Periodic Reporting for period 1 - GDS (A safe and effective non-surgical and reversible procedure for weight loss) Reporting period: 2018-06-01 to 2018-09-30 Summary of the context and overall objectives of the project Allevetix Medical Ltd is an Israeli biotech company founded in 2014 that is working towards bringing to market the new standard in T2DM and weight loss treatments. The team’s vision is to address the emerging obesity and diabetes problems with a simple, effective, reversible and affordable solution, addressing the needs of millions. The NOBIX System.The key objectives of the development are miniaturization of the delivery system; improvement of the anticorrosion surface treatment; optimization of the locking mechanism of the anchor and improvement of the sleeve; safety and efficacy validation on T2DM patients; CE mark and ISO 13485 certification. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Throughout the duration of the project, Allevetix defined the preliminary updates in the miniaturisation and optimisation of the device, reviewed its development plan, supply chain, and scouted for third parties to support in the development stage and the distribution channels. The market segments and opportunities have also been evaluated, defining the TAM and SAM. A commercialisation strategy has been established. The Phase 1 feasibility assessment has determined that a development plan for the NOBIX System is technically and commercially viable, and that further engineering, manufacturing and commercialisation plan should be pursued. The SME Instrument Phase 2 funding could provide the correct amount of funding and support to allow the stated activities to be implemented successfully. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) There are about 60 million people with diabetes in Europe, or about 10.3% of men and 9.6% of women aged 25 years and over. This number is expected to increase up to 71.1 million by 2040. T2DM accounts for at least 90% of all cases of diabetes, and it is often associated with overweight or obesity. Obesity has become a serious global health problem: nearly 15% of people over 18 years are obese (11% of men and 15% of women) according to WHO standards. Obesity has a far-ranging negative effect on health, leading to diabetes, coronary heart disease, and several types of cancers.The NOBIX System is a non-surgical reversible solution for hormonal balance and weight-loss of patients with T2DM, with zero side effects, immediate recovery and no need for a prolongued hospitalization. nobix-system.png
