Periodic Reporting for period 1 - LIAC FLASH (LIACFLASH: a life changing IOeRT technology for oncology care)
Berichtszeitraum: 2022-12-01 bis 2023-11-30
Cancer is a leading cause of death worldwide, with 19.3m new cancer cases and almost 10m cancer deaths (2020). Despite significant technological and scientific improvements, cancer remains an unsolved, global health challenge.
Radiation Therapy is, along with surgery, the most effective therapeutic approach for the treatment of solid tumors, with about 2/3 cancer patients being treated with radiation therapy during their illness.
Although considerable progress has been made in the field in terms of imaging, ballistics and dosimetry over the last few decades, still several tumors can’t be successfully treated due to location and biology. The biological effects of radiation dose to organs at risk (often surrounding targeted tumor mass) represent a major dose-limiting constraint in Radiation Therapy. This implies that tumors cannot be always successfully treated, as delivered dose might not be enough for an effective treatment, decreasing survival of these cancer patients.
LIACFLASH is an IOeRT system for cancer treatment built on a breakthrough scientific discovery: the FLASH effect, which enables delivery of high radiation dose with significantly reduced associated cytotoxicity, while achieving efficient tumor killing, widening the therapeutic window. With 8 degrees of freedom, our system provides easy access to patient’s anatomical region of interest.
LIACFLASH will also count with an imaging and planning unit to design most accurate case-tailored treatments using artificial intelligent software. The positioning process of the accelerator (docking) is entirely automated and guided. Additionally, its features and size make LIACFLASH easy to handle in standard operating rooms. By virtue of its features, LIACFLASH constitutes a disruptive method to deliver Radiation Therapy treatments either delivering conventional doses with much lower side effects or delivering higher doses maintaining side effects low.
Radiation Therapy is, along with surgery, the most effective therapeutic approach for the treatment of solid tumors, with about 2/3 cancer patients being treated with radiation therapy during their illness.
Although considerable progress has been made in the field in terms of imaging, ballistics and dosimetry over the last few decades, still several tumors can’t be successfully treated due to location and biology. The biological effects of radiation dose to organs at risk (often surrounding targeted tumor mass) represent a major dose-limiting constraint in Radiation Therapy. This implies that tumors cannot be always successfully treated, as delivered dose might not be enough for an effective treatment, decreasing survival of these cancer patients.
LIACFLASH is an IOeRT system for cancer treatment built on a breakthrough scientific discovery: the FLASH effect, which enables delivery of high radiation dose with significantly reduced associated cytotoxicity, while achieving efficient tumor killing, widening the therapeutic window. With 8 degrees of freedom, our system provides easy access to patient’s anatomical region of interest.
LIACFLASH will also count with an imaging and planning unit to design most accurate case-tailored treatments using artificial intelligent software. The positioning process of the accelerator (docking) is entirely automated and guided. Additionally, its features and size make LIACFLASH easy to handle in standard operating rooms. By virtue of its features, LIACFLASH constitutes a disruptive method to deliver Radiation Therapy treatments either delivering conventional doses with much lower side effects or delivering higher doses maintaining side effects low.
Robotic Unit functioning: after many experiments in the laboratory, we understood 7 degrees of freedom contributes little to the benefits of the product but will result in a bulkier, more expensive and more complex product. We worked on a 5 degrees of freedom system which fits perfectly within the standards to be the most competitive IOeRT FLASH system available on the market. We named the product LIAC HWL FLASH to keep a logic and strong marketing correlation with our product portfolio. This technical change allowed us also to launch the LIAC HWL FLASH on the market before the planned schedule assuring it will be the first CE labelled IOeRT FLASH system treating humans.
C band optimised and functioning: this all new very complex part has been object of extensive studies; initially we considered a triode gun to be mounted in the LINAC structure and we invested to achieve this goal. Down the path, considering new regulatory information and scientific environment evolution we opted for a diode gun solution. This process and consequent change took longer than expected but has significant benefits: more reliable LINAC system, performances according to the latest scientific findings, faster manufacturing process and quicker testing.
TPS component functioning and optimised: Treatment Planning System has been object of market requirement adaptations. We understood time to market and easy to use technological solution was the key for success and fast dissemination. We invested in having an ultra-fast calculus tool able to calculate in less than one minute coupled with an appropriate HMI. The calculus and simulation system development took more time than expected
LIAC FLASH prototype with all components integrated: as consequence of the above the integration of the whole system is slightly delayed respect to the initial forecast.
CE Mark application/filing: when this EIC project started was not clear if for obtaining the CE label for the new product CE clinical investigation was needed or not. CE clinical investigation is an expensive and very long process which aims to demonstrate the iso-efficacy and non-inferiority of a certain new treatment. It has no weight in terms of clinical relevance (like a proper clinical trial would have) but it’s just a bureaucratic process of the CE label. We were able to achieve an exceptional goal: thanks to the abundant and qualitative preclinical data collected with our ElectronFlash (preclinical FLASH research system) combined with available scientific global literature lead the notified body (IMQ) to the decision of excluding CE linked clinical investigation on humans considering FLASH RT with electrons equivalent in efficacy compared to conventional RT and less toxic compared to conventional RT. This game changing news allowed us to book the electromagnetic tests for our equipment on 4th March 2024 which makes us expecting to obtain the CE label by September/October 2024.
C band optimised and functioning: this all new very complex part has been object of extensive studies; initially we considered a triode gun to be mounted in the LINAC structure and we invested to achieve this goal. Down the path, considering new regulatory information and scientific environment evolution we opted for a diode gun solution. This process and consequent change took longer than expected but has significant benefits: more reliable LINAC system, performances according to the latest scientific findings, faster manufacturing process and quicker testing.
TPS component functioning and optimised: Treatment Planning System has been object of market requirement adaptations. We understood time to market and easy to use technological solution was the key for success and fast dissemination. We invested in having an ultra-fast calculus tool able to calculate in less than one minute coupled with an appropriate HMI. The calculus and simulation system development took more time than expected
LIAC FLASH prototype with all components integrated: as consequence of the above the integration of the whole system is slightly delayed respect to the initial forecast.
CE Mark application/filing: when this EIC project started was not clear if for obtaining the CE label for the new product CE clinical investigation was needed or not. CE clinical investigation is an expensive and very long process which aims to demonstrate the iso-efficacy and non-inferiority of a certain new treatment. It has no weight in terms of clinical relevance (like a proper clinical trial would have) but it’s just a bureaucratic process of the CE label. We were able to achieve an exceptional goal: thanks to the abundant and qualitative preclinical data collected with our ElectronFlash (preclinical FLASH research system) combined with available scientific global literature lead the notified body (IMQ) to the decision of excluding CE linked clinical investigation on humans considering FLASH RT with electrons equivalent in efficacy compared to conventional RT and less toxic compared to conventional RT. This game changing news allowed us to book the electromagnetic tests for our equipment on 4th March 2024 which makes us expecting to obtain the CE label by September/October 2024.
The LIACFLASH will be the first and only IOeRT (Intra Operative electron Radiation Therapy) system capable of delivering both Conventional and FLASH dose rate Radiation Therapy for cancer treatment, both intraoperatively and transcutaneous for superficially located tumors. Because of the FLASH effect, which enables delivery of high radiation dose with significantly reduced associated cytotoxicity, the system will achieve efficient tumor killing, widening the therapeutic window.
The system has been developed with features and size that makes it easy to handle and compatible with any standard Operating Room and does not require additional shielding enabling more protection for patients and healthcare staff. LIACFLASH will also count with an imaging and planning unit to design most accurate case-tailored treatments using artificial intelligent software. The positioning process of the accelerator (docking) is entirely automated and guided.
Our innovation allows for the first-time use of ultra-high dose of electron radiotherapy (RT), that has proven to disrupt the way tumors are shrunk without affecting healthy cells, on a clinical FLASH RT system that will open a new avenue to leverage the incredible power of the “FLASH Effect” to even cure tumors for which no options are currently available. Along with this technical innovation, LIAC FLASH is the only system that can enable automatic treatment planning thanks to the AI based software with an
additional improvement in health outcome for patients. Additionally, LIAC FLASH does not need to be installed into shielded bunker, and it is portable, resulting in a significant scale-up potential as its installation does not require dedicated areas with heavy infrastructure in place (reducing costs of installation, technical requirements, and installation assistance).
The system has been developed with features and size that makes it easy to handle and compatible with any standard Operating Room and does not require additional shielding enabling more protection for patients and healthcare staff. LIACFLASH will also count with an imaging and planning unit to design most accurate case-tailored treatments using artificial intelligent software. The positioning process of the accelerator (docking) is entirely automated and guided.
Our innovation allows for the first-time use of ultra-high dose of electron radiotherapy (RT), that has proven to disrupt the way tumors are shrunk without affecting healthy cells, on a clinical FLASH RT system that will open a new avenue to leverage the incredible power of the “FLASH Effect” to even cure tumors for which no options are currently available. Along with this technical innovation, LIAC FLASH is the only system that can enable automatic treatment planning thanks to the AI based software with an
additional improvement in health outcome for patients. Additionally, LIAC FLASH does not need to be installed into shielded bunker, and it is portable, resulting in a significant scale-up potential as its installation does not require dedicated areas with heavy infrastructure in place (reducing costs of installation, technical requirements, and installation assistance).