Development plan<\/h2>\n\n\n\n<\/div>\n\n\n\n![\"\"](\"https:\/\/dev.realheart.se\/wp-content\/uploads\/2021\/09\/blobar-eng-kopiera-1024x851.jpg\")
<\/figure>\n\n\n\nPreclinical studies<\/h4>\n\n\n\n<\/div>\n\n\n\nDigital studies<\/strong><\/h5>\n\n\n\n- Virtual implants in animals and human heart failure patients in collaboration with Virtonomy GmbH<\/li>
- Computer simulation of blood flow in the pump (Computational Fluid Dynamics, CFD) in collaboration with University of Bath under the direction of Dr. Katharine Fraser <\/li><\/ul>\n\n\n\n
Laboratory studies<\/strong><\/h5>\n\n\n\n- Blood tests at Karolinska University Hospital in a jointly run laboratory <\/li>
- Performance studies in simulated clinical scenarios using a hybrid mock circulation simulator (simulating the human body) at KU Leuven under the direction of Dr. Libera Fresiello<\/li>
- Blood flow pattern analysis using 4D MRI in collaboration with Link\u00f6ping University<\/li>
- Endurance tests of components and the whole TAH system in custom made test rigs at Realheart’s laboratory in V\u00e4ster\u00e5s<\/li><\/ul>\n\n\n\n
Anatomical and animal studies<\/strong><\/h5>\n\n\n\n- Anatomy studies in humans under the direction of Professor Bart Meyns at KU Leuven<\/li>
- Short-term and long-term studies in sheep at Medanex Clinic in Belgium <\/li><\/ul>\n\n\n\n<\/div>\n\n\n\n
Clinical trials<\/h4>\n\n\n\n<\/div>\n\n\n\nAs artificial hearts are not a common product category the description below is the current best estimate of the route to market. However, based on Realheart\u2019s communication with the notified body and regulatory authorities the demands may be updated. There is a great clinical need, and it is in everyone\u2019s interest to bring innovative products that can improve quality of life to the market as swiftly as possible. <\/p>\n\n\n\n
Small clinical trial in patients<\/strong><\/h5>\n\n\n\nThis trial will form the first evaluation of the product for the treatment of heart failure in human patients. The number of patients will be decided by the relevant authorities. Realheart is already planning for these trials by identifying collaborating physicians and hospitals.<\/p>\n\n\n\n
Large clinical trial in patients<\/strong><\/h5>\n\n\n\nFollowing the small clinical trial, Realheart will work with several physicians and hospitals in parallel to speed up the patient recruitment process. The number of participating patients will be determined by the authorities.<\/p>\n\n\n\n
<\/div>\n\n\n\nProduct launch<\/h4>\n\n\n\n<\/div>\n\n\n\nAfter the authorities evaluate data from the large clinical trial and assess the safety of the device, Realheart will seek regulatory permission to launch the product on the market. <\/p>\n\n\n\n
<\/div>\n\n\n\n<\/p>\n\n\n\n![\"\"](\"https:\/\/dev.realheart.se\/wp-content\/uploads\/2021\/09\/filmbild-eng-1024x576.jpg\")
In the latest animal study, Realheart reached a milestone when the sheep was able to wake up, breathe, and move – good signs of well-being.<\/em><\/figcaption><\/figure>\n\n\n\n<\/div>\n\n\n\nCollaborations<\/h3>\n\n\n\n
In addition to collaboration with institutions and clinics, Realheart works with an international network of expert heart surgeons, veterinarians, engineers, and biomedical researchers. In 2020, a scientific advisory board was established to further support Realheart\u2019s medical and technical competencies. You can read more about the scientific advisory board here<\/a><\/strong>.<\/p>\n\n\n\n
<\/figure>\n\n\n\nPreclinical studies<\/h4>\n\n\n\n<\/div>\n\n\n\nDigital studies<\/strong><\/h5>\n\n\n\n- Virtual implants in animals and human heart failure patients in collaboration with Virtonomy GmbH<\/li>
- Computer simulation of blood flow in the pump (Computational Fluid Dynamics, CFD) in collaboration with University of Bath under the direction of Dr. Katharine Fraser <\/li><\/ul>\n\n\n\n
Laboratory studies<\/strong><\/h5>\n\n\n\n- Blood tests at Karolinska University Hospital in a jointly run laboratory <\/li>
- Performance studies in simulated clinical scenarios using a hybrid mock circulation simulator (simulating the human body) at KU Leuven under the direction of Dr. Libera Fresiello<\/li>
- Blood flow pattern analysis using 4D MRI in collaboration with Link\u00f6ping University<\/li>
- Endurance tests of components and the whole TAH system in custom made test rigs at Realheart’s laboratory in V\u00e4ster\u00e5s<\/li><\/ul>\n\n\n\n
Anatomical and animal studies<\/strong><\/h5>\n\n\n\n- Anatomy studies in humans under the direction of Professor Bart Meyns at KU Leuven<\/li>
- Short-term and long-term studies in sheep at Medanex Clinic in Belgium <\/li><\/ul>\n\n\n\n<\/div>\n\n\n\n
Clinical trials<\/h4>\n\n\n\n<\/div>\n\n\n\nAs artificial hearts are not a common product category the description below is the current best estimate of the route to market. However, based on Realheart\u2019s communication with the notified body and regulatory authorities the demands may be updated. There is a great clinical need, and it is in everyone\u2019s interest to bring innovative products that can improve quality of life to the market as swiftly as possible. <\/p>\n\n\n\n
Small clinical trial in patients<\/strong><\/h5>\n\n\n\nThis trial will form the first evaluation of the product for the treatment of heart failure in human patients. The number of patients will be decided by the relevant authorities. Realheart is already planning for these trials by identifying collaborating physicians and hospitals.<\/p>\n\n\n\n
Large clinical trial in patients<\/strong><\/h5>\n\n\n\nFollowing the small clinical trial, Realheart will work with several physicians and hospitals in parallel to speed up the patient recruitment process. The number of participating patients will be determined by the authorities.<\/p>\n\n\n\n
<\/div>\n\n\n\nProduct launch<\/h4>\n\n\n\n<\/div>\n\n\n\nAfter the authorities evaluate data from the large clinical trial and assess the safety of the device, Realheart will seek regulatory permission to launch the product on the market. <\/p>\n\n\n\n
<\/div>\n\n\n\n<\/p>\n\n\n\nIn the latest animal study, Realheart reached a milestone when the sheep was able to wake up, breathe, and move – good signs of well-being.<\/em><\/figcaption><\/figure>\n\n\n\n<\/div>\n\n\n\nCollaborations<\/h3>\n\n\n\n
In addition to collaboration with institutions and clinics, Realheart works with an international network of expert heart surgeons, veterinarians, engineers, and biomedical researchers. In 2020, a scientific advisory board was established to further support Realheart\u2019s medical and technical competencies. You can read more about the scientific advisory board here<\/a><\/strong>.<\/p>\n\n\n\n
Digital studies<\/strong><\/h5>\n\n\n\n- Virtual implants in animals and human heart failure patients in collaboration with Virtonomy GmbH<\/li>
- Computer simulation of blood flow in the pump (Computational Fluid Dynamics, CFD) in collaboration with University of Bath under the direction of Dr. Katharine Fraser <\/li><\/ul>\n\n\n\n
Laboratory studies<\/strong><\/h5>\n\n\n\n- Blood tests at Karolinska University Hospital in a jointly run laboratory <\/li>
- Performance studies in simulated clinical scenarios using a hybrid mock circulation simulator (simulating the human body) at KU Leuven under the direction of Dr. Libera Fresiello<\/li>
- Blood flow pattern analysis using 4D MRI in collaboration with Link\u00f6ping University<\/li>
- Endurance tests of components and the whole TAH system in custom made test rigs at Realheart’s laboratory in V\u00e4ster\u00e5s<\/li><\/ul>\n\n\n\n
Anatomical and animal studies<\/strong><\/h5>\n\n\n\n- Anatomy studies in humans under the direction of Professor Bart Meyns at KU Leuven<\/li>
- Short-term and long-term studies in sheep at Medanex Clinic in Belgium <\/li><\/ul>\n\n\n\n<\/div>\n\n\n\n
Clinical trials<\/h4>\n\n\n\n<\/div>\n\n\n\nAs artificial hearts are not a common product category the description below is the current best estimate of the route to market. However, based on Realheart\u2019s communication with the notified body and regulatory authorities the demands may be updated. There is a great clinical need, and it is in everyone\u2019s interest to bring innovative products that can improve quality of life to the market as swiftly as possible. <\/p>\n\n\n\n
Small clinical trial in patients<\/strong><\/h5>\n\n\n\nThis trial will form the first evaluation of the product for the treatment of heart failure in human patients. The number of patients will be decided by the relevant authorities. Realheart is already planning for these trials by identifying collaborating physicians and hospitals.<\/p>\n\n\n\n
Large clinical trial in patients<\/strong><\/h5>\n\n\n\nFollowing the small clinical trial, Realheart will work with several physicians and hospitals in parallel to speed up the patient recruitment process. The number of participating patients will be determined by the authorities.<\/p>\n\n\n\n
<\/div>\n\n\n\nProduct launch<\/h4>\n\n\n\n<\/div>\n\n\n\nAfter the authorities evaluate data from the large clinical trial and assess the safety of the device, Realheart will seek regulatory permission to launch the product on the market. <\/p>\n\n\n\n
<\/div>\n\n\n\n<\/p>\n\n\n\nIn the latest animal study, Realheart reached a milestone when the sheep was able to wake up, breathe, and move – good signs of well-being.<\/em><\/figcaption><\/figure>\n\n\n\n<\/div>\n\n\n\nCollaborations<\/h3>\n\n\n\n
In addition to collaboration with institutions and clinics, Realheart works with an international network of expert heart surgeons, veterinarians, engineers, and biomedical researchers. In 2020, a scientific advisory board was established to further support Realheart\u2019s medical and technical competencies. You can read more about the scientific advisory board here<\/a><\/strong>.<\/p>\n\n\n\n
Laboratory studies<\/strong><\/h5>\n\n\n\n- Blood tests at Karolinska University Hospital in a jointly run laboratory <\/li>
- Performance studies in simulated clinical scenarios using a hybrid mock circulation simulator (simulating the human body) at KU Leuven under the direction of Dr. Libera Fresiello<\/li>
- Blood flow pattern analysis using 4D MRI in collaboration with Link\u00f6ping University<\/li>
- Endurance tests of components and the whole TAH system in custom made test rigs at Realheart’s laboratory in V\u00e4ster\u00e5s<\/li><\/ul>\n\n\n\n
Anatomical and animal studies<\/strong><\/h5>\n\n\n\n- Anatomy studies in humans under the direction of Professor Bart Meyns at KU Leuven<\/li>
- Short-term and long-term studies in sheep at Medanex Clinic in Belgium <\/li><\/ul>\n\n\n\n<\/div>\n\n\n\n
Clinical trials<\/h4>\n\n\n\n<\/div>\n\n\n\nAs artificial hearts are not a common product category the description below is the current best estimate of the route to market. However, based on Realheart\u2019s communication with the notified body and regulatory authorities the demands may be updated. There is a great clinical need, and it is in everyone\u2019s interest to bring innovative products that can improve quality of life to the market as swiftly as possible. <\/p>\n\n\n\n
Small clinical trial in patients<\/strong><\/h5>\n\n\n\nThis trial will form the first evaluation of the product for the treatment of heart failure in human patients. The number of patients will be decided by the relevant authorities. Realheart is already planning for these trials by identifying collaborating physicians and hospitals.<\/p>\n\n\n\n
Large clinical trial in patients<\/strong><\/h5>\n\n\n\nFollowing the small clinical trial, Realheart will work with several physicians and hospitals in parallel to speed up the patient recruitment process. The number of participating patients will be determined by the authorities.<\/p>\n\n\n\n
<\/div>\n\n\n\nProduct launch<\/h4>\n\n\n\n<\/div>\n\n\n\nAfter the authorities evaluate data from the large clinical trial and assess the safety of the device, Realheart will seek regulatory permission to launch the product on the market. <\/p>\n\n\n\n
<\/div>\n\n\n\n<\/p>\n\n\n\nIn the latest animal study, Realheart reached a milestone when the sheep was able to wake up, breathe, and move – good signs of well-being.<\/em><\/figcaption><\/figure>\n\n\n\n<\/div>\n\n\n\nCollaborations<\/h3>\n\n\n\n
In addition to collaboration with institutions and clinics, Realheart works with an international network of expert heart surgeons, veterinarians, engineers, and biomedical researchers. In 2020, a scientific advisory board was established to further support Realheart\u2019s medical and technical competencies. You can read more about the scientific advisory board here<\/a><\/strong>.<\/p>\n\n\n\n
Anatomical and animal studies<\/strong><\/h5>\n\n\n\n- Anatomy studies in humans under the direction of Professor Bart Meyns at KU Leuven<\/li>
- Short-term and long-term studies in sheep at Medanex Clinic in Belgium <\/li><\/ul>\n\n\n\n<\/div>\n\n\n\n
Clinical trials<\/h4>\n\n\n\n<\/div>\n\n\n\nAs artificial hearts are not a common product category the description below is the current best estimate of the route to market. However, based on Realheart\u2019s communication with the notified body and regulatory authorities the demands may be updated. There is a great clinical need, and it is in everyone\u2019s interest to bring innovative products that can improve quality of life to the market as swiftly as possible. <\/p>\n\n\n\n
Small clinical trial in patients<\/strong><\/h5>\n\n\n\nThis trial will form the first evaluation of the product for the treatment of heart failure in human patients. The number of patients will be decided by the relevant authorities. Realheart is already planning for these trials by identifying collaborating physicians and hospitals.<\/p>\n\n\n\n
Large clinical trial in patients<\/strong><\/h5>\n\n\n\nFollowing the small clinical trial, Realheart will work with several physicians and hospitals in parallel to speed up the patient recruitment process. The number of participating patients will be determined by the authorities.<\/p>\n\n\n\n
<\/div>\n\n\n\nProduct launch<\/h4>\n\n\n\n<\/div>\n\n\n\nAfter the authorities evaluate data from the large clinical trial and assess the safety of the device, Realheart will seek regulatory permission to launch the product on the market. <\/p>\n\n\n\n
<\/div>\n\n\n\n<\/p>\n\n\n\nIn the latest animal study, Realheart reached a milestone when the sheep was able to wake up, breathe, and move – good signs of well-being.<\/em><\/figcaption><\/figure>\n\n\n\n<\/div>\n\n\n\nCollaborations<\/h3>\n\n\n\n
In addition to collaboration with institutions and clinics, Realheart works with an international network of expert heart surgeons, veterinarians, engineers, and biomedical researchers. In 2020, a scientific advisory board was established to further support Realheart\u2019s medical and technical competencies. You can read more about the scientific advisory board here<\/a><\/strong>.<\/p>\n\n\n\n
Clinical trials<\/h4>\n\n\n\n<\/div>\n\n\n\nAs artificial hearts are not a common product category the description below is the current best estimate of the route to market. However, based on Realheart\u2019s communication with the notified body and regulatory authorities the demands may be updated. There is a great clinical need, and it is in everyone\u2019s interest to bring innovative products that can improve quality of life to the market as swiftly as possible. <\/p>\n\n\n\n
Small clinical trial in patients<\/strong><\/h5>\n\n\n\nThis trial will form the first evaluation of the product for the treatment of heart failure in human patients. The number of patients will be decided by the relevant authorities. Realheart is already planning for these trials by identifying collaborating physicians and hospitals.<\/p>\n\n\n\n
Large clinical trial in patients<\/strong><\/h5>\n\n\n\nFollowing the small clinical trial, Realheart will work with several physicians and hospitals in parallel to speed up the patient recruitment process. The number of participating patients will be determined by the authorities.<\/p>\n\n\n\n
<\/div>\n\n\n\nProduct launch<\/h4>\n\n\n\n<\/div>\n\n\n\nAfter the authorities evaluate data from the large clinical trial and assess the safety of the device, Realheart will seek regulatory permission to launch the product on the market. <\/p>\n\n\n\n
<\/div>\n\n\n\n<\/p>\n\n\n\nIn the latest animal study, Realheart reached a milestone when the sheep was able to wake up, breathe, and move – good signs of well-being.<\/em><\/figcaption><\/figure>\n\n\n\n<\/div>\n\n\n\nCollaborations<\/h3>\n\n\n\n
In addition to collaboration with institutions and clinics, Realheart works with an international network of expert heart surgeons, veterinarians, engineers, and biomedical researchers. In 2020, a scientific advisory board was established to further support Realheart\u2019s medical and technical competencies. You can read more about the scientific advisory board here<\/a><\/strong>.<\/p>\n\n\n\n
As artificial hearts are not a common product category the description below is the current best estimate of the route to market. However, based on Realheart\u2019s communication with the notified body and regulatory authorities the demands may be updated. There is a great clinical need, and it is in everyone\u2019s interest to bring innovative products that can improve quality of life to the market as swiftly as possible. <\/p>\n\n\n\n
Small clinical trial in patients<\/strong><\/h5>\n\n\n\nThis trial will form the first evaluation of the product for the treatment of heart failure in human patients. The number of patients will be decided by the relevant authorities. Realheart is already planning for these trials by identifying collaborating physicians and hospitals.<\/p>\n\n\n\n
Large clinical trial in patients<\/strong><\/h5>\n\n\n\nFollowing the small clinical trial, Realheart will work with several physicians and hospitals in parallel to speed up the patient recruitment process. The number of participating patients will be determined by the authorities.<\/p>\n\n\n\n
<\/div>\n\n\n\nProduct launch<\/h4>\n\n\n\n<\/div>\n\n\n\nAfter the authorities evaluate data from the large clinical trial and assess the safety of the device, Realheart will seek regulatory permission to launch the product on the market. <\/p>\n\n\n\n
<\/div>\n\n\n\n<\/p>\n\n\n\nIn the latest animal study, Realheart reached a milestone when the sheep was able to wake up, breathe, and move – good signs of well-being.<\/em><\/figcaption><\/figure>\n\n\n\n<\/div>\n\n\n\nCollaborations<\/h3>\n\n\n\n
In addition to collaboration with institutions and clinics, Realheart works with an international network of expert heart surgeons, veterinarians, engineers, and biomedical researchers. In 2020, a scientific advisory board was established to further support Realheart\u2019s medical and technical competencies. You can read more about the scientific advisory board here<\/a><\/strong>.<\/p>\n\n\n\n
Following the small clinical trial, Realheart will work with several physicians and hospitals in parallel to speed up the patient recruitment process. The number of participating patients will be determined by the authorities.<\/p>\n\n\n\n
Product launch<\/h4>\n\n\n\n<\/div>\n\n\n\nAfter the authorities evaluate data from the large clinical trial and assess the safety of the device, Realheart will seek regulatory permission to launch the product on the market. <\/p>\n\n\n\n
<\/div>\n\n\n\n<\/p>\n\n\n\nIn the latest animal study, Realheart reached a milestone when the sheep was able to wake up, breathe, and move – good signs of well-being.<\/em><\/figcaption><\/figure>\n\n\n\n<\/div>\n\n\n\nCollaborations<\/h3>\n\n\n\n
In addition to collaboration with institutions and clinics, Realheart works with an international network of expert heart surgeons, veterinarians, engineers, and biomedical researchers. In 2020, a scientific advisory board was established to further support Realheart\u2019s medical and technical competencies. You can read more about the scientific advisory board here<\/a><\/strong>.<\/p>\n\n\n\n
After the authorities evaluate data from the large clinical trial and assess the safety of the device, Realheart will seek regulatory permission to launch the product on the market. <\/p>\n\n\n\n
<\/p>\n\n\n\n In addition to collaboration with institutions and clinics, Realheart works with an international network of expert heart surgeons, veterinarians, engineers, and biomedical researchers. In 2020, a scientific advisory board was established to further support Realheart\u2019s medical and technical competencies. You can read more about the scientific advisory board here<\/a><\/strong>.<\/p>\n\n\n\nCollaborations<\/h3>\n\n\n\n