Periodic Reporting for period 1 - ComFyt (The revolution of the Compression Therapy Market: an easy-to-wear and comfortable compression stocking based on Electro-Active Polymers technology.)
Reporting period: 2017-06-01 to 2017-09-30
For patients with venous and lymphatic diseases, compression therapy is a proven, simple and very effective treatment. Compression therapy increases the pressure on the subcutaneous tissue, which helps to reduce and prevent swelling. Indeed, the compression of the subcutaneous tissue lets excess fluid (swelling) move back into the capillaries, preventing the leaking out of too much fluid from these little vessels. Compression therapy also reduces the ability of the superficial veins in the leg to expand and overfill with blood. This in turn helps to prevent blood in these veins from flowing backward causing congestion. Congestion in the leg produces pain, swelling, and skin changes common in persons with venous problems.
The therapy uses a number of different devices, including elastic and non-elastic bandages, boots, hosiery, pneumatic devices and graduated compression stockings. Graduated compression stockings have the largest market diffusion because they are less cumbersome and therefore more acceptable than bandaging and pneumatic devices. However, most patients do not tolerate using graduated compression stockings as well . There are a range of reasons for non-adherence: difficulty in applying and removing the stocking, intolerance of the squeeze of the stocking, poor fit, pain, and low efficacy, all play role . Users require a clinically effective device that is easy to apply and to remove, without impeding their regular lifestyle and mobility.
ElastiMed has developed ComFyt, a light and easy-to-wear compression stocking that guarantees high clinical effectiveness while eliminating the discomfort and the difficulties of traditional stockings, such as doffing and donning. ComFyt helps reducing the diameter of distended veins and produces an increase in venous blood flow velocity and valve effectiveness. While ensuring movement of venous blood by squeezing blood from the underlying deep veins. These features are proven to improve user’s compliance, thus improving the outcomes of the compression therapy.
The therapy uses a number of different devices, including elastic and non-elastic bandages, boots, hosiery, pneumatic devices and graduated compression stockings. Graduated compression stockings have the largest market diffusion because they are less cumbersome and therefore more acceptable than bandaging and pneumatic devices. However, most patients do not tolerate using graduated compression stockings as well . There are a range of reasons for non-adherence: difficulty in applying and removing the stocking, intolerance of the squeeze of the stocking, poor fit, pain, and low efficacy, all play role . Users require a clinically effective device that is easy to apply and to remove, without impeding their regular lifestyle and mobility.
ElastiMed has developed ComFyt, a light and easy-to-wear compression stocking that guarantees high clinical effectiveness while eliminating the discomfort and the difficulties of traditional stockings, such as doffing and donning. ComFyt helps reducing the diameter of distended veins and produces an increase in venous blood flow velocity and valve effectiveness. While ensuring movement of venous blood by squeezing blood from the underlying deep veins. These features are proven to improve user’s compliance, thus improving the outcomes of the compression therapy.
Throughout the duration of the project, ElastiMed expanded its knowledge of the medical device market, including regulations, medical device reimbursements standards, market size and competitors. The company has established a sound commercialisation strategy for the anticipated market launch.
The feasibility study showed that ComFyt is viable technically and commercially, determining the business project to be a profitable investment.
During the project, ElastiMed gained some crucial feedback from early beta testing (study on healthy subjects started in October 2017) that was highly valuable in defining remaining technical activities to be performed to enable the start of the clinical trials with edema patients. The objective of the future clinical study is to prove the efficacy and efficiency of the device, and to obtain clearance for the CE marking. As well, to gather additional real-life scenario information, that will be extremely valuable for the subsequent dissemination and communication activities.
ElastiMed analysed in detail the customer segments and selected Germany, UK, France, Netherlands, Italy and Spain as the primary markets to target.
The feasibility study showed that ComFyt is viable technically and commercially, determining the business project to be a profitable investment.
During the project, ElastiMed gained some crucial feedback from early beta testing (study on healthy subjects started in October 2017) that was highly valuable in defining remaining technical activities to be performed to enable the start of the clinical trials with edema patients. The objective of the future clinical study is to prove the efficacy and efficiency of the device, and to obtain clearance for the CE marking. As well, to gather additional real-life scenario information, that will be extremely valuable for the subsequent dissemination and communication activities.
ElastiMed analysed in detail the customer segments and selected Germany, UK, France, Netherlands, Italy and Spain as the primary markets to target.
As evident from the Technical and Business Assessment conducted within the Phase 1 study, in compression therapy there isn’t a perfect problem/solution fit. Every option comes with specific pros and cons. But, in general, the therapy suffers from a low compliance rate of about 40% and continues to seek innovative solutions that will reduce patient’s discomfort and improve the patient quality of life.
ElastiMed is working to address such unmet need. ComFyt will be the only product combining effective compression therapy with complete mobility, high comfort and ease-of-use. The device will guarantee the best-value-for-money on the market, competing in performances with more expensive and complex systems used in inpatient care.
ElastiMed is working to address such unmet need. ComFyt will be the only product combining effective compression therapy with complete mobility, high comfort and ease-of-use. The device will guarantee the best-value-for-money on the market, competing in performances with more expensive and complex systems used in inpatient care.