Periodic Reporting for period 1 - Anapphylaxis (The first Integrated m-Health solution for anaphylaxis management.)
Reporting period: 2017-05-01 to 2017-09-30
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.
ANAPPHYLAXIS PHASE 1 PROJECT OBJECTIVES
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.
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.