The agreement with EC started in November 2019. However, the project started earlier. In September 2019, pre-clinical tests were carried out with the titanium devices provided by Recornea. These tests concluded that the material of these devices did not allow the shape memory necessary for non-invasive implantation in patients. For this reason, at the official starting of the project, the material was changed to nitinol.
During the first months of the project, Blueacre, with the technical support of REC, adapted the tasks for the creation of the devices in nitinol. At this point, it required the support of suppliers whose delivery times were greatly delayed by the global pandemic situation. In particular, there was a delay in the dies and in the press.
These delays and the difficulties to replicate the design proposed in the project by Blueacre, caused that the devices created were not delivered to CHU and IMO for their pre-clinical study until the last week of the 12th month of the project.
The preclinical tests concluded that the devices created by Blueacre did not have the necessary shape memory nor did they meet the curvature criteria or other necessary technical specifications for a human clinical trial.
Since Blueacre was not able to produce a viable prototype and spent almost all of its project budget in year 1, the Consortium decided to completely rethink the project, without Blueacre's participation, to outsource the production of the devices. During year 2 of the project, alternatives have been found that meet the technical and qualitative requirements necessary for a device to be implanted in human eyes.
In its third year, the project successfully scaled up production of the GROSSO Implant, implementing numerical simulations and quality control to meet regulatory standards. With an additional €600k from third parties, the Humaneye project remains on track according to the January amendment. Despite delays, the team plans to complete device production, biocompatibility, and animal testing by year 4's end. Pending ethical committee approval, and considering war-induced delays and rising material costs, human study recruitment is slated to begin in year 5.
In the project's fourth year, the GROSSO Implant's production and provider processes were validated, enabling successful pre-clinical testing for regulatory compliance, including MR conditional certification and various safety evaluations. REC secured €805k in investments, with an additional €150k under negotiation with Scientifica VC. The consortium is focused on completing the first-in-human (FIH) study, pending final approval from Spain's AEMPS, although it has already received a favorable review from the Ethics committee in February 2024.
