CORDIS - Resultados de investigaciones de la UE

The first Integrated m-Health solution for anaphylaxis management.

Periodic Reporting for period 1 - Anapphylaxis (The first Integrated m-Health solution for anaphylaxis management.)

Período documentado: 2017-05-01 hasta 2017-09-30

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. The only adequate treatment is an immediate intramuscular epinephrine injection. However, patient self-management of epinephrine has several associated problems, being the most important ones:
Need to check periodically drug condition.
The subject might forget to carry the auto-injector
The subject might forget how to use the auto-injector, be unable of injecting him/herself under stress.
Adanmi has developed the first integrated solution to solve all the issues related to epinephrine management:
The smart auto-injector case monitors epinephrine condition and communicates it to the smartphone APP via Bluetooth.
The smartphone alerts distance from auto-injector in case the subject forgets it, increasing adherence to the lifesaving drug.
It initiates an automated emergency protocol alerting contacts with exact GPS location and providing administration video-instructions for non-trained people to administer the drug correctly.
Phase 1 objectives were the following:
1) To perform a complete market analysis.
2) To define a plan for pre-commercial readiness
3) To evaluate the regulatory requirements and to define for FDA/CE approval
4) To elaborate a complete business plan based on the outcome of the feasibility study.
MARKET FEASIBILITY ASSESSMENT: The detailed market analysis, performed during this phase 1, has clearly showed the validity (unmet needs) and potential profitability. Moreover, the knowledge of the main market features (value, segmentation, competitors…), end users’ characteristics, as well as the last market and social trends has allowed us, on the one hand, to find and decide the best way to reach the market.
PLAN FOR PRE-COMMERCIAL READINESS: We have identified the main stakeholders and deigned a robust dissemination plan and marketing strategy with two primary objectives: i) to reach all essential stakeholders for product visibility and credibility (physician, advocacy groups and patients & relatives) and ii) to increase social anaphylaxis awareness.
REGULATORY FEASIBILITY ANALYSIS: We have identified the regulatory classification of anaPPhylaxis and requirements to design a Regulatory Strategy Plan for EU & the US.
Rise in prevalence of allergic diseases has continued in the industrialized world for more than 50 years with sensitization rates among school children approaching 40-50%. This directly impacts on the sustained growth for epinephrine auto-injectors users, which currently exceed 5 Million; all of them being potential clients for our patented technology. The uniqueness of the solution proposed will not only benefit patient´s quality of life but it will contribute to reduce healthcare associated costs, as well as to provide valuable information and data for professionals.