Periodic Reporting for period 1 - SWeetLight (Suturing with Light) Reporting period: 2015-05-01 to 2015-10-31 Summary of the context and overall objectives of the project The SWeetLight System is a medical device for performing a safe closure of the cornea at the end of a keratoplasty (cornea transplantation) intervention. Scope of the Feasibility Study is to evaluate in details all the necessary components to the industrial development of the SWeetLight System and its economic convenience, with the objective to establish a NewCo.The transplant of the cornea can be performed with different approaches and different surgical tools, depending on surgeon skills and patient pathology and specificity. The basic principle is to substitute the unhealthy corneal tissue (the whole cornea or a portion of it) with a donor cornea or its portion. The standard procedure is to cut the patient and donor cornea with a manual procedure, using corneal trephines, microkeratome, knives, etc. Nowadays it is also possible to perform laser assisted preparation of corneal tissue, cutting in depth different geometries and shapes, thus offering the possibility to design a “customized” surgery, tailored on patient’s pathology and morphology.In the last ten years laser welding of corneal tissue has been studied and proposed in order to perform laser assisted suturing of the cornea, concluding the transplant procedure. It provides an immediate closuring effect of the transplanted tissue, to stabilize the flap in its final position, avoiding mechanical tensions and deformation in the healing phase and to suture thin tissues in inaccessible sites (laser-assisted microsurgery). The proposed technique has been tested in preclinical and clinical studies but, much more important it has been performed in clinical trials in more than 300 hundred patients, since 2004. The SWeetLight System is composed by computer assisted robotic platform that can move a Laser diode around the cut line of the corneas, all controlled by a NIR camera and a thermal camera by means a human interface.The work performed includes the following main aspects: a Profit and Loss Statement, a Market Analysis and Commercialization strategy in more than 10 countries (also outside EU), a commercial partner evaluation, a Risk Assessment on many possible recognized threats, the Intellectual property management and the CE labelling bottlenecks and pathway.The results of the Phase I study is very promising and as soon as the development of the robotic platform will reach a reasonable level of development the team will apply at Phase II of SME INST. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far In a few words, the work was focused at trying to answer at the following two basic questions with the final objective to establish a focused NewCo/Start-up: is it convenient to invest in the SWeetLight system? If so, how?We did not have any doubts concerning the technical feasibility and the medical convenience, but, as often happens, not everything that is technically feasible and also very useful for the surgeon is possible to turn it into a salable product for reasons of cost-benefit ratio, given also the restrictive spending policies of public (but also private) healthcare system.The works follows for the large majority the proposal, we a little modification as outlined at the end of this paragraph. The first point of the team investigated is the end-user price. This theoretical simple question required an huge and partially unexpected effort: we asked for information to the most important stakeholders related to the field of surgical ophthalmology, including opinion leader surgeons, vendors, agents and hospital purchasing departments. At the same time we also understood the payment methods (see paragraph 3.1.2). During the work we performed an accurate market analysis (including concurrent companies and related devices), a commercialization strategy in more than 10 countries (also outside EU), a commercial partner evaluation, a Risk Assessment on many possible recognized threats, the Intellectual property management and the CE labelling bottlenecks and pathway.We want also to underline that this document represents a sort of an “ideal partnership” with the La Roses project, presented (and won) in the framework of Echord++ initiative of the European Commission. La Roses is dedicated to the development of an industrial version of the keratoplasty laser-based medical device: SWeetLight is dedicated to the evaluation of a Business Plan and other related activities as described in the next chapters.La Roses Team is composed by Ekymed Srl, Fastenica Srl, and IFAC-CNR (the scientific partner, see chapter 11 for a short partner profile).In order to have a clearer document we slightly modified the WP as follows: in T1 we have eliminated “commercialization strategy and growth model”: this activity has been included in T3, modified from “Market penetration growth model” to “Market analysis and commercialisation strategy”. All the other activities remain the same. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) The results of our efforts during Phase 1 fully support our initial ideas in regard to develop and market a novel system to assist the surgeon for performing the cornea transplantation. Upon the successful completion of the remaining industrial R&D phases, ophthalmologists will have an innovative and safe new medical device tool able to perform a long-term protected closure of the surgical wound of the cornea.Our solution may improve quality of life of thousands of patients every year worldwide with, at the same time an overall saving in terms of time and money for the healthcare system, due to the vertical decrease re-implantation and postoperative inspection of the wound. SWeet-Light Visual Interface SWeet-Light concept including robotic arm, handpiece and patient
