The UK National Institute for Health and Care Research (NIHR) has awarded £1m from its Invention for Innovation (i4i) programme to a team of scientists who have developed a device designed to improve the delivery of progesterone for women experiencing threatened miscarriage.
The team at London’s Calla Lily Clinical Care will use the funds to initiate a clinical trial of Callavid, a small, tampon-shaped device, inserted vaginally, that holds in place as progesterone is absorbed.
Go deeper with GlobalData
Progesterone is commonly administered in the form of pessaries to women who experience bleeding in early pregnancy, with the hormone preparing the uterus for implantation, and suppressing uterine contractions to avert miscarriage.
However, research by the London School of Economics’ Care Policy and Evaluation Centre (CPEC) indicates that across the UK National Health Service (NHS), leaky progesterone pessaries result in £236m in avoidable costs per year.
Led by miscarriage and preterm birth specialist Siobhan Quenby, the team at University Hospitals Coventry and Warwickshire NHS Trust’s Clinical Trials Unit will launch a study this month to ensure Callavid’s use is well-understood by prospective users. This will be followed by a clinical feasibility study, due to begin in the second half of 2025.
A subsequent pivotal bioequivalence trial is planned for 2026, with the team intending to file for device approval with the UK Medicines and Healthcare products Regulatory Agency (MHRA) thereafter. If approved, Callavid would become the first drug-device combination product in the UK to be approved for the treatment of threatened miscarriage.
Siobhan Quenby stated that pessary leakage is a “recurring issue” among her patients, with new methods to reduce additional psychological anxiety “badly needed” in the field.
Dr Lara Zibners, chair and co-founder of Calla Lily Clinical Care, commented: “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.”
Venture capital investment in women’s health startups is lagging, despite the fact there is a clear business case, given that women make up 51% of the global population. In addition, a research collaboration between McKinsey & Company and the World Economic Forum found that while women live longer than men, they spend 25% more of their lives in debilitating health.
Despite the evidence, women’s health is still often viewed as a ‘niche’ market. Pushing back on the perception at the Royal Society of Medicine’s Innovation in Women’s Health and Femtech meeting in London on 3 March 2025, Lesley Regan, women’s health ambassador for England, said: “Whenever anyone says that you just have to shout at them. How can 51% of the population be a niche market?”
