A New Device Could Improve How Progesterone is Delivered in Early Pregnancy

Miscarriage is one of the most common pregnancy complications in the UK, and also one of the least talked about. It is estimated that between 120,000 and 250,000 miscarriages occur each year in the country, a range that already signals how poorly captured this data remains. Against that backdrop, a London-based medical technology company has reached an important milestone: the first patients have been dosed in a clinical trial evaluating a new intravaginal drug delivery platform designed to administer progesterone more reliably in women at risk of pregnancy loss.

Calla Lily Clinical Care announced on 6 May 2026 that its FREEDOM study, a first-in-human safety and usability trial, had begun enrolling patients at University Hospitals Coventry and Warwickshire NHS Trust. The trial is funded by the National Institute for Health and Care Research (NIHR) and will evaluate the company's Callavid device in women diagnosed with luteal phase insufficiency: a condition in which the body produces insufficient progesterone during the second half of the menstrual cycle to sustain early pregnancy, increasing the risk of infertility and recurrent miscarriage.

What is the problem with existing progesterone delivery?

Progesterone supplementation in early pregnancy is not new. Administering 400mg micronised progesterone twice daily is recommended by NICE for women who have suffered a previous miscarriage and experience bleeding in early pregnancy, clinically termed threatened miscarriage. However, current delivery relies on vaginal pessaries, suppository-style products that, as any patient using them knows, are far from ideal. They can leak, their placement during use is uncertain, and women are routinely advised to lie horizontally for extended periods following each administration.

These aren't trivial inconveniences. Unreliable placement means uncertain drug absorption, which raises genuine questions about whether the intended therapeutic dose is actually being delivered at the moments it matters most. Calla Lily argues that its Callavid device, described as tampon-like in form, with a patented leak-free design, directly addresses these shortcomings, enabling more consistent intravaginal drug delivery with better user experience.

If that holds up under clinical scrutiny, it would represent a genuine improvement in care for a patient population navigating an already stressful period. The FREEDOM study - which stands for FiRst in human safEty and Ease of use assessment of 400mg progesterone CallaviD in wOMen with luteal phase insufficiency - is designed to assess safety, user acceptability, and progesterone absorption, building the evidential foundation regulators will require before any wider deployment.

What do the trial investigators say?

Professor Siobhan Quenby MBE, a world-leading authority on miscarriage and preterm birth who serves as Chief Investigator of the FREEDOM trial, offered a clear-eyed view of the clinical gap Callavid is intended to fill.

The company's co-founder and chair, Dr Lara Zibners, brings a perspective that goes beyond the clinical.

How does this connect to England's Women's Health Strategy 2026?

The Renewed Women's Health Strategy for England was recently published in April 2026. It is forthright about the scale of the problem it is attempting to address. The Secretary of State for Health and Social Care opens the document with a frank admission that the NHS has a problem with medical misogyny, citing women being ignored, gaslit, and disrespected as experiences shared by more than eight in ten women when engaging with healthcare professionals. The strategy explicitly prioritises improving support for fertility and pregnancy loss, and commits to reviewing the evidence for rolling out a graded model of care for repeated pregnancy loss.

More broadly, the strategy positions women's health innovation as central to its ambitions. The NIHR R&D Innovation Catalyst, launched this year, is intended to provide funding and wrap-around support for high-priority innovations, explicitly including those in reproductive health. Within two years, the government also plans to launch a FemTech healthcare challenge with a £1.5 million funding pot, aimed at developers addressing areas of unmet clinical need, with a focus on community service models and health inequalities.

A device like Callavid which targets a specific, well-documented gap in a high-need area, backed by NIHR funding, and developed with patient experience at its centre, is precisely the kind of innovation that framework is designed to support. Whether it will ultimately benefit from such mechanisms depends on what the FREEDOM trial data shows.

Reproductive health innovation in a broader moment

The Calla Lily announcement sits within a period of genuine, if uneven, progress in women's reproductive health innovation. At BioFocus, we've covered related developments that are worth placing alongside this one. We reported on research published in The BMJ demonstrating that menstrual blood collected on a modified sanitary pad could detect HPV with comparable accuracy to clinician-collected cervical samples, a finding with significant implications for cervical cancer screening access, particularly among women who avoid clinic-based procedures. And in a broader analysis of cross-sector collaboration, we examined the systemic barriers that continue to prevent cervical cancer elimination from becoming a reality, despite the tools to achieve it already existing.

These are not unrelated stories. They share a common thread of healthcare systems not designed around women's bodies or women's lives, and the slow, often incremental work of addressing that deficit through innovation, policy, and a growing determination, at both industry and government level, to close the gap.

What are the limitations and what comes next?

Callavid has not yet demonstrated anything beyond safety and usability in this initial human trial. The FREEDOM study is an early-phase assessment, and the path from first-in-human data to an approved product that reaches patients at scale is long and uncertain. CEO Thang Vo-Ta was candid about where the company sees the device's potential:

That language signals a commercial pipeline that extends well beyond miscarriage, which is a reasonable ambition for a drug-device combination platform if the underlying delivery technology proves out.

For context, the average time from first seeing a doctor with symptoms to an official endometriosis diagnosis in the UK is around nine years and four months. It is a useful reminder of how far intention and evidence-gathering remain from patient impact in women's health. But it is also precisely because that gap has been so persistent and so consequential that early-stage trials like FREEDOM deserve attention.