knaap resigned, leaving CFO Malik Jainudeen to fill the hot seat temporarily. Finally, Morgans values Imricor Medical Systems (ASX:IMR) at $2.28, a 40% increment on the current price. The company has developed the world's first cardiac ablation device that can be guided by magnetic resonance imaging. This week Imricor won European (CE Mark) approval for its Northstar Mapping System, a key component of its offering.
The Advertiser
a day ago
- The Advertiser
Cochlear launches new implant, downgrades guidance
Hearing implant developer and manufacturer Cochlear is sounding out the market, launching its latest implant and cutting earnings guidance on the same day. Weaker-than-expected sales forced the health technology company to trim net profit expectations to between $390 to $400 million, down from $410 million to $430 million, but still higher than FY24's $387 million result. Implant sales were expected to increase by around 10 per cent this financial year, with growth weighted to the emerging markets as expansion in developed markets undershot expectations. The update came as Cochlear launched its latest implant in Australia, the first of its kind with upgradeable firmware and internal memory. Investors opted to take the good news over the bad, sending Cochlear shares 0.4 per cent higher to $271.65 after dipping more than nine per cent at the market's open. Jenny Young, one of the first to try the new device, was in her late 40s when her audiologist told her she would need hearing aids. Phone conversations were hard, she needed friends and family to repeat themselves and the country music shows she loved had become muffled and unclear. "I just gave up because I didn't know what song was coming on," Ms Young, now 58, told AAP. She initially ignored her audiologist's advice until life became too difficult. "Sometimes you felt excluded, and you tended to exclude yourself because you weren't quite sure what was said, and you didn't want to pop in and embarrass yourself," Ms Young said. After mixed results with hearing aids, her audiologist suggested her for a trial of the Cochlear's new implant, the 8th generation of the device which directly stimulates the auditory nerve, as opposed to hearing aids which amplify sound. The new internal memory allowed users to store their personal hearing settings on the implant, while upgrades could improve the way the auditory nerve was stimulated, implant program director Robert Briggs said. "That's a big change, and in the longer run we're hoping new stimulation strategies will allow better clarity of hearing and better speech understanding," Professor Briggs told AAP. The new device was developed over a decade with the help of Cochlear's 600-strong research and development teams across six global centres. One in six Australians, or 3.6 million people, suffer from some form of hearing loss. Cochlear has provided more than 750,000 hearing implants to people around the world over four decades, and helped children born deaf to hear for the first time. When Ms Young first had the implant, she said interpreting the signals was like learning a new language. "To me it sounded like a lot of magpies talking all at once in my head," she said. But with time and a little patience from friends and family, she was soon back where she wanted to be. "Six weeks after I got my implant, I went to the Deni Ute Muster in the front row and watched my country music," she said. "It has given me back my social aspect, my confidence ... It's just given me a new lease for life." She urged anyone noticing changes in their hearing to get checked. "I just want to suggest anybody that has trouble hearing or think they're having a difficulty - get onto it," she said. "Don't sit back like I did." Hearing implant developer and manufacturer Cochlear is sounding out the market, launching its latest implant and cutting earnings guidance on the same day. Weaker-than-expected sales forced the health technology company to trim net profit expectations to between $390 to $400 million, down from $410 million to $430 million, but still higher than FY24's $387 million result. Implant sales were expected to increase by around 10 per cent this financial year, with growth weighted to the emerging markets as expansion in developed markets undershot expectations. The update came as Cochlear launched its latest implant in Australia, the first of its kind with upgradeable firmware and internal memory. Investors opted to take the good news over the bad, sending Cochlear shares 0.4 per cent higher to $271.65 after dipping more than nine per cent at the market's open. Jenny Young, one of the first to try the new device, was in her late 40s when her audiologist told her she would need hearing aids. Phone conversations were hard, she needed friends and family to repeat themselves and the country music shows she loved had become muffled and unclear. "I just gave up because I didn't know what song was coming on," Ms Young, now 58, told AAP. She initially ignored her audiologist's advice until life became too difficult. "Sometimes you felt excluded, and you tended to exclude yourself because you weren't quite sure what was said, and you didn't want to pop in and embarrass yourself," Ms Young said. After mixed results with hearing aids, her audiologist suggested her for a trial of the Cochlear's new implant, the 8th generation of the device which directly stimulates the auditory nerve, as opposed to hearing aids which amplify sound. The new internal memory allowed users to store their personal hearing settings on the implant, while upgrades could improve the way the auditory nerve was stimulated, implant program director Robert Briggs said. "That's a big change, and in the longer run we're hoping new stimulation strategies will allow better clarity of hearing and better speech understanding," Professor Briggs told AAP. The new device was developed over a decade with the help of Cochlear's 600-strong research and development teams across six global centres. One in six Australians, or 3.6 million people, suffer from some form of hearing loss. Cochlear has provided more than 750,000 hearing implants to people around the world over four decades, and helped children born deaf to hear for the first time. When Ms Young first had the implant, she said interpreting the signals was like learning a new language. "To me it sounded like a lot of magpies talking all at once in my head," she said. But with time and a little patience from friends and family, she was soon back where she wanted to be. "Six weeks after I got my implant, I went to the Deni Ute Muster in the front row and watched my country music," she said. "It has given me back my social aspect, my confidence ... It's just given me a new lease for life." She urged anyone noticing changes in their hearing to get checked. "I just want to suggest anybody that has trouble hearing or think they're having a difficulty - get onto it," she said. "Don't sit back like I did." Hearing implant developer and manufacturer Cochlear is sounding out the market, launching its latest implant and cutting earnings guidance on the same day. Weaker-than-expected sales forced the health technology company to trim net profit expectations to between $390 to $400 million, down from $410 million to $430 million, but still higher than FY24's $387 million result. Implant sales were expected to increase by around 10 per cent this financial year, with growth weighted to the emerging markets as expansion in developed markets undershot expectations. The update came as Cochlear launched its latest implant in Australia, the first of its kind with upgradeable firmware and internal memory. Investors opted to take the good news over the bad, sending Cochlear shares 0.4 per cent higher to $271.65 after dipping more than nine per cent at the market's open. Jenny Young, one of the first to try the new device, was in her late 40s when her audiologist told her she would need hearing aids. Phone conversations were hard, she needed friends and family to repeat themselves and the country music shows she loved had become muffled and unclear. "I just gave up because I didn't know what song was coming on," Ms Young, now 58, told AAP. She initially ignored her audiologist's advice until life became too difficult. "Sometimes you felt excluded, and you tended to exclude yourself because you weren't quite sure what was said, and you didn't want to pop in and embarrass yourself," Ms Young said. After mixed results with hearing aids, her audiologist suggested her for a trial of the Cochlear's new implant, the 8th generation of the device which directly stimulates the auditory nerve, as opposed to hearing aids which amplify sound. The new internal memory allowed users to store their personal hearing settings on the implant, while upgrades could improve the way the auditory nerve was stimulated, implant program director Robert Briggs said. "That's a big change, and in the longer run we're hoping new stimulation strategies will allow better clarity of hearing and better speech understanding," Professor Briggs told AAP. The new device was developed over a decade with the help of Cochlear's 600-strong research and development teams across six global centres. One in six Australians, or 3.6 million people, suffer from some form of hearing loss. Cochlear has provided more than 750,000 hearing implants to people around the world over four decades, and helped children born deaf to hear for the first time. When Ms Young first had the implant, she said interpreting the signals was like learning a new language. "To me it sounded like a lot of magpies talking all at once in my head," she said. But with time and a little patience from friends and family, she was soon back where she wanted to be. "Six weeks after I got my implant, I went to the Deni Ute Muster in the front row and watched my country music," she said. "It has given me back my social aspect, my confidence ... It's just given me a new lease for life." She urged anyone noticing changes in their hearing to get checked. "I just want to suggest anybody that has trouble hearing or think they're having a difficulty - get onto it," she said. "Don't sit back like I did." Hearing implant developer and manufacturer Cochlear is sounding out the market, launching its latest implant and cutting earnings guidance on the same day. Weaker-than-expected sales forced the health technology company to trim net profit expectations to between $390 to $400 million, down from $410 million to $430 million, but still higher than FY24's $387 million result. Implant sales were expected to increase by around 10 per cent this financial year, with growth weighted to the emerging markets as expansion in developed markets undershot expectations. The update came as Cochlear launched its latest implant in Australia, the first of its kind with upgradeable firmware and internal memory. Investors opted to take the good news over the bad, sending Cochlear shares 0.4 per cent higher to $271.65 after dipping more than nine per cent at the market's open. Jenny Young, one of the first to try the new device, was in her late 40s when her audiologist told her she would need hearing aids. Phone conversations were hard, she needed friends and family to repeat themselves and the country music shows she loved had become muffled and unclear. "I just gave up because I didn't know what song was coming on," Ms Young, now 58, told AAP. She initially ignored her audiologist's advice until life became too difficult. "Sometimes you felt excluded, and you tended to exclude yourself because you weren't quite sure what was said, and you didn't want to pop in and embarrass yourself," Ms Young said. After mixed results with hearing aids, her audiologist suggested her for a trial of the Cochlear's new implant, the 8th generation of the device which directly stimulates the auditory nerve, as opposed to hearing aids which amplify sound. The new internal memory allowed users to store their personal hearing settings on the implant, while upgrades could improve the way the auditory nerve was stimulated, implant program director Robert Briggs said. "That's a big change, and in the longer run we're hoping new stimulation strategies will allow better clarity of hearing and better speech understanding," Professor Briggs told AAP. The new device was developed over a decade with the help of Cochlear's 600-strong research and development teams across six global centres. One in six Australians, or 3.6 million people, suffer from some form of hearing loss. Cochlear has provided more than 750,000 hearing implants to people around the world over four decades, and helped children born deaf to hear for the first time. When Ms Young first had the implant, she said interpreting the signals was like learning a new language. "To me it sounded like a lot of magpies talking all at once in my head," she said. But with time and a little patience from friends and family, she was soon back where she wanted to be. "Six weeks after I got my implant, I went to the Deni Ute Muster in the front row and watched my country music," she said. "It has given me back my social aspect, my confidence ... It's just given me a new lease for life." She urged anyone noticing changes in their hearing to get checked. "I just want to suggest anybody that has trouble hearing or think they're having a difficulty - get onto it," she said. "Don't sit back like I did."
