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Biomimetic nano-coatings for healthcare. Targeting the contact lenses market

Periodic Reporting for period 1 - LIPOCOAT (Biomimetic nano-coatings for healthcare. Targeting the contact lenses market)

Reporting period: 2017-12-01 to 2018-03-31

Biomaterials used in medical devices are prone to biofouling and an associated thwarted performance. 1 in 20 patients develop health-care acquired infections, of which 50% can be attributed to contaminated medical devices causing more than 140,000 deaths a year and costing over € 13B. Our revolutionary coating technology will make any (bio)material surface non-thrombogenic, non-fouling and resistant towards surface pollution of micro-organisms and proteins. The use of LipoCoat coatings can increase the performance, comfort and safety of medical devices. We, the LipoCoat team, have envisaged a project to commercialize our coating solution that involves 7WP intended to industrialize, validate and protect our solution, the production and the coating process for soft and rigid contact lenses. We will increase production through FAST to provide our solution and concentrate. We will be ready for industrialization, commercialization and market launch by 2021.
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.
LipoCoat is a multipurpose bio-inspired coating that mimics the natural coating of the cell surface avoiding biofouling and offering extra features such as lubricity, wetting, thrombogenicity and self-regeneration to medical devices. LipoCoat technology consists of: the formulation of LipoCoat solution, the process to produce the solution (FAST) and on the process to coat medical devices, dip-coating. With an investment of €1.5M the expected impact for LipoCoat in 2025 is to generate 10 new job positions, expecting a cumulative 5-Yr revenue of €62M and a return of investment by year 2. By 2025 we expect to reach >1.3% of the market share for rigid contact lenses and over 7% for the soft contact lenses market.
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