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Virtual eye model system for personalised refractive surgery treatment

Periodic Reporting for period 1 - VEMoS (Virtual eye model system for personalised refractive surgery treatment)

Reporting period: 2019-12-01 to 2020-05-31

We have confirmed the commercial and economic viability of our Virtual Eye Model System (VEMoS) solution, developed a comprehensive roadmap for technical maturity and built a strategic business plan to reach commercialization. The VEMoS project is a crucial step to execute these plans and enter the refractive surgery market. The project objectives aim at fine-tuning and automatizing the software (SW) of the Virtual Eye Model system and updating the hardware (HW) to get an optimum and customized diagnostic platform with seamless communication (WP1). This will allow us to advance the solution to TRL8. Finally, we will test our system in the real-life environment via a clinical trial to TRL9 in compliance with the relevant regulations for this type of medical device. To support commercial viability, we will also undertake market maturation activities, including supply chain consolidation, market surveillance, certification, dissemination measures and IPR strategy.
Since the beginning of the project, CSO has performed part of the hardware maturation (WP1) including the definition of adjustments, which ranges from a feasibility study and concept design to product requirement specifications of the diagnostic technology. On the one hand, for the open field aberrometer, we tested the optoelectronic components and the chinrest and dichroic filter. On the other hand, for the MS 39 plus axial length measurement, we focused on the optical design of the dichroic filter and corner cube, as well as on the mechanical design and testing of the mechanical stability of the variable-length part of the reference arm and a two-path reference arm. Similarly, Vissum has performed part of the software refinement (WP2). Together with CHUC and AUH, we have set eye measurements and diagnostic equipment required. Moreover, we have agreed on a manufacturer agnostic DICOM export protocol, updated the SW architecture, and migrated from Matlab to JAVA code, and developed the reading module for BCS files. Regarding the supply chain consolidation and scale-up (WP4), CSO has identified a new supplier for the optoelectronics element. CSO has also analysed in collaboration with Vissum the regulatory requirements (WP5). Related to WP6, we have identified stakeholders and drafted a Dissemination and Exploitation Plan (DEP), including initial dissemination and communication activities. Finally, we have managed the project and innovation (WP7), including risk management and mitigation measures related to the COVID-19 related delays, as well as drafting the Business Innovation Plan (BIP).
VEMoS is the first system combining all-in-one diagnostic device with SW to provide personalised clinical decision support based on each patient’s eye measurements and neural network simulations of post-surgery outcomes. Key novelties are:
• All-in-one device: Single device for all measurements
• Predictive Power: Advanced algorithms to predict post-operative visual acuity
• Decreased likelihood of adverse effects: Standardised decision-making considering HOA and other factors responsible for most adverse effects
• Personalised treatment: Laser parameters adjusted based on patient parameters
The VEMoS project contributes to the following expected impacts:
• Economic: Based on the performance of the first prototype of VEMoS system, the implementation of our diagnostic solution will decrease the need for re-procedures by 90% – corresponding to reducing the total number of second operations in the EU to 2,372 per year. This means potential annual savings of €38.88m in the EU alone in direct costs.
• Industrial and technological: The unique modelling software will not only increase growth in the refractive surgery market, but it will also open the door of a new market focused on virtual modelling of patients’ eyes, with a first application in refractive surgery, but also with future applications in other eye-related diseases. VEMoS project will disrupt the market of refractive surgery offering personalised surgery solutions, in line with current health trends that seek personalised medicine (e.g. EC action plan on personalised medicine “ICPerMed”).
• Innovation capacity: The VEMoS project represents a unique opportunity for members of the consortium to develop their innovation capacity: 1) the first software for realistic and accurate virtual modelling of patients’ eyes will further the knowledge of our software engineers, and 2) the open field aberrometer and the all-in-one diagnostic device represent technology developments beyond the SoA for the most detailed characterisation of eye structure available at the market.
• Competitiveness and scale-up: The VEMoS project is key for the consortium growth and scale-up capacity. We have estimated a conservative financial forecast for the first 5 years post-project based on a 16% market share of the total refractive surgery market. According to this forecast, the consortium will obtain €145.3m in revenues and €58.2m in profits over the first 5 years. Moreover, our preliminary plan for scale-up includes the creation of 60 new job positions over this period.
• Social: Implementation of VEMoS technology in ophthalmic clinics and hospitals departments will bring substantial social impact for the patients affected by visual impairment and for the ophthalmic clinics staff: 1) it will decrease the need of preventable second operations and the appearance of avoidable side effects, increasing the overall quality of life of patients; 2) it will increase the number of patients treated by refractive surgery since we will gain their trust offering a technology that is reliable, accurate and safe while freeing resources otherwise required for re-procedures; and 3) it will promote the use of refractive surgery, potentiating the number of trained ophthalmologists and number of refractive surgery clinics, creating new jobs and opportunities and further help to ameliorate the challenge of visual impairment and its consequences, in alignment with the WHO initiatives “Universal Eye Health: A Global Action Plan 2014-2019” and “VISION 2020: The right to Sight”.
• Environmental: The reduction in the number of re-procedures will result in wider resources savings, such as water and energy for sterilisation of instruments. Further, one of the aims in the industrial maturation of the VEMoS hardware will be reducing the resource footprint of manufacture while ensuring that its components will be easily repurposed or recycled. The all-in-one diagnosis device will save in materials and electronics used for manufacturers, as well as in space and resources for hospitals.
VEMoS SW diagram
Virtual eye model
Virtual and physical eye match