Periodic Reporting for period 1 - LEILA (Closed-Loop and multisEnsing delIvery tool for controlled Laser Ablation of tumors)
Reporting period: 2022-11-01 to 2024-10-31
Thermal ablation therapies have been used for a long time under clinical investigation as a potential alternative to traditional surgery. Being minimally invasive treatment of localized tumors, thermal therapies can be used to treat patients who are not eligible for surgery or who refuse surgery and are increasingly used as a bridge to liver transplantation in patients with hepatocellular carcinoma. Hyperthermal thermal ablation techniques uses heat to thermally destroy cancer cells, and include mainly microwave, radiofrequency and laser ablation. Over microwave and radiofrequency, the laser holds good promises for clinical application of thermal therapy, taking advantage of the small and flexible fiber optic applicators guiding laser energy into deep-lying tumors, which makes the procedure also safe and feasible. LA utilizes very fine needles to insert the fibers (< 1mm) into the lesion, and such a characteristic makes LA particularly safe for the treatment of nodules with difficult location. However, there are still some challenges to be faced. The tissue-specific characteristics, including blood perfusion, can affect in unpredictable ways the final therapeutic outcome. Additionally, as always happens for any thermal ablation procedure, the laser parameters (power, position, and treated shape) are usually set before the procedure without any modulation during the procedure. This approach can cause both the insufficient delivery of the therapeutic heat to the tumor boundary and the uncontrollable heating of delicate and healthy structures close to the target, such as blood vessels and nerves. For all these reasons, the availability of a system for real-time monitoring of the effects of the treatment is highly demanded. Improvements in all these fields will bring to a more accurate and safe tumor removal.
The LEILA team has tackled all the main challenges currently present for laser ablation of tumors, and has turned them into the opportunity to establish a technological development and a new strategic approach. The main achievements of the LEILA team, composed of academic researchers and experts in business and innovation, are:
NOVEL TECHNOLOGY: Through LEILA, the research team has prototyped a novel laser delivery device with sensing capability. In this way, we can modulate the laser settings when the procedure is ongoing, thus adjusting the thermal affects based on the tumor dimension. The platform has been successfully validated in both ex vivo and in vivo porcine liver, through the accomplishment of relevant key parameter indexes (KPIs).
BUSINESS STRATEGY – The team has completed: 1) the business model, which has positioned LEILA as a medical device manufacturer, 2) the business plan, which has identified the resources needed to complete the next step of LEILA maturation with the selection of the industrial collaborators to involve in the next step pf this project.
POTENTIAL MARKETS – the deep analysis of the markets to target and the existing competitors has resulted in the treatment of tumors into key organs with increasing burden in Europe.
FREEDOM TO OPERATE - The FTO has been completed.
COMPLIANCE WITH MEDICAL DEVICE DIRECTIVE - LEILA was classified as a medical device class II, and the preclinical path has been studied in detail.
NOVEL TECHNOLOGY: Through LEILA, the research team has prototyped a novel laser delivery device with sensing capability. In this way, we can modulate the laser settings when the procedure is ongoing, thus adjusting the thermal affects based on the tumor dimension. The platform has been successfully validated in both ex vivo and in vivo porcine liver, through the accomplishment of relevant key parameter indexes (KPIs).
BUSINESS STRATEGY – The team has completed: 1) the business model, which has positioned LEILA as a medical device manufacturer, 2) the business plan, which has identified the resources needed to complete the next step of LEILA maturation with the selection of the industrial collaborators to involve in the next step pf this project.
POTENTIAL MARKETS – the deep analysis of the markets to target and the existing competitors has resulted in the treatment of tumors into key organs with increasing burden in Europe.
FREEDOM TO OPERATE - The FTO has been completed.
COMPLIANCE WITH MEDICAL DEVICE DIRECTIVE - LEILA was classified as a medical device class II, and the preclinical path has been studied in detail.
The technological innovation and the positive outcome of the business analysis make LEILA ready for the next steps toward its maturation and validation.
The key needs to accomplish the introduction of LEILA in the market have been already identified, and include the main following steps:
Further research is planned to refine the prototype and build a system that can be certified as a medical device.
A regulatory consultancy company will be involved in the further steps of LEILA, to identify the standards to follow for the test of the final components of the device. The team will also ensure all guidelines are met so that the device can obtain certifications.
Finally, the LEILA technology, already validated in ex vivo and in vivo trials, will be tested in a real clinical environment performed by clinical experts. This phase will augment the final value of the system and streamline its acceptance as a future medical device.
The key needs to accomplish the introduction of LEILA in the market have been already identified, and include the main following steps:
Further research is planned to refine the prototype and build a system that can be certified as a medical device.
A regulatory consultancy company will be involved in the further steps of LEILA, to identify the standards to follow for the test of the final components of the device. The team will also ensure all guidelines are met so that the device can obtain certifications.
Finally, the LEILA technology, already validated in ex vivo and in vivo trials, will be tested in a real clinical environment performed by clinical experts. This phase will augment the final value of the system and streamline its acceptance as a future medical device.