Activities performed during the RESEE project include:
- Conclusion of a first-in-human clinical study, implanting the CorNeat KPRo device in 10 patients, most of whom were previously defined as terminally blind. The study proved the CorNeat KPro's ability to integrate with the native eye, enabling patients to regain their sight and independence, some, following decades of blindness. Our first patient, who is now more than three years post op (implanted prior to the RESEE project initiation), is still enjoying his vision and independence. He previously failed four transplantations and was blind over the last decade. Our fourth patient, a lady from Paris, who previously went through six transplantations and 12 failure episodes, completed two years from the procedure. Surgical challenges that were encountered during the first 5 patients were addressed by the company, these resulted in formal amendments to the clinical protocol, implementing changes in the surgical technique, patient selection, and pre-post op treatment. A subsequent decision to conclude the first-in-human study and initiate a pivotal trial, opened up the opportunity to implement several minor modifications in the device which accelerate its bio-integration and increase production yield.
- Design and bulid of a robotic cell for fabricating the bio-mimetic (electrospun) tissue-integrating skirt around the CorNeat KPro optics rim. The conceptual design selected, which was designed and approved during the first year of the project, supports the production of ~200 devices a day by integrating a customized industrial electrospinning machine, a robotic arm and a set of production and testing technologies, which include a coating station, laser cutting station, high precision touchless laser thickness measurement station and more. Following the approval of the design, the company has competed the actual building of the robotic cell, which is now available for the use of the company in its facility. A clean room for hosting the production line was designed and built in the Company's building. This clean room, which hosted the manual production line, now hosts the robotic cell allowing the company to manufacture a many CorNeat KPro devices as needed.
- Production and release of improved CorNeat KPro implantation kits for supporting the second clinical study. The new kits implement several modifications such as thinner skirt (promoting faster bio-integration), a set of holes around the edge of the skirt that allows the conjunctiva to directly adhere to the sclera hence anchor the skirt in the subconjunctival space. This also provides the conjunctiva with closer supply of nutrients and oxygen which are critical to its viability. These improvements are now being validated in humans during the second clinical trial.
