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A big jump in preventing problems in refractive surgery for myopia

Periodic Reporting for period 1 - KERASTOP (A big jump in preventing problems in refractive surgery for myopia)

Reporting period: 2017-06-01 to 2017-08-31

Refractive surgery -Laser vision correction (LVC) and Phakic intraocular lens (IOL) implantation- is an easy surgical procedure with limited complication rates (during the operation) and with a significant impact on patient satisfaction. The most common form of LVC is the Laser assisted in situ keratomileusis (LASIK). However, demand for this business has decreased in recent years due to fears of post-surgery complications derived from keratoconus (KC).

Keratoconus is a progressive and degenerative pathology of the cornea, which is the optical element of the eye providing most of the optical power of the whole eye. The incidence of this condition is 1 per 375 in the general population (265 cases per 100,000). Many aspects of this pathology remain unknown, especially those concerning its aetiology. It can severely degrade vision and has no cure, although there are methods to prevent its progression when detected at an early stage.

We at Conrea have developed the first method to detect KC in the most incipient stages. The early detection of KC allows ophthalmologists to screen their patients prior to surgery, therefore reducing the number of complications, increasing patients satisfaction, and creating a new business in the market of refractive surgery worth more than €200M per year.

The main objective of the technical work performed during the phase 1 period was the analysis of the global laser refractive market, identifying important trends and key factors for future success. Our method of research consisted in conducting a thorough desktop research and a series of analyses, all of which will help us understand our potential market, who will be the final user of our solution and who else do we have to consider along the value chain.
Market analysis.
We carried out an in-depth market analysis with key market players to find out what the problem/need is at source, what interest, acceptance; and therefore, the market potential that exists for Kerastop among refractive surgeons.
The main conclusions of this analysis are:
a) Many patients would be willing to pay more to find a way to live without the need of any of the current vision correction methods
b) Many surgeons would be willing to use new methods to prevent post-surgery complications for their patients.
c) A technology such as Kerastop has the potential to disrupt the existing vision correction market.

Technological and regulatory roadmap.
We intend to commercialise Kerastop, an in vitro diagnostic medical device (IVDD) certified according to the directive 98/79/CEE, through a Point of Care system (lab-in-a-chip) for an efficient, fast and early detection of the biomarkers associated with keratoconus in patients that are candidates for refractive surgery.
We have performed a regulatory roadmap and development plan for the new diagnostic kit within the EU-US regulatory system. These include the: a) classification of Kerastop following the CE and FDA regulations; b) technical documentation required; c) product development stages; d) design of the device; e) performance evaluation; f) analytical performance evaluation; and g) clinical validation.
According to all the recommendations pointed out in the report, there are three potential scenarios for the combined EU & US regulatory development. We decided to go for the third scenario for SME-2 and conduct a parallel EU/US development due to it being the smartest and simplest scenario.

Business plan.
Our business model is based on introducing Kerastop as a new essential test to be performed on all those patients who undergo refractive surgery. So, even though our end-users will be patients, our customers will be their surgeons. We have considered a business model in which the main revenues come from the sales of fungible material (disposable cards), instead of from the medical device itself. Apart from that, the company will also offer services that will complement both the sales and supply provided to customers.
Kerastop is extremely innovative. To date, there is no similar technology in the market. The most similar technology found is based on obtaining tear samples and analysing the presence of some specific proteins in their composition, but it does not allow a detection of the ectasia in very early stages in which no clinical signs are apparent. Furthermore, this technology is not commercialised yet and is still under development.

Kerastop will provide for the first-time biomarkers that are sensitive (90-98%) for the early diagnosis of corneal ectasia and that prevent its development after refractive surgery.

Currently, the prevention of post-LASIK ectasia is difficult as it is based on the appearance of the corneal topographic profile and some risk factors identified in retrospective analyses. Corneal topography devices analyse the variations of curvature along the corneal surface. Some detection algorithms based on different corneal topographic indices have been developed, but all of them with sensitivities values below 71%. There are other factors that have been defined for the detection of subclinical keratoconus, such as corneal aberrations or pachymetric distribution, but with very limited sensitivities and specificities values (around 60-70%).
Normal cornea vs. Keratoconus