The development of a new cardidesignator, known as 18F, for the assessment of myocardial perfusion and diagnosis of coronary artery disease in the PET survey. (Q77657): Difference between revisions
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(Removed claim: summary (P836): Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).The project consists of the preparation and implementation by Synectar S.A. (hereinafter:“Company” or “Synetik”) of a new product — cardidesignator for perfu...) |
(Created claim: summary (P836): Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The project consists of the development and implementation by Synektik S.A. (hereinafter: “Company” or “Synektik”) of a new product – a cardiomet...) |
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Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The project consists of the development and implementation by Synektik S.A. (hereinafter: “Company” or “Synektik”) of a new product – a cardiometer to evaluate cardiac perfusion and non-invasive diagnosis of coronary artery disease during the PET study (Positron Emission Tomography). As cardiovascular disease affects an increasing number of people, there is an increase in heart perfusion imaging tests. Currently, only three cardiometers are available, used to evaluate blood flow through the heart in PET tests. However, they all have significant limitations. The subject of the project is the [18F]-EMO cardiometer, 18F fluorine-labelled ammonium salt for PET tests (hereinafter: “EMO”), whose development and implementation is characterised by huge commercial potential, due to new features and functionalities, which will increase the use of clinical PET testing in cardiological imaging diagnostics. We have selected preliminary lead structures that meet the parameters required for the PET test cardiometer. The marker is currently characterised by the third level of technological readiness. In order to achieve the effects of the Project, a series of “cold” synthesis and use of 18F radionuclide, evaluation of biodistribution and animal toxicity, quality control methods, production process validation according to GMP (Good Manufacturing Practice), preclinical studies and Phase I, II and III of clinical trials are planned. The planned work (industrial research, development) will end with the submission of a report from Phase III clinical trials. (English) | |||||||||||||||
| Property / summary: Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The project consists of the development and implementation by Synektik S.A. (hereinafter: “Company” or “Synektik”) of a new product – a cardiometer to evaluate cardiac perfusion and non-invasive diagnosis of coronary artery disease during the PET study (Positron Emission Tomography). As cardiovascular disease affects an increasing number of people, there is an increase in heart perfusion imaging tests. Currently, only three cardiometers are available, used to evaluate blood flow through the heart in PET tests. However, they all have significant limitations. The subject of the project is the [18F]-EMO cardiometer, 18F fluorine-labelled ammonium salt for PET tests (hereinafter: “EMO”), whose development and implementation is characterised by huge commercial potential, due to new features and functionalities, which will increase the use of clinical PET testing in cardiological imaging diagnostics. We have selected preliminary lead structures that meet the parameters required for the PET test cardiometer. The marker is currently characterised by the third level of technological readiness. In order to achieve the effects of the Project, a series of “cold” synthesis and use of 18F radionuclide, evaluation of biodistribution and animal toxicity, quality control methods, production process validation according to GMP (Good Manufacturing Practice), preclinical studies and Phase I, II and III of clinical trials are planned. The planned work (industrial research, development) will end with the submission of a report from Phase III clinical trials. (English) / rank | |||||||||||||||
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| Property / summary: Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The project consists of the development and implementation by Synektik S.A. (hereinafter: “Company” or “Synektik”) of a new product – a cardiometer to evaluate cardiac perfusion and non-invasive diagnosis of coronary artery disease during the PET study (Positron Emission Tomography). As cardiovascular disease affects an increasing number of people, there is an increase in heart perfusion imaging tests. Currently, only three cardiometers are available, used to evaluate blood flow through the heart in PET tests. However, they all have significant limitations. The subject of the project is the [18F]-EMO cardiometer, 18F fluorine-labelled ammonium salt for PET tests (hereinafter: “EMO”), whose development and implementation is characterised by huge commercial potential, due to new features and functionalities, which will increase the use of clinical PET testing in cardiological imaging diagnostics. We have selected preliminary lead structures that meet the parameters required for the PET test cardiometer. The marker is currently characterised by the third level of technological readiness. In order to achieve the effects of the Project, a series of “cold” synthesis and use of 18F radionuclide, evaluation of biodistribution and animal toxicity, quality control methods, production process validation according to GMP (Good Manufacturing Practice), preclinical studies and Phase I, II and III of clinical trials are planned. The planned work (industrial research, development) will end with the submission of a report from Phase III clinical trials. (English) / qualifier | |||||||||||||||
point in time: 14 October 2020
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Revision as of 10:04, 14 October 2020
Project in Poland financed by DG Regio
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | The development of a new cardidesignator, known as 18F, for the assessment of myocardial perfusion and diagnosis of coronary artery disease in the PET survey. |
Project in Poland financed by DG Regio |
Statements
5,582,376.15 zloty
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10,494,630.29 zloty
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53.19 percent
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1 June 2015
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31 August 2021
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SYNEKTIK SPÓŁKA AKCYJNA
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52°14'1.3"N, 21°4'17.0"E
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Numer_referencyjny_programu_pomocowego: SA.41471(2015/X) Przeznaczenie_pomocy_publicznej: art. 25 rozporządzenia KE nr 651/2014 z dnia 17 czerwca 2014 r. uznające niektóre rodzaje pomocy za zgodne z rynkiem wewnętrznym w stosowaniu art. 107 i 108 Traktatu (Dz. Urz. UE L 187/1 z 26.06.2014). Projekt polega na opracowaniu i wdrożeniu przez Synektik S.A. (dalej: „Spółka” lub „Synektik”) nowego produktu – kardioznacznika do oceny perfuzji mięśnia sercowego i nieinwazyjnej diagnostyki choroby wieńcowej podczas badania PET (Positron Emission Tomography). Jako, że choroby układu krążenia dotyczą coraz większej liczby osób, obserwuje się wzrost ilości wykonywanych badań obrazowania perfuzji serca. Obecnie dostępne są tylko trzy kardioznaczniki, wykorzystywane do oceny przepływu krwi przez serce w badaniach PET. Wszystkie posiadają jednak istotne ograniczenia. Przedmiotem projektu jest kardioznacznik [18F]-EMO, znakowana izotopem fluoru 18F sól amoniowa do badań PET (dalej: „EMO”), którego opracowanie i wdrożenie charakteryzuje ogromny potencjał komercyjny, ze względu na nowe cechy i funkcjonalności, które zwiększą wykorzystanie kliniczne badania PET w kardiologicznej diagnostyce obrazowej. Wybraliśmy wstępne struktury wiodące, które spełniają parametry wymagane dla kardioznacznika do badania PET. Znacznik charakteryzuje obecnie III poziom gotowości technologicznej. W celu osiągnięcia efektów Projektu planowane jest przeprowadzenie szeregu syntez „zimnych” oraz z użyciem radionuklidu 18F, ocena biodystrybucji i toksyczności na zwierzętach, opracowanie metod kontroli jakości, walidacja procesu wytwarzania zgodnie ze standardami GMP (Good Manufacturing Practice), przeprowadzenie badań przedklinicznych oraz I, II i III fazy badań klinicznych. Zaplanowane w ramach realizacji Projektu prace (badania przemysłowe, prace rozwojowe) zakończą się złożeniem raportu z III fazy badań klinicznych. (Polish)
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Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The project consists of the development and implementation by Synektik S.A. (hereinafter: “Company” or “Synektik”) of a new product – a cardiometer to evaluate cardiac perfusion and non-invasive diagnosis of coronary artery disease during the PET study (Positron Emission Tomography). As cardiovascular disease affects an increasing number of people, there is an increase in heart perfusion imaging tests. Currently, only three cardiometers are available, used to evaluate blood flow through the heart in PET tests. However, they all have significant limitations. The subject of the project is the [18F]-EMO cardiometer, 18F fluorine-labelled ammonium salt for PET tests (hereinafter: “EMO”), whose development and implementation is characterised by huge commercial potential, due to new features and functionalities, which will increase the use of clinical PET testing in cardiological imaging diagnostics. We have selected preliminary lead structures that meet the parameters required for the PET test cardiometer. The marker is currently characterised by the third level of technological readiness. In order to achieve the effects of the Project, a series of “cold” synthesis and use of 18F radionuclide, evaluation of biodistribution and animal toxicity, quality control methods, production process validation according to GMP (Good Manufacturing Practice), preclinical studies and Phase I, II and III of clinical trials are planned. The planned work (industrial research, development) will end with the submission of a report from Phase III clinical trials. (English)
14 October 2020
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Identifiers
POIR.01.01.01-00-0089/15
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