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.
