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.
