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UroPharma has successfully completed another major step

Colleagues,

I am pleased to inform you that UroPharma has successfully completed another major step on the road to bringing our innovative #bladder drug-device #deliverysystem to market. From the perspective of #regulatory approval, we are now in the final stretch with, only one more hurdle to jump before we submit our intermittent drug-delivery device for the UKCA mark in order to launch in the UK market.

 

With the UKCA mark, the dtb-instilla will allow clinicians to provide intravesical (direct-to-bladder) drug delivery treatments to patients through a licensed device, providing better treatments whilst avoiding the major problems associated with the oral delivery of #antibiotics and other drugs for #bladdermanagement.

 

Human factors (HF) studies of the dtb-instilla intermittent device, both formative and summative, now have been completed in the UK. The latter one also validated that our instructions for use (IFU) document is suitable for incorporation with the product. Positive results on both of these aspects are compliance requirements for the device to enter the market. The conclusion from the latest study was that: “When considered as a whole, the test outcomes provide evidence that the dtb-instilla intermittent device can be safely and effectively used for intravesical administration of medication for bladder management”.

 

Our current intention is to launch the dtb-instilla onto the UK market in the first quarter of 2025 with only #biocompatibility studies ahead of us before we can submit for the UCKA mark we continue to seek #investment, so if you would like further information, especially given that we now have these positive results from the human factors studies, then please contact me. 

 

The sooner we can get to market the sooner we can start helping patients who are suffering from the often life changing effects of bladder conditions and diseases and the sooner we can contribute to the overall campaign against #antimicrobialresistance that threatens the future of our #healthcare.

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