During the Phase 1 feasibility assessment, CellPly accomplished a full analysis of the technical and business potential of ONCOSMART platform. Throughout the duration of the project, CellPly expanded its knowledge of the medical device market, including regulations, medical device reimbursement standards, market size and competitors. During the Feasibility Study, the internal clinical validation was extended and interim results on 7 patients reported a correct prediction of the outcome of the therapy in more than 85% of the cases; a new design of the disposable diagnostic kit was developed, according to a series of specifications identified through interviews with the end users; the business model and go-to-market strategy were defined and include a first phase where the innovative platform will be used to offer services to pharmaceutical companies supporting their drug development needs, possibly leading to the development of Companion Diagnostic products, followed by a second phase where sales of the platform to hospitals when certifications will be obtained and reimbursement issued will be overcome. The product development was decided accordingly, foreseeing the need to conduct a multicentre clinical trial in Europe to eventually obtain the CE-IVD mark, followed by FDA approval in the US , with the aim to start commercialising the device to hospitals in Europe and later in the US. A deep assessment concerning the right business model which held in consideration the right path in terms of time to market and company strategy and vision led to consider the model of the service to pharma as the most promising to start the commercialization. In addition, CellPly established a commercialisation plan supporting direct sales to hospitals.
