Over 150,000 women experience threatened miscarriage every year. Calla Lily Clinical Care, founded in 2021 by Dr. Lara Zibners and Thang Vo-Ta, has announced £1 million in funding from the National Institute for Health and Care Research (NIHR) to progress the development of its Callavid drug-device combination. If approved, it will be the world’s first drug-device combination for the condition, designed to improve treatment for women experiencing threatened miscarriage.
The funding will support a phased clinical trial process. If successful, it could transform the lives of hundreds of thousands of women who experience threatened miscarriage during their pregnancy.
Threatened miscarriage: a common and distressing experience
Dr. Lara Zibners co-founded Calla Lily Clinical Care after experiencing multiple failed IVF cycles that exposed her to the inefficiencies of leaky pessaries and painful injections. Her personal struggles inspired her vision for better drug delivery solutions for women’s health. Thang Vo-Ta partnered with Zibners after transitioning from investment banking at Goldman Sachs into entrepreneurship focused on addressing unmet needs in women’s healthcare. Together, they have built an award-winning company recognised as a Certified B-Corporation.
Characterised by bleeding during early pregnancy, current recommendations for miscarriage by the National Institute for Health and Care Excellence are for vaginal micronised progesterone for women who have already experienced at least one miscarriage. However, the treatment is not without its drawbacks.
The current delivery method, using self-administered pessaries, is prone to leakage. This causes additional distress for already anxious patients, and also results in less efficient absorption of the drug. Research has suggested that, cumulatively, leakage results in £236 million in avoidable loss to the NHS and wider economy.
Calla Lily operates within the growing FemTech sector alongside competitors like Elvie (focused on intimate health devices) and Nixit (menstrual care innovations). However, Callavid stands out due to its unique focus on vaginal drug delivery systems specifically targeting miscarriage prevention and fertility treatments.
Calla Lily has attracted the attention of global healthcare leaders and investors. Its co-founders were named among the ‘200 Trailblazinging Leaders in Women’s Health & FemTech’ for their contributions to advancing healthcare access. The company also explores partnerships with pharmaceutical firms while hosting delegations from international organizations like Japan’s Ministry of Affairs.
From innovation, to clinical trials, to improving lives
Callavid provides a better alternative to the pessary. Instead, progesterone is delivered via a tampon-shaped device with an integrated mini-liner. It improves progesterone delivery, preventing leakage and ensuring better absorption. Once the drug has been absorbed, the device can be easily removed.
The Invention for Innovation NIHR funding will support Calla Lily Clinical Care as they take their innovative drug-device combination through clinical trials. The first ‘usability’ study will begin this month, testing the product and instructions to ensure potential users can understand them clearly. A NIHR-funded clinical feasibility study is then scheduled to take place in the second half of 2025.
If both are successful, a bioequivalence trial, testing that the delivery method offers the same pharmaceutical benefits as alternatives, will take place in 2026. The final step will see Calla Lily apply to the Medicines and Healthcare products Regulatory Agency for UK regulatory approval.
The feasibility study will be led by Professor Siobhan Quenby MBE, a miscarriage specialist, who said, “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.”
The NIHR’s Professor Michael Lewis, Scientific Director for Innovation, highlighted how Callavid aligns with their goals, “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.”
Beyond threatened miscarriage: Callavid’s wider potential
Callavid has the potential to transform the lives of millions of people. As well as helping to treat threatened miscarriage, it also has potential to benefit women undergoing IVF treatment, which requires progesterone administration, with more than 1.3 million cycles having been administered for this purpose since 1991.
The team behind Callavid are confident, from their own experience, of its potential to improve lives. Co-founder and Chair of Calla Lily Clinical Care, Dr Lara Zibners explained, “having been through seven rounds of IVF, I have first-hand experience of how awful taking progesterone can be… Vaginal progesterone leaks. Badly. Excessive leakage causes so much additional and unnecessary distress,” she said. “Our device has significant potential to improve women’s quality of life.”
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