A team of scientists and biomedical engineers at Calla Lily Clinical Care have developed pioneering technology designed to treat threatened miscarriage, which has secured £1 million in Invention for Innovation (i4i) funding from the National Institute for Health and Care Research (NIHR), the U.K.'s leading funder of health and social care research.
The technology, known as Callavid, delivers a dose of progesterone via a small, tampon-shaped device featuring the same integrated used in Callaly tampliner fem care products. The device can be hygienically inserted and remains in place while the drug is being absorbed. Afterwards it is easily and cleanly removed. Delivering progesterone with this device is designed to reduce leakage anxiety and ensure the drug is administered in a comfortable and reliable way.
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 U.K. alone 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. 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 £236 million per year.**
The funding from the NIHR will allow the research team to move towards in-person trials. The first phase of this process will be a ‘usability’ study beginning this month which will ensure the product and its instructions can be clearly understood by prospective users. This will be followed by an NIHR-funded clinical feasibility study, which is due to begin in 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 to take place in 2026, set to be followed by an application for UK regulatory approval. If approved, Callavid would become the first drug-device combination product in the U.K. to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of threatened miscarriage.
The team behind the innovation believes that the same technology will also prove beneficial for women undergoing IVF treatment, which requires progesterone administration (more than 1.3m cycles in the UK since 1991), as well as for delivering other vaginally-delivered medications.
Additional advisers on the project include Consultant Gynaecologist and Specialist in Reproductive Medicine and Surgery, Stuart Lavery, who is also the official spokesman for the British Fertility Society.
“Having been through seven rounds of IVF, I have first-hand experience of how awful taking progesterone can be," says Lara Zibners, co-founder and chair of Call Lily Clinical Care. "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," she adds. "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.”
