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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - 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.)

Teaser

Summary

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 patientâ€™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.

Work performed

In the first ten months of the project, Elastimed has started and made progresses in every work package. Below, we present an overview of the results achieved so far:

1) In June 2018, the company presented the findings of the ongoing clinical feasibility study on stage at the ICC (International Compression Club) conference in Rotterdam. The presentation received a strong validation from the medical community.

2) In July 2018, the company completed the clinical feasibility study for the 1st generation of the ComFyt device. The study involved 11 healthy volunteers and was performed at the Hillel Yafe Medical Centre in Israel. Results show an average improvement in the peak flow velocity in the popliteal vein of 141%, and an average reduction in the diameter of the GSV and SSV of 18%. While the results matched the clinical effect received by commercial pneumatic compression devices, user experience questionnaires demonstrated a much higher comfort level. The MD supervising the study, Dr. Ofer Galili, is highly excited by the results.

3) In October 2018, after an intense 4 months effort, the company have successfully completed the development of the ComFyt 2nd generation, including doubling the pressure range the device can apply, reducing the device thickness and weight.

4) Elastimed is now in the process of verification and validation of the device in preparation for filing for regulatory approvals in EU and in the US.

5) The company have begun the process of raising its next round of financing of $6M - funds will be used for building the production line, obtaining regulatory approvals and establishing distribution channels. The company is already in discussion with a few VCâ€™s and private investors.

Final results

During the first reporting period, Elastimed completed the design of the second generation of the ComFyt device. The expected results related to the use of this second generation (ComFyt able to achieve edema volume reduction) will be verified within the clinical study planned for the second reporting preriod of the present project.

However, Elastimed has already been able to obtain good results in terms of dissemination and communication of the projects\' interim outcomes, establishing significant relationships with potential investors, distributors and customers.