Calla Lily Clinical Care funding news – London-based Calla Lily Clinical Care Secures £1 Million in Funding

The new technology 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* (ref 1) 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.

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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.

Having successfully secured £1 million 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.

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.

Dr Lara Zibners, Co-founder and Chair of Calla Lily Clinical Care, comments: “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 be leading the NIHR-funded study, comments: “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, comments: “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.”

About Calla Lily Clinical Care

Calla Lily Clinical Care is an ambitious women’s health focused company that has developed the proprietary Callavid® platform for intravaginal drug delivery. Initial target indications are in fertility and pregnancy, where the company seeks to offer the world’s first drug-device combination product for both threatened miscarriage and IVF luteal phase support.