A new medical device designed to address threatened miscarriage has secured £1 million in funding from the National Institute for Health and Care Research (NIHR) to begin clinical trials. The Callavid device, developed by UK-based Calla Lily Clinical Care, aims to transform how progesterone is delivered to women experiencing threatened miscarriage – potentially helping over 150,000 women each year in the UK alone. If approved, it would become the world’s first drug-device combination product to treat threatened miscarriage.
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 bleeding during early pregnancy. Currently, progesterone is self-administered by patients via vaginal pessaries, a method that presents significant challenges. The current delivery system is prone to substantial leakage, causing undue anxiety and inconvenience for patients during an already distressing time.
To avoid medication leakage before absorption, many women must lie down for extended periods 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 leaky progesterone pessaries for miscarriage prevention and IVF across England and Wales is estimated at £236 million per year.
The Callavid device addresses these issues through an innovative design that delivers progesterone via a small, tampon-shaped device with an integrated mini-liner. This design allows for hygienic insertion, remains in place during drug absorption, and can be easily and cleanly removed.
With the £1 million NIHR funding secured, Calla Lily Clinical Care is now moving toward in-person trials. The process will begin with a usability study this month to ensure the product and its instructions are clearly understood by prospective users.
This will be followed by an NIHR-funded clinical feasibility study scheduled for the second half of 2025. The study will be led by Professor Siobhan Quenby MBE, one of the world’s leading authorities on miscarriage and preterm birth, and the team at University Hospitals Coventry and Warwickshire NHS Trust‘s Clinical Trials Unit.
A subsequent pivotal bioequivalence trial is planned for 2026, after which the company plans to apply for UK regulatory approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
The team behind the innovation believes the same technology will also benefit women undergoing IVF treatment, which requires progesterone administration (more than 1.3 million cycles in the UK since 1991), as well as for delivering other vaginally-administered medications.
Dr. Lara Zibners, Co-founder and Chair of Calla Lily Clinical Care, shared her personal experience with the current treatment methods: “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. 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. The NIHR funding will enable us to test our technology via a feasibility study this autumn, bringing us one step closer to making this product available to help women at one of the most distressing moments of their lives.”
Professor Siobhan Quenby MBE, who will lead the NIHR-funded study, commented: “This new product will be extremely welcomed by miscarriage patients. Pessary leakage is a recurring issue amongst my patients, causing acute anxiety and significant inconvenience during a very difficult time. New methods to reduce additional psychological anxiety are badly needed in this field. Through this innovation, one which is being pioneered right here in the UK, I believe there is potential to transform women’s experience.”
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.”
