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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - OLDIAS2 (On-line Dialysis Sensor Phase2)

Teaser

Summary

End-stage renal disease (ESRD) is an incurable health failure with approximately 3.4 million patients worldwide that need artificial methods to replace regular kidney functions in their organism. The main factors behind a steady growth of ESRD patients are the ageing of the population and the growing number of people suffering from various health problems like diabetes and obesity around the world.
As ESRD is incurable the patients have only two options: either receive renal replacement therapy called dialysis on a regular basis or undergo surgery to receive a kidney transplant. Dialysis is a process for removing waste and excess water from the blood. The primary type of dialysis is haemodialysis (HD) where the patient\'s blood is pumped through a dialyzer. Blood flows through the dialyzer to artificially clean the blood.
The main drawback with the treatment process is that the dialysis procedures give relatively little feedback about the treatment efficiency. The current dialysis quality parameters rely on principles that are severely outdated as there is no technology that would give adequate feedback on the treatment by constantly monitoring all the important parameters.
Optofluid Technologies is addressing this problem by offering a new solution for HD treatment monitoring that enables to monitor all the important parameters by measuring all the clinically relevant uremic toxins that affect the treatment quality. The previous R&D efforts have resulted in a patented concept of a multicomponent dialysis monitor utilising optical techniques. This allows to offer a more automated, reliable, economical and compact dialysis machinery and more environmentally sustainable treatment practices by introducing a dialysis sensor for on-line monitoring and removal estimation of all uremic toxinsâ€™ groups.
The main objective for the OLDIAS2 project is to validate the performance of the device in a clinical environment. The project combines activities regarding product development, testing and validation as well as communication and commercialization activities.
As a result, the project will provide internationally accepted evidence about the clinical and technical performance of the technology. This will allow OFT to start collaboration with the HD equipment producers and pave the way for the market launch of the novel sensor.

Work performed

The work performed covers the full length of the project duration, i.e. 27 months.
There were five objectives planned for the project:
1. Finalize the development of the sensor (WP1)
2. Validate the sensor performance in a small scale clinical study (WP2)
3. Validate the sensor performance in a large scale clinical study (WP3)
4. Finalize the awareness building activities (WP4)
5. Carry out the commercialization and communication activities (WP5)

WP1 focused on the physical design of a miniaturized version of the sensor. First prototypes of the miniaturized sensor were built according to the updated specifications. This work included updating the embedded software for the miniaturized sensor. In order to prepare the product for clinical testing, the user interface and data processing software were created. Both the hardware and the software were tested in-house before moving forward with the clinical studies.
The small scale clinical study allowed to validate the performance of the sensor in a clinical environment with partner hospitals from Estonia and Sweden. In addition, the clinical study protocol was confirmed for completing additional studies on larger scale.
The large scale clinical study allowed to validate the performance of the sensor in a multicentre clinical environment with partner hospitals from Estonia, Sweden, Belgium and Spain. In addition, the clinical study protocol was validated for survival study preparation and initiation.
Specialized work packages (WP4 and WP5) focused on the promotion of the project and its results during the lifetime of the project. WP4 focused on enhancing the awareness of the patients, medical and scientific community and industry members to ensure more successful market up-take of the new technology. WP5 ensured the commercial success of the MCM sensor and supported the market up-take and awareness building with communication and dissemination activities.
All of the objectives were reached and the whole project has been considered a success.

Final results

The project is looking to establish a new level beyond the current state of the art by developing the first dialysis monitoring sensor that is able to monitor all the relevant uremic toxinsâ€™ groups (small molecular weight, middle molecular weight and protein bound molecules).
By making the HD process more efficient and offering improved clinical decisions, the project has a great potential in reducing the economic, environmental and social impacts. This results in:
Reduction of healthcare costs
Reduction of additional expenses related to HD treatment sessions for HD patients
Reduction of resource consumption (mainly water and electricity)
Reduction of medical wastes and chemical reagents
Reduction of each HD patientÂ´s carbon footprint
Increased revenue and economic sustainability for HD service providers
Innovation opportunities to improve HHD solutions for larger market uptake
Increased efficiency of HD treatment and improved life-quality of HD patients
As small and large scale clinical studies have been proven a success, it shows that the MCM has high potential to deliver meaningful results in all the mentioned criteria.