Periodic Reporting for period 1 - PRISMA (MICRO-MECHANICAL PUMP FOR NEXT GENERATION INSULIN DELIVERY SYSTEMS)
Reporting period: 2022-07-01 to 2023-06-30
PRISMA is a revolutionary thin-film micropump realized with novel ceria-based oxides actuating materials in the frame of the FETOPEN BioWings project, which can be used as an innovative pumping system in wearable insulin delivery devices for the treatment of diabetes. The integration of the PRISMA micropump in insulin patch pumps addresses the 3 most important pain points that still keep the vast majority of diabetic patients away from this life-saving treatment:
1. Size, which is more than two orders of magnitude smaller than state of the art.
2. Higher drug delivery accuracy within the ?5% range ensures the highest therapeutic efficacy.
3. Drastic reduction in energy consumption.
Besides the short-term vision to realise extremely compact and accurate patch pumps, the long term goal is to allow the realisation of multi-drug delivery systems, making real the much-lauded multi-hormone treatment. The main objective of this project is to validate the pump and its manufacturing process in a real operating environment, proving to system integrators that all specifications are consistently met to pave the way for the post-project system integration and clinical validation. This will pave the way to the launch of a startup company that will take care of the final steps of the development roadmap and will establish long-term cooperation agreements with prominent medical device manufacturers for the integration of PRISMA in next-generation single and multi-hormone smart patches.
1. Size, which is more than two orders of magnitude smaller than state of the art.
2. Higher drug delivery accuracy within the ?5% range ensures the highest therapeutic efficacy.
3. Drastic reduction in energy consumption.
Besides the short-term vision to realise extremely compact and accurate patch pumps, the long term goal is to allow the realisation of multi-drug delivery systems, making real the much-lauded multi-hormone treatment. The main objective of this project is to validate the pump and its manufacturing process in a real operating environment, proving to system integrators that all specifications are consistently met to pave the way for the post-project system integration and clinical validation. This will pave the way to the launch of a startup company that will take care of the final steps of the development roadmap and will establish long-term cooperation agreements with prominent medical device manufacturers for the integration of PRISMA in next-generation single and multi-hormone smart patches.
A short summary of progress towards the achievement of each of the project objectives
1) In the first year, the basic numerical model was completed as planned (reported in Deliverable 2.1 M01-10). The model yields the geometrical features and specifications of the materials for the single flat-capillary unit to meet the insulin micro-pump criteria. The model also highlights the stress-strain condition to be generated by the actuators to activate the travelling wave pump mechanisms. Based on this basic model, the simulation of an optimal pump design (Task 2.2 M06-21) has started. This work is to be completed in the coming months. It will clarify the effect of the viscous boundary layer at the capillary wall, determine the optimal geometry and the actuation sequence of the transducer elements, and implement the fluid feature to be closer to typical variations in the insulin viscosity. It will be used to simulate multi-hormone and modular systems.
2) For the manufacturing of the micro-pump, we have concentrated our efforts on producing thin-film supported polyimide flat capillaries. We have demonstrated that the production is feasible and upscalable for thin-film-based actuators made of TiN and Ceria below an overall thickness of ca 2µm. Production methodologies for fabrication are already on the market, and no ad-hoc modification would be needed for full industrialization. The tests also show that the deposited thin-film actuators are operational and yield the expected actuation. The recent results from the simulation have, however, demonstrated that thin film electrostrictors would not supply the necessary forces to activate the travelling wave mechanism. The consortium has then moved towards thicker films for multi-layered actuators (MLA) with typical thicknesses in the 10-100 µm at each layer. Such technology is already on the market for lead-based piezoelectrics. In the first year, we showed that ceria-based electrostrictors MLAs activate the travelling-wave pump without sacrificing compactness and low power consumption, and they greatly simplify the fabrication process of the pump by reducing fabrication costs. Ceria-MLAs also have disruptive potential in the current actuation market as they present a more effective lead-based piezoelectric MLA alternative.
3) For the assembling of the pump, the consortium has dedicated the first-year activities to identifying the needed competencies and components to be used to assemble a pump. Besides the designing activities, we have produced the first set of prototypes for the pumping mechanisms for the single capillary, which include the board, the electrical connections, the driving electronics and the mechanical support. The electronics for the MLA design have been identified, and the power necessary for the ceria MLAs is demonstrated to be competitive in compactness and lifetime.
4) Early activities have been carried out by identifying the key criteria for diabetes treatment and specific features of the simulated PRISMA pump in real-life conditions. The analysis especially shows great potential in the delivery accuracy and for the micro-dose infusion, especially relevant for kids. Notably, the technology shows a unique potential for dual-hormone therapy, where none of the pumps currently on the market can ensure an effective time response to glucagon infusion.
5) The consortium has actively worked on the go-to-market strategy through different actions.
1) IPR: preparing three patents about the travelling wave pump, ceria-zirconia-based electrostrictors and the MLAs based on ceria and specialized electrode materials developed in the project. A legal firm has performed a freedom-to-operate analysis, confirming the possibility of developing these innovations and some indications on how to avoid risking conflicts with existing or pending third-party patents.
2) Business model: Day One has worked on the definition, evaluation and validation of Prisma's business model by studying the current market configuration, interviewing experts and patients and engaging several companies among market leaders, innovators and other possible partners
3) Spin-off activities: The consortium has identified the key personnel within and outside the consortium to startup a company to develop the insulin pump and the on-demand pumping mechanism for other applications.
4) Exploitation strategy: Concurrently, we have consolidated the strategy to build the PRISMA pump device towards an investment-ready development stage and a startup to exploit it within and beyond the current project.
1) In the first year, the basic numerical model was completed as planned (reported in Deliverable 2.1 M01-10). The model yields the geometrical features and specifications of the materials for the single flat-capillary unit to meet the insulin micro-pump criteria. The model also highlights the stress-strain condition to be generated by the actuators to activate the travelling wave pump mechanisms. Based on this basic model, the simulation of an optimal pump design (Task 2.2 M06-21) has started. This work is to be completed in the coming months. It will clarify the effect of the viscous boundary layer at the capillary wall, determine the optimal geometry and the actuation sequence of the transducer elements, and implement the fluid feature to be closer to typical variations in the insulin viscosity. It will be used to simulate multi-hormone and modular systems.
2) For the manufacturing of the micro-pump, we have concentrated our efforts on producing thin-film supported polyimide flat capillaries. We have demonstrated that the production is feasible and upscalable for thin-film-based actuators made of TiN and Ceria below an overall thickness of ca 2µm. Production methodologies for fabrication are already on the market, and no ad-hoc modification would be needed for full industrialization. The tests also show that the deposited thin-film actuators are operational and yield the expected actuation. The recent results from the simulation have, however, demonstrated that thin film electrostrictors would not supply the necessary forces to activate the travelling wave mechanism. The consortium has then moved towards thicker films for multi-layered actuators (MLA) with typical thicknesses in the 10-100 µm at each layer. Such technology is already on the market for lead-based piezoelectrics. In the first year, we showed that ceria-based electrostrictors MLAs activate the travelling-wave pump without sacrificing compactness and low power consumption, and they greatly simplify the fabrication process of the pump by reducing fabrication costs. Ceria-MLAs also have disruptive potential in the current actuation market as they present a more effective lead-based piezoelectric MLA alternative.
3) For the assembling of the pump, the consortium has dedicated the first-year activities to identifying the needed competencies and components to be used to assemble a pump. Besides the designing activities, we have produced the first set of prototypes for the pumping mechanisms for the single capillary, which include the board, the electrical connections, the driving electronics and the mechanical support. The electronics for the MLA design have been identified, and the power necessary for the ceria MLAs is demonstrated to be competitive in compactness and lifetime.
4) Early activities have been carried out by identifying the key criteria for diabetes treatment and specific features of the simulated PRISMA pump in real-life conditions. The analysis especially shows great potential in the delivery accuracy and for the micro-dose infusion, especially relevant for kids. Notably, the technology shows a unique potential for dual-hormone therapy, where none of the pumps currently on the market can ensure an effective time response to glucagon infusion.
5) The consortium has actively worked on the go-to-market strategy through different actions.
1) IPR: preparing three patents about the travelling wave pump, ceria-zirconia-based electrostrictors and the MLAs based on ceria and specialized electrode materials developed in the project. A legal firm has performed a freedom-to-operate analysis, confirming the possibility of developing these innovations and some indications on how to avoid risking conflicts with existing or pending third-party patents.
2) Business model: Day One has worked on the definition, evaluation and validation of Prisma's business model by studying the current market configuration, interviewing experts and patients and engaging several companies among market leaders, innovators and other possible partners
3) Spin-off activities: The consortium has identified the key personnel within and outside the consortium to startup a company to develop the insulin pump and the on-demand pumping mechanism for other applications.
4) Exploitation strategy: Concurrently, we have consolidated the strategy to build the PRISMA pump device towards an investment-ready development stage and a startup to exploit it within and beyond the current project.
Only 10% of type 1 diabetic patients use insulin pumps. Among these 40% use a patch pump. Although pump therapy has already proven to allow a better glycemic control, most of the patients continue using insulin pens or syringes.
Prisma's pumping technology and algorithm will translate into a patch pump capable of addressing the reasons why 90% of Type 1 diabetic patients still don't use insulin pumps:
1) Size and discreteness, the PRISMA device will be smaller and lighter than ever. Our pumping technology will allow for a better shape and size of the resevoir and will use way less energy. The resulting device will then be smaller, lighter and more discrete.
2) Full glycemic control, thanks to the higher drug delivery accuracy, especially in the transient between different flows, allowing a better closed loop control.
3) Automatic bolus removing meals and exercise announcement.
Prisma's pumping technology and algorithm will translate into a patch pump capable of addressing the reasons why 90% of Type 1 diabetic patients still don't use insulin pumps:
1) Size and discreteness, the PRISMA device will be smaller and lighter than ever. Our pumping technology will allow for a better shape and size of the resevoir and will use way less energy. The resulting device will then be smaller, lighter and more discrete.
2) Full glycemic control, thanks to the higher drug delivery accuracy, especially in the transient between different flows, allowing a better closed loop control.
3) Automatic bolus removing meals and exercise announcement.