Periodic Reporting for period 2 - Calypso (The next-generation heart pump to change patients’ lives and create a new standard of care)
Okres sprawozdawczy: 2021-10-01 do 2023-09-30
Heart failure (HF) is a deadly pandemic, affecting 11 million Europeans, with a prognosis worse than most cancers. Currently, cardiac pumps (or "LVADs", left ventricular assist devices) for patients with advanced HF are based on rotary technology, which creates a constant blood flow. As a result, patients with LVADs have no pulse, which is highly disturbing to the body's physiology. Despite the good survival rates of patients with LVADs, their overall quality of life is strongly affected by severe adverse events (stroke, etc.) and restrictions of daily activities.
To help HF patients return to a fully active life, CorWave develops an LVAD based on a proprietary breakthrough technology. CorWave LVAD is a biomimetic pump that uses a membrane mimicking the undulating motion of marine animals. With this unique technology, CorWave LVAD intends to fully respect the patient's physiology, reduce adverse events, and remove current daily limitations.
Through the EIC Accelerator project, CorWave’s objective is to complete the preclinical work and validate clinically CorWave LVAD.
To help HF patients return to a fully active life, CorWave develops an LVAD based on a proprietary breakthrough technology. CorWave LVAD is a biomimetic pump that uses a membrane mimicking the undulating motion of marine animals. With this unique technology, CorWave LVAD intends to fully respect the patient's physiology, reduce adverse events, and remove current daily limitations.
Through the EIC Accelerator project, CorWave’s objective is to complete the preclinical work and validate clinically CorWave LVAD.
Intellectual Property: During the period of the project, CorWave significantly grew its patent portfolio. A total of 5 provisional patent applications and 10 standard patent applications were filed.
Organizational Development: Key executive positions have been filled to bolster various departments.
One significant addition was Paul Cornelison, who serves as the Vice President of Regulatory Affairs, Quality Assurance, and Clinical Affairs. Paul Cornelison brought over 30 years of experience in the field of medical device regulatory affairs, quality assurance, and clinical operations, he has been pivotal in shaping and engaging in the regulatory strategy of CorWave.
Another key recruit is Michael Webb, CorWave’s Vice President of Manufacturing. Prior to joining CorWave he supervised the production of over 18,000 heart pumps and was pivotal in the industrial development of HeartWare, a former successful LVAD startup. His contribution has been a true breakthrough in the industrial deployment which placed CorWave one step closer to clinical trials.
In addition, a new Chief Financial Officer, Magalie Durrèche, was recruited. She brings a wealth of experience, having previously served as Senior VP of Circular Economy and Aftermarket, Senior VP of Consolidation and Financial Reporting, and Financial Director of PSA Bank at Stellantis. She is a pillar of CorWave’s financial management, but she is also a crucial asset for the future fundraising activities of CorWave.
Regulatory & Quality:
Risk analysis has been a continuous activity. The internal risk management procedure, in accordance with NF EN ISO 14971, has guided strategic design choices to improve the pump's performance.
CorWave’s regulatory strategy has been refined for both EU and US pathways, and there has been ongoing monitoring of changes in regulatory requirements, especially considering the European Medical Devices Regulation (2017/745), which became applicable in 2021.
Extensive in vitro and in vivo testing has been conducted to assess pump synchronization with the native heart, autonomous pump response to physiological events, hemocompatibility and pump lifetime.
Human factors and usability have been assessed through various means, including external expert reviews, workshops with clinicians, patients, and caregivers.
Clinical Trial:
The elaboration of the study protocol has been a continuous activity, with the first version undergoing revision and subsequent versions being refined. The selection of investigating centers has been a crucial step, ensuring that the trials are conducted in facilities equipped with the necessary expertise and infrastructure.
An operation plan was defined and refined, focusing on the clinical protocol review and validation, engagement of principal investigators, and the screening, selection and preparation of clinical trial centers.
The protocol for the CE Mark Trial was reviewed by external clinicians.
Organizational Development: Key executive positions have been filled to bolster various departments.
One significant addition was Paul Cornelison, who serves as the Vice President of Regulatory Affairs, Quality Assurance, and Clinical Affairs. Paul Cornelison brought over 30 years of experience in the field of medical device regulatory affairs, quality assurance, and clinical operations, he has been pivotal in shaping and engaging in the regulatory strategy of CorWave.
Another key recruit is Michael Webb, CorWave’s Vice President of Manufacturing. Prior to joining CorWave he supervised the production of over 18,000 heart pumps and was pivotal in the industrial development of HeartWare, a former successful LVAD startup. His contribution has been a true breakthrough in the industrial deployment which placed CorWave one step closer to clinical trials.
In addition, a new Chief Financial Officer, Magalie Durrèche, was recruited. She brings a wealth of experience, having previously served as Senior VP of Circular Economy and Aftermarket, Senior VP of Consolidation and Financial Reporting, and Financial Director of PSA Bank at Stellantis. She is a pillar of CorWave’s financial management, but she is also a crucial asset for the future fundraising activities of CorWave.
Regulatory & Quality:
Risk analysis has been a continuous activity. The internal risk management procedure, in accordance with NF EN ISO 14971, has guided strategic design choices to improve the pump's performance.
CorWave’s regulatory strategy has been refined for both EU and US pathways, and there has been ongoing monitoring of changes in regulatory requirements, especially considering the European Medical Devices Regulation (2017/745), which became applicable in 2021.
Extensive in vitro and in vivo testing has been conducted to assess pump synchronization with the native heart, autonomous pump response to physiological events, hemocompatibility and pump lifetime.
Human factors and usability have been assessed through various means, including external expert reviews, workshops with clinicians, patients, and caregivers.
Clinical Trial:
The elaboration of the study protocol has been a continuous activity, with the first version undergoing revision and subsequent versions being refined. The selection of investigating centers has been a crucial step, ensuring that the trials are conducted in facilities equipped with the necessary expertise and infrastructure.
An operation plan was defined and refined, focusing on the clinical protocol review and validation, engagement of principal investigators, and the screening, selection and preparation of clinical trial centers.
The protocol for the CE Mark Trial was reviewed by external clinicians.
Based on a breakthrough proprietary technology, CorWave must go beyond the state of the art to deliver the safest, most beneficial LVAD to heart failure patients and clinicians. To predict the hemocompatibility and hemodynamic performance of different pump designs, CorWave has developed unique simulation tools. The synchronous pulsatility algorithm, which was successfully tested in chronic in vivo studies, is also groundbreaking.
CorWave aims at making a major impact on the treatment of advanced HF patients by offering them excellent survival and improved quality of life. Decreasing rehospitalizations should also reduce the cost of LVAD therapy and improve its adoption, allowing more patients to benefit from this life-saving therapy.
CorWave will also have wider societal impacts, such as a socioeconomic one with job creations, and a scientific one with major progress on mechanical fluid simulations and hydraulic bench testing.
CorWave aims at making a major impact on the treatment of advanced HF patients by offering them excellent survival and improved quality of life. Decreasing rehospitalizations should also reduce the cost of LVAD therapy and improve its adoption, allowing more patients to benefit from this life-saving therapy.
CorWave will also have wider societal impacts, such as a socioeconomic one with job creations, and a scientific one with major progress on mechanical fluid simulations and hydraulic bench testing.