Onsdag 5 Februari | 09:49:47 Europe / Stockholm

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2025-11-13 13:00 Kvartalsrapport 2025-Q3
2025-08-21 13:00 Kvartalsrapport 2025-Q2
2025-05-15 13:00 Kvartalsrapport 2025-Q1
2025-03-28 N/A Årsstämma
2025-02-28 08:00 Bokslutskommuniké 2024
2024-11-13 - Kvartalsrapport 2024-Q3
2024-08-21 - Kvartalsrapport 2024-Q2
2024-05-15 - Kvartalsrapport 2024-Q1
2024-03-28 - X-dag ordinarie utdelning CESSA 0.00 DKK
2024-03-27 - Årsstämma
2024-02-29 - Bokslutskommuniké 2023
2023-11-16 - Kvartalsrapport 2023-Q3
2023-08-24 - Kvartalsrapport 2023-Q2
2023-05-12 - Kvartalsrapport 2023-Q1
2023-03-24 - X-dag ordinarie utdelning CESSA 0.00 DKK
2023-03-23 - Årsstämma
2023-02-28 - Bokslutskommuniké 2022
2022-11-18 - Kvartalsrapport 2022-Q3
2022-11-04 - Extra Bolagsstämma 2022
2022-08-19 - Kvartalsrapport 2022-Q2
2022-04-19 - Kvartalsrapport 2022-Q1
2022-03-18 - X-dag ordinarie utdelning CESSA 0.00 DKK
2022-03-17 - Årsstämma
2022-02-24 - Bokslutskommuniké 2021
2021-11-19 - Kvartalsrapport 2021-Q3
2021-08-19 - Kvartalsrapport 2021-Q2
2021-04-19 - Kvartalsrapport 2021-Q1
2021-03-29 - X-dag ordinarie utdelning CESSA 0.00 DKK
2021-03-26 - Årsstämma
2021-02-11 - Bokslutskommuniké 2020

Beskrivning

LandDanmark
ListaSpotlight DK
SektorHälsovård
IndustriBioteknik
Cessatech är verksamt inom läkemedelsbranschen. Bolaget är specialiserat inom forskning och utveckling av smärtstillande nässpray som vidare används för behandling av akuta smärttillstånd hos barn. Utöver huvudverksamheten erbjuds även tillhörande kringtjänster och relaterade produkter. Verksamheten drivs globalt med störst närvaro inom den nordiska marknaden. Huvudkontoret ligger i Köpenhamn.
2025-02-04 11:30:00
  • CT001 receives positive opinion during the Medical Device Regulation (MDR) approval process.
  • Confirms that CT001 meets the General Safety and Performance Requirements of the MDR.
  • An important milestone for Cessatech's EMA filing, planned for later this year - and highlights Cessatech's commitment to quality and evidence-based treatments.

On 4 February (11.30) - Cessatech A/S ("Cessatech" or "the Company") announces that the Company has received a positive Notified Body Opinion under Article 117 of the Medical Devices Regulation (EU) 2017/745 (MDR) for its lead asset CT001. The technical documentation for CT001 was reviewed in accordance with Annex I of Regulation (EU) 2017/745. The assessment has been performed for the purpose of an initial application - and the objectives of this assessment were found to have been met. Technical documentation for the device is considered adequate to support compliance with the General Safety and Performance Requirements of the MDR.

The MDR opinion ensures medical devices with a drug component are safe and effective. The EMA reviews the drug part, while a Notified Body evaluates the device. Together, they ensure the product meets EU efficacy and safety standards.

Martin Juhl, CSO, Cessatech
We are very proud to have received this positive opinion from the Notified Body. It is a testament to the team's dedication to scientific rigor and quality in meeting MDR requirements. We are pleased that the quality of our technical documentation and approach has been recognized through this positive opinion. As a side note, this marks the first time a company has used the Interactive Online Review Process through the selected Notified Body organization for Article 117, which underscores our commitment to innovation and improved efficiency.

Jes Trygved, CEO, Cessatech
The MDR assessment is a major achievement for the Company and is an integrated part of the EMA approval process of CT001. We are now one important step closer to getting CT001 approved in Europe for children aged 1-17 years old, together with our commercial partner Proveca. Since the introduction of the MDR process in 2021, it is estimated that some +3,000 certificates and opinions have been completed in Europe, while there is still a large backlog of some 3-4000 pending - it is an amazing effort that we completed our assessment within the estimated timeframe. Thanks to all for an amazing effort.