The Para-T transfusional safety project

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Two recent good news occurred last March in relation to the Para-T Transfusion Safety project . First, the project has been approved for funding by the Horizon 2020 Framework Programme SME Instrument (phase 1) of the European Commission. This program finances disruptive technologies with market potential. See valuation with 13,29 points over 15..

In the last February 2018 announcement, 2.009 projects applied for Phase I projects, and were approved 257 (12,7%) of witch 47 were in the “Health” area. One of them was the Para-T transfusional safety system headed by PRoPosit Bio. The only one project related to blood transfusion approved in the February 2018 announcement. Phase I finaces viability projects for a further Phase II, but suggest that the financed projects are in concordance with the European objectives. Below you have a link with the approved projects. Left in the screen you can filter where yo can select our announcement (February 2018) and our area (Health). Write “transfusion” in the magnifying glass icon for this area. https://sme.easme-web.eu/
The second good new in that the Spanish Patent Office has granted the patent to the para-T system device, that also will ease getting the European Patent currently ongoing, hopefully at the beginning 2019.

The Para-T System

A quick blood group device to match in situ the donor bag and the receptor arm during a blood transfusion, avoiding major incompatible errors.

The Para-T system is defined as an affordable double plastic cassette (medical device) that performs and visually displays a direct, instantaneous and permanent blood group identification (ABO) in the bag containing Whole Blood (WB) or Red Blood Cells (RBCs) and in the catheter inserted in the vein of a patient. The system automatically matches the ABO groups in both lines and operates a solenoid-type valve, preventing incompatible transfusions between the blood bag and the recipient arm.

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The Para-T device aims to achieve the goal declared by the European authorities of “0 errors” resulting in death or major morbidity in blood transfusions due to incompatibilities between the patient’s blood and the transfusion bag. This occurs statistically in one of every 15,000 transfusions, which degenerates into death in 1 out of 10 cases and in major morbidity in 4 out of 10. These calculations, which have been based on the most complete hemovigilance study that exists today (SHOT 2016, UK), can be the tip of an iceberg, since this information is often hidden or unknown in most countries. The reason for this are the significant criminal and economic consequences that this error causes, resulting in jail due to medical malpractice and/or heavy economic compensations.

The solutions to avoid this problem are of two types; on one side, transfusion safety protocols based on the systematic taking of blood samples throughout the process from donation to infusion in the patient (up to 7 ABO group test re-checking to avoid errors) with positive identification of the patient and/or bed-side tests or the use of electronic systems that guarantee traceability based on wristbands and the use of proprietary software support. Both systems are very expensive and do not guarantee that there may be errors in the process although these are obviously minimized. The Para-T system is between 4 to 10 times (complex/simple solution) cheaper than any competing solution but provides better performance than the electronic option, preventing ABO incompatible transfusions regardless of the staff’s competence.

The objectives are the following:

  • Validate the technology and refine the product features according to the market study, clarifying the most interesting applications for the device and on that basis, determining its final characteristics.
  • Implement the Market Study. Potential competitors, sales channels, manufacturing requirements, suppliers, etc. must be checked and identified.
  • Define the business model, risks and the industrialization pathway. The industrialization pathway for the developed product and all the associated risks arising from the market uptake of the new product will be also revised (pricing, costs, who manufacture, alliances, risks, etc).
  • Stablish a clear strategy for the IPR, certification process and freedom to operate. The feasibility study will help to identify this IPR strategy and the certification process.

The proponent company PRoPosit may achieve a leading position in the market providing a new solution untold in the sector and able to add a differential value in a very competitive sector.
Para-T system prevents the need to perform 4 ABO tests in the transfusion route from donor to the patient ‘arm. Below, in yellow colour and marked with a red cross, those typing actions avoidable with Para-T (the blood ABO type is marked in the cassette attached to the bag, so you don’t need to recheck it). Savings due to avoided tests reaches 25.000 €/year (in personnel and material costs) for a 20.000 yearly transfusions Hospital and around 75.000 € compared to the electronic solution.

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Table 1. Donation process and ABO typing procedure (in yellow)

In summary, the costs of the Para-T system are easily offset by the savings in personnel costs (by typing tasks elimination), but at same time the Hospitals and Blood Centres will achieve the same or even better safety levels than using the coded electronic wristbands, but at one tenth (simple solution) or one forth (complex) of the costs.

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