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A short update on our key priorities and some of the most important events for 2024 - we are off to a good start and looking forward to a year with many achievements.
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Thank you for reading and supporting Cessatech !
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The US launch is approaching
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CT001 launch under the Early Access program in the US is approaching
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Both teams have been very busy preparing for the launch under the Early Access Program in the US - and this includes both the new manufacturing setup outside New York and all the marketing activities supporting the launch. We anticipate within a few months that CT001 will reach the first hospitals.
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Extensive planning and meetings have set the stage for a successful initial rollout, thus ensuring physicians understand the product, its profile and limitations and especially that patients have a positive experience. The first month is hence limited to selected states and hospitals before a wider distribution and promotion will take place. We will share more updates on the process after a few months on the market.
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Ventis Pharma is almost done with the final packaging, the brand name and design and we are eager to share this once the final quality assurance has been completed, as the perception testing was completed last month. This will always be important for a launch, even if it is an Early Access Program, and it becomes very real once this is final and ready to be shipped.
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Cessatech strengthens its patent portfolio for CT001 to treat acute pain in children, with the publication of a new U.S. patent application (US20240100035A1) to reflects our ongoing commitment to building a strong intellectual property position around our intranasal CT001 combination product. We anticipate more news regarding the application during 2025.
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Paediatric data to be published
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Paediatric data is fundamental in later potential approval and commercialisation
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Dental Study 0205 updates
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In Dec 2023 we published the positive topline data in the important Dental study 0205 supporting further advancement of CT001. The demonstrated significant reduction in on a pain scale, and although superiority was not achieved for the sufentanil control arm in adults, the co-primary endpoint of preliminary modelled exposure-response data substantiates that CT001 is superior in children. The is an important statement and the team has been working hard to publish these data in children.
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Modelling and simulations in Children
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We anticipate this important unified PK-PD model, developed based on all available both adult and paediatric study data (0201, 0204, 0205, and 0206), which are modelling and simulating exposure-response is to be published at the end of Q2 this year. This will have significant importance to the company, the regulatory process and later commercialisation of CT001.
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Highlights of our major milestone
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A short recap and overview of our milestones and achievements to date. We continue to make good progress on our journey towards commercialisation of CT001.
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Shareholders
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Management, Board of Directors and other Insiders.
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Together currently hold 16%
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FOR PAIN TREATMENT OF CHILDREN.
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Studies show that off label use of medication is the rule rather than the exception and that 79% of the emergency rooms in Scandinavia use physical restraint on children.
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Cessatech aims to meet that need – and the first product and lead asset, CT001, is a nasal spray for children aged 1-17 years that experience acute pain or pain related to medical procedures.
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Drugs that are developed by Cessatech should be proven effective in adults and represent a medical unmet need in children where a good effect can be documented. Thus offering economic value creation by identifying and developing drugs with a short time to market and risk-reduced profile.
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