Within the first year of the FRONTIER project, the work undertaken focused primarily on technology development to redesign four key subsystems within the MSOT device: (i) the laser system, (ii) the data acquisition system, (iii) image reconstruction algorithms, and (iv) the user interface. Additionally, first steps were taken to pursue market access preparation in the form of market prioritization desk research.
This work was continued in the second year of the project with ongoing development of the MSOT Frontier system as well as escalated market access preparation efforts.
On the technology development front, the four redesigned subsystems were integrated into a first prototype of the next-generation MSOT Frontier imaging platform. Internal verification testing and usability testing were initiated to confirm the core functionality, safety, and performance of the system. Available test results indicate that the primary objectives to reduce the device size, weight, and manufacturing costs without sacrificing performance compared to the current state-of-the-art device (the MSOT Acuity Echo) have been achieved. Beyond the project end, this work will continue through ongoing device optimization, continuation of internal verification testing (of all subsystems as well as the complete system), external verification testing, and preparation for high-priority regulatory approval submissions.
FRONTIER market access activities expanded considerably in the second year. Based on the previous market prioritization research, a country- and application-specific market access strategy was developed. In particular, market entry requirements and potential reimbursement paths for the high-priority markets of Germany, the United Kingdom, and the United States were assessed. Additionally, a clinical trial strategy was developed for the two leading indications of peripheral arterial disease and neuromuscular disease, based on input from strategic clinical partners (including key opinion leaders). With an aim to facilitate market access in the high-priority markets, the strategy employs a stepwise approach and targets specific use cases to bridge existing diagnostic gaps.
With the project now formally concluded, the major outcomes of the work described are that the first preproduction unit of the new MSOT Frontier system is complete and that ITM is able to conduct the final stages of product verification and validation in anticipation of market launch. In addition, a foundation has been laid for both near-term as well as long-term market access activities, including regulatory approval and reimbursement negotiations. ITM will continue to build on this work in the coming years, starting with an initial commercial rollout of the MSOT Frontier and ongoing market access activities to reach a broad clinical environment.
