Clinical Evidence Generation Strategy & Implementation;
Revenue Generation Roadmap Development
4Dx needed clinical data to support its FDA application and early evidence of clinical utility in multiple respiratory indications to support market access. Additionally, our client required an understanding of all possible revenue-generating strategies for their entire suite of services, inclusive of pre-clinical animal scanners and pre-clinical SaaS products. TTi designed and is currently implementing a 3-phase clinical evidence generation program to: 1) Establish “proof of concept”; 2) Demonstrate performance “as good as” current pulmonary function tests (PFTs); and 3) Establish the technology as “better than” current PFTs for managing patients with severe respiratory disease. Additionally, TTi developed a Revenue Generation Roadmap outlining multi-faceted revenue opportunities both inside and outside traditional reimbursement pathways. The robust evidence generation and revenue generation strategies developed by TTi allowed 4Dx to secure additional investment to carry them through their FDA approval.