Periodic Reporting for period 2 - ComFyt (ComFyt, the revolution in compression therapy. A novel Electro-Active Polymers technology applied to a smart stocking that mimics rhythmic calf muscle contractions and stimulates the blood flow.)
Période du rapport: 2019-04-01 au 2020-06-30
The ComFyt project addresses the issues of present compression therapy devices for Venous Diseases (VD). Worldwide, one in four people die from causes related to VDs, as thrombosis.
Compression therapy was proven as a very effective and simple treatment for VDs. It is based on a mechanical principle of applying a constant or intermittent pressure on the lower limbs using a wearable sleeve or stocking. Today, 2 types of compression therapy devices are available: medical compression stockings and active pneumatic compression devices. However, both solutions are flawed with numerous shortcomings, especially in patient’s discomfort, causing low compliance from patients.
Compression stockings offer limited effectiveness, are very hard to put on/off and the constant pressure causes discomfort. Active compression devices are expensive, very cumbersome to use, noisy and require the patient to be stationary while receiving the treatment, due to the necessity of connecting the compressor to an electric socket.
The ComFyt project is aimed at developing and commercialising a unique and easy-to-wear active compression stocking based on an innovative smart material technology (EAP). The ComFyt is poised to be the only product combining effective compression therapy with complete mobility, high comfort and ease-of-use.
Compression therapy was proven as a very effective and simple treatment for VDs. It is based on a mechanical principle of applying a constant or intermittent pressure on the lower limbs using a wearable sleeve or stocking. Today, 2 types of compression therapy devices are available: medical compression stockings and active pneumatic compression devices. However, both solutions are flawed with numerous shortcomings, especially in patient’s discomfort, causing low compliance from patients.
Compression stockings offer limited effectiveness, are very hard to put on/off and the constant pressure causes discomfort. Active compression devices are expensive, very cumbersome to use, noisy and require the patient to be stationary while receiving the treatment, due to the necessity of connecting the compressor to an electric socket.
The ComFyt project is aimed at developing and commercialising a unique and easy-to-wear active compression stocking based on an innovative smart material technology (EAP). The ComFyt is poised to be the only product combining effective compression therapy with complete mobility, high comfort and ease-of-use.
The SME Instrument played a fundamental role in accelerating the development of ComFyt, enabling ElastiMed to progress with the device development, perform small-scale industrialization and preparation for the clinical validation. During the project the company has also achieved significant business development results that pointed the company towards a sustainable business model that will accelerate the time to market. The Phase 2 project is deemed successfully completed, despite a few technical and business challenges. The EAP straps broke down during the first production cycle and required studies for material and production process. The Company successfully identified the cause of the breakdown and designed a new production process that resulted in an improved operations of the device, doubling both the product service life and production yield. The previously planned clinical validation has been postponed due to the state of the emergency cause by the COVID-19 pandemic.
The resultes achieved with the Horizon 2020 SME Instrument Phase 2 project has allowed ElastiMed to develop a device ready for industrialisation, and clinical validation. These results have allowed the company to engage with important industry leaders interested in licensing ElastiMed's technology. In-depth due diligence has been made and ElastiMed is already involved in the codevelopment of new innovative devices with the identified industrial partners. This result is likely to have a tremendous impact on the commercialisation of the technology, enabling the ComFyt to reach multiple markets in EU and the USA through established sales channels.