The British medical device startup raises funds from National Institute for Health and Care Research to move towards in-person trials for its device that treats threatened miscarriage.
British medical device startup Calla Lily Clinical Care has secured £1 million in National Institute for Health and Care Research (NIHR) funding to begin clinical trials of its device that treats threatened miscarriage.
The device is designed to improve the delivery of progesterone medication. Administering doses of vaginal micronised progesterone is the NICE-recommended guideline for women who have suffered at least one miscarriage and subsequently face threatened miscarriage.
It is estimated that more than 150,000 women in the UK could be eligible for prescriptions of progesterone for threatened miscarriage each year.
Progesterone is currently self-administered by patients via vaginal pessaries. This delivery method is prone to significant leakage, which can cause substantial anxiety and inconvenience for patients at an already distressing time.
To avoid leakage of the prescribed medication before it has been absorbed into the body, many women lie down for an extended period after inserting each pessary.
“Having been through seven rounds of IVF, I have first-hand experience of how awful taking progesterone can be. Any woman who is trying to have a baby knows she will do anything to make sure she is getting the right medications and maximising her chance of success,” says Lara Zibners, co-founder and chair of Calla Lily Clinical Care.
Halts pessary leakage
Calla Lily Clinical Care’s device delivers a dose of progesterone via a small, tampon-shaped device with an integrated mini-liner. It can be hygienically inserted, remains in place while the drug is being absorbed, and can then be cleanly removed.
The medtech company plans to use the funding to move towards in-person trials.
The first phase of the process will be a usability study which begins this month. This will be followed by an NIHR-funded clinical feasibility study at University Hospitals Coventry and Warwickshire NHS Trust’s Clinical Trials Unit, which is due to begin in the second half of the year.
A subsequent pivotal bioequivalence trial is planned to take place in next year, set to be followed by an application for UK regulatory approval. If approved, it will become the first drug-device combination product in the UK to be approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of threatened miscarriage.
Additional advisers on the project include Stuart Lavery, consultant gynaecologist and specialist in reproductive medicine and surgery, who is also the official spokesman for the British Fertility Society.
