A Feasibility analysis has been carried out according to the work plan set in phase 1. We have developed the following tasks:
Commercially, we have assessed the particularities of selling each type of contact lenses in two business models, stablished relationships with manufacturers and suppliers, and contacted subcontractors to design the FAST machine. We have benchmarked our product against existing alternatives and selected preferred regulatory route for LipoCoat (ISO 10993 testing and compliance to ISO 13485 quality management system). Additionally, we have defined mitigation measures to avoid the envisaged commercial risks. LipoCoat BV has formalized technology transfer agreements with the University of Twente, based on an exclusive, royalty-free license to the WO2014184383A1 patent family.
On the technical side, we have defined the industrialization roadmap to reach the end-product and performed an in-depth analysis on the market for coatings devoted to two types of contact lenses: soft and rigid. We have envisaged the design of a machine able to conduct the FAST process automatically, which will enable industrial production of our solution. The subsequent steps to validate and certify LipoCoat are planned and have found that an additional testing will suffice to certify our product under CE mark. Difficulties arising from the industrialization of our process are the main envisaged technical risks, with low probability of occurrence and of impact. We have defined mitigation measures accordingly.
Financially, we propose business plans that envisage cumulative revenues of €62.9 M and a ROI >15% for year 2025. Revenues will be boosted by 2022 by JDA and sales of Rigid Lens (RGP) product, RGP lens care solution and Daily disposable soft lenses with a gross margin of 38%. LipoCoat. The payback for the requested investment of €1.5M will be in 2 years of commercialization.
