For WP1, a series of activities have been performed in order to optimize the manufacturing process. In particular: (1) the device (REGENERA) shaping automation was studied through a dedicated R&D project, with positive results. (2) The device purification upscaling was completed at design level, although the realization of the equipment was postponed due to a change of the company strategy to accelerate the CE mark achievement; (3) The setup of a new manufacturing facility has been postponed to 2026, while a revamping of the cleanroom in the current manufacturing facility has been planned for 2025, to allow the achievement of GMP and MDR compliance. (4) A continuous monitoring of the applicable international standards for the definitions of the User Requirements of the new manufacturing process has been completed. (5) The in-house production of Regenera devices for V&V activities and the clinical pivotal trial has been successfully performed.
For WP2, the additional testing needed for commercialization has been performed according to the scheduled plan. In particular, (1) the chemical characterization of leachable and extractables including degradation products of Regenera device has been performed and a toxicological risk assessment has been carried out according to ISO 10993-17:2009. (2) The Biological Evaluation Plan drafting has been completed and a GAP analysis has been performed between the two versions of the relevant standard. (3) The non-GLP feasibility study has been successfully performed including the MR Safety test.
For WP3, the Clinical Investigation Protocol has been submitted and the approval for the execution of the Pivotal clinical trial has been received by the relevant authorities (Ministry of Health) in all the countries involved. To accelerate the enrollment, 6 additional clinical centers have been added to the study and a series of countermeasures have been actuated for each specific clinical center already included in the study. The clinical study has been concluded with positive results.
For WP4, several strategic actions have been implemented to prepare for the commercialization of the REGENERA device and to strengthen the company's market positioning. (1) A comprehensive communication campaign was launched targeting key stakeholders in the healthcare sector, including clinicians, hospitals, and payors. Leveraging interim clinical results, REGENERA’s unique selling points (USPs) were emphasized through targeted outreach and participation in international business and venture capital events. Strategic discussions with investors were pursued to support future growth, R&D for additional indications, and post-market surveillance studies. (2) In collaboration with regulatory consultants (GDCI Consulting Inc., MNMMEM Consultants LLC, and Advice Pharma), the documentation required for CE marking as a Class III medical device was prepared, including the clinical evaluation reports. Parallel efforts were made to prepare the submission for FDA clearance in the U.S. as a Class II device, starting with a Q-submission to gather early feedback. The team also maintained ISO 13485 certification to ensure QMS compliance throughout. (3) Tensive refined and implemented a robust IP Management Strategy to align with its business plan. The strategy includes ongoing assessment of publication content, contractual clauses to secure ownership of arising IP, and the filing of additional patents to protect innovations developed during the project. (4) In collaboration with reimbursement consultants, Tensive performed a detailed analysis of reimbursement pathways and market access strategies. A global product positioning strategy was developed, assessing its impact on payer engagement, clinical evidence planning, timelines, and ROI.
For WP5, project coordination and management activities were conducted to ensure the successful execution of all work packages and adherence to timelines and budget. The Project Management Team provided overall supervision of project planning, execution, and performance monitoring. Particular attention was paid to tracking deliverables, resource utilization, and alignment with the planned budget. The Management Team was responsible for collecting, organizing, and maintaining all technical documentation, including schematics, reports, and images, to be included in the project deliverables and final reporting. Regular internal communication was maintained to ensure coordination across departments and with external service providers. A project risk assessment was carried out to identify potential risks and define appropriate mitigation strategies.
