The Para-T transfusional safety project

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We had two pieces of good news in March 2018 in relation to the Para-T Transfusional System project.

Firstly, the project was 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 an announcement in February 2018, 2.009 projects applied for Phase I projects. 257 were approved (12,7%) of wich 47 were in the “Health” area. One of these was the Para-T transfusional safety system headed by PRoPosit Bio. The only project related to blood transfusion approved in the February 2018 announcement. Phase I finances viable 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. To the left of the screen you can use the filter to 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 bit of good news was that the Spanish Patent Office has granted the patent for the Para-T system device, wich will also facilitate 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 out of every 15,000 transfusions. Of these, 1 out of 10 cases results in death and 4 out of 10 in major morbidity. These calculations, which have been based on the most complete hemovigilance study that exists today (SHOT 2016, UK), might be just the tip of the iceberg, since this information is often hidden or unknown in most countries. The reasons 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.

There are two types of solutions to this problem; on the one hand, imporve 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 won´t 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 options, 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 market studies, 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 route to market or commercialisation process and industrialization pathway. Theroute to market 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).
  • Establish a clear strategy for the IPR, certification process and freedom to operate. The feasibility study will help to identify THE IPR strategy and the certification process.

THE Para-T system avoid the need to perform 4 ABO tests in the transfusion route from donor to the patient ‘arm. Those typing actions,-see below in yellow and marked with a red cross-, are 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 would reach 25.000 €/year (in personnel and material costs) for a 20.000 yearly transfusions Hospital and around 75.000 € compared to the electronic solution.

UE

The Para-T system project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No H2020-SMEINST-816466

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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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