Development of a women-centric gynaecological drug delivery device to improve psychosocial and physical wellbeing during treatment for miscarriage & pre-term birth prevention, and IVF

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Calla Lily Clinical Care (CLCC) is an ambitious British startup that has successfully invented a novel hybrid tampon and pantyliner that can be designed in such a way that it delivers drugs to a woman's vagina when in place.The current way of delivering drugs to the vagina is to use a pessary, but these are inconvenient, unhygienic, prone to movement such that women report being highly anxious during this stressful time i.e. these treatments are typically used during fertility treatment or to prevent miscarriage or premature births. CLCC's device, called a Tampliner, was invented by a leading gynaecologist and is more convenient to use with enhanced leakage protection and features a thin "sheath" to provide a cleaner and convenient user experience.CLCC has produced small quantities of this device that have been successfully evaluated in basic laboratory tests. The business has then protected the idea with a number of granted patents in various key markets (including the US/EU). The next key stage, and focus of the enclosed funding request, is to move to the next level and develop a device that is loaded with an actual drug that can then be tested in laboratory conditions to ensure it correctly releases the drug as required. Once this work is completed, CLCC will be in a position to proceed with trials of the device with female volunteers.This project is focused on the following goals.* **Drug Development**: develop how the drug (in this case hormone progesterone) is mixed or formulated with other drug components so that it is released into the body in the correct way.* **Laboratory Feasibility Testing**: Drug release profile testing, biocompatibility and sterility testing, functional/mechanical testing, and other evaluation of the finalised prototypes.* **Product Claim Validation**: Pilot in vivo study to validate product claims by measuring drug levels in the blood and observing leakage against current method (control).Through this project, CLCC will collaborate with experts in drug delivery, materials science and pharmacology, internationally-renowned gynaecologists, and a leading biopharmaceutical laboratory to help us with the development of this drug delivery device.