During Phase 1, work has been focused on developing deeper understanding of market and users’ demands, establishing a sound framework for future clinical validation activities, including the definition of a worldwide network of clinical validation centers, and developing a business plan for successful market introduction; the following activities have been performed:
- Development of an original comprehensive epidemiological study based on world literature, aimed at identifying diseases more impacted by comorbid depression, to be selected as target disease
for the use of LUCY
- Quantification of the number of patients in Europe and USA eventually affected by depression comorbid to more severely impacted chronic diseases
- Identification and critical analysis of standard clinical practice in chronic diseases management; identification of pain points and constraints
- Development of LUCY implementation paradigm in clinical contests, with the definition of the competitive advantage of LUCY with respect to standard operative practice and potential competitors
- Analysis of public and private health structures for target countries, with specific reference to public and private hospitals
- Identification of standardization and certification procedures to be followed to comply with healthcare regulations and guidelines in view of FDA certification
- Definition of LUCY target product development during Phase II and beyond, incorporating outcomes from market analysis and end-users’ involvement, including scale-up infrastructure
requirements and integration of added-value services
-Analysis of possible revenue models, selection of appropriate revenue model, definition of market segmentation, development of product line-up and pricing strategy
- Definition of a financial plan, forecasting revenues sales volumes and revenues for LUCY market introduction and commercialization
- IPRs recognition, patentability assessment, freedom of exploitation; trademark anteriority search, deposit of commercial trademark
Main results achieved so far:
- A clear picture has been produced about the impact depression generates in individuals affected by 7 major chronic disease affecting overall 170 M people in Europe and 140 M people in USA
By way of example, people with stroke affected by depression suffer from a risk of death which is reported to be between 30% and 50% higher; similar values are reported for course, involving
relapses, complications, hospital readmissions and further therapies
- An analysis of conventional medical practice allowed to highlight significant shortcomings, constraints and pain points, detecting general awareness by healthcare professionals that new models
have to be implemented and enabled.
- A complete set of technical product development specifications have been produced, complying with the implementation scenario generated by the analysis of conventional practice and users’
interviews.
- A long term product development roadmap, including the definition of the Minimum Viable Product and incremental development stages has been produced, including the identification of added
value services increasing LUCY
- The Group of worldwide clinical Validation Centres has been identified, including 10 major renowned partners from 8 countries in Europe, USA and South America, targeting a randomized screening
involving nearly 1,500 patients, a preliminary version of the clinical validation protocol has been agreed
- Economic projections developed confirm LUCY remarkable market potential
