Clinical validation of retinal oximetry as a biomarker

Project Information

RETOXY

Grant agreement ID: 673562

DOI

10.3030/673562

Project closed

EC signature date 15 April 2015

Start date 1 May 2015

End date 31 October 2015

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

OXYMAP EHF
Iceland

Periodic Reporting for period 1 - RETOXY (Clinical validation of retinal oximetry as a biomarker)

Reporting period: 2015-05-01 to 2015-10-31

Summary of the context and overall objectives of the project

Disturbance in oxygenation of the retina of the eye is believed to be involved in many sight-threatening diseases, such as diabetic retinopathy, glaucoma and age-related macular degeneration. Oxymap (SME) has developed an oximeter to measure retinal oxygenation. The oximeter is already used by over 30 research groups and the results of small-scale studies indicate that the oximeter can measure disturbed oxygenation in various common and serious eye diseases.
The Oxymap oximeter is currently only usable for research and the aim of the phase 1 and 2 projects is to validate oximetry for clinical use. This will allow earlier intervention and better monitoring of disease progress, benefiting individual patients. Due to the high prevalence and severity of the diseases, societal and economic gains are also considerable. Moving retinal oximetry from being a research tool only to being a validated clinical biomarker will also create a much larger market for Oxymap.
The phase 1 will lay the foundation for later uptake of retinal oximetry in clinical practice and the concurrent successful commercialization.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The critical next steps and barriers to success for Oxymap were explored.
The primary conclusion was that Oxymap must focus on clinical validation, obtain regulatory clearances, and optimize and improve manufacturing costs.
With the feasibility study results, Oxymap will pursue a Phase 2 grant to overcome the barriers to success.
The clinical studies will focus on the E.U. U.S. and select Asian markets, data from which will be the basis for regulatory clearance. Concurrently, Oxymap will focus efforts on lowering the total cost of the device. Based upon the successes of marketing and sales into our limited research market and the overwhelming success of cutting-edge research using Oxymap technology, we are confident in penetrating the clinical market.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

With the results of this Phase 1 project in hand Oxymap can proceed with a Phase 2 grant application which will tackle the primary barrier for Oxymap, i.e. clinical validation of retinal oximetry as an important biomarker in the most common blindness causing diseases affecting the retina. In parallel Oxymap will also use the results and connections made during the Phase 1 project to seek additional VC funding in order to continue R&D, scale up and prepare for the results of the clinical validation studies. It is expected that Oxymap will be able to enter the clinical ophthalmology market in 2018 with a revolutionary diagnostics device which will vastly improve the diagnosis and monitoring of treatment of sight threatening diseases such as diabetic retinopathy, CRVO and glaucoma.

The Oxymap T1 Installed on Top of the Topcon TRC-50DX Fundus Camera

Results from Oxymap Analyzer