Periodic Reporting for period 2 - ClearPlasma (An innovative filtration system to improve the coagulation properties of plasma units to treat patients with massive bleeding)
Période du rapport: 2022-11-01 au 2023-07-31
Massive Bleeding is a worldwide problem. Nowadays, there are limited treatment options to control Hemorrhage. As a consequence, treatments targeting hemorrhage control, both locally and systemically, are highly prioritize research areas in mitigating this potential loss of life. PLAS-FREE is addressing this unmet need by developing ClearPlasma, an innovative filtration system that modifies human plasma to improve its coagulation properties for the treatment of massive bleeding. By extracting plasminogen, an important protein responsible for dissolving blood clots, ClearPlasma™ enhances coagulation and favors haemostasis. Within this project, we aim is to demonstrate the ability of ClearPlasma to treat massive bleeding patients. To reach this goal PLAS-FREE will need to achieve some goals that includes generating of mould that can generate ClearPlasma kit in high volumes and to generate ClearPlasma kits and to test them during clinical study. These clinical results will be used as part of the submission for the technical file to achieve CE mark. For society the ClearPlasma technology can reduce the need in vial blood products that are in shortage. Today there is a shortage in blood donation and less red blood cells, plasma and platelets are available to treat bleeding patients. Due to that and more there is an increase in the use of high-cost drugs that aimed to stop bleeding. The outcome of this issue is an increase in the economic burden to treat bleeding patients. In addition, increasing in the last few years and the Covid-19 only emphasizes this issue. ClearPlasma can reduce the amount of blood units needed for treating bleeding patients this is because it can stop the bleeding faster and subsequently to reduce the economic burden treating bleeding patients. Taking in consideration the objectives of this program that includes clinical study in Upper gastrointestinal bleeding patients (UGIB) and demonstrates ClearPlasma ability to reduce bleeding and to be new therapeutic modality for bleeding patients. Lastly, the ability to perform clinical and to prepare the technical file for submission will allow PLAS-FREE the ability to reach CE mark and subsequently to provide better and safer treatment for bleeding patients in Europe.
During this project there are 9 different milestone PLAS-FREE needs to achieve, including:
1. Obtention(submission)of CE Mark- the company is aiming to achieve CE mark. PlasFree completed clinical study technical file submission was done and the company is waiting for BSI resolution.
2. Developed Protocol for clinical trials approved- PLAS-FREE has completed its clinical study on patients presenting gastrointestinal bleeding (UGIB).
3. 600 ClearPlasma units for clinical trials manufactured
4. Clinical trials performed on patients presenting gastrointestinal bleeding (UGIB).
5. Updated Business Plan- As PLAS-FREE collects more data and information about the use of ClearPlasma and the medical benefit generated by this device.
6. Participation in conferences and events
7. Participation of 4 hospitals: PLAS-FREE has preform it clinical study in 4 different hospitals in Europe:
8. Enrolment of 56 patients for ClearPlasma trials
9. Optimised industrial mould manufactured for the ClearPlasma device. Mould is deigned to 100,000 rounds of plastic injection that will be able to generate more than 100,000 ClearPlasma kits.
1. Obtention(submission)of CE Mark- the company is aiming to achieve CE mark. PlasFree completed clinical study technical file submission was done and the company is waiting for BSI resolution.
2. Developed Protocol for clinical trials approved- PLAS-FREE has completed its clinical study on patients presenting gastrointestinal bleeding (UGIB).
3. 600 ClearPlasma units for clinical trials manufactured
4. Clinical trials performed on patients presenting gastrointestinal bleeding (UGIB).
5. Updated Business Plan- As PLAS-FREE collects more data and information about the use of ClearPlasma and the medical benefit generated by this device.
6. Participation in conferences and events
7. Participation of 4 hospitals: PLAS-FREE has preform it clinical study in 4 different hospitals in Europe:
8. Enrolment of 56 patients for ClearPlasma trials
9. Optimised industrial mould manufactured for the ClearPlasma device. Mould is deigned to 100,000 rounds of plastic injection that will be able to generate more than 100,000 ClearPlasma kits.
Since ClearPlasma helps to stabilize clots and subsequently to reduces blood loss we estimate that ClearPlasma will impact the following topics: A. Significantly reduces the cost of treating massive bleeding. – Most complicated massively bleeding patients have been previously treated with anticoagulants. Thus, to stop the bleeding, there is a need to reverse the effects of the anticoagulant. By efficiently removing fibrinolytic proteins such as plasminogen, ClearPlasma increases the coagulation parameters and efficiency. Patients transfused with ClearPlasma demonstrated an increased ability to form stable hemostatic clots. Moreover, the use of ClearPlasma minimized the need for expensive therapies, s that may be required after standard plasma transfusions. B. Effective treatment - clinical data shows that ClearPlasma can reduce the number of regular platelets units required during excessive bleeding by improving the clinical outcome, cost, and the number of transfusion bags used, subsequently reducing the hospitalization time. C. Safety and selectivity - ClearPlasma significantly reduces the concentration of the target protein by >90%, without altering other coagulation parameters, such as fibrinogen concentration or Partial Thromboplastin Time (PTT), or causing adverse events. Current therapies are cost-inefficient in reducing massive bleeding, risky for the patients, and leading to re-bleeding episodes (33% of patients with GI bleeding). As a consequence, additional corrective interventions are required increasing the economic burden on healthcare systems. In our clinical study, we demonstrated that no adverse events occurred using Clear Plasma compared to realgar plasma transfusion.