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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - SmartSyringe (SmartSyringe, world easiest, safest and fastest blood collection ever made.)

Teaser

Summary

Blood is the essential physiological parameter when it comes to assess our health, going from routine check-ups to complex tests for infectious diseases. However, for over 150 years, blood collection techniques have not evolved. Skilled healthcare professionals are still required to pursuit complex procedures (venipuncture) to attain proper blood samples for further analyses. For patients, common adverse effects of venipuncture are bruising at the site of puncture, fainting, nerve damage and hematomas. Moreover, venipuncture is prone to erros in diagnostics as each step in the process of the blood draw affects the quality. When 80% of all medical decisions are based on blood results, it really matters. Venipunctre require trained staff. in low resource settings where money and time is scarce, a lack of trained staff leads to shortcomings of peoplesâ€™ health. Furthermore, this procedure is also unsafe to workers: In UK, a total of 2,947 sharps injuries involving a source patient infected with a blood borne virus were reported by health care workers during 2002-2011.

We are developing a needle-free solution which is able to extract and collect capillary blood in a simple, safe and painless way: SmartSyringe. It is a revolutionary technology which enables simple, safe and painless blood collection without needles. It enjoys several advantages over venous blood sampling: it is less invasive, it requires smaller amounts of blood volume and it can be performed quickly and easily.

The ultimate objective is to make SmartSyringe ready for market launch in Europe. This entails a number of technical and strategic objectives, including the completion of product development, the industrialization to reach commercial scale production, the clinical validation through a European clinical study and the exploitation of its results. The SME-I plays a key role in this strategy by providing the financial resources needed for a rapid and effective market uptake.

Work performed

During this study, we have defined the remaining optimization and upgrade activities required for SmartSyringe final product and the identified all necessary suppliers and stakeholders for a successful completion of the project. The clinical validation was also defined with the key objective of demonstrating the clinical grade of blood specimens collected by SmartSyringe, as well as the safety and usability of the medical device. The worldwide competitive analysis performed confirmed that Loop-Medical will be the first to commercialise a re-usable device able to integrate painless blood collection and incomparable safety. We have also defined the commercialisation strategy and estimated financial projections based on it. These promising projections coupled with confirmed productâ€™s feasibility lead us to the decision to follow-up with this innovation project.

Final results

Phlebotomy is currently the gold standard procedure for blood extraction, it works with most of the laboratories and is normally well integrated into hospitalâ€™s workflow. However, it is an expensive procedure that requires trained professionals. On top, in laboratories problems in the management of sharps containers, recapping, needle disassembly by hand and blood transfer from syringes into tubes were accounted for two-thirds of injuries. Unlike this, SmartSyringe empowers healthcare workers and simplifies access to diagnostics to patients by providing simple and safe blood collection anytime, anywhere, with incomparable safety standards, ease of use and cost-effectiveness. SmartSyringe intends to combine the quality of veins blood specimen with the simplicity of capillary blood collection, integrating it with blood analysis workflow.

Annual blood testing is the most important step aging adults can take to prevent life-threatening disease. With the share of elderly people rapidly increasing, capillary blood testing is particularly recommended for old age patients, due to the damage or weakening of blood vessels. Having the proper blood tests can empower society to enact a science-based disease-prevention program that could add decades of healthy life. In these settings, SmartSyringe can offer a more efficient blood collection method and a greatly improved patient experience.