Periodic Reporting for period 2 - LIAC FLASH (LIACFLASH: a life changing IOeRT technology for oncology care)
Periodo di rendicontazione: 2023-12-01 al 2025-05-31
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 5 degrees of freedom, our system provides easy access to patient’s anatomical region of interest.
LIACFLASH will also count on an imaging and planning unit to design the most accurate case-tailored treatments using artificial intelligent software. The positioning process of the accelerator (docking) is extremely simplified thanks to image guidance. 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 5 degrees of freedom, our system provides easy access to patient’s anatomical region of interest.
LIACFLASH will also count on an imaging and planning unit to design the most accurate case-tailored treatments using artificial intelligent software. The positioning process of the accelerator (docking) is extremely simplified thanks to image guidance. 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.
During the project period, the LIACFLASH team successfully designed, developed, and validated the first medical linear accelerator (LINAC) capable of delivering both conventional and FLASH dose-rate electron radiotherapy, optimized for intraoperative use (IOeRT). The project reached TRL8 by May 2025, demonstrating full integration of key components including hardware, software, and AI-assisted treatment planning.
Key milestones included the optimization and functional validation of the LIACFLASH system (TRL7), followed by full-system qualification and pre-compliance testing for TRL8. The system is fully compatible with standard operating room (OR) environments and does not require dedicated shielding infrastructure. A dedicated imaging and planning unit—featuring proprietary AI-based algorithms—has been developed to enable fast, patient-specific intraoperative treatment planning.
Work on regulatory compliance progressed in parallel, with alignment to IEC 60601-2-1 safety standards, implementation of project-wide risk management strategies, and fulfillment of ethics-related deliverables.
The project’s dissemination and exploitation strategy included major events such as ESTRO 2025 and the launch of the FLASH MD! BE the FIRST scientific contest, which will award a LIACFLASH system on loan to a qualified EU clinical center. Promotional activities included website updates, digital campaigns, and printed materials.
Three new patent applications were submitted in 2025, covering the accelerator structure, the AI-based treatment planning module, and radiation safety innovations.
Initial conversations with potential strategic partners were initiated, and early co-investment interest has been registered, although formal agreements are still under evaluation.
A total of 14 scientific papers have been published during the project, including peer-reviewed journal articles and conference proceedings. Dissemination activities have also included participation in international events such as ESTRO and FRPT.
Key milestones included the optimization and functional validation of the LIACFLASH system (TRL7), followed by full-system qualification and pre-compliance testing for TRL8. The system is fully compatible with standard operating room (OR) environments and does not require dedicated shielding infrastructure. A dedicated imaging and planning unit—featuring proprietary AI-based algorithms—has been developed to enable fast, patient-specific intraoperative treatment planning.
Work on regulatory compliance progressed in parallel, with alignment to IEC 60601-2-1 safety standards, implementation of project-wide risk management strategies, and fulfillment of ethics-related deliverables.
The project’s dissemination and exploitation strategy included major events such as ESTRO 2025 and the launch of the FLASH MD! BE the FIRST scientific contest, which will award a LIACFLASH system on loan to a qualified EU clinical center. Promotional activities included website updates, digital campaigns, and printed materials.
Three new patent applications were submitted in 2025, covering the accelerator structure, the AI-based treatment planning module, and radiation safety innovations.
Initial conversations with potential strategic partners were initiated, and early co-investment interest has been registered, although formal agreements are still under evaluation.
A total of 14 scientific papers have been published during the project, including peer-reviewed journal articles and conference proceedings. Dissemination activities have also included participation in international events such as ESTRO and FRPT.
LIACFLASH is the first and only IOeRT (Intra Operative electron Radiation Therapy) medical device capable of delivering both Conventional and FLASH dose-rate electron radiotherapy for cancer treatment, addressing both intraoperative applications and superficial tumors through transcutaneous irradiation.
By harnessing the FLASH effect—where ultra-high dose-rate radiation significantly reduces toxicity to healthy tissue while maintaining tumor control—LIACFLASH enables effective treatment of previously untreatable tumors, thus widening the therapeutic window and improving patient outcomes.
The system has been engineered with compact dimensions and smart integration to ensure full compatibility with standard operating rooms, eliminating the need for dedicated shielding infrastructure. This enhances safety for both patients and healthcare professionals while significantly reducing installation costs and logistical barriers.
A key innovation lies in the integration of an AI-powered imaging and planning unit that enables real-time, case-specific treatment planning. Image-guided positioning supports precise targeting of the anatomical region of interest, facilitating fast and accurate treatment delivery even in complex surgical scenarios.
LIACFLASH represents a disruptive breakthrough in the field of radiation oncology. It is the first clinical system designed to deliver ultra-high dose electron beams in a way that is portable, scalable, and operationally sustainable within existing healthcare infrastructure. This positions LIACFLASH not only as a technological milestone, but also as a socio-economic enabler of equitable access to advanced cancer care.
From a wider societal perspective, the project supports the transition to personalized, minimally invasive oncologic treatments, potentially reducing hospitalization time, side effects, and healthcare costs. The expected impact includes improved quality of life for patients, new clinical pathways for radioresistant tumors, and enhanced competitiveness for EU-based medical device innovation.
By harnessing the FLASH effect—where ultra-high dose-rate radiation significantly reduces toxicity to healthy tissue while maintaining tumor control—LIACFLASH enables effective treatment of previously untreatable tumors, thus widening the therapeutic window and improving patient outcomes.
The system has been engineered with compact dimensions and smart integration to ensure full compatibility with standard operating rooms, eliminating the need for dedicated shielding infrastructure. This enhances safety for both patients and healthcare professionals while significantly reducing installation costs and logistical barriers.
A key innovation lies in the integration of an AI-powered imaging and planning unit that enables real-time, case-specific treatment planning. Image-guided positioning supports precise targeting of the anatomical region of interest, facilitating fast and accurate treatment delivery even in complex surgical scenarios.
LIACFLASH represents a disruptive breakthrough in the field of radiation oncology. It is the first clinical system designed to deliver ultra-high dose electron beams in a way that is portable, scalable, and operationally sustainable within existing healthcare infrastructure. This positions LIACFLASH not only as a technological milestone, but also as a socio-economic enabler of equitable access to advanced cancer care.
From a wider societal perspective, the project supports the transition to personalized, minimally invasive oncologic treatments, potentially reducing hospitalization time, side effects, and healthcare costs. The expected impact includes improved quality of life for patients, new clinical pathways for radioresistant tumors, and enhanced competitiveness for EU-based medical device innovation.