Periodic Reporting for period 1 - NAO.VNS (NAO.VNS: A New Personalized Neural Stimulation Therapy For Drug-resistant Epilepsy)
Período documentado: 2023-03-01 hasta 2024-02-29
The global challenge of Drug-Resistant Epilepsy (DRE) affects approximately 19.5 million people, with a significant portion, 8 million, not qualifying for brain surgery due to various reasons. Current treatment modalities, such as vagus nerve stimulation have been hindered by their one-size-fits-all approach, leading to complex and financially burdensome patient care pathways. In response to this critical gap, the NAO.VNS project was conceived to introduce a next-generation implantable vagus nerve neurostimulator. This innovative device leverages optical fibers instead of metallic wires, making it compatible with MRI, which crucial for ongoing patient care. MRI compatibility also gives the potential of unique feature of providing feedback on the effectiveness of the neural stimulation allows for precise, patient-specific therapy adjustments. With the support of EIC funding, the project aims to conduct a clinical pilot trial and pivotal study in the EU and US to secure market approvals, offering a tailored and more efficient treatment solution for DRE patients.
Throughout the year, Synergia Medical dedicated its efforts to the development, verification, validation (V&V), and manufacturing processes crucial for the First-in-Human (FiH) study planned for 2024. The introduction of a sophisticated dashboard tool and the regular updating of the GANTT chart facilitated meticulous tracking of activities related to clinical trial submissions and device development. Emphasis on using collaborative tools such as Jira and Confluence has bolstered project management efficiency and enhanced Synergia’s commitment to information security and data privacy.
Manufacturing:
The manufacturing phase of the NAO.VNS project encountered and overcame several challenges, showcasing the team's ability to adapt and innovate. The project team's strategic planning around supplier schedules demonstrated a proactive approach to mitigating production risks, ensuring that manufacturing timelines could be met without compromising on product quality.
As the project progressed into the third quarter, the focus shifted towards scaling up production for verification and validation (V&V) purposes. Critical supplier engagement became a focal point, emphasizing the importance of quality and planning control in the manufacturing process. The exploration of transferring some manufacturing activities in-house was considered as a means to simplify supply chains and enhance logistical efficiency, reflecting the project's ongoing pursuit of operational excellence.
The final quarter of the year centered on producing the batch destined for the First-in-Human (FiH) study. This phase saw part of the team dedicating efforts to drafting the necessary manufacturing documentation, ensuring that all processes were meticulously documented and compliant with regulatory standards. Challenges encountered in manufacturing processes were systematically addressed, showcasing the team's commitment to quality and precision. These efforts were crucial in ensuring that the production process met the planned timelines and quality standards, paving the way for the next phase of clinical trials.
The manufacturing journey of the NAO.VNS project, from addressing early material and production challenges to scaling up for clinical readiness, reflects a comprehensive approach to overcoming obstacles. Through strategic planning, quality control, and innovative problem-solving, the project team has laid a solid foundation for the successful production of a device poised to transform the treatment landscape for Drug-Resistant Epilepsy.
Clinical, preclinical, and regulatory:
The journey through clinical, preclinical, and regulatory milestones for the NAO.VNS project encapsulates a series of strategic steps aimed at demonstrating the device's safety, efficacy, and regulatory compliance. The completion of preclinical safety studies marked a pivotal beginning, with Good Laboratory Practice (GLP) studies showcasing positive safety outcomes. These studies were essential for establishing a solid foundation for regulatory discussions and for setting the stage for an FDA pre-submission meeting. The positive feedback received from the FDA on these preclinical studies not only boosted confidence but also paved the way for presenting the device's potential at international congresses, enhancing its visibility within the medical and scientific communities.
The project team diligently developed clinical strategies tailored to the unique requirements of the First-in-Human (FiH) study in Europe, followed by pivotal studies in both the EU and the US. The preparation of the EU FiH involved contracting with Belgian clinical sites and finalizing the selection of a Clinical Research Organization (CRO) to oversee the trials. Regulatory preparations were meticulously carried out, drafting essential documents for the EU FIH study and strategizing to meet FDA expectations. The proactive engagement in regulatory efforts underscored the project's commitment to compliance and excellence.
As the project moved into the fourth quarter, innovative efforts such as initiating an fMRI method for neurostimulation parameter adjustment and the strategic replacement of the electrode cuff in preclinical studies highlighted the project's adaptability and focus on optimizing therapeutic outcomes. Engagements with Key Opinion Leaders (KOLs) at the American Epilepsy Society (AES) meeting underlined the device's advantages, fostering industry and academic interest. The clinical and regulatory activities geared towards the FiH study, including partnerships for trial management and the completion of critical submission documents, exemplify the project's thorough approach to navigating the complex landscape of medical device approval.
Manufacturing:
The manufacturing phase of the NAO.VNS project encountered and overcame several challenges, showcasing the team's ability to adapt and innovate. The project team's strategic planning around supplier schedules demonstrated a proactive approach to mitigating production risks, ensuring that manufacturing timelines could be met without compromising on product quality.
As the project progressed into the third quarter, the focus shifted towards scaling up production for verification and validation (V&V) purposes. Critical supplier engagement became a focal point, emphasizing the importance of quality and planning control in the manufacturing process. The exploration of transferring some manufacturing activities in-house was considered as a means to simplify supply chains and enhance logistical efficiency, reflecting the project's ongoing pursuit of operational excellence.
The final quarter of the year centered on producing the batch destined for the First-in-Human (FiH) study. This phase saw part of the team dedicating efforts to drafting the necessary manufacturing documentation, ensuring that all processes were meticulously documented and compliant with regulatory standards. Challenges encountered in manufacturing processes were systematically addressed, showcasing the team's commitment to quality and precision. These efforts were crucial in ensuring that the production process met the planned timelines and quality standards, paving the way for the next phase of clinical trials.
The manufacturing journey of the NAO.VNS project, from addressing early material and production challenges to scaling up for clinical readiness, reflects a comprehensive approach to overcoming obstacles. Through strategic planning, quality control, and innovative problem-solving, the project team has laid a solid foundation for the successful production of a device poised to transform the treatment landscape for Drug-Resistant Epilepsy.
Clinical, preclinical, and regulatory:
The journey through clinical, preclinical, and regulatory milestones for the NAO.VNS project encapsulates a series of strategic steps aimed at demonstrating the device's safety, efficacy, and regulatory compliance. The completion of preclinical safety studies marked a pivotal beginning, with Good Laboratory Practice (GLP) studies showcasing positive safety outcomes. These studies were essential for establishing a solid foundation for regulatory discussions and for setting the stage for an FDA pre-submission meeting. The positive feedback received from the FDA on these preclinical studies not only boosted confidence but also paved the way for presenting the device's potential at international congresses, enhancing its visibility within the medical and scientific communities.
The project team diligently developed clinical strategies tailored to the unique requirements of the First-in-Human (FiH) study in Europe, followed by pivotal studies in both the EU and the US. The preparation of the EU FiH involved contracting with Belgian clinical sites and finalizing the selection of a Clinical Research Organization (CRO) to oversee the trials. Regulatory preparations were meticulously carried out, drafting essential documents for the EU FIH study and strategizing to meet FDA expectations. The proactive engagement in regulatory efforts underscored the project's commitment to compliance and excellence.
As the project moved into the fourth quarter, innovative efforts such as initiating an fMRI method for neurostimulation parameter adjustment and the strategic replacement of the electrode cuff in preclinical studies highlighted the project's adaptability and focus on optimizing therapeutic outcomes. Engagements with Key Opinion Leaders (KOLs) at the American Epilepsy Society (AES) meeting underlined the device's advantages, fostering industry and academic interest. The clinical and regulatory activities geared towards the FiH study, including partnerships for trial management and the completion of critical submission documents, exemplify the project's thorough approach to navigating the complex landscape of medical device approval.
The NAO.VNS project stands on the brink of redefining the treatment paradigm for DRE by transitioning from preparatory phases to pivotal human trials. This transition is not merely procedural but signifies a substantial advance in personalized care for epilepsy. The device’s compatibility with MRI, combined with its capability for real-time therapy adjustments, positions NAO.VNS as a pioneer in enhancing safety, treatment efficacy, and patient quality of life. This aligns with a broader vision of integrating innovative technology with patient-centered care to meet the nuanced needs of the DRE community.