Latest news with #ISSCR
CNN
30-07-2025
- Health
- CNN
Could stem cells be used to create life without sperm or egg? Not yet, but here's why scientists are concerned
Scientists are exploring ways to mimic the origins of human life without two fundamental components: sperm and egg. They are coaxing clusters of stem cells – programmable cells that can transform into many different specialized cell types – to form laboratory-grown structures that resemble human embryos. These embryo models are far from perfect replicas. But as labs compete to grow the best likeness, the structures are becoming increasingly complex, looking and behaving in some way as embryos would. The structures could further the study of human development and the causes infertility. However, the dizzying pace of the research, which started little more than a decade ago, is posing ethical, legal and regulatory challenges for the field of developmental biology. 'We could have never anticipated the science would have just progressed like this. It's incredible, it's been transformative how quickly the field has moved, said Amander Clark, a professor of molecular cell and developmental biology at the University of California, Los Angeles, and the founding director of the UCLA Center for Reproductive Science, Health and Education. 'However, as these models advance, it is crucial that they are studied in a framework that balances scientific progress with ethical, legal and social considerations.' Clark is co-chair of the International Society of Stem Cell Research (ISSCR) Embryo Models Working Group, which is now trying to update such a framework on a global scale. At issue is the question of how far researchers could go with these stem cells, given time and the right conditions. Could scientists eventually replicate an actual embryo that has a heartbeat and experiences pain, or one that could grow into a fully developed human model? As current research stands, no model mimics the development of a human embryo in its entirety — nor is any model suspected of having the potential to form a fetus, the next stage in human development equivalent to week 8 or day 56 in a human pregnancy. Creating embryo models has also been a hit-and-miss process for most research groups, with only a small percentage of stem cells going on to self-organize into embryo-like structures. However, the models do exhibit several internal features and cell types that an embryo needs to develop, such as the amnion, yolk sac and primitive streak, and that could, 'with future improvements, eventually progress toward later embryo structures including heart, brain, and other organ rudiments,' according to a June paper coauthored by Clark and published in the journal Stem Cell Reports. Similar models made with mouse cells have reached the point where the brain begins to develop and a heart forms. Nobel laureate Jennifer Doudna tells Fareed about her path to becoming a leading scientist and explains how her discovery of CRISPR can help cure diseases and improve crops. Critically, the goal isn't to develop these models into viable fetuses, ultimately capable of human sentience, but to develop a useful research tool that unlocks the mysteries of how a human cell divides and reproduces to become a human body. The models also make way for experiments that can't be performed on donated embryos in a lab. However, it's possible as research advances that the distinction between a lab-grown model and a living human embryo could become blurred. And because the models lie at the intersection of historically controversial fields — stem cell biology and embryology — the work merits closer oversight than other forms of scientific research, Clark said. Clark and the ISSCR's Embryo Models Working Group in June recommended enhanced oversight of research involving the models. The society's guidelines, which first included guidance on embryo models in 2021, are being revised to incorporate the recommendations of the group and will be released in a few weeks. The current ISSCR guidelines make a distinction between 'integrated embryo models' that replicate the entire embryo, and 'non-integrated models' that replicate just one part of an embryo, requiring stricter oversight of the former. The updated guidelines will instead recommend that all research involving both types of embryo models should undergo 'appropriate ethical and scientific review.' The proposed update will also set out two red lines: The current guidance already prohibits the transfer of human embryo models into a human or animal uterus. The updated version will also advise scientists not use human embryo models to pursue ectogenesis: the development of an embryo outside the human body via the use of artificial wombs — essentially creating life from scratch. According to Clark, the stem cell-based embryo models she and other research teams work on should be considered distinct from research on actual human embryos, usually surplus IVF embryos donated to science. Such research is tightly regulated in many countries, and banned in others, including Germany, Austria and Italy. It makes sense, at least for now, to treat models and real embryos differently, said Emma Cave, a professor of healthcare law at Durham University in the UK who works on embryo models. She uses diamonds as an analogy: Natural diamonds and their commercially lab-grown equivalents are made from the same chemical components, but society assigns them different values. She cautioned there shouldn't be a rush to regulate embryo models too quickly in case it shuts down promising research. 'We are at an early stage in their development, where it could be that in 5, 10, 15, 20 years, that they could look very like a human embryo, or it might be they never get to that stage,' she said. As the scientific research unfolds, oversight of embryo models is taking different shapes in different jurisdictions. Australia has taken the strictest approach. It includes embryo models within the regulatory framework that governs the use of human embryos, requiring a special permit for research. The Netherlands in 2023 similarly proposed treating 'non-conventional embryos' the same as human embryos in the eyes of the law. The proposal is still under discussion, according to the Health Council of the Netherlands. Researchers in the United Kingdom released a voluntary code of conduct in 2024, and Japan has also issued new guidelines governing research in the field. In the United States, embryo models aren't covered by any specific legal framework, and research proposals are considered by individual institutions and funding bodies, Clark noted. The National Institutes of Health said in 2021 that it would consider applications for public funding of research into embryo models on a case-by-case basis and monitor developments to understand the capabilities of these models. Few other countries, however, appear poised to adopt specific legislation on embryo models, making the guidelines issued by the ISSCR a 'highly influential' reference for researchers around the world, according to the Nuffield Council on Bioethics, a London-based organization that advises on ethical issues in biomedicine. The council said in a November 2024 report that international guidelines were key to avoid 'research being carried out that does not meet high ethical and scientific standards; this in turn could impact on the national public perception of risk, leading to a more risk-averse approach that hinders responsible scientific development.' Clark said the ISSCR's updated voluntary guidelines would help scientific funding bodies around the world better evaluate applications and publishers of research understand whether work was performed in an ethically responsible way, particularly in places where the law or other guidelines don't take embryo models into account. The future challenge for regulators is to understand when and whether an embryo model would be functionally the same as a human embryo and therefore potentially afforded the same or similar protection as those surrounding human embryos, said Naomi Moris, group leader at The Francis Crick Institute's developmental models laboratory. The only definitive test would be to transfer the model into the uterus of a surrogate, a move that's forbidden by current bioethical standards. However, Moris is among a group of researchers that has proposed to two tipping points or 'Turing tests' — inspired by computer scientist Alan Turing's way of determining whether machines can think like humans — to evaluate when distinctions between a lab-gown model and a human embryo would disappear. 'These things are not embryos at the moment, they clearly don't have the same capacity as an embryo does. But how would we know ahead of time that we were approaching that?' Moris said. 'That was the logic behind it. What metrics would we use as a kind of proxy for the potential of an embryo model that might then suggest that it was at least approaching the same sorts of equivalency as an embryo.' The first test would measure whether the models can be consistently produced and faithfully develop over a given period as normal embryos would. The second test would assess when animal stem cell embryo models — particularly animals closest to humans such as monkeys — show the potential to form living and fertile animals when transferred into surrogate animal wombs, thus suggesting that the same outcome would in theory be possible for human embryo models. That hasn't happened yet, but Chinese researchers in 2023 created embryo models from the stem cells of macaque monkeys that when implanted in a surrogate monkey triggered signs of early pregnancy. Proponents of the technology say the models offer an equally, and possibly more, useful, ethical alternative to research on scarce and precious human embryos. The models have the potential to be produced at scale in a lab to screen drugs for embryo toxicology, a impactful application given that pregnant women have often been excluded from drug trials because of safety concerns. Yet, the potential for these models to be used in the creation of life has been cause for worry among bioethicists. 'There are commercial and other groups raising the possibility of building an embryo in vitro and combining different bioengineering approaches to bring such an entity to viability,' according to the June paper coauthored by Clark and other members of the ISSCR's embryo model working group. 'Currently the practice of bringing an SCBEM (stem cell-based embryo model) to viability is considered unsafe and unethical and should not be pursued,' the study noted. Cave said ectogenesis may sound like the realm of science fiction, but it isn't impossible. As embryo models continue to be developed, and separate research is advancing into artificial wombs, the two technologies could meet, Cave said. The challenge, she added, is recognizing the value of these research paths but at the same time preventing misuse. Jun Wu, an associate professor at the Department of Molecular Biology at the University of Texas Southwestern is one of a number of stem cell biologists involved in the field. He agreed that ectogenesis should be off the table but explained that researchers developing embryo models must engage in a delicate dance: To the unlock the mysteries of the human embryo, models have to resemble embryos closely enough to offer real insight but they must not resemble them so closely that they risk being viewed as viable. Magdalena Zernicka-Geotz, the Bren professor of biology and biological engineering at Caltech, said she welcomed the new guidelines. She announced in 2023 that her team had succeeded in a world first: growing embryo-like models to a stage resembling 14-day-old embryos. Later the same year, Jacob Hanna, a professor of stem cell biology and embryology at the Weizmann Institute of Science in Israel, said his team had gone a step further with a model derived from skin cells that showed all the cell types that are essential for an embryo's development — including the precursor of the placenta. Together the work represented a breakthrough for the models' potential use in research on pregnancy loss: At 14 days the human embryo has begun to attach to the lining of the uterus, a process known as implantation. Many miscarriages occur around this stage, Zernicka-Geotz said. Lab research on human embryos beyond 14 days, including those donated from IVF treatments, is prohibited in most jurisdictions. And while some scientists do study tissue obtained from abortions, such tissue is limited because few procedures take place between week 2 and week 4 of an embryo's development. The ability to grow an embryo model outside of a womb at this developmental stage paves the way for studies that are not possible in living human embryos. 'Far more pregnancies fail than succeed during the critical window just before, during and immediately after implantation. This is why we created in my lab the embryo-like structures from stem cells as a way to really understand this critical and so highly fragile stage of development,' Zernicka-Goetz said. Clark agreed that embryo models could potentially be used to address infertility problems: 'Implantation. It's the big black box. Once the embryo implants in the uterus, we understand very little about the development,' Clark added. 'And if we can't study it, we don't know what we're missing.'
CNN
30-07-2025
- Health
- CNN
Could stem cells be used to create life without sperm or egg? Not yet, but here's why scientists are concerned
Scientists are exploring ways to mimic the origins of human life without two fundamental components: sperm and egg. They are coaxing clusters of stem cells – programmable cells that can transform into many different specialized cell types – to form laboratory-grown structures that resemble human embryos. These embryo models are far from perfect replicas. But as labs compete to grow the best likeness, the structures are becoming increasingly complex, looking and behaving in some way as embryos would. The structures could further the study of human development and the causes infertility. However, the dizzying pace of the research, which started little more than a decade ago, is posing ethical, legal and regulatory challenges for the field of developmental biology. 'We could have never anticipated the science would have just progressed like this. It's incredible, it's been transformative how quickly the field has moved, said Amander Clark, a professor of molecular cell and developmental biology at the University of California, Los Angeles, and the founding director of the UCLA Center for Reproductive Science, Health and Education. 'However, as these models advance, it is crucial that they are studied in a framework that balances scientific progress with ethical, legal and social considerations.' Clark is co-chair of the International Society of Stem Cell Research (ISSCR) Embryo Models Working Group, which is now trying to update such a framework on a global scale. At issue is the question of how far researchers could go with these stem cells, given time and the right conditions. Could scientists eventually replicate an actual embryo that has a heartbeat and experiences pain, or one that could grow into a fully developed human model? As current research stands, no model mimics the development of a human embryo in its entirety — nor is any model suspected of having the potential to form a fetus, the next stage in human development equivalent to week 8 or day 56 in a human pregnancy. Creating embryo models has also been a hit-and-miss process for most research groups, with only a small percentage of stem cells going on to self-organize into embryo-like structures. However, the models do exhibit several internal features and cell types that an embryo needs to develop, such as the amnion, yolk sac and primitive streak, and that could, 'with future improvements, eventually progress toward later embryo structures including heart, brain, and other organ rudiments,' according to a June paper coauthored by Clark and published in the journal Stem Cell Reports. Similar models made with mouse cells have reached the point where the brain begins to develop and a heart forms. Nobel laureate Jennifer Doudna tells Fareed about her path to becoming a leading scientist and explains how her discovery of CRISPR can help cure diseases and improve crops. Critically, the goal isn't to develop these models into viable fetuses, ultimately capable of human sentience, but to develop a useful research tool that unlocks the mysteries of how a human cell divides and reproduces to become a human body. The models also make way for experiments that can't be performed on donated embryos in a lab. However, it's possible as research advances that the distinction between a lab-grown model and a living human embryo could become blurred. And because the models lie at the intersection of historically controversial fields — stem cell biology and embryology — the work merits closer oversight than other forms of scientific research, Clark said. Clark and the ISSCR's Embryo Models Working Group in June recommended enhanced oversight of research involving the models. The society's guidelines, which first included guidance on embryo models in 2021, are being revised to incorporate the recommendations of the group and will be released in a few weeks. The current ISSCR guidelines make a distinction between 'integrated embryo models' that replicate the entire embryo, and 'non-integrated models' that replicate just one part of an embryo, requiring stricter oversight of the former. The updated guidelines will instead recommend that all research involving both types of embryo models should undergo 'appropriate ethical and scientific review.' The proposed update will also set out two red lines: The current guidance already prohibits the transfer of human embryo models into a human or animal uterus. The updated version will also advise scientists not use human embryo models to pursue ectogenesis: the development of an embryo outside the human body via the use of artificial wombs — essentially creating life from scratch. According to Clark, the stem cell-based embryo models she and other research teams work on should be considered distinct from research on actual human embryos, usually surplus IVF embryos donated to science. Such research is tightly regulated in many countries, and banned in others, including Germany, Austria and Italy. It makes sense, at least for now, to treat models and real embryos differently, said Emma Cave, a professor of healthcare law at Durham University in the UK who works on embryo models. She uses diamonds as an analogy: Natural diamonds and their commercially lab-grown equivalents are made from the same chemical components, but society assigns them different values. She cautioned there shouldn't be a rush to regulate embryo models too quickly in case it shuts down promising research. 'We are at an early stage in their development, where it could be that in 5, 10, 15, 20 years, that they could look very like a human embryo, or it might be they never get to that stage,' she said. As the scientific research unfolds, oversight of embryo models is taking different shapes in different jurisdictions. Australia has taken the strictest approach. It includes embryo models within the regulatory framework that governs the use of human embryos, requiring a special permit for research. The Netherlands in 2023 similarly proposed treating 'non-conventional embryos' the same as human embryos in the eyes of the law. The proposal is still under discussion, according to the Health Council of the Netherlands. Researchers in the United Kingdom released a voluntary code of conduct in 2024, and Japan has also issued new guidelines governing research in the field. In the United States, embryo models aren't covered by any specific legal framework, and research proposals are considered by individual institutions and funding bodies, Clark noted. The National Institutes of Health said in 2021 that it would consider applications for public funding of research into embryo models on a case-by-case basis and monitor developments to understand the capabilities of these models. Few other countries, however, appear poised to adopt specific legislation on embryo models, making the guidelines issued by the ISSCR a 'highly influential' reference for researchers around the world, according to the Nuffield Council on Bioethics, a London-based organization that advises on ethical issues in biomedicine. The council said in a November 2024 report that international guidelines were key to avoid 'research being carried out that does not meet high ethical and scientific standards; this in turn could impact on the national public perception of risk, leading to a more risk-averse approach that hinders responsible scientific development.' Clark said the ISSCR's updated voluntary guidelines would help scientific funding bodies around the world better evaluate applications and publishers of research understand whether work was performed in an ethically responsible way, particularly in places where the law or other guidelines don't take embryo models into account. The future challenge for regulators is to understand when and whether an embryo model would be functionally the same as a human embryo and therefore potentially afforded the same or similar protection as those surrounding human embryos, said Naomi Moris, group leader at The Francis Crick Institute's developmental models laboratory. The only definitive test would be to transfer the model into the uterus of a surrogate, a move that's forbidden by current bioethical standards. However, Moris is among a group of researchers that has proposed to two tipping points or 'Turing tests' — inspired by computer scientist Alan Turing's way of determining whether machines can think like humans — to evaluate when distinctions between a lab-gown model and a human embryo would disappear. 'These things are not embryos at the moment, they clearly don't have the same capacity as an embryo does. But how would we know ahead of time that we were approaching that?' Moris said. 'That was the logic behind it. What metrics would we use as a kind of proxy for the potential of an embryo model that might then suggest that it was at least approaching the same sorts of equivalency as an embryo.' The first test would measure whether the models can be consistently produced and faithfully develop over a given period as normal embryos would. The second test would assess when animal stem cell embryo models — particularly animals closest to humans such as monkeys — show the potential to form living and fertile animals when transferred into surrogate animal wombs, thus suggesting that the same outcome would in theory be possible for human embryo models. That hasn't happened yet, but Chinese researchers in 2023 created embryo models from the stem cells of macaque monkeys that when implanted in a surrogate monkey triggered signs of early pregnancy. Proponents of the technology say the models offer an equally, and possibly more, useful, ethical alternative to research on scarce and precious human embryos. The models have the potential to be produced at scale in a lab to screen drugs for embryo toxicology, a impactful application given that pregnant women have often been excluded from drug trials because of safety concerns. Yet, the potential for these models to be used in the creation of life has been cause for worry among bioethicists. 'There are commercial and other groups raising the possibility of building an embryo in vitro and combining different bioengineering approaches to bring such an entity to viability,' according to the June paper coauthored by Clark and other members of the ISSCR's embryo model working group. 'Currently the practice of bringing an SCBEM (stem cell-based embryo model) to viability is considered unsafe and unethical and should not be pursued,' the study noted. Cave said ectogenesis may sound like the realm of science fiction, but it isn't impossible. As embryo models continue to be developed, and separate research is advancing into artificial wombs, the two technologies could meet, Cave said. The challenge, she added, is recognizing the value of these research paths but at the same time preventing misuse. Jun Wu, an associate professor at the Department of Molecular Biology at the University of Texas Southwestern is one of a number of stem cell biologists involved in the field. He agreed that ectogenesis should be off the table but explained that researchers developing embryo models must engage in a delicate dance: To the unlock the mysteries of the human embryo, models have to resemble embryos closely enough to offer real insight but they must not resemble them so closely that they risk being viewed as viable. Magdalena Zernicka-Geotz, the Bren professor of biology and biological engineering at Caltech, said she welcomed the new guidelines. She announced in 2023 that her team had succeeded in a world first: growing embryo-like models to a stage resembling 14-day-old embryos. Later the same year, Jacob Hanna, a professor of stem cell biology and embryology at the Weizmann Institute of Science in Israel, said his team had gone a step further with a model derived from skin cells that showed all the cell types that are essential for an embryo's development — including the precursor of the placenta. Together the work represented a breakthrough for the models' potential use in research on pregnancy loss: At 14 days the human embryo has begun to attach to the lining of the uterus, a process known as implantation. Many miscarriages occur around this stage, Zernicka-Geotz said. Lab research on human embryos beyond 14 days, including those donated from IVF treatments, is prohibited in most jurisdictions. And while some scientists do study tissue obtained from abortions, such tissue is limited because few procedures take place between week 2 and week 4 of an embryo's development. The ability to grow an embryo model outside of a womb at this developmental stage paves the way for studies that are not possible in living human embryos. 'Far more pregnancies fail than succeed during the critical window just before, during and immediately after implantation. This is why we created in my lab the embryo-like structures from stem cells as a way to really understand this critical and so highly fragile stage of development,' Zernicka-Goetz said. Clark agreed that embryo models could potentially be used to address infertility problems: 'Implantation. It's the big black box. Once the embryo implants in the uterus, we understand very little about the development,' Clark added. 'And if we can't study it, we don't know what we're missing.'
Yahoo
13-06-2025
- Business
- Yahoo
Medera and Novoheart Presented Breakthroughs in Human mini-Heart Platforms and Gene Therapy at ISSCR 2025
Showcased 7 presentations at ISSCR 2025, including a featured oral presentation on first-in-human gene therapy for heart failure, powered by their proprietary human mini-Heart technology. FDA-backed human-based screening platform recognized as an animal-free alternative in drug development, supporting IND and Fast Track approvals under the FDA Modernization Act 2.0. Breakthroughs in high-throughput screening, AI-driven drug classification, and patient-specific disease modelling underscored the platform's potential to de-risk development and accelerate clinical translation. BOSTON, June 13, 2025 (GLOBE NEWSWIRE) -- Medera Inc. ('Medera'), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing a range of next-generation therapeutics, and Novoheart, its wholly owned pre-clinical subsidiary pioneering human-based cardiac tissue engineering for disease modelling and drug screening, today announced the successful presentation of seven scientific abstracts at the 2025 International Society for Stem Cell Research (ISSCR) Annual Meeting, held June 11–14 in Hong Kong. The annual ISSCR meeting brought together nearly 4,000 of the world's leading stem cell researchers and regenerative medicine experts. Medera's presentations showcased how the company's human mini-Heart technology has informed and accelerated clinical translation of novel gene therapies, including two ongoing first-in-human clinical trials for heart failure. 'Regulatory momentum is clearly building toward human-specific models in place of traditional animal testing,' said Ronald Li, PhD, CEO and co-founder of Medera and Novoheart. 'At ISSCR 2025, we demonstrated that engineered human mini-Hearts not only predict human outcomes better, as well as directly support clinical and regulatory decisions—including trial design and therapeutic validation.' 'The advances in human mini-Heart platforms presented at ISSCR exemplify the translational promise of stem cell technologies,' said Dr. Kevin Costa, co-founder of Novoheart. 'By creating more physiologically relevant human cardiac tissues, we significantly reduce the time and cost of bringing new therapies to patients while aligning with evolving FDA guidance on alternatives to animal testing.' Featured Oral Presentation 'Gene Therapy Clinical Trial for Heart Failure with Preserved Ejection Fraction (MUSIC-HFpEF) Informed by In Vitro Screening with Stem Cell-Based Bioengineered Mini-Hearts' (Abstract #2036995)Track: Clinical ApplicationsPresenter: Dr. Kevin Costa, co-founder of NovoheartThis presentation showcased how data generated from Novoheart's human mini-Heart platform informed both the FDA's Investigational New Drug (IND) approval and Fast Track Designation of the MUSIC-HFpEF gene therapy trial (NCT06061549). The trial is investigating SRD-002, a one-time gene therapy treatment delivered through proprietary minimally invasive intracoronary infusion methodology. The FDA's recognition of these in vitro human cardiac models reflects a broader regulatory embrace of non-animal technologies to advance safer and more targeted therapies, in line with new federal policy. Poster Highlights 'Reversal of Contractile Defects in Engineered Human Tissue Models of Heart Failure with Preserved Ejection Fraction (HFpEF) Leads to First-In-Human Gene Therapy Clinical Trial' (Abstract #2035967)Track: Disease Modeling and Drug DiscoveryThis poster described how disease-specific mini-Heart models enabled rational dose selection and mechanistic insight into SERCA2a-targeted AAV gene therapy now in clinical trials for HFpEF. 'Modulation of SERCA2a of Intra-Myocytic Calcium Trafficking in Patients with Heart Failure with Reduced Ejection Fraction (MUSIC-HFrEF) and Stem Cell Models of Heart Failure' (Abstract #2036913)Track: Clinical ApplicationsThis presentation detailed how mini-Heart models supported the ongoing MUSIC-HFrEF trial (NCT04703842) evaluating SRD-001 gene therapy for patients with HFrEF. 'Enhanced Drug Classification Using Machine Learning with Multiplexed Cardiac Contractility Assays' (Abstract #2035910)Track: Disease Modeling and Drug DiscoveryNovel ensemble algorithms trained on contractility and electrophysiology data from human cardiac tissues were demonstrated to outperform conventional approaches for drug classification. 'Automating High-Throughput Screening of Cardiac Contractility by Robotically Controlled Functional Testing of Stem Cell-Derived Micro-Tissues in a 96-Well Plate Format' (Abstract #2036321)Track: Disease Modeling and Drug DiscoveryThis technology was shown to reduce cell use and screening time by over 90%, scaling up human-relevant cardiac safety and efficacy profiling. 'Collagen Matrix Improves Cardiomyocyte Contractility and Maturity Compared to Fibrin in 3D Engineered hiPSC Cardiac Tissue Strips' (Abstract #2036017)Track: Disease Modeling and Drug DiscoveryThe researchers demonstrated how matrix optimization yields more physiologically relevant tissue phenotypes for improved drug screening and disease modeling. 'Transcriptomic Analysis and Bioengineered Tissue Model of Dystrophinopathy with Patient-Derived iPSC-Cardiomyocytes" (Abstract #2035586)Track: Disease Modeling and Drug DiscoveryA personalized medicine platform was presented for understanding and treating rare genetic cardiomyopathies such as Duchenne Muscular Dystrophy-associated cardiomyopathy. These advances underscore the transformative role of human organoid technologies in bridging the lab-to-clinic gap while helping to realize the vision of ethical, efficient, and precision-driven biomedical innovation. On September 5, 2024, Medera and Keen Vision Acquisition Corporation ('KVAC') (NASDAQ: KVAC, KVACW), announced they had entered into a definitive merger agreement. About Heart Failure with Preserved Ejection Fraction (HFpEF) Heart failure (HF) is a global pandemic with an estimated 64.3 million cases worldwide and a rising prevalence trend. Accounting for 50% or more of the overall HF population, HFpEF is an age-related condition that has become increasingly prevalent in recent years. This surge is partly due to better awareness and identification of the condition and partly due to lifestyle changes affecting cardiac myocytes. Individuals affected by HFpEF experience similar morbidity and mortality to patients with HF with reduced ejection fraction (HFrEF). Despite the growing epidemic of this emerging syndrome, HFpEF-focused interventional trials have had little success, except for the use of sacubitril-valsartan (Entresto™) and the sodium glucose transporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance™) for reducing cardiovascular mortality and heart failure hospitalization. However, these agents are not disease-modifying, highlighting the critical need for therapeutic interventions targeting the physiological mechanisms involved in HFpEF. About Medera Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via its two preclinical and clinical business units, Novoheart and Sardocor, respectively. Novoheart capitalizes on the world's first and award-winning 'mini-Heart' Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart's versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart's technology platform for their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor's lead therapeutic candidates that are currently in clinical trials. Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart's human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-associated Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor's pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases. For more information, please visit About Keen Vision Acquisition Corporation Keen Vision Acquisition Corp ("KVAC"), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance ("ESG") imperatives. For more information, please visit Forward-Looking Statements Certain statements included in this press release are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are also forward-looking statements. In some cases, you can identify forward-looking statements by words such as "estimate," "plan," "project," "forecast," "intend," "expect," "anticipate," "believe," "seek," "strategy," "future," "opportunity," "may," "target," "should," "will," "would," "will be," "will continue," "will likely result," "preliminary," or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements include, without limitation, KVAC's, Medera's, or their respective management teams' expectations concerning the outlook for their or Medera's business, productivity, plans, and goals for future operational improvements and capital investments, operational performance, future market conditions, or economic performance and developments in the capital and credit markets and expected future financial performance, including expected net proceeds, expected additional funding, the percentage of redemptions of KVAC's public shareholders, growth prospects and outlook of Medera' operations, individually or in the aggregate, including the achievement of project milestones, commencement and completion of commercial operations of certain of Medera's projects, as well as any information concerning possible or assumed future results of operations of Medera. Forward-looking statements also include statements regarding the expected benefits of the transactions contemplated by the merger ("Transaction"). The forward-looking statements are based on the current expectations of the respective management teams of Medera and KVAC, as applicable, and are inherently subject to uncertainties and changes in circumstance and their potential effects. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, (i) the risk that the Transaction may not be completed in a timely manner or at all, which may adversely affect the price of KVAC's securities; (ii) the risk that the Transaction may not be completed by KVAC's business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by KVAC; (iii) the failure to satisfy the conditions to the consummation of the Transaction, including the adoption of the Merger Agreement by the shareholders of KVAC and the receipt of certain regulatory approvals; (iv) market risks; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; (vi) the effect of the announcement or pendency of the Transaction on Medera's business relationships, performance, and business generally; (vii) the outcome of any legal proceedings that may be instituted against Medera or KVAC related to the Merger Agreement or the Transaction; (viii) failure to realize the anticipated benefits of the Transaction; (ix) the inability to maintain the listing of KVAC's securities or to meet listing requirements and maintain the listing of Medera's securities on Nasdaq; (x) the inability to implement business plans, forecasts, and other expectations after the completion of the Transaction, identify and realize additional opportunities, and manage its growth and expanding operations; (xi) risks related to Medera's ability to develop, license or acquire new therapeutics; (xii) the risk that Medera will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (xiii) the risk of product liability or regulatory lawsuits or proceedings relating to Medera's business; (xiv) uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; (xv) risks related to regulatory review, and approval and commercial development; (xvi) risks associated with intellectual property protection; (xvii) Medera's limited operating history and risk that it may never successfully commercialise its products; (xviii) Medera expects to continue to incur significant losses and may never achieve or maintain profitability; and (xix) the risk that additional financing in connection with the Transaction may not be raised on favorable terms. The foregoing list is not exhaustive, and there may be additional risks that neither KVAC nor Medera presently knows or that KVAC and Medera currently believe are immaterial. You should carefully consider the foregoing factors, any other factors discussed in this press release and the other risks and uncertainties described in the "Risk Factors" section of KVAC's Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 29, 2024, the risks to be described in the registration statement, which will include a preliminary proxy statement/prospectus, and those discussed and identified in filings made with the SEC by KVAC from time to time. Medera and KVAC caution you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth in this press release speak only as of the date of this press release. Neither Medera nor KVAC undertakes any obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs. In the event that any forward-looking statement is updated, no inference should be made that Medera or KVAC will make additional updates with respect to that statement, related matters, or any other forward-looking statements. Any corrections or revisions and other important assumptions and factors that could cause actual results to differ materially from forward-looking statements, including discussions of significant risk factors, may appear, up to the consummation of the Transaction, in KVAC's public filings with the SEC, and which you are advised to review carefully. Important Information for Investors and Shareholders In connection with the Transaction, KVAC and Medera filed a registration statement with the SEC, which includes a prospectus with respect to the securities to be issued in connection with the Transaction and a proxy statement to be distributed to holders of KVAC's ordinary shares in connection with KVAC's solicitation of proxies for the vote by KVAC's shareholders with respect to the Transaction and other matters to be described in the Registration Statement (the "Proxy Statement"). After the SEC declares the registration statement effective, KVAC plans to mail copies to shareholders of KVAC as of a record date to be established for voting on the Transaction. This press release does not contain all the information that should be considered concerning the Transaction and is not a substitute for the registration statement, Proxy Statement or for any other document that KVAC may file with the SEC. Before making any investment or voting decision, investors and security holders of KVAC are urged to read the registration statement and the Proxy Statement, and any amendments or supplements thereto, as well as all other relevant materials filed or that will be filed with the SEC in connection with the Transaction as they become available because they will contain important information about, Medera, KVAC and the Transaction. Investors and security holders will be able to obtain free copies of the registration statement, the Proxy Statement and all other relevant documents filed or that will be filed with the SEC by KVAC through the website maintained by the SEC at In addition, the documents filed by KVAC may be obtained free of charge from KVAC's website at or by directing a request to info@ The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release. Participants in the Solicitation KVAC, Medera and their respective directors, executive officers and other members of management and employees may, under the rules of the SEC, be deemed to be participants in the solicitations of proxies in connection with the Transaction. For more information about the names, affiliations and interests of KVAC's directors and executive officers, please refer to KVAC's annual report on Form 10-K filed with the SEC on March 29, 2024, which can be found at and registration statement, Proxy Statement and other relevant materials filed with the SEC in connection with the Transaction when they become available. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, which may, in some cases, be different than those of KVAC's shareholders generally, will be included in the registration statement and the Proxy Statement and other relevant materials when they are filed with the SEC when they become available. Shareholders, potential investors and other interested persons should read the registration statement and the Proxy Statement and other such documents carefully, when they become available, before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above. No Offer or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in the Transaction shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Contacts: Keen Vision Acquisition CorporationAlex DavidkhanianChief Financial OfficerEmail: MederaInvestor RelationsStephanie CarringtonICR 277-1282 Media RelationsSean LeousICR 866-4012
Yahoo
12-06-2025
- Health
- Yahoo
Hong Kong Hosts World's Largest ISSCR Stem Cell Gathering for the First Time
Some 2,400 stem cell and regenerative medicine pioneers convene to chart new frontiers, resulting from bidding efforts of Hong Kong Convention Ambassadors of the Hong Kong Tourism Board HONG KONG, HK / / June 11, 2025 / Reputed to be a leading research and development (R&D) hub for medical sciences, Hong Kong hosts the world's largest and most significant gathering of stem cell research and regenerative medicine, the International Society of Stem Cell Research (ISSCR) 2025 Annual Meeting. The event is brought to Hong Kong for the first time, thanks to the joint effort of three local universities - The University of Hong Kong, The Chinese University of Hong Kong and the Hong Kong University of Science and Technology, which are appointed organisations under the Hong Kong Convention Ambassador (HKCA) programme of the Hong Kong Tourism Board (HKTB). The four-day meeting held on June 11-14 gathers more than 2,400 local and international experts in stem cell research and regenerative medicine from 58 countries and regions, from Asia to North America, Europe, Australia, the Middle East, and Mainland China. Pioneers share the latest advances in the field, with topics spanning the field of regenerative medicine including topics such as advances in cell therapies, fundamental discoveries, understanding disease processes and more. Dr Peter Lam, HKTB Chairman, said, "The International Society for Stem Cell Research (ISSCR) is a globally leading organisation in medical sciences and research, and its annual meeting is one of the world's most significant international academic conventions in medical science. Hong Kong is the first city chosen to host this annual event in Asia after a 13-year hiatus, underscoring the city's status as the 'World's Meeting Place'. I am grateful for the active participation of the Hong Kong Convention Ambassadors from the three local universities, who leveraged their influence and network during the bidding for the host of the event to make the event come true. We are also delighted to see that more professionals from a wider range of expertise are joining HKTB's league of Convention Ambassadors, and we believe their participation can help identify and contribute to the staging of more significant international events in Hong Kong." Valentina Greco, ISSCR President, remarked, "Hosting ISSCR 2025 in Hong Kong marks a defining moment for global stem cell science. As a vibrant research hub at the crossroads of Asia and the world, Hong Kong offers an ideal setting to connect diverse scientific communities, spark new collaborations, and accelerate innovation. The ISSCR is deeply grateful to the city of Hong Kong and to our generous co-sponsors - the University of Hong Kong, The Chinese University of Hong Kong, and the Hong Kong University of Science and Technology - for their support and commitment to bringing The Global Stem Cell Event to this beautiful city. With the unwavering support of the Hong Kong Tourism Board, these three leading universities, and inspired leadership from our 2025 Annual Meeting Program Committee, this meeting exemplifies the power of partnership and shared vision. We are proud to return to Asia for the first time in more than a decade at a time when our collective progress in stem cell research and regenerative medicine and to advancing therapies that have life altering impact on patients depends on the exchange of bold ideas across borders." The extensive programme features plenary sessions, concurrent tracks, poster presentations, and networking opportunities. Contributing to the success of the event, the HKTB has provided comprehensive support, from arranging reconnaissance to venue sourcing, bid proposal, network support and more. Hong Kong Convention Ambassador Programme Aligns a Record Lineup of 180 Industry Leaders HKTB hosted the "Hong Kong Conference Ambassador Appreciation Night" last year to honor the contributions of the ambassadors in reinforcing Hong Kong as a "World Meeting Place" Hong Kong Convention Ambassadors from the Mainland recently participated in a business forum. HKCAs have been instrumental in winning the ISSCR 2025 Annual Meeting for Hong Kong. Launched in 2020 by the HKTB as a strategic initiative, the HKCA programme recruits high-level representatives of Hong Kong's eight universities, chambers of commerce, professional organisations, public bodies, industrial entities and professional societies to act as ambassadors for Hong Kong's convention sector. With their professional influence and networks, HKCAs have led efforts to bring in events ranging from medical sciences to innovation and technology (I&T), financial services, aviation, transportation and more. The close collaboration between HKCAs and the HKTB has proven effective in promoting Hong Kong as a premier hub for world-class conventions. As an alliance of distinguished local and Mainland leaders in business, medicine, professional services, I&T and other fields, the HKCA programme has been growing from strength to strength, with 72 new members in the latest record-sized cohort for the 2025-2026 term, taking the total to about 180, some 30% more than the previous cohort. Among the 76 international events for 2025 to 2027 lined up by the HKTB, with an estimated attendance of over 180,000 MICE visitor arrivals and 27 resulted from HKCAs' efforts. The events cover diverse fields ranging from I&T to aviation and medical sciences. Some are held in Hong Kong for the first time, including IEEE Electron Devices Technology and Manufacturing Conference held in March 2025, Routes World in September 2025 and World Cancer Congress 2026. The HKTB is committed to working closely with HKCAs to welcome more world-class events to Hong Kong, attracting high-yield overnight business visitors to the city and reinforcing the city's status as the world's meeting place. Large-scale conventions facilitated by Hong Kong Convention Ambassadors: Date Events (*first-ever in Hong Kong) Theme/Sector March 2025 IEEE Electron Devices Technology and Manufacturing Conference * Innovation & Technology May 2025 IEEE International Conference on Data Engineering Innovation & Technology Jun 2025 International Society for Stem Cell Research (ISSCR) Annual Meeting* Medical sciences Sep 2025 Routes World* Aviation Dec 2025 The International Society of Sport Psychology 16th World Congress Sports & Medical sciences 2026 Asia-Pacific Association for International Education 2026 Conference and Exhibition Education 2026 17th Asian Congress of Oral and Maxillofacial Surgery Medical sciences 2026 Asian Venture Philanthropy Network Conference Philanthropy 2026 International Federation of Landscape Architects World Congress Architecture 2026 Lions International Convention Social Services 2026 The Association of National Olympic Committees General Assembly Sports 2026 The Council Meeting of the Asian Patent Attorneys Association Intellectual property 2026 World Cancer Congress* Medical sciences 2027 International Association for Energy Economics Annual International Conference Economics 2027 Lions Clubs International Orient and Southeast Asian Lions Forum Social Services 2027 World Organization of Family Doctors Asia Pacific Regional Conference Medical sciences Ivy Chung Tel: 2807 6255 Email： Mr Leung Ho-yinTel: 2807 6358Email: SOURCE: Hong Kong Tourism Board View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-06-2025
- Health
- Yahoo
Hong Kong Hosts World's Largest ISSCR Stem Cell Gathering for the First Time
Some 2,400 stem cell and regenerative medicine pioneers convene to chart new frontiers, resulting from bidding efforts of Hong Kong Convention Ambassadors of the Hong Kong Tourism Board HONG KONG, HK / / June 11, 2025 / Reputed to be a leading research and development (R&D) hub for medical sciences, Hong Kong hosts the world's largest and most significant gathering of stem cell research and regenerative medicine, the International Society of Stem Cell Research (ISSCR) 2025 Annual Meeting. The event is brought to Hong Kong for the first time, thanks to the joint effort of three local universities - The University of Hong Kong, The Chinese University of Hong Kong and the Hong Kong University of Science and Technology, which are appointed organisations under the Hong Kong Convention Ambassador (HKCA) programme of the Hong Kong Tourism Board (HKTB). The four-day meeting held on June 11-14 gathers more than 2,400 local and international experts in stem cell research and regenerative medicine from 58 countries and regions, from Asia to North America, Europe, Australia, the Middle East, and Mainland China. Pioneers share the latest advances in the field, with topics spanning the field of regenerative medicine including topics such as advances in cell therapies, fundamental discoveries, understanding disease processes and more. Dr Peter Lam, HKTB Chairman, said, "The International Society for Stem Cell Research (ISSCR) is a globally leading organisation in medical sciences and research, and its annual meeting is one of the world's most significant international academic conventions in medical science. Hong Kong is the first city chosen to host this annual event in Asia after a 13-year hiatus, underscoring the city's status as the 'World's Meeting Place'. I am grateful for the active participation of the Hong Kong Convention Ambassadors from the three local universities, who leveraged their influence and network during the bidding for the host of the event to make the event come true. We are also delighted to see that more professionals from a wider range of expertise are joining HKTB's league of Convention Ambassadors, and we believe their participation can help identify and contribute to the staging of more significant international events in Hong Kong." Valentina Greco, ISSCR President, remarked, "Hosting ISSCR 2025 in Hong Kong marks a defining moment for global stem cell science. As a vibrant research hub at the crossroads of Asia and the world, Hong Kong offers an ideal setting to connect diverse scientific communities, spark new collaborations, and accelerate innovation. The ISSCR is deeply grateful to the city of Hong Kong and to our generous co-sponsors - the University of Hong Kong, The Chinese University of Hong Kong, and the Hong Kong University of Science and Technology - for their support and commitment to bringing The Global Stem Cell Event to this beautiful city. With the unwavering support of the Hong Kong Tourism Board, these three leading universities, and inspired leadership from our 2025 Annual Meeting Program Committee, this meeting exemplifies the power of partnership and shared vision. We are proud to return to Asia for the first time in more than a decade at a time when our collective progress in stem cell research and regenerative medicine and to advancing therapies that have life altering impact on patients depends on the exchange of bold ideas across borders." The extensive programme features plenary sessions, concurrent tracks, poster presentations, and networking opportunities. Contributing to the success of the event, the HKTB has provided comprehensive support, from arranging reconnaissance to venue sourcing, bid proposal, network support and more. Hong Kong Convention Ambassador Programme Aligns a Record Lineup of 180 Industry Leaders HKTB hosted the "Hong Kong Conference Ambassador Appreciation Night" last year to honor the contributions of the ambassadors in reinforcing Hong Kong as a "World Meeting Place" Hong Kong Convention Ambassadors from the Mainland recently participated in a business forum. HKCAs have been instrumental in winning the ISSCR 2025 Annual Meeting for Hong Kong. Launched in 2020 by the HKTB as a strategic initiative, the HKCA programme recruits high-level representatives of Hong Kong's eight universities, chambers of commerce, professional organisations, public bodies, industrial entities and professional societies to act as ambassadors for Hong Kong's convention sector. With their professional influence and networks, HKCAs have led efforts to bring in events ranging from medical sciences to innovation and technology (I&T), financial services, aviation, transportation and more. The close collaboration between HKCAs and the HKTB has proven effective in promoting Hong Kong as a premier hub for world-class conventions. As an alliance of distinguished local and Mainland leaders in business, medicine, professional services, I&T and other fields, the HKCA programme has been growing from strength to strength, with 72 new members in the latest record-sized cohort for the 2025-2026 term, taking the total to about 180, some 30% more than the previous cohort. Among the 76 international events for 2025 to 2027 lined up by the HKTB, with an estimated attendance of over 180,000 MICE visitor arrivals and 27 resulted from HKCAs' efforts. The events cover diverse fields ranging from I&T to aviation and medical sciences. Some are held in Hong Kong for the first time, including IEEE Electron Devices Technology and Manufacturing Conference held in March 2025, Routes World in September 2025 and World Cancer Congress 2026. The HKTB is committed to working closely with HKCAs to welcome more world-class events to Hong Kong, attracting high-yield overnight business visitors to the city and reinforcing the city's status as the world's meeting place. Large-scale conventions facilitated by Hong Kong Convention Ambassadors: Date Events (*first-ever in Hong Kong) Theme/Sector March 2025 IEEE Electron Devices Technology and Manufacturing Conference * Innovation & Technology May 2025 IEEE International Conference on Data Engineering Innovation & Technology Jun 2025 International Society for Stem Cell Research (ISSCR) Annual Meeting* Medical sciences Sep 2025 Routes World* Aviation Dec 2025 The International Society of Sport Psychology 16th World Congress Sports & Medical sciences 2026 Asia-Pacific Association for International Education 2026 Conference and Exhibition Education 2026 17th Asian Congress of Oral and Maxillofacial Surgery Medical sciences 2026 Asian Venture Philanthropy Network Conference Philanthropy 2026 International Federation of Landscape Architects World Congress Architecture 2026 Lions International Convention Social Services 2026 The Association of National Olympic Committees General Assembly Sports 2026 The Council Meeting of the Asian Patent Attorneys Association Intellectual property 2026 World Cancer Congress* Medical sciences 2027 International Association for Energy Economics Annual International Conference Economics 2027 Lions Clubs International Orient and Southeast Asian Lions Forum Social Services 2027 World Organization of Family Doctors Asia Pacific Regional Conference Medical sciences Ivy Chung Tel: 2807 6255 Email： Mr Leung Ho-yinTel: 2807 6358Email: SOURCE: Hong Kong Tourism Board View the original press release on ACCESS Newswire Sign in to access your portfolio
