PRISMA

The FET Innovation LAUNCHPAD PRISMA is an EU-funded project for the development of a new micro-pump, to be integrated in a transdermal patch, for the delivery of three hormones by micro-needles. This project is born from the previous FET Open project Biowings, during which the thin and biocompatible film cerium oxide actuating electrostrictor membrane is developing, for the application in silicon-based MEMS (Micro-Electro-Mechanical-System) and microfluidic systems. The objective is to exploit the Biowings results to design a novel MEMS that works as a multistage peristaltic pump.

Diabetes treatment starts from a change in lifestyle and always entails a life-long insulin administration. This is not a trivial task for diabetic patients, as the amount of insulin to deliver is patient specific, and has a highly dynamic evolution over time, for example due to meals composition, sleep cycles and physical activity. New Closed-loop Artificial Pancreas are currently being studied and promise an agile solution to the difficult challenge of insulin treatment for patients with type 1 diabetes management. However, the technical limitations of current electromechanical micro-pumps do not allow a simultaneously multiple hormones delivery, with small dimensions and the adequate performances. The challenge is to have a pump system that is small enough not to be visible under the clothes of the user, smart enough to be able to administer the correct injections at the appropriate times and precise enough to yield a fine control as well as a correct mixing ratio of particularly the insulin and amylin.

As said, the project stems from the FET-OPEN BioWings, where the concept of a thin-film micro-pump was prototyped. The achievement of a multi-hormone closed-loop system requires two innovations:
• A transdermal hormone delivery device, which replaces state-of-the-art invasive insulin delivery systems, and administers the correct amount of insulin, glucagon, and amylin;
• A micropump able to precisely mix the right amount of hormones through a smart patch with microneedles.
With PRISMA we aims to validate the feasibility, both from a technical and from the business point of view, of a new infusion device, which integrates this micro-pump to deliver three hormones in reduced dimensions. The Prisma core innovation is a flat smart patch containing MEMS peristaltic micropumps which enable transdermal delivery of a triple-hormone solution for diabetes patients. The proposed closed-loop solution consists of:
1. The smart patch containing the MEMS micropump, a battery, a microprocessor that control its activation and the microneedles system for the transdermal delivery of the hormones;
2. A glucose monitoring sensor;
3. A mobile app that process the glucose level in real time, convert it into injection volumes of the three hormones and submit instructions wirelessly to the microprocessor. The mobile app also serves as user interface.

The social and economic benefits of the successful introduction of the Prisma innovation are significant.  Diabetes is a major global problem, directly responsible for more than 1.6 million deaths, and other 2.2 million due to high blood glucose levels. It is estimated that around 422 million people are affected by this disease globally, with an incidence of about 8.5% of the adult population. The introduction of a the new PRISMA device could have a huge impact both on life expectancy and European health systems. The business opportunity for Prisma is huge. The system will compete in the wearable medical devices market, which was valued USD 13 billion in 2019 and is expected to exceed USD 90 billion by 2027, growing at a CAGR of 27.9% (Grand View Research).

The venture building activieties of this FET Innovation Launchpad project including the definition and the validation of the business model following 3 different approaches:

• Producing and selling the entire device.
• Producing the peristaltic micro-pump and selling it to a medical devices producer who will integrate it into the system.
• Licensing the generated IP to a large medical device manufacturer.

Day One is helping the research and development team in the design and development of the new micro-pump, analyzing its future application scenario to derive specific product requirements. The Concept Validation, carried out following a Design Thinking approach applied to high-tech technology transfer, starts from a deep knowledge of the needs from all the stakeholders involved in the product value chain.

For this purpose, Day One is carrying out an analysis of the competitive scenario of the treatment of type 1 diabetes by interacting with diabetologists and experts to verify that the current needs, both clinical, economic and above all of the patients, are the same as the our new infusion device will be able to satisfy once developed.

Day One’s support to CeOx, the spin-off company launched as part of the BioWings project to market the IP generated by the DTU project coordinator, includes the creation of a product development roadmap defining the business conditions necessary for the raising additional funds that will be used to complete product development. Once the technical and business feasibility of the device is validated, the team intends to achieve clinical validation, and ultimately market entry.