Periodic Reporting for period 1 - FUTURA2020 (Focused Ultrasound Therapy Using Robotics Approaches towards 2020)
Período documentado: 2018-09-01 hasta 2020-02-29
Focused Ultrasound Surgery (FUS), also commonly referred as High Intensity Focused Ultrasound (HIFU), is a revolutionary, non-invasive therapeutic technique with the potential to transform the treatment of many serious medical problems, including tumors and brain disorders. The aim of FUS is to induce biological effects in the target tissues, by either thermal effects (i.e. ablation) or mechanical mechanisms (i.e. cavitation), during the treatment of many clinical diseases while preserving healthy tissues.
However, despite the encouraging results obtained in clinical studies and the promising interest around this innovative technology (see the efforts of the FUS Foundation, i.e. www.fusfoundation.org) FUS suffers from an important drawback, i.e. the limited flexibility in therapy delivery, which narrows its applicability to non-moving and non-essential organs, mainly under magnetic resonance imaging. By better controlling in space and position the focused US beam, FUS could address unmet clinical needs and provide treatments which are superior to the best current therapies, thereby improving the quality of life and longevity for millions of patients around the world. The number of diseases being treated using focused US has doubled in the last five years: in 2016, there have been nearly 168,000 patients treated with focused US.
In this framework, robotics has demonstrated to represent the enabling technology for the treatment of different pathologies, by adding image guidance, controllability and flexibility to many therapy procedures. In this direction, the FUTURA project (Focused Ultrasound Therapy Using Robotic Approaches, grant agreement number: 611963 - www.futuraproject.eu) has developed an autonomous, multi-functional and multi-robotic assisted platform able to perform non-invasive FUS under US guidance and monitoring (Figure 1). At the end of the 3-year project, the assessment of the complete system was demonstrated using simplified phantoms and ex-vivo tissues. In order to move some steps forwards the clinical application of the FUTURA technology, it is mandatory to demonstrate the system in the operational environment and, whenever possible, in a reasonable timeframe, in order to achieve qualification and credibility through tests and demonstration. Based on this consideration, FUTURA2020 stems from the idea to consolidate the FUTURA technologies (with its promising achievements and results) with the final aim to reach a level of maturity adequate to move towards the FUTURA exploitation.
However, despite the encouraging results obtained in clinical studies and the promising interest around this innovative technology (see the efforts of the FUS Foundation, i.e. www.fusfoundation.org) FUS suffers from an important drawback, i.e. the limited flexibility in therapy delivery, which narrows its applicability to non-moving and non-essential organs, mainly under magnetic resonance imaging. By better controlling in space and position the focused US beam, FUS could address unmet clinical needs and provide treatments which are superior to the best current therapies, thereby improving the quality of life and longevity for millions of patients around the world. The number of diseases being treated using focused US has doubled in the last five years: in 2016, there have been nearly 168,000 patients treated with focused US.
In this framework, robotics has demonstrated to represent the enabling technology for the treatment of different pathologies, by adding image guidance, controllability and flexibility to many therapy procedures. In this direction, the FUTURA project (Focused Ultrasound Therapy Using Robotic Approaches, grant agreement number: 611963 - www.futuraproject.eu) has developed an autonomous, multi-functional and multi-robotic assisted platform able to perform non-invasive FUS under US guidance and monitoring (Figure 1). At the end of the 3-year project, the assessment of the complete system was demonstrated using simplified phantoms and ex-vivo tissues. In order to move some steps forwards the clinical application of the FUTURA technology, it is mandatory to demonstrate the system in the operational environment and, whenever possible, in a reasonable timeframe, in order to achieve qualification and credibility through tests and demonstration. Based on this consideration, FUTURA2020 stems from the idea to consolidate the FUTURA technologies (with its promising achievements and results) with the final aim to reach a level of maturity adequate to move towards the FUTURA exploitation.
The main results achieved during the 18-months project can be summarized as below:
- Technology assessment of the FUTURA platform. Preliminary tests in a simulated environment were carried out with the aim to optimize targeting strategies and treatment control.
- Exhaustive ex-vivo experimentation was completed by reproducing the very same working conditions of the in-vivo testing on large animals.
The FUTURA platform was widely tested on ex-vivo tissues (i.e. chicken breast and pic uterus) for demonstrating its precision in performing focused ultrasound therapy on both static and moving targets. Finally, the coupling capabilities between the HIFU transducer and the tissue were analysed. The obtained results demonstrate the high precision, accuracy and repeatability of the FUTURA platform, thus paving the way to successful preclinical trials.
- The industrial labelling pathway definition for CE mark was deeply analysed, according to the European 2017/745 Medical Device Regulation (MDR). Based on the classification analysis – ruled by the Annex VIII of the 2017/745 MDR – the FUTURA platform could belong to two different classes: Class IIb under Rule 9 of European 2017/745 MDR; Class III under Rule 22 of European 2017/745 MDR, whether the tracking module is integrated into the system or not. Depending on the class of the device, the certification procedure could require clinical studies.
- FUTURA platform must comply to different consensus standards for being classified as medical device (e.g. ISO 14971:2012, ISO 13485:2016). The first preliminary test for the CE mark we performed regards Electrical Safety. The test aimed at verifying if the FUTURA platform was grounded.
- HIFU Market analysis was carried out by using the “Global Analysis and Forecasts of High Intensity Focused Ultrasound market” as reference (The Insight Partners, www.theinsightpartners.com). The global HIFU market is expected to grow from US$ 417.98 Mn in 2018 to US$755.46 Mn by 2027 with a Compound annual growth rate (CAGR) of 7.1% in the period 2019-2027 (Figure 2). In this framework, Europe is the second-largest market for HIFU therapy. These data highlight European – and Italian - non-invasive HIFU market as a breeding ground where the FUTURA2020 project has its roots.
- A specific business case was defined. Taking into account the market analysis and the current FUS trend, veterinary applications can be considered a promising business case for FUTURA platform.
- In order to better exploit the FUTURA2020 possibilities for moving ahead the FUTURA platform and to approach the market with a solid business plan, a specific founding strategy was envisaged and investigated.
- FUTURA2020 team took part to the final phase of the KUKA Innovation Award 2020_Medical Robotics Challenge with a project related to the focused ultrasound surgery, i.e. High Intensity Focused Ultrasound Surgery based on KUKA robot – HIFUSK project.
- FUTURA2020 was presented during 14 international events.
- 4 papers/conference contributions have been published.
- 1 journal paper was submitted - now under revision.
- Technology assessment of the FUTURA platform. Preliminary tests in a simulated environment were carried out with the aim to optimize targeting strategies and treatment control.
- Exhaustive ex-vivo experimentation was completed by reproducing the very same working conditions of the in-vivo testing on large animals.
The FUTURA platform was widely tested on ex-vivo tissues (i.e. chicken breast and pic uterus) for demonstrating its precision in performing focused ultrasound therapy on both static and moving targets. Finally, the coupling capabilities between the HIFU transducer and the tissue were analysed. The obtained results demonstrate the high precision, accuracy and repeatability of the FUTURA platform, thus paving the way to successful preclinical trials.
- The industrial labelling pathway definition for CE mark was deeply analysed, according to the European 2017/745 Medical Device Regulation (MDR). Based on the classification analysis – ruled by the Annex VIII of the 2017/745 MDR – the FUTURA platform could belong to two different classes: Class IIb under Rule 9 of European 2017/745 MDR; Class III under Rule 22 of European 2017/745 MDR, whether the tracking module is integrated into the system or not. Depending on the class of the device, the certification procedure could require clinical studies.
- FUTURA platform must comply to different consensus standards for being classified as medical device (e.g. ISO 14971:2012, ISO 13485:2016). The first preliminary test for the CE mark we performed regards Electrical Safety. The test aimed at verifying if the FUTURA platform was grounded.
- HIFU Market analysis was carried out by using the “Global Analysis and Forecasts of High Intensity Focused Ultrasound market” as reference (The Insight Partners, www.theinsightpartners.com). The global HIFU market is expected to grow from US$ 417.98 Mn in 2018 to US$755.46 Mn by 2027 with a Compound annual growth rate (CAGR) of 7.1% in the period 2019-2027 (Figure 2). In this framework, Europe is the second-largest market for HIFU therapy. These data highlight European – and Italian - non-invasive HIFU market as a breeding ground where the FUTURA2020 project has its roots.
- A specific business case was defined. Taking into account the market analysis and the current FUS trend, veterinary applications can be considered a promising business case for FUTURA platform.
- In order to better exploit the FUTURA2020 possibilities for moving ahead the FUTURA platform and to approach the market with a solid business plan, a specific founding strategy was envisaged and investigated.
- FUTURA2020 team took part to the final phase of the KUKA Innovation Award 2020_Medical Robotics Challenge with a project related to the focused ultrasound surgery, i.e. High Intensity Focused Ultrasound Surgery based on KUKA robot – HIFUSK project.
- FUTURA2020 was presented during 14 international events.
- 4 papers/conference contributions have been published.
- 1 journal paper was submitted - now under revision.
If compared with state of the art systems, FUTURA demonstrated the first prototype of a versatile, flexible robotic platform able to guarantee high robustness, flexibility/adaptability and precision of FUS therapy, as well as improving safety and acceptability of multifunctional robotic platforms in the surgical room. FUTURA2020 had, then, the ambitious goal to move robotics and autonomous systems well beyond their usual constrained environments, by developing a computer-assisted platform that can assist physicians during the delivery of non-invasive therapy using HIFU. FUTURA2020 contributed to the expected impact by:
- Evaluating economic and/or societal benefits resulting from this innovation - The possibility to contribute to the clinical evidence of the benefits of HIFU and the introduction of a new and sustainable technology for HIFU-base therapy has important social implications and relevant impacts for the EU healthcare system. FUTURA solution already provided a proof-of-concept that allows larger applicability of FUS in different clinical conditions, thus amplifying the positive social impact. The expected impact of FUTURA2020 has partially, yet substantially, contributed to this important achievement.
- Taking into account the innovation beyond the research dimension - FUTURA has been flagged up as a success story not only from the technological viewpoint, but also in terms of possible exploitation of results and potential clinical value; therefore, we focused since the beginning on assessing the market potential and the possibility of further commercial development. We presented the FUTURA system during major scientific events and in international journals; in parallel we gathered and solicited also the interest of end-users and clinicians from Italy, France, Spain and Bulgaria.
- Evaluating economic and/or societal benefits resulting from this innovation - The possibility to contribute to the clinical evidence of the benefits of HIFU and the introduction of a new and sustainable technology for HIFU-base therapy has important social implications and relevant impacts for the EU healthcare system. FUTURA solution already provided a proof-of-concept that allows larger applicability of FUS in different clinical conditions, thus amplifying the positive social impact. The expected impact of FUTURA2020 has partially, yet substantially, contributed to this important achievement.
- Taking into account the innovation beyond the research dimension - FUTURA has been flagged up as a success story not only from the technological viewpoint, but also in terms of possible exploitation of results and potential clinical value; therefore, we focused since the beginning on assessing the market potential and the possibility of further commercial development. We presented the FUTURA system during major scientific events and in international journals; in parallel we gathered and solicited also the interest of end-users and clinicians from Italy, France, Spain and Bulgaria.