Cessatech A/S

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Cessatech A/S

Developing evidence based medicine

21/08/2025

Today we released our Q2 financial report, marking the end of an extremely busy and rewarding quarter. We finalized the Clinical and CMC program for CT001 and completed our Marketing Authorisation Application (MAA) in record time. In addition, our new US manufacturing setup has made excellent progress, and we look forward to sharing more updates later this year. A huge thank you to our team and partners for their amazing effort and dedication!
https://cessatech.com/wp-content/uploads/2025/08/Q2_2025-Report_final-.pdf

15/08/2025

We are very pleased to announce that the Marketing Authorisation Application (MAA) for CT001 has been submitted to the European Medicines Agency (EMA) for acute pain management in children - thanks to a great effort from everyone !
https://cessatech.com/marketing-authorisation-application-maa-for-ct001-has-been-submitted-to-the-european-medicines-agency-ema-for-acute-pain-management-in-children/

27/06/2025

Please find the Q&A overview from the Company Presentation - thanks for all your questions and comments !

https://cessatech.com/wp-content/uploads/2025/06/QA-Cessatech_June.pdf

26/06/2025

Please find the presentation from today - thanks for your participation and questions !

29/05/2025

We are proud to share that we have released the Top-line Results of final study for CT001, Peadiatric Study 0202.

The primary endpoint of responder analysis of pain relief was met and and overall pain reduction was 75% after 30 minutes, and 86% after 60 minutes. No drug related unexpected adverse effects, and they were all transient and of mild to moderate intensity. Thanks to a great effort from all.
https://cessatech.com/positive-top-line-results-from-its-final-ct001-study-0202/

21/05/2025

Advantages of intranasal administration in children are several...
We are proud to make a difference in the clinical settings !

30/04/2025

Cessatech today announces that recruitment has completed in the Paediatric Study 0202, and now the EMA submission process can be initiated for CT001 - thanks for great efforts by all sites!

- 150 paediatric patients have been recruited
- Study 0202 is the final required clinical study
- Top-line results are expected within the next 3-6 weeks
- The EMA submission process can now be initiated

We are looking forward to share the top-line results soon.
https://cessatech.com/wp-content/uploads/2025/04/250430-Last-patient-Study-0202_final.pdf

28/02/2025

Today we released the Annual Report for 2024, which includes key events both on development activities – but also the start of hopefully a very promising commercialization process. Thanks for your support.

https://cessatech.com/wp-content/uploads/2025/02/250228-AR-Q4_2024-Report_final-1.pdf

04/02/2025

CT001 today receives positive opinion during the Medical Device Regulation (MDR) approval process, which 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. Thanks to all for an amazing effort !

https://cessatech.com/wp-content/uploads/2025/02/250204-CT001-MDR-assessment.pdf

23/12/2024

2024 is coming to an end – and milestones are in focus.

We are very pleased with the progress Cessatech has made during 2024, and this is truly the result of an incredible team-effort and partnership collaboration.

During 2024 we closed the agreement with Proveca for CT001 – and this was proof that our business model is working; to provide several paediatric solutions where there is a large unmet need. During the next years we want more products in development, through partnerships in Europe and with more involvement in the US. Some of the important milestones anticipated for 2025:

• The US launch has been delayed, mainly due to manufacturing issues – and we believe this has almost been solved, and hence anticipate launch during 1H 2025, more details will follow soon.
• The paediatric study 0202 is coming to an end, and we anticipate having last patient in the beginning of 2025. We are very excited about this study and hope to present good results of CT001 in children.
• Together with Proveca, we will initiate the regulatory EMA submission for CT001, this also includes the Notify Body process for medical devices.
• In 2025 we will also work hard for new partnerships, look for new opportunities and get moving with CT002.

Thanks for your support for 2024 and we look forward to communicating in more detail on the topics above in the year to come.

Happy holidays from the Cessatech team

16/10/2024

Cessatech announces that recruitment has today reached the halfway point for patient recruitment with 75 included patients in the Paediatric Study 0202 - thanks for a great efforts by all sites!

https://cessatech.com/wp-content/uploads/2024/10/241016-Status-on-Study-0202_final.pdf

07/10/2024

Today Cessatech and Proveca Ltd has announced the commercial partnership for CT001 - we really look forward to this partnership, and the opportunity that many more approved products can be made available to children...
Thanks for an amazing effort by both teams!

https://cessatech.com/cessatech-and-proveca-announce-world-wide-excluding-us-commercial-partnership-for-ct001/

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Strandvejen 60

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http://www.cessatech.com/

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