Calla Lily Clinical Care

What Calla Lily Clinical Care does

Calla Lily Clinical Care is a London-based, clinical-stage women's health medical technology company founded in 2021 as a spin-off from Callaly. The company develops the patented Callavid® platform, a leak-resistant, tampon-shaped intravaginal drug delivery device featuring a flexible sheath with a biocompatible polymer scaffold and an integrated absorbent mini-liner designed to prevent medication leakage, ensure placement confidence, and provide mess-free self-administration. The technology has received FDA clearance (originally for its predecessor Tampliner® period care device) and is covered by granted and pending patents plus design registrations. Calla Lily's initial clinical focus is progesterone delivery for IVF luteal phase support and threatened miscarriage prevention via the FREEDOM clinical trial at University Hospitals Coventry and Warwickshire NHS Trust, with pipeline applications extending to menopause hormone therapy, oncology, infectious diseases, and live biotherapeutic delivery for bacterial vaginosis and vaginal microbiome restoration.

The business operates on a drug-device combination product model intended to monetize through pharmaceutical partnerships and licensing arrangements rather than direct sales. Go-to-market is enterprise-focused, targeting fertility clinics, NHS trusts, and hospital systems, with stated expansion intent into the US, Middle East, and Asia. The company is ISO 9001:2015 certified for three consecutive years with zero non-conformities, is a Certified B-Corporation, and has built a multi-university research ecosystem with the University of Warwick, Queen Mary University of London, and UCL Consultants Ltd to deepen its scientific pipeline.

The company is pre-revenue; products are explicitly stated as under development and not yet approved for sale under applicable medical device regulation. Cumulative capital raised includes approximately £2.2 million in Innovate UK grants, £1 million from NIHR (April 2025), and more than £4.5 million in private investment. In February 2026, Calla Lily entered its first industry partnership with Merck KGaA for co-development and potential commercialization across fertility, oncology, and hormone therapy applications, marking the most significant commercial milestone to date.

Name

Calla Lily Clinical Care

Legal name

Calla Lily Clinical Care Ltd.

Website

https://callali.ly

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

Calla Lily Clinical Care is a London-based, clinical-stage women's health medical technology company developing the patented Callavid® intravaginal drug delivery platform, initially targeting fertility and threatened miscarriage with pipeline applications in menopause, oncology, and vaginal microbiome restoration.

Ownership category

akta.pro rank

Product category

Women's Health Drug-Device Combination Products

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Contraception & Family Planning Telehealth (birth control, counseling, follow-up) (HLALAHAB)

akta.pro secondary industry

Fertility & Reproductive Endocrinology Telehealth (IVF/IUI, infertility evaluation) (HLALAHAA)

Keywords

• Intravaginal drug delivery
• Drug-device combination products
• Women's health medical devices
• Fertility and pregnancy therapeutics
• Vaginal microbiome delivery

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Supply Chain, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Drug-Device Combination Products: Revenue from development and commercialization of proprietary Callavid® platform loaded with therapeutic drugs (progesterone for fertility/miscarriage prevention, with pipeline in oncology, hormones, live biotherapeutics). Platform technology enables lifecycle extension of existing drugs and creation of differentiated combination products.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Calla Lily Clinical Care develops and is commercializing the patented Callavid® platform, a leak-resistant, tampon-shaped intravaginal drug delivery device with an integrated absorbent mini-liner and biocompatible polymer scaffold for accurate, mess-free dosing of vaginal therapeutics. The lead clinical program loads the device with progesterone for IVF luteal phase support and prevention of threatened miscarriage, with pipeline applications in menopause hormone therapy, oncology, infectious diseases, and live biotherapeutic delivery to restore a healthy vaginal microbiome. The company also retains the FDA 510(k)-cleared Tampliner® period care product from its predecessor entity Callaly.

Product overview

Calla Lily Clinical Care is a medical technology company commercializing its proprietary Callavid® platform technology for intravaginal drug delivery. The flagship product is Callavid®, a patented, leak-free, tampon-shaped device with an integrated absorbent liner designed to improve dosing accuracy and patient comfort for vaginal therapeutics. The company also maintains its original Tampliner® period care product with FDA clearance. The technology portfolio addresses multiple therapeutic areas including fertility/IVF support, threatened miscarriage prevention, menopause, oncology, infectious diseases, and live biotherapeutics delivery for vaginal microbiome restoration.

Differentiator

Problem solved

Functional benefit

Brands

• Callavid®: Proprietary intravaginal drug delivery platform technology featuring a leak-resistant, tampon-shaped device with integrated absorbent liner for improved drug delivery in women's health applications including fertility, pregnancy, and menopause.
• Tampliner®

Products and services

• Callavid® A patented, leak-resistant, tampon-shaped intravaginal drug delivery platform designed for use by fertility and women's health patients. Features an integrated absorbent mini-liner that prevents leakage, a flexible sheath for therapeutic delivery, and a biocompatible polymer scaffold for comfortable insertion, secure placement, and mess-free removal. Currently in clinical stage with a progesterone-loaded variant for IVF luteal phase support and threatened miscarriage (FREEDOM trial); future applications include menopause, oncology, infectious diseases, and delivery of live biotherapeutics for vaginal microbiome restoration.
• Tampliner® A period care product combining a tampon with an integrated applicator. FDA 510(k) cleared and retained from the predecessor Callaly business.

Quantifiable outcome

• Current pessary leakage is the most frequent complaint from miscarriage patients, causing significant anxiety - Callavid addresses this directly
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Five partnerships are on record, tiered core and secondary.

• Merck KGaAcoreStrategic or Co-development Partner · 10 February 2026Strategic collaboration with Germany's Merck KGaA to support continued development of Callavid®, an intravaginal drug delivery platform. This is the first industry partnership for the Callavid technology, with Merck providing both financial and strategic support to advance the platform toward potential commercialization for fertility, oncology, and hormone therapies.
• University Hospitals Coventry and Warwickshire NHS TrustcoreStrategic or Co-development PartnerCollaboration with UHCW NHS Trust on FREEDOM clinical trial of Callavid® for threatened miscarriage. The NIHR-funded feasibility study is led by Professor Siobhan Quenby MBE and scheduled for execution in 2025.
• University of WarwicksecondaryStrategic or Co-development PartnerPartnership establishes a fully funded 4-year MSc/PhD program dedicated to advancing scientific research in vaginal microbiota and women's reproductive health, exploring mechanisms by which vaginal microbiota protect against inflammation and pregnancy complications.
• Queen Mary University of LondonsecondaryStrategic or Co-development PartnerInnovative PhD studentship focused on developing breakthrough solutions for bacterial vaginosis using a novel microbiome organ-chip model to explore probiotic interventions for a condition affecting 30% of reproductive-aged women.
• UCL / UCL Consultants LtdsecondaryStrategic or Co-development PartnerMultiyear partnership with UCL Consultants Ltd, working closely with Professor Catherine Tuleu's team to advance drug formulation technology for the Callavid® device.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Ferring Pharmaceuticals: Privately held Swiss pharma company whose Crinone vaginal progesterone gel competes directly with Callavid® in fertility and threatened miscarriage indications. Ferring's established physician relationships, manufacturing scale, and reimbursement infrastructure make it the most directly comparable competitor in the target therapeutic area.
• Daré Bioscience: Clinical-stage women's health company focused on novel drug delivery and gynecologic conditions, with a similarly pre-commercial profile and indication overlap in areas such as bacterial vaginosis and contraception. Closely comparable as a development-stage peer pursuing differentiated women's health therapeutics.
• ObsEva: Swiss-based clinical-stage biopharmaceutical company developing therapies for women's health, with focus on preterm labor and fertility indications. Highly comparable as a similarly sized clinical-stage peer in the same therapeutic areas Calla Lily targets.
• Theramex: Women's health-focused pharmaceutical company with portfolio across fertility, contraception, menopause, and osteoporosis. Comparable as a women's health specialist with overlapping indications in hormone therapy and fertility where Callavid® is pursuing platform applications.
• Myovant Sciences: Women's health company (acquired by Sumitomo Pharma) developing therapies for uterine fibroids, endometriosis, and prostate cancer. Overlaps with Calla Lily's fertility and women's health focus areas and operates as a similarly specialized peer in reproductive health drug development.
• Evofem Biosciences: Women's health company that commercialized Phexxi, a vaginal pH modulator for contraception. Directly comparable as a peer focused on vaginal drug delivery for women's reproductive health, with overlapping contraception and STI prevention use cases.

Broad incumbents

• Organon & Co. Women's health-focused pharma spin-off from Merck (US) with a broad portfolio spanning fertility, contraception, and hormone therapy. Overlaps with Callavid®'s target indications but operates as a larger incumbent with established brands rather than as a drug-device platform developer.
• Bayer: Global pharmaceutical company with a substantial women's health portfolio including hormonal contraception, IUDs, and menopausal hormone therapy. Overlaps broadly with Callavid®'s hormone therapy and fertility applications but operates at a vastly larger scale as an incumbent.
• AbbVie: Major global pharmaceutical company whose women's health portfolio (including products acquired via Allergan) spans fertility, endometriosis, and hormone therapy. Comparable as a broad incumbent with overlapping therapeutic areas, though not a focused drug-device delivery player.
• Hologic: Women's health-focused medical technology company with leadership in diagnostics, surgical, and skeletal health solutions. Comparable as an incumbent women's health specialist with overlapping clinical end markets in reproductive health, though focused on diagnostics and surgical rather than drug delivery.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/CallaLilyCC
• LinkedInlinkedin.com/company/calla-lily-clinical-care
• Instagraminstagram.com/callalilyclinicalcare

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles20 records

Funding overview

Funding rounds7 records

Investors4 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Calla Lily Clinical Care