Latest news with #MichaelKnaap
The Age
4 days ago
- Health
- The Age
Trust in IVF is broken – it must be restored
The fertility industry in Australia is big business. Its annual revenue is $800 million. The two largest IVF companies, Virtus Health and Monash IVF, make more than half that money, revenue built on people's dreams and desperate hopes. The financial and emotional investment in making a dream of bringing a child into the world a reality is profound. IVF providers are often the last resort for aspiring parents when nature seems to have conspired against them. They are the facilitators of that hope. Patients put their trust in them. It should never be broken. And yet, as recent news reports and developments have shown, it is. This is unconscionable. This is human life after all. An error in the delivery of this precious gift is devastatingly traumatic to those involved. The Age has recently reported on two incidents involving Monash IVF. In one, a woman received the wrong embryo at its Clayton clinic in June, and in 2023 at its Brisbane facility, an embryo transfer error led to a Queensland woman giving birth to a stranger's baby. A few years earlier, Monash paid $56 million in compensation to settle a class action involving 700 families affected in a bungled genetic testing program. The error might have caused healthy embryos to be tossed out. Monash chief executive Michael Knaap resigned this month. Loading Australia's health ministers agreed last week to a three-month review to look into the best model for an independent accreditation body to oversee the assisted reproductive technology sector. The states' health secretaries will also examine a possible realignment of the state-based regulators, their axing for a national regulator, and if registration requirements should be extended to embryologists and scientists involved in fertility processes. The Age welcomes these developments. At present, the industry operates under a self-accreditation and licensing system under the Reproductive Technology Accreditation Committee. Queensland is the only state not to endorse a national body, having only recently adopted a regulation scheme. Victorian Health Minister Mary-Anne Thomas said last week that the present system was not working. 'It simply doesn't pass the pub test that the people that provide the service are also the ones that determine who provides the service,' she said. It is equally troubling that, as Thomas conceded, the errors that are made public may represent only a percentage of the true figure of fertility patient complications across the industry. 'I think it's concerning that, in fact, there may well be more errors that we don't know about, and that is because the body that currently accredits fertility care providers is made up of fertility care providers,' she said.
News.com.au
13-06-2025
- Business
- 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.
The Star
12-06-2025
- Business
- The Star
Australia's Monash IVF CEO quits days after second embryo mix-up in 2 months
BENGALURU: Australian fertility business Monash IVF said on Thursday (June 12) that chief executive officer and managing director Michael Knaap has resigned, days after the company disclosed a second fertility clinic mix-up within two months. Shares of the company ended the session 9.1 per cent higher, indicating the news helped alleviate investor concerns that had sent the stock plummeting 38 per cent in the two months since the first mix-up was revealed after market hours on April 10. The IVF provider's finance chief, Malik Jainudeen, has taken over as acting CEO. The company, which has not yet disclosed the reason behind Knaap's resignation, did not immediately respond to a Reuters request for comment. Knaap had served as Monash's CFO for more than three years before taking over as CEO in April 2019. The second mix-up, reported a few days ago, raised concerns about an industry that did not have much active government attention until recently. In April, the fertility company confirmed a mix-up at its Brisbane clinic, where a patient unknowingly gave birth to another couple's child after an embryo from a different patient was mistakenly transferred. "Monash IVF has a lot of work to do to win back public trust and confidence, (and) they need a strong leadership team to do that," said Mary-Anne Thomas, Victoria's Minister for Health. Jefferies analysts, in a note from June 10, said they believe publicity around these incidents will likely lead to Australian IVF market share losses in the shorter-to-medium term. - Reuters
Sky News AU
12-06-2025
- Business
- Sky News AU
ASX 200 see-saws on Thursday as Monash IVF rises following second embryo mix-up, CEO departing
The ASX 200 has see-sawed on Thursday with an embattled health company jumping and a luxury fashion brand nosediving. The index is up flat after the first hour of trading after jumping 0.2 per cent in the first 20 minutes. Qantas has soared 4.8 per cent, Beach Energy jumped four per cent and gold miner West African Resources added 3.8 per cent. Luxury fashion brand Cettire is down 21.5 per cent after its CEO warned of weaker US demand, despite revealing sales revenue was up 1.7 per cent year-on-year. Embattled healthcare company Monash IVF has jumped again on Thursday after the company dropped 26 per cent when it informed the public of a second embryo mix-up at a clinic. The company informed shareholders on Thursday its chief executive Michael Knaap was resigning, leading to a four per cent bump in the share price, and its CFO Malik Jainudeen was appointed acting CEO. 'Since his appointment in 2019, Michael has led the organisation through a period of significant growth and transformation, and we thank him for his years of dedicated service,' Monash IVF's statement read. The bourse hit a new high on Wednesday as it shot up more than half a per cent before sinking throughout the day. The Dow Jones fell flat on Wednesday while the S&P 500 sank 0.3 per cent and the Nasdaq dropped 0.5 per cent. London's FTSE 250 Index added 0.2 per cent, Germany's DAX fell 0.2 per cent and the STOXX Europe 600 dropped 0.3 per cent on Wednesday. New Zealand's NZX 50 Index is down 0.2 per cent on Thursday and Japan's Nikkei 225 has dropped 0.6 per cent.
Time of India
12-06-2025
- Business
- Time of India
Australia's Monash IVF CEO steps down days after reporting second embryo incident
Bengaluru: Australian fertility business Monash IVF said on Thursday its chief executive officer and managing director, Michael Knaap , had resigned, days after reporting a second fertility clinic mix-up over a two-month span. Shares of the company rose as much as 5.8 per cent to A$0.64 at open in Sydney, signaling the news has helped calm investor concerns that had led to a 42 per cent drop in Monash stock since the first mix-up was disclosed in April. The company did not give out a reason behind Knaap's resignation, and it did not immediately respond to a Reuters request for comment. Knaap previously served as Monash CFO for over three years and took over the CEO role in April 2019. The second mix-up, reported a couple of days ago, raised concerns around an industry that did not have much active government attention until recently. In April, the fertility company acknowledged that a patient at its Brisbane clinic had unknowingly given birth to another couple's child, following the accidental transfer of an embryo belonging to a different patient. The IVF provider's finance chief, Malik Jainudeen, has taken over as acting CEO. Jefferies analysts, in a note from June 10, said they believe publicity around these incidents is likely to lead to Australia IVF market share losses in the short-to-medium term. The brokerage forecast Monash to lose 73 basis points of market share in fiscal 2026.
