Periodic Reporting for period 1 - RETOXY (Clinical validation of retinal oximetry as a biomarker)
Période du rapport: 2015-05-01 au 2015-10-31
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.
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.