A team of scientists and biomedical engineers developing tech designed to treat threatened miscarriage has secured £1m in Invention for Innovation (i4i) funding.
The funding comes from the National Institute for Health and Care Research (NIHR) and will be used for the team’s first clinical trial.
The new technology, created by the team at Calla Lily Clinical Care, is a novel device 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 prior miscarriage and subsequently face “threatened miscarriage”, the clinical term for when there is bleeding during early pregnancy.
It’s estimated that over 150,000 women in the UK could be eligible for prescriptions of progesterone for threatened miscarriage each year.
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.
According to analysis by health economists from the London School of Economics’ Care Policy and Evaluation Centre (CPEC), the avoidable cost to the economy and the NHS from the use of leaky progesterone pessaries for miscarriage prevention and IVF across England and Wales is £236m per year.
The first-of-its-kind technology – called Callavid – delivers a dose of progesterone via a small, tampon-shaped device with an integrated mini-liner.
The new product can be hygienically inserted, remains in place whilst the drug is being absorbed, and is then easily and cleanly removed.
Having successfully secured £1m in funding from the NIHR, the UK’s leading funder of health and social care research, the clinicians and scientists behind the innovation will now move towards in-person trials.
The first phase of the process will be a ‘usability’ study beginning this month which will ensure the product and its instructions can be clearly understood by prospective users.
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This will be followed by an NIHR-funded clinical feasibility study, which is due to begin in the second half of 2025.
“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,” said Dr Lara Zibners, co-founder and chair of Calla Lily Clinical Care.
“Vaginal progesterone leaks. Badly. Excessive leakage causes so much additional and unnecessary distress. Our device has significant potential to improve women’s quality of life; improving their experience of administering progesterone and playing a role in tackling threatened miscarriage.”
“We’re incredibly proud to have reached this critical milestone in our development of a brand new medical device designed to enhance how women administer vaginal progesterone.”
Professor Michael Lewis, scientific director for innovation at the NIHR, added: “The NIHR’s mission is to enable world-leading research that improves people’s health and wellbeing.
“The innovation being pioneered by the team at Calla Lily Clinical Care aligns exactly with this vision.
“We are delighted to have awarded them this funding and are looking forward to seeing the results of this year’s clinical trial and the long-term positive impact it will have for women.”