• Scientists developing a pioneering device designed to address threatened miscarriage have secured £1 million in NIHR funding to begin clinical trials
• Designed to deliver vital doses of progesterone, the Callavid® device stands to help over 150,000 women each year in the UK* (ref 1)
• If approved, it would become the world’s first drug-device combination product to treat threatened miscarriage

London, UK – A team of scientists and biomedical engineers developing pioneering technology designed to treat threatened miscarriage has secured £1 million in Invention for Innovation (i4i) funding from the National Institute for Health and Care Research (NIHR) for its first clinical trial.

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.

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.** (ref 2)

Created by the team at Calla Lily Clinical Care to tackle this issue, the first-of-its-kind technology – called Callavid® – delivers a dose of progesterone via a small, tampon-shaped device with an integrated mini-liner. The new product can be hygienically inserted, remains in place whilst the drug is being absorbed, and is then 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.

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.

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 UK 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.

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.”

ENDS

Notes to Editors

Photos available here.

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. Callavid® is also capable of delivering other therapeutics including live biotherapeutic products (LBPs) to treat recurrent Bacterial Vaginosis, cutting antibiotic usage and helping to reduce the spread of antimicrobial resistance (AMR).

Prior to securing the NIHR funding, Calla Lily Clinical Care previously secured over £1m in grant funding from Innovate UK to further their research and development. The company is a certified B Corp.

About the treatment

Administering doses of vaginal micronised progesterone (i.e. “body-identical” progesterone) is the NICE-recommended guideline for women who have suffered at least one prior miscarriage and subsequently face threatened miscarriage.

About the founders

Dr Lara Zibners, Co-founder & Chairman

Dr. Lara Zibners is a board-certified pediatrician and pediatric emergency medicine specialist with over two decades of experience in clinical practice and medical education. She earned her medical degree from The Ohio State University College of Medicine, followed by a residency and a fellowship at Nationwide Children’s Hospital in Columbus, Ohio. She holds a Masters of Medical Education from the University of Dundee and an MBA from the UNC Kenan-Flagler School of Business. Dr. Zibners has held academic positions, including Assistant Professor of Pediatrics and Emergency Medicine at Mount Sinai Hospital in New York, and has served as an Honorary Consultant in pediatric emergency medicine at St. Mary’s Hospital in London.

Lara co-founded Calla Lily Clinical Care based on her experience from multiple failed IVF cycles which involved hundreds of painful intramuscular injections as well as leaky pessaries and suppositories.

Thang Vo-Ta, Co-founder & CEO

Thang Vo-Ta began his career in investment banking and private equity in the New York and London offices of Goldman Sachs. He then spent over a decade in various successful entrepreneurial ventures including in property development working on London landmarks such as St Pancras Chambers. Thang has been named a Sunday Times Maserati Top 100 entrepreneur and The Manufacturer’s Top 100 manufacturing leader. He has a BSc in Management from Massachusetts Institute of Technology (MIT) and is completing an MSc in Translation Health Sciences from the University of Oxford.

Thang co-founded Calla Lily Clinical Care and as CEO he manages the team and its strategic direction, including its commitment to the environment, people and communities as a certified B Corp.

About the feasibility study (to be conducted by University Hospitals Coventry and Warwickshire NHS Trust’s Clinical Trials Unit)

• Calla Lily Clinical Care will undertake a feasibility study to establish safety and compare the delivery of vaginal progesterone into the blood using the Callavid® device versus existing pessaries, as well as comparing their respective usability/acceptability to patients.
• The study is planned for the second half of 2025 and will be a randomised, open-label, single-centre crossover study, involving non-pregnant recurrent miscarriage luteal phase insufficiency patients.
• The data collected will help to inform the design of the subsequent pivotal bioequivalence trial.

About UHCW Clinical Trials Unit

University Hospitals Coventry and Warwickshire NHS Trust has been designed to have research at its core, with purpose-built clinical research facilities embedded within the healthcare setting.

The dedicated Coventry and Warwickshire Clinical Research Facility (CRF) provides an excellent environment to conduct research close to but independent from clinical areas and with the support and expertise required to conduct high quality clinical studies.

About the NIHR

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

• Funding high quality, timely research that benefits the NHS, public health and social care;
• Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
• Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
• Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
• Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
• Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK international development funding from the UK government.

* Ref 1: Threatened miscarriage and treatment – impact estimate

• It is estimated that over 150,000 women in the UK* could be eligible for prescriptions of vaginal progesterone for threatened miscarriage each year
• This estimate is based on the following sources and has been verified by statistical experts:
  • https://pmc.ncbi.nlm.nih.gov/articles/PMC7408486/ – “In the United Kingdom, we estimate that implementing this treatment strategy would result in an additional 8450 live births per year”
  • https://pubmed.ncbi.nlm.nih.gov/32003141/ – “For women with at least one previous miscarriage, progesterone was more effective than placebo with an effect difference of 0.055”

** Ref 2: Analysis led by LSE CPEC economist David McDaid

David McDaid is an Associate Professorial Research Fellow in Health Policy and Health Economics within CPEC at LSE. With more than 25 years of research experience and over 350 publications he has advised many national governments and international agencies, including work to assess intersectoral actions to promote health and wellbeing for the World Health Organization.