Periodic Reporting for period 2 - FRONTIER (From Research Optoacoustic Novelty To Imaging Established in Routine diagnostics)
Berichtszeitraum: 2023-04-01 bis 2024-03-31
Within medical diagnostics, a wide range of procedures allow clinicians to diagnose diseases, track disease progression, and monitor treatment response. However, many fields have unmet diagnostic needs, where the current gold standard approaches lack accurate and quantitative measurements, incur a high patient burden, or have high operating costs that hinder adoption in smaller clinics. Because of these challenges, currently available diagnostic procedures are not able to meet the specific diagnostic needs of several key disease areas.
Over the last years, iThera Medical GmbH (ITM) has developed Multispectral Optoacoustic Tomography (MSOT) – an innovative biomedical imaging technology that enables visualization of living tissue at depth. This non-invasive technology allows assessment of the concentration and distribution of a variety of clinically relevant molecules in the body and uniquely delivers information of important biological functions, such as tissue oxygenation, inflammation, and fibrotic changes.
Through the two-year EIC Accelerator project FRONTIER, ITM will translate an optimized MSOT system (the next-generation MSOT Frontier system) from a research environment to application in routine clinical imaging. The project’s three core objectives are: (1) redesign key components within the MSOT system to lower the cost of manufacturing and decrease the overall device size, (2) strategize for clinical validation to demonstrate the technology’s clinical value, and (3) develop a robust market access strategy to enable successful deployment into the diagnostic market.
Ultimately, the MSOT Frontier system will be utilized as a diagnostic tool to assist in diagnosis and treatment monitoring in a variety of disease areas, starting with high-priority application areas of peripheral arterial disease and neuromuscular diseases. This will provide clinicians with more and better information about disease status, and thereby help them to make better-informed decisions regarding treatment choice and prognosis, resulting in better patient outcomes. Additionally, MSOT’s non-invasiveness will offer a lower patient burden compared to many gold-standard approaches. Adoption of MSOT will also have significant long-term benefits for healthcare systems by replacing other more costly imaging approaches and reducing ineffective treatments. Increased sales of MSOT technology will support economic growth and employment in Europe and strengthen the European medical technology sector.
Over the last years, iThera Medical GmbH (ITM) has developed Multispectral Optoacoustic Tomography (MSOT) – an innovative biomedical imaging technology that enables visualization of living tissue at depth. This non-invasive technology allows assessment of the concentration and distribution of a variety of clinically relevant molecules in the body and uniquely delivers information of important biological functions, such as tissue oxygenation, inflammation, and fibrotic changes.
Through the two-year EIC Accelerator project FRONTIER, ITM will translate an optimized MSOT system (the next-generation MSOT Frontier system) from a research environment to application in routine clinical imaging. The project’s three core objectives are: (1) redesign key components within the MSOT system to lower the cost of manufacturing and decrease the overall device size, (2) strategize for clinical validation to demonstrate the technology’s clinical value, and (3) develop a robust market access strategy to enable successful deployment into the diagnostic market.
Ultimately, the MSOT Frontier system will be utilized as a diagnostic tool to assist in diagnosis and treatment monitoring in a variety of disease areas, starting with high-priority application areas of peripheral arterial disease and neuromuscular diseases. This will provide clinicians with more and better information about disease status, and thereby help them to make better-informed decisions regarding treatment choice and prognosis, resulting in better patient outcomes. Additionally, MSOT’s non-invasiveness will offer a lower patient burden compared to many gold-standard approaches. Adoption of MSOT will also have significant long-term benefits for healthcare systems by replacing other more costly imaging approaches and reducing ineffective treatments. Increased sales of MSOT technology will support economic growth and employment in Europe and strengthen the European medical technology sector.
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.
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.
The underlying physical principle of MSOT – the photoacoustic effect – fundamentally sets it apart from existing imaging methods. This approach uniquely enables imaging molecular characteristics of chromophores in deep tissue. The type of information and subsequent clinical insight provided by MSOT cannot be replicated by any existing technologies, thus providing clinicians a new dimension of biomedical information and making MSOT already beyond the state-of-the-art in medical diagnostics.
Within FRONTIER, the technological foundation of MSOT has evolved through strategic component and subsystem redesigns. Compared to the current state-of-the-art optoacoustic imaging devices, the MSOT Frontier device offers enhanced imaging capabilities, with a smaller form-factor and reduced manufacturing costs. Altogether, these improvements will be crucial for successful deployment into wider medical diagnostic markets.
The major results of the project are: (1) a preproduction unit of the MSOT Frontier device, (2) a market access roadmap to guide reimbursement strategy, and (3) a clinical trial strategy outlining the planned validation activities for the next years.
Beyond the work performed within the project, several important steps must still be taken to facilitate a successful launch into the wider clinical imaging market. These steps will be a core focus for ITM to continue the work undertaken in FRONTIER:
(1) Ongoing system optimization, concurrent with internal and external verification testing.
(2) Regulatory approval (i.e. CE marking and FDA approval) to enable the marketing and sale of the MSOT Frontier as a medical device in relevant markets.
(3) Clinical validation of the MSOT Frontier for specific use-cases in the high priority disease areas of peripheral arterial disease and neuromuscular disease.
(4) Successful negotiation with insurance infrastructures to introduce reimbursement for MSOT procedures, thereby reinforcing the business case for hospitals and clinics to invest in the technology.
Within FRONTIER, the technological foundation of MSOT has evolved through strategic component and subsystem redesigns. Compared to the current state-of-the-art optoacoustic imaging devices, the MSOT Frontier device offers enhanced imaging capabilities, with a smaller form-factor and reduced manufacturing costs. Altogether, these improvements will be crucial for successful deployment into wider medical diagnostic markets.
The major results of the project are: (1) a preproduction unit of the MSOT Frontier device, (2) a market access roadmap to guide reimbursement strategy, and (3) a clinical trial strategy outlining the planned validation activities for the next years.
Beyond the work performed within the project, several important steps must still be taken to facilitate a successful launch into the wider clinical imaging market. These steps will be a core focus for ITM to continue the work undertaken in FRONTIER:
(1) Ongoing system optimization, concurrent with internal and external verification testing.
(2) Regulatory approval (i.e. CE marking and FDA approval) to enable the marketing and sale of the MSOT Frontier as a medical device in relevant markets.
(3) Clinical validation of the MSOT Frontier for specific use-cases in the high priority disease areas of peripheral arterial disease and neuromuscular disease.
(4) Successful negotiation with insurance infrastructures to introduce reimbursement for MSOT procedures, thereby reinforcing the business case for hospitals and clinics to invest in the technology.