Pioneering technology to address threatened miscarriage secures £1 million funding

Dr Zibners is co-founder of Calla Lily Clinical Care (CLCC), a company changing the way women are treated for a range of medical conditions from infertility to cervical cancer to a healthy vaginal microbiome.

The company has developed the Callavid platform for leak-free vaginal drug delivery.

This week they are announcing a prestigious £1 million ($1.29 million) award of NIHR funding to begin clinical trials for their first use-case: progesterone, a drug that is commonly used for a variety of conditions including infertility, miscarriage prevention, preterm birth prevention, and menopause. 

Why progesterone?

Because of Dr Zibners’ personal experience on her journey to motherhood.

She said: “I never thought, oh let me try to get pregnant and then there will be seven rounds of failed IVF and one day I’ll start a women’s healthcare company.

“It just turned out that way.”

She is always quick to add that she is the mother of three, thanks to adoption and surrogacy.

On the way there, however, she became intimately knowledgeable about the leaky pessaries and very painful muscular injections that are part of taking progesterone.

In the UK, vaginal pessaries are the standard but cause a great deal of anxiety due to leakage, with women being advised to lie down for at least half an hour after administering the drug, two or three times each day.

A US-trained physician, Dr Zibners started on vaginal progesterone during her infertility journey, but because of the leakage and dosage uncertainty she was quickly moved to the injected formulation.

She said: “There will be different needles in the bag, that’s what my doctor said. But progesterone wasn’t like the other injections.

“It is an oil-based, very thick, emulsion that needs to go into a large muscle.

“For five months, I had to steel myself every single time before plunging that needle into my own hip. It was traumatic.”

The announcement of such significant funding support from the NIHR (National Institute for Health and Care Research) is a significant validation for the company.

As the UK’s leading funder of health and social care research, grant applicants must align with the NIHR’s focus on bettering society through impactful innovation.

These grants are not easy to come by and this was not their first attempt. Each application is hundreds of pages long and consumes very many hours of a start-up’s scarce resources.

The possibility of a prestigious source of non-dilutive funding kept the team moving forward with a resubmission.  

The monies received will fund the company’s first clinical feasibility trial starting later this year.

Vaginal micronised progesterone is recommended by the UK’s National Institute for Health and Care Excellence (NICE) for every woman who has had at least one prior miscarriage and faces a “threatened miscarriage,” defined as bleeding in early pregnancy.

While this is national guidance in the UK and there is similar guidance in Australia, Dr Zibners maintains that progesterone for early pregnancy support is used around the world.

She said: “In a certain number of patients, there are inadequate levels of circulating progesterone to support the endometrium as a pregnancy takes root and develops a sure footing in there.

“By giving progesterone, there is evidence that up to 15 per cent of miscarriages in patients with recurrent pregnancy loss could be prevented.” 

Calla Lily Clinical Care is being fast-tracked through the UK regulatory body, the MHRA (US FDA equivalent), for both infertility support and miscarriage prevention.

If, following their clinical studies, the vaginal progesterone product is approved, it will become the world’s first drug-device combination to prevent miscarriage.  

The Callavid device is similar to a tampon but has been adapted to release drug while selectively absorbing leakage.

A mini-liner that remains external to the body has been integrated into the device to absorb any additional fluid and for completely hygienic removal after the prescribed wearing time.

Dr Zibners has partnered with Thang Vo-Ta, a former Goldman Sachs investment banker with a long history in the women’s health space to bring their vision to life. 

The upcoming study is being led by Professor Siobhan Quenby MBE, a world leading expert on recurrent miscarriage.

In the company’s press release, Professor Quenby is quoted as saying: “This new product will be extremely welcomed by miscarriage patients.

“Pessary leakage is a common issue amongst my patients, causing acute anxiety and significant inconvenience during a very difficult time…Through this innovation…I believe there is potential to transform women’s experience.” 

Dr Zibners echoed the Professor’s sentiment: “If I had been able to use this product, my IVF journey would have been better. Simple as that.

“Once women know there is a different option, why would you ever allow yourself to go through the trauma of injections or leaky pessaries?”