About

Over the past several decades, cataract extraction and/or refractive lens exchange (RLE) have been two of the most common surgeries worldwide with significant visual outcomes. The only way to remove the cataract and/or perform RLE is through surgical replacement of the human natural crystalline lens by an artificial IntraOcular lens (IOL) implant. Despite the explosion of innovations designed to optimise the visual outcome of the procedure, several postoperative complications may occur related to the fibrotic reaction and collapse of the human lens capsule. In some cases, a tilt can occur while placing the IOL or the IOL may end up in a slightly different depth within the eye than the pre-operative prediction. In other cases, post cataract opacification (PCO) behind the IOL may develop. Both cases lead to deterioration of visual function and may require secondary treatment and/or eventually the use of glasses and/or contact lenses to obtain “glasses free” visual performance.

Solution & Product

fixOflex is a novel intraocular ophthalmic implant that was developed to “reconstruct” and hold the human lens capsule similar to its natural form during surgical replacement of the human lens and address post-operative complications. Moreover, it is a placeholder for any IOL and acts as complementary to IOL implantation providing a beneficial optical outcome to the surgery. fixOflex combines low-cost manufacturing, easiness to use, safety and minimal training for surgeons, giving Ophthalmologists’ the opportunity to achieve optimal satisfaction for cataract and RLE patients. fixOflex aims to more personalized care, tailored specifically to every single patient’s needs for improvement to achieve optimal satisfaction.

Innovation & Scalability

A novel approach in the lens removal surgeries has been long anticipated to tackle successfully the aforementioned problems. The product's innovation relies on its benefits which are a) circumferential barrier against cell migration and development of PCO, b) consistent “bed” for IOL placement, c) secure IOL replacement at any time, d) partial prevention of forward movement of vitreous, e) universal design, that can be used with most IOLs , and f) preservation of capsular bag form and enclosed volume resembling the normal lens. The company has already developed a network of partners in Egypt, Greece, Germany, Austria and Spain. In the scale up phase, expansion to other countries and adjacent market is planned. The scale up strategy is twofold: a) Industrialization phase, improve production and manufacturing to reduce defects, and cost per unit. Reduction of costs and defects will be one of the main concerns as the company will design the third generation of fixOflex that will carry significant enhancements to the second generation. The company will acquire its own equipment and develop its own production facilities to manufacture the device. b) Expanding to geographical markets, gradually (depending on strategic objectives and operational conditions to exploit economies of scale. The operations of the company will expand to selected geographical markets according to market and economic conditions. Countries under consideration at the moment are USA, countries in the EU, Kore

Traction & achievements

EYE PCR is building on long experience. First generation of reconstructor conceived, designed and tested more than 10 years ago. Inventor Ioannis Pallikaris, globally respectable scientists, pioneer in the field of ophthalmology, has a long track record on introducing innovation to ophthalmology. Strong interdisciplinary medical, science and engineering team. Design and development is advanced, clinical application is ongoing. Additional technologies may arise as a result of know-how related to intracapsular implants, such as paediatric. Prototype design lock and manufacturing and initial assessment to a small number of eyes Optimisation of prototype and final design and manufacturing of universal version of product Initiation of clinical trials towards CE mark application (expected submission towards beginning of 2022) Presentation of clinical trial's clinical results in a number of conferences in 2021 Initial publication in a peer reviewed journal of initial case study Initiation of a sample trial in Japan through the inquiry of a highly respected ophthalmologist from Japan Design, optimisation, and manufacturing of additional prototype for paediatric cases ISO 13485 certification

Team & Why Us

We are thinkers and doers. We experiment, we research, and we invent, always evolving and creating results. Collectively, our team forms a solid, cohesive partnership of vastly skilled Ophthalmologists, Engineers and Administrative Specialists, with the expertise, resilience, spirit and professionalism necessary for development against novel targets. Ioannis Pallikaris, Medical Director, Father of LASIK, the most popular technique used for refractive surgery. Awarded 25 international awards, among which the “Barraquer Award” by the American Academy of Ophthalmology, the highest achievement a refractive surgeon can receive. Past president and board member of the European Society of Cataract and Refractive Surgery Aris Pallikaris, Chief Coordinator, Working experience overall management of the Biomedical Optics and Imaging sub laboratory of the Laboratory of Optics and Vision, Medical School, University of Crete. Principal local investigator in numerous international trials Harilaos Ginis, Regulatory Affairs Manager, principal investigator for the development of medical devices and surgical instruments (industry and academia). consultancy services to several major (US and Europe) companies in the field of biomedical devices Onurscan Sahin, Product Manager, Mechanical Engineer Loukia Leonidoy, Quality Manager/Clinical Monitor

Funding Needs

EYE-PCR managed to attract investments from private investors for the development stage but there is no available funding mechanisms to support the conduction of risky and costly clinical trails. The product has reached an advanced technological level but there is a definite financial gap for allowing the technological maturity of the product. At this critical point, with the absence of high-risk investment, the financial support seems to be the only way forward. It is essential for the company to be successful to win the race and launch its innovation first in the market becoming the leader in the field, leaving little room for any potential competitors.