logo
Fertility CEO resigns after embryo transferred to wrong patient in major bungle

Fertility CEO resigns after embryo transferred to wrong patient in major bungle

Monash IVF CEO Michael Knaap resigned on June 12 just days after the fertility behemoth admitted to the transfer of the wrong embryo into a patient.
The board accepted Mr Knaap's resignation just two months after a similar incident occurred at a Brisbane clinic.
Monash IVF confirmed on June 10 that a patient was transferred her own embryo, rather than her partner's, at its Clayton clinic in Melbourne.
Monash IVF believes the June 5 bungle will "fall within the scope of its insurance coverage" as insurers were notified.
It comes two months after a Queensland woman gave birth to a stranger's child in an embryo mix-up at Monash IVF's Brisbane clinic.
Monash IVF said in a statement to the ASX that an internal investigation would be conducted.
The scope of an independent review into the Queensland mix-up, conducted by Fiona McLeod, would also be "extended", Monash IVF said.
Additional processes would be put in place at Monash IVF to avoid a similar mistake, the clinic said.
"Commencing immediately, Monash IVF will implement interim additional verification processes and patient confirmation safeguards over and above normal practice and electronic witness systems, to ensure patients and clinicians have every confidence in its processes," the clinic said.
"Whilst industry-leading electronic witness systems have and are being rolled out across Monash IVF, there remain instances and circumstances whereby manual witnessing is required.
"Monash IVF has disclosed the Incident to the relevant assisted reproductive technology (ART) regulators, namely the Reproductive Technology Accreditation Committee certifying body and Victorian Health Regulator.
The fertility clinic said it has "extended its sincere apologies to the affected couple".
University of Melbourne associate professor Alex Polyakov, a medical director of Genea Fertility Melbourne, said Australia's assisted reproduction sector was internationally recognised for its "rigorous oversight".
"The report of a second embryo transfer error is profoundly troubling and, while still extremely rare, shifts this issue from an isolated anomaly to one demanding broader reflection," he said.
"IVF clinics operate within some of the most highly regulated and scrutinised environments in medicine.
"Multiple safeguards, including dual verification and electronic tracking, exist at every step to prevent precisely this kind of error."
Monash IVF CEO Michael Knaap resigned on June 12 just days after the fertility behemoth admitted to the transfer of the wrong embryo into a patient.
The board accepted Mr Knaap's resignation just two months after a similar incident occurred at a Brisbane clinic.
Monash IVF confirmed on June 10 that a patient was transferred her own embryo, rather than her partner's, at its Clayton clinic in Melbourne.
Monash IVF believes the June 5 bungle will "fall within the scope of its insurance coverage" as insurers were notified.
It comes two months after a Queensland woman gave birth to a stranger's child in an embryo mix-up at Monash IVF's Brisbane clinic.
Monash IVF said in a statement to the ASX that an internal investigation would be conducted.
The scope of an independent review into the Queensland mix-up, conducted by Fiona McLeod, would also be "extended", Monash IVF said.
Additional processes would be put in place at Monash IVF to avoid a similar mistake, the clinic said.
"Commencing immediately, Monash IVF will implement interim additional verification processes and patient confirmation safeguards over and above normal practice and electronic witness systems, to ensure patients and clinicians have every confidence in its processes," the clinic said.
"Whilst industry-leading electronic witness systems have and are being rolled out across Monash IVF, there remain instances and circumstances whereby manual witnessing is required.
"Monash IVF has disclosed the Incident to the relevant assisted reproductive technology (ART) regulators, namely the Reproductive Technology Accreditation Committee certifying body and Victorian Health Regulator.
The fertility clinic said it has "extended its sincere apologies to the affected couple".
University of Melbourne associate professor Alex Polyakov, a medical director of Genea Fertility Melbourne, said Australia's assisted reproduction sector was internationally recognised for its "rigorous oversight".
"The report of a second embryo transfer error is profoundly troubling and, while still extremely rare, shifts this issue from an isolated anomaly to one demanding broader reflection," he said.
"IVF clinics operate within some of the most highly regulated and scrutinised environments in medicine.
"Multiple safeguards, including dual verification and electronic tracking, exist at every step to prevent precisely this kind of error."
Monash IVF CEO Michael Knaap resigned on June 12 just days after the fertility behemoth admitted to the transfer of the wrong embryo into a patient.
The board accepted Mr Knaap's resignation just two months after a similar incident occurred at a Brisbane clinic.
Monash IVF confirmed on June 10 that a patient was transferred her own embryo, rather than her partner's, at its Clayton clinic in Melbourne.
Monash IVF believes the June 5 bungle will "fall within the scope of its insurance coverage" as insurers were notified.
It comes two months after a Queensland woman gave birth to a stranger's child in an embryo mix-up at Monash IVF's Brisbane clinic.
Monash IVF said in a statement to the ASX that an internal investigation would be conducted.
The scope of an independent review into the Queensland mix-up, conducted by Fiona McLeod, would also be "extended", Monash IVF said.
Additional processes would be put in place at Monash IVF to avoid a similar mistake, the clinic said.
"Commencing immediately, Monash IVF will implement interim additional verification processes and patient confirmation safeguards over and above normal practice and electronic witness systems, to ensure patients and clinicians have every confidence in its processes," the clinic said.
"Whilst industry-leading electronic witness systems have and are being rolled out across Monash IVF, there remain instances and circumstances whereby manual witnessing is required.
"Monash IVF has disclosed the Incident to the relevant assisted reproductive technology (ART) regulators, namely the Reproductive Technology Accreditation Committee certifying body and Victorian Health Regulator.
The fertility clinic said it has "extended its sincere apologies to the affected couple".
University of Melbourne associate professor Alex Polyakov, a medical director of Genea Fertility Melbourne, said Australia's assisted reproduction sector was internationally recognised for its "rigorous oversight".
"The report of a second embryo transfer error is profoundly troubling and, while still extremely rare, shifts this issue from an isolated anomaly to one demanding broader reflection," he said.
"IVF clinics operate within some of the most highly regulated and scrutinised environments in medicine.
"Multiple safeguards, including dual verification and electronic tracking, exist at every step to prevent precisely this kind of error."
Monash IVF CEO Michael Knaap resigned on June 12 just days after the fertility behemoth admitted to the transfer of the wrong embryo into a patient.
The board accepted Mr Knaap's resignation just two months after a similar incident occurred at a Brisbane clinic.
Monash IVF confirmed on June 10 that a patient was transferred her own embryo, rather than her partner's, at its Clayton clinic in Melbourne.
Monash IVF believes the June 5 bungle will "fall within the scope of its insurance coverage" as insurers were notified.
It comes two months after a Queensland woman gave birth to a stranger's child in an embryo mix-up at Monash IVF's Brisbane clinic.
Monash IVF said in a statement to the ASX that an internal investigation would be conducted.
The scope of an independent review into the Queensland mix-up, conducted by Fiona McLeod, would also be "extended", Monash IVF said.
Additional processes would be put in place at Monash IVF to avoid a similar mistake, the clinic said.
"Commencing immediately, Monash IVF will implement interim additional verification processes and patient confirmation safeguards over and above normal practice and electronic witness systems, to ensure patients and clinicians have every confidence in its processes," the clinic said.
"Whilst industry-leading electronic witness systems have and are being rolled out across Monash IVF, there remain instances and circumstances whereby manual witnessing is required.
"Monash IVF has disclosed the Incident to the relevant assisted reproductive technology (ART) regulators, namely the Reproductive Technology Accreditation Committee certifying body and Victorian Health Regulator.
The fertility clinic said it has "extended its sincere apologies to the affected couple".
University of Melbourne associate professor Alex Polyakov, a medical director of Genea Fertility Melbourne, said Australia's assisted reproduction sector was internationally recognised for its "rigorous oversight".
"The report of a second embryo transfer error is profoundly troubling and, while still extremely rare, shifts this issue from an isolated anomaly to one demanding broader reflection," he said.
"IVF clinics operate within some of the most highly regulated and scrutinised environments in medicine.
"Multiple safeguards, including dual verification and electronic tracking, exist at every step to prevent precisely this kind of error."

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Scott Power: ASX stocks fall as investors hear mixed news from Cochlear
Scott Power: ASX stocks fall as investors hear mixed news from Cochlear

News.com.au

time36 minutes 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.

The collateral damage from Monash IVF's colossal embryo bungles
The collateral damage from Monash IVF's colossal embryo bungles

The Age

timea day ago

  • The Age

The collateral damage from Monash IVF's colossal embryo bungles

The next part of the script unusually involves activists calling for enhanced regulation or better laws. Advocates are also lobbying for all those who use assisted reproductive technology to have their babies DNA tested, which, if implemented, could uncover if other mistakes have gone undetected. And no scandal is complete without a politician or two making some hay by grabbing a microphone and castigating the culprits. Victorian Health Minister Mary-Anne Thomas was the first to step up this week, calling the embryo mix-up 'completely unacceptable'. 'It's very clear to me that the board of Monash IVF needs to have a very good look at what's going on,' Thomas said. Loading 'Clearly their clinical governance standards are not what they should be.' But amid the outrage there is another group that will also sustain collateral damage – the shareholders – although sympathy for this group will be way more muted. They have seen the share price of Monash IVF plunge after the first incident was revealed in April and after the company cut its 2025 full-year profit guidance by 11 per cent. It took another dive this week when the second implant bungle was revealed, taking this calendar year's stock performance down by 50 per cent. The shares kicked up by 5.7 per cent on Thursday on the news of the departing chief, but this represents a small recovery. Enter the investment bank analysts who use their sophisticated models to provide commentary on the impacts of these types of events on a company's market share and future earnings. In the case of Monash, their opinions run the gamut of possibilities. RBC Capital markets suggests that the fallout from the original bungle in Monash's Queensland clinic would confine the loss of market share to that state, and not impact too heavily on other state operations. But given there have now been two separate embryo transfer incidents in different states, it believes there is risk of a greater impact of a spread of reputational damage and market share losses. It has a negative stance on the stock. Macquarie Equities has a somewhat different view. It acknowledges the reputational damage, but says the stock is oversold and represents a good buying opportunity. You could characterise its advice as 'don't throw the baby out with the bathwater'.

The collateral damage from Monash IVF's colossal embryo bungles
The collateral damage from Monash IVF's colossal embryo bungles

Sydney Morning Herald

timea day ago

  • Sydney Morning Herald

The collateral damage from Monash IVF's colossal embryo bungles

The next part of the script unusually involves activists calling for enhanced regulation or better laws. Advocates are also lobbying for all those who use assisted reproductive technology to have their babies DNA tested, which, if implemented, could uncover if other mistakes have gone undetected. And no scandal is complete without a politician or two making some hay by grabbing a microphone and castigating the culprits. Victorian Health Minister Mary-Anne Thomas was the first to step up this week, calling the embryo mix-up 'completely unacceptable'. 'It's very clear to me that the board of Monash IVF needs to have a very good look at what's going on,' Thomas said. Loading 'Clearly their clinical governance standards are not what they should be.' But amid the outrage there is another group that will also sustain collateral damage – the shareholders – although sympathy for this group will be way more muted. They have seen the share price of Monash IVF plunge after the first incident was revealed in April and after the company cut its 2025 full-year profit guidance by 11 per cent. It took another dive this week when the second implant bungle was revealed, taking this calendar year's stock performance down by 50 per cent. The shares kicked up by 5.7 per cent on Thursday on the news of the departing chief, but this represents a small recovery. Enter the investment bank analysts who use their sophisticated models to provide commentary on the impacts of these types of events on a company's market share and future earnings. In the case of Monash, their opinions run the gamut of possibilities. RBC Capital markets suggests that the fallout from the original bungle in Monash's Queensland clinic would confine the loss of market share to that state, and not impact too heavily on other state operations. But given there have now been two separate embryo transfer incidents in different states, it believes there is risk of a greater impact of a spread of reputational damage and market share losses. It has a negative stance on the stock. Macquarie Equities has a somewhat different view. It acknowledges the reputational damage, but says the stock is oversold and represents a good buying opportunity. You could characterise its advice as 'don't throw the baby out with the bathwater'.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store