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The future of family: unveiling 45 cutting-edge advancements in IVF

By FinDBest IVF 

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The past couple of years have witnessed exciting advancements in the IVF/ART space, driven by cutting-edge technologies and a relentless pursuit of improving fertility outcomes. Here, FinDBest IVF offers a glimpse into some notable breakthroughs.

1. EMBRYOSCOPE (VITROLIFE) – iDAScore

  • Area: Artificial Intelligence (AI) in Embryo Selection
  • Description: Time-lapse imaging AI platform analysing embryo development for improved selection.
  • Impact: Predicts implantation potential, increasing pregnancy rates and reducing miscarriages.
  • URL: Vitrolife iDAScore

2. EXAMEN – SpermComet

  • Area: Non-invasive Sperm Selection
  • Description: DNA fragmentation assay for improved sperm selection.
  • Impact: Identifies sperm with minimal DNA damage, potentially increasing fertilisation and implantation rates.
  • URL: Examen SpermComet

3. EXCELLENT SCIENCE (Cherry Biotech) – MicroFSMA

  • Area: Microfluidics-based Sperm Analysis
  • Description: Automated method for semen analysis and quality sperm isolation.
  • Impact: Improves detection of male infertility and quality sperm isolation.
  • URL: MicroFSMA

4. OVERTURE LIFE – DaVitri, m|z, and ICSI.A

  • Area: Automation of Full ART Cycle
  • Description: Automated IVF process technologies to enhance consistency and affordability.
  • Impact: Reduces variability in outcomes and makes IVF more affordable.
  • URL: Overture Life

5. IVF 2.0 – SiD

  • Area: Computer-enabled Sperm Quality Tracker
  • Description: Computer vision-based sperm selection tool.
  • Impact: Analyses sperm motility more accurately than the human eye.
  • URL: IVF 2.0 SiD

6. IVF 2.0 – ERICA

  • Area: AI and Machine Learning for Embryo Selection
  • Description: Prioritises euploid embryos using AI without sampling or biopsy.
  • Impact: Enhances embryo selection for higher success rates.
  • URL: IVF 2.0 ERICA

7. TMRW LifeSciences – CryoRobot Select

  • Area: Automation of Tracking, Monitoring, and Storing of Frozen Embryos
  • Description: AI-integrated platform for tracking and storing frozen eggs and embryos.
  • Impact: Improves clinical outcomes and optimises treatment costs.
  • URL: TMRW CryoRobot Select

8. LIFE WHISPERER – Life Whisperer Genetics (LWG)

  • Area: AI-powered Euploid Pre-screening of Embryos
  • Description: AI evaluation of genetic normality in embryos.
  • Impact: Non-invasive pre-screening of embryos for genetic normality.
  • URL: Life Whisperer Genetics

9. LIFE WHISPERER – Life Whisperer Viability (LWV)

  • Area: AI-powered Embryo Selection
  • Description: AI evaluation of embryo viability for clinical pregnancy.
  • Impact: Enhances embryo selection for better pregnancy outcomes.
  • URL: Life Whisperer Viability

10. INITO – Inito

  • Area: Point-of-Care Fertility Testing
  • Description: Home-based hormone testing kit for fertility assessment.
  • Impact: Provides affordable and convenient fertility screening.
  • URL: Inito

11. Cooper Surgical Fertility Companies – RI Witness ART Management System

  • Area: Witness System for Monitoring ART Cycles
  • Description: Automated control system for monitoring sample and embryo handling.
  • Impact: Standardises the environment and minimises human error.
  • URL: RI Witness

12. HAMILTON THORNE, MICROPTIC – CASA (Computer-Assisted Sperm Analysis), SCA (Sperm Class Analyzer)

  • Area: Advanced Sperm Motility Analysis
  • Description: Enhanced motility and morphology assessment systems.
  • Impact: Provides detailed sperm quality data for better selection.
  • URL: Hamilton-Thorne CASA
  • URL: SCA

13. AVA WOMEN – The Ava Bracelet

  • Area: Wearables
  • Description: Predicts optimal implantation window through cervical secretion analysis.
  • Impact: Identifies the most receptive time for embryo transfer.
  • URL: Ava Women

14. NATERA – Panorama™ Test

  • Area: Non-invasive Preimplantation Genetic Testing (PGT)
  • Description: NIPT-based analysis of foetal DNA for genetic abnormalities.
  • Impact: Safer and less invasive option for PGT.
  • URL: Natera Panorama

15. CONCEPTION BIO – Invitro Gametogenesis (IVG)

  • Area: Human Eggs from Stem Cells
  • Description: Generates eggs from induced pluripotent stem cells.
  • Impact: Potential breakthrough in fertility preservation.
  • URL: Conception Bio

16. KITAZATO – Soft Microrobot

  • Area: Microrobot-guided Embryo Transfer
  • Description: Controls the implantation position during embryo transfer.
  • Impact: Increases pregnancy rates and prevents ectopic pregnancy.
  • URL: Kitazato Microrobot

17. OURA – Oura Ring

  • Area: Wearable Health and Fertility Trackers
  • Description: Tracks biometric data relevant to fertility cycles.
  • Impact: Provides personalised insights into menstrual cycles and ovulation windows.
  • URL: Oura Ring

18. FERTILIS – Micro Devices for IVF Techniques

  • Area: General Automation of ART Process
  • Description: Micro medical devices for enhancing IVF treatment quality.
  • Impact: Improves oocyte retrieval, ICSI performance, and more.
  • URL: Fertilis

19. EMBL-EBI – AlphaFold DB

  • Area: AI-powered Sperm Morphology Analysis
  • Description: AI-based protein structure prediction for sperm morphology assessment.
  • Impact: Offers high-resolution analysis of sperm structure.
  • URL: AlphaFold

20. OVAREPRED (Pekin University Third Hospital) – OvaRePred

  • Area: Online Model for Ovarian Reserve Assessment
  • Description: Predicts the quantity of potential female eggs suitable for fertilisation.
  • Impact: Aids in treatment planning and optimising outcomes.
  • URL: OvaRePred

21. IGENOMIX (VITROLIFE) – WES

  • Area: IVF Genomics
  • Description: Whole exome sequencing for analysing gene coding sequences.
  • Impact: Cost-effective technique for genetic analysis.
  • URL: Igenomix WES

22. VISCOFAN, IT3D GROUP, TISSUELABS, ADVANCED SOLUTIONS

23. FERTIL IBÉRICA – SpermVD

  • Area: Next-Generation Sperm Cryopreservation Techniques
  • Description: Vitrification process for improved sperm survival and motility.
  • Impact: Offers potential for longer sperm storage and improved fertilisation rates.
  • URL: Fertil Ibérica SpermVD

24. FLUIGENT – Microfluidics for Cell Biology

  • Area: Microfluidics for Cell Analysis
  • Description: Cell biology is crucial for medical innovation. Fluigent’s microfluidics technology integrates precise fluid flow control with microscopy, creating automated platforms for cell growth in physiologically relevant environments. This minimises error manipulation by automating fluid delivery at controlled rates.
  • Impact: Enhances accuracy and efficiency in cell biology experiments, facilitating better understanding and treatment of diseases.
  • URL: FLUIGENT – Microfluidics for Cell Biology

25. MICRONIT – Organ-on-a-Chip (OOC)

  • Area: Organ-on-a-Tube Microdevices
  • Description: Organ-on-a-chip devices simulate biological systems for in-vitro drug testing. Cells are cultured on membranes with separately controllable fluid flows, leading to more accurate biological representations than traditional methods. These resealable OOC flow cells allow cell seeding through standard protocols.
  • Impact: Provides more precise drug testing results, enhancing the drug development process.
  • URL: MICRONIT – Organ-on-a-Chip

26. ONI, BRUKER, WASATCH PHOTONICS, MALVERN PANALYTICAL, SPECTRA SOLUTIONS – Ultrasound-Guided TESA

  • Area: Non-invasive Testicular Sperm Extraction (TESA) with Ultrasound Guidance
  • Description: This technology offers a minimally invasive alternative to traditional sperm retrieval methods, using multiphoton microscopy, Raman spectroscopy, and optical coherence tomography for better visualisation and retrieval of sperm.
  • Impact: Potentially less painful and more efficient sperm retrieval method, improving patient comfort and outcomes.
  • URL: ONIBrukerWasatch PhotonicsMalvern Panalytical

27. MIM FERTILITY – FolliScan

  • Area: AI-powered Follicle Tracking and Ovulation Prediction
  • Description: AI software that analyses transvaginal ultrasound images to identify and measure follicles with high precision.
  • Impact: Improves accuracy in tracking ovulation, enhancing the chances of successful fertilisation.
  • URL: MIM FERTILITY – FolliScan

28. BERRY GENOMICS – NIPT-Based Analysis

  • Area: Non-invasive Prenatal Screening for Multiple Genetic Diseases
  • Description: Advanced NIPT technology that screens foetal DNA for a wide range of genetic abnormalities, beyond traditional panels.
  • Impact: Provides comprehensive prenatal genetic screening, leading to early detection and better management of genetic conditions.
  • URL: BERRY GENOMICS

29. Fairtility – CHLOE™

  • Area: Transparency in AI
  • Description: CHLOE™ is a transparent AI-based decision support tool that provides visibility into clinical and laboratory data to help improve IVF outcomes.
  • Impact: Enhances IVF success rates by offering detailed insights and data transparency to clinicians and prospective parents.

URL: Fairtility – CHLOE™30. ARWorks and The IVF Company – IVF Sim Pro

  • Area: Educational Tools with Virtual Reality (VR)
  • Description: VR software designed for technical training in ICSI and embryo biopsy, aimed at professionals, universities, and clinics.
  • Impact: Improves technical skills and training efficiency in IVF procedures through immersive virtual reality.
  • URL: IVF Sim Pro

31. Eggschain – Eggschain

  • Area: Blockchain Technology for IVF Patient Data
  • Description: Blockchain-integrated system for genomics, medical records, and biospecimen tracking, enabling patients to have greater control over their healthcare data.
  • Impact: Enhances data security and patient empowerment in managing healthcare information.
  • URL: Eggschain

32. Ovogene – Ovogene

  • Area: AI-Driven Donor Bank
  • Description: An international egg donor bank offering Genetically Certified Oocyte® technology, providing oocyte NGS screening and 100% euploid oocytes.
  • Impact: Increases success rates and reduces the need for multiple IVF attempts by ensuring high-quality oocytes.
  • URL: Ovogene

33. IVF-assistants.com – Skillsets

  • Area: AI-Driven Digital Assistants for Fertility Clinics
  • Description: Provides personalised access to information about ART and IVF services, helping patients understand their options and book consultations.
  • Impact: Enhances patient engagement and trust, improving consultation bookings and clinic-patient communication.
  • URL: IVF-assistants.com

34. inviTRA – Eeva Test

  • Area: Genomics for Optimal Embryo Selection
  • Description: Eeva test predicts which embryos have the greatest developmental potential using a time-lapse system attached to the incubator.
  • Impact: Improves embryo selection for transfer, enhancing the success rates of assisted reproduction treatments.
  • URL: inviTRA – Eeva Test

35. Lumiris – Metaphor™

  • Area: Embryo selection with metabolism data.
  • Description: Using metabolic imaging with AI-hyperspectral microscopy, the metabolic stress of embryos is assessed to determine its quality.
  • Impact: Improve selection of optimal embryos and therefore transfer success and fertilziation ratios.
  • URL:IBEC-Metaphor

36. Clue – Clue Birth Control, Clue Conceive

  • Area: Self-Managed Patient Care Using Smartphones (mHealth)
  • Description: App-based system for monitoring menstrual periods, ovulation, and PMS, offering numerous educational resources.
  • Impact: Empowers female patients to manage their reproductive health effectively using smartphone technology.
  • URL: Clue

37. ViOHealthTech – OvuSense OvuFirst, OvuSense OvuCore, and OvuSense Pro

  • Area: App-Based Patient Health Monitoring
  • Description: An app-based platform that helps screen for common health issues related to reproductive health, including ovulation tracking and fertility monitoring.
  • Impact: Provides comprehensive health monitoring, improving fertility tracking and assisting in managing reproductive health.
  • URL: ViOHealthTech

38. HERA Biotech – MetriDx

  • Area: Non-Surgical (Non-Invasive) Diagnostic Test for Endometriosis
  • Description: The world’s first non-surgical test for definitive diagnosis and staging of endometriosis.
  • Impact: Offers a less invasive and more accessible option for diagnosing and managing endometriosis.
  • URL: HERA Biotech

39. Labcorp – Preeclampsia Test

  • Area: Blood-based Screening Test
  • Description: The first screening test for assessing preeclampsia risk in the first trimester of pregnancy.
  • Impact: Enables early detection and management of preeclampsia, potentially improving maternal and fetal outcomes.
  • URL: Labcorp

40. EVOLUTIVE MEDICA – BreastDS, MiniPc Koios Medical, InferScholar, Airs Medical

  • Area: AI for Medical Image Analysis (Rx)
  • Description: AI-driven analysis and diagnostic technology for early and precise cancer detection.
  • Impact: Enhances accuracy and efficiency in cancer diagnostics, improving early detection and treatment outcomes.
  • URL: EVOLUTIVE MEDICA

41. Rhea – RheaLabs (including recently acquired Embryonics for AI-Driven Diagnostics)

  • Area: Technology Integration for Improved Patient Experience
  • Description: Integrated approach to patient engagement using AI and machine learning, enhancing clinic workflow and patient case management.
  • Impact: Provides a more seamless and meaningful patient experience, improving care quality and operational efficiency.
  • URL: Rhea – RheaLabs

42. AIVF – EMA Platform, ART Compass by AIVF

  • Area: AI Technology for Improved IVF Cycle Success and Management
  • Description: AI-powered IVF solutions for clinics, labs, and patients, including embryo evaluation, patient communication, and analytical tools.
  • Impact: Increases the certainty of successful IVF cycles by enhancing evaluation and communication processes.
  • URL: AIVF

43. Nilotech – Nilochecker

  • Area: State-of-the-Art Lab Equipment Calibration
  • Description: All-in-one reference instrument for controlling and calibrating critical laboratory equipment, such as incubators and warming systems.
  • Impact: Ensures accurate calibration and control, improving laboratory efficiency and reliability.
  • URL: Nilotech – Nilochecker

44. IBM and Ovum Health – IBM Watsonx Assistant

  • Area: Chatbot Assistant for Patient Communication and Management
  • Description: Custom AI applications for managing data sources and accelerating AI workflows, designed for enhanced patient communication and management in fertility clinics.
  • Impact: Streamlines patient interaction and clinic management, improving overall efficiency and patient satisfaction.
  • URL: IBM Watsonx

45. Spring Molecular Diagnostics – IVFinfo.AI

  • Area: ChatGPT-Like Site for IVF/ART Questions
  • Description: Multilingual website featuring an AI chatbot that answers questions about assisted reproduction (ART) and fertility.
  • Impact: Provides accessible and reliable information to patients, enhancing their understanding and decision-making in fertility treatments.
  • URL: AI

Pioneering frontiers in reproductive medicine

As the field of reproductive medicine continues to evolve, several pioneering areas of research are emerging. These cutting-edge advancements have the potential to revolutionise infertility treatments and offer new hope to individuals and couples facing reproductive challenges. Below, we highlight some of the most promising developments currently under investigation:

  • Mitochondrial Replacement Therapy: This experimental technique aims to prevent the transmission of mitochondrial diseases by replacing the mother’s mitochondria in the egg with healthy ones from a donor.
  • Artificial Womb Development: Artificial womb technology is under exploration for potential use in certain cases of infertility or high-risk pregnancies.
  • In Vitro Gametogenesis (IVG): Researchers are exploring ways to create sperm and egg cells from stem cells, which could offer new possibilities for infertile individuals and couples.
  • Nanotechnology in Reproductive Medicine: Nanotechnology holds promise in enhancing drug delivery systems, improving embryo culture conditions, and developing novel diagnostic tools for infertility.
  • 3D Bioprinting of Reproductive Tissues: Researchers are exploring the use of 3D bioprinting technology to create reproductive tissues, such as ovaries and uterine scaffolds, for transplantation or in vitro study, offering potential solutions for fertility preservation and restoration.
  • Non-Invasive Embryo Assessment Techniques: Non-invasive imaging modalities, such as optical coherence tomography (OCT) and time-lapse microscopy, are being explored for real-time monitoring and assessment of embryo development within the incubator, reducing the need for invasive embryo biopsy procedures.

These innovative approaches represent the forefront of reproductive research, promising to expand the possibilities of assisted reproduction and improve outcomes for patients worldwide.

The future is now: partnering with FinDBest IVF to realise your vision

The advancements outlined in this article paint a hopeful picture for the future of IVF/ART. While some technologies are still under development, many are already being implemented or can be brought to market faster through the right partnerships. This is where FinDBest IVF steps in.

FinDBest IVF: your partner for global expansion and innovation in IVF/ART

FinDBest IVF goes beyond connecting you with distributors; we’re your gateway to a world of possibilities. Our platform curates a network of service providers specializing in:

  • Market expansion services: Leverage market research firms to identify regions with the highest demand for your innovations.
  • Clinical trial management: Partner with experienced firms to navigate regulatory hurdles and conduct successful trials with leading fertility clinics.
  • Marketing and communication experts: Craft targeted campaigns that resonate with fertility clinics and healthcare professionals, ensuring your technology reaches the right audience.
The benefits of a comprehensive approach

Partnering with FinDBest IVF offers numerous advantages:

  • Faster time to market: Identify the right partners and navigate market complexities with greater efficiency.
  • Enhanced innovation: Collaborate with leading research institutions to bring groundbreaking technologies to market faster.
  • Streamlined communication: Connect with fertility clinics seeking solutions and build lasting relationships with key stakeholders.
FinDBest IVF: your partner in progress

The future of IVF/ART is bright. FinDBest IVF empowers you to foster innovation, build strong partnerships, and ensure your life-changing technologies reach the patients who need them most.

Join us and unlock the full potential of your IVF/ART solutions on a global scale. Let’s revolutionise the path to parenthood, together.

Fertility

Housing, work and fertility stop Britons having the families they want – research

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Housing, work and fertility pressures are stopping many Britons growing the families they want, new research suggests.

A UK fertility report found that 79 per cent of people surveyed who had tried to conceive in the past five years would like more children than they currently have.

Among parents with one child, that figure rises to 88 per cent.

The report surveyed more than 1,000 people across the UK who had tried for a baby in the past five years.

While birth rates continue to fall, the findings suggest it is not because people no longer want children. Instead, many respondents said external pressures are making it harder to grow their families.

The findings, from wellness brand Wild Nutrition’s Fertility Disconnect report, highlight how financial pressures, fertility struggles and gaps in reproductive health knowledge are shaping modern family life in the UK.

Gail Madalena, fertility nutritional therapist at Wild Nutrition, said: “People often assume fertility begins the moment they decide to try [for a baby].

“In reality, egg and sperm health are shaped months and years earlier.

“By the time someone starts thinking about fertility, their body has already been responding to its environment for a long time.”

Among the biggest barriers, 26 per cent said career progression affected their family plans, 25 per cent cited housing affordability and lack of space, and 52 per cent said they required medical intervention during their fertility journey.

The report also found that almost a quarter of respondents had spent more than two years trying to conceive.

Trying for a baby can take a significant toll on mental health and relationships, especially for those navigating fertility treatment.

According to the research, 38 per cent of respondents said trying to conceive had negatively affected their mental health. That figure rose to 99 per cent among people undergoing fertility treatment.

Julianne Boutaleb is a perinatal psychologist.

She said: “Navigating a fertility journey is about so much more than medical appointments and procedures.

“It’s an emotional marathon that can take a huge toll on your mental wellbeing.

“Sadly, the stats show that 15 per cent of couples going through fertility treatment say their relationship has been irrevocably impaired.”

The report also highlighted the realities of secondary infertility, which affects around one in 20 people, challenging the assumption that having one child means conceiving again will be straightforward.

Researchers found many people felt under-informed about fertility, particularly younger adults.

Ten per cent of Gen Z respondents said they “know nothing” about fertility, while only one in five respondents said they know “a lot” about egg health.

The report also found that 60 per cent of women were unaware of fertility testing options, and one in five Gen Z respondents said they felt uncomfortable discussing fertility, even with their partner.

Around 40 per cent of those surveyed supported fertility education being included in schools, covering topics such as egg health, sperm health and hormonal health.

The report also explored how lifestyle and long-term health may influence fertility outcomes.

Many respondents said they only made changes once they started trying to conceive.

Some 44 per cent improved their diet when trying for a baby, while 32 per cent reduced alcohol intake at that stage.

The report also referenced emerging research that suggests ultra-processed foods and microplastics could have an impact on reproductive health.

While fertility conversations often focus on women, the findings showed male fertility issues are also affecting many families.

Seventeen per cent of respondents cited sperm health issues as a barrier to conception, while male factors contribute to around half of all fertility challenges.

Only one in four men said they would share fertility struggles with friends.

“Many causes of male infertility are entirely treatable yet so often the last resort is the first response,” said Ian Stones, co-founder at Test Him Ltd.

The findings come as UK birth rates remain below replacement level.

The report noted that the UK fertility rate is now 1.41, meaning that on average women give birth to 1.41 children over their lifetimes. The replacement rate, or rate that maintains population numbers, is 2.1.

It also said the average age of mothers has risen to 31, while birth rates are falling across most age groups except among over-40s.

“There is no single fertility story, and it is rarely a simple, linear narrative,” said Dr Zeynep Gurtin, lecturer in women’s health at UCL.

Dr Gurtin added that better fertility education, fairer access to treatment and more open conversations around infertility and pregnancy loss are needed.

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Fertility

Femtech World reveals fertility innovation award shortlist

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Femtech World is thrilled to reveal the shortlist for the Fertility Innovation Award.

The award, sponsored by FinDBest IVF, celebrates a pioneering product, service or initiative that is transforming fertility care and support.

FinDBest IVF is a global B2B digital platform created to simplify and accelerate how IVF and ART manufacturers connect with trusted, pre-vetted distributors around the world.

This year’s nominees represent a remarkable breadth of approaches to fertility care: from clinic-floor breakthroughs to at-home hormone intelligence to truly borderless access.

Three companies made the cut, with each tackling a real, persistent barrier in reproductive health.

Congratulations to the shortlist and many thanks to everyone who entered.

Fertility Innovation Award Shortlist

 

HRC Fertility’s Needle-Free IVF is a pioneering advancement designed to transform one of the most challenging aspects of fertility treatment: daily hormone injections.

Developed by board-certified reproductive endocrinologist Dr Rachel Mandelbaum, this innovative approach reimagines how stimulation medications are delivered during IVF and egg freezing, dramatically improving the patient experience while maintaining the same trusted clinical outcomes.

Inspired by feedback from patients who struggled with the injection process, Dr Mandelbaum adapted an innovative drug-delivery system commonly used in other areas of medicine and applied it to reproductive care

Mira is a hormonal health technology company that provides lab-grade hormone testing and AI-driven insights to help women and couples understand their fertility. 

The platform has already supported more than 200,000 couples on their fertility journeys worldwide, helping over 60,000+ users achieve pregnancy.

For some users, pregnancy rates have reached up to 89 per cent within six months, demonstrating how accurate hormone data can significantly improve fertility outcomes.

 

Founded in 2021 by Marija Skujina, a Certified Fertility Nurse Specialist accredited by the European Society of Human Reproduction and Embryology, with nearly 15 years of clinical experience at one of the world’s top IVF clinics, and having navigated her own fertility journey as a patient, Marija built the clinic she had always wished existed.

Plan Your Baby began with a bold, but simple mission – make best quality fertility and pregnancy available anywhere.

Plan Your Baby has created a new generation fertility and pregnancy clinic with patients accessing expert consultations remotely, while blood tests and ultrasound scans are available at over 450 locations across the UK, eliminating the exhausting travel burden that often forces people to take days off work, relocate appointments, or abandon treatment altogether

What happens now

The shortlist will be judged by a representative from category sponsor FindBestIVF, with the winner announced at a virtual event on June 19.

Winners will receive a trophy and be interviewed by a Femtech World journalist.

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Fertility

First patients dosed in miscarriage trial

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The first patients have been dosed in a UK miscarriage trial testing a new intravaginal drug delivery platform for threatened miscarriage.

The FREEDOM study is evaluating 400mg progesterone Callavid in patients diagnosed with luteal phase insufficiency, a condition in which progesterone levels may be too low to support early pregnancy, increasing the risk of infertility and recurrent miscarriage.

Callavid uses a patented leak-free, tampon-like design intended to address the limitations of current vaginal treatments, which rely on self-administered pessaries, or vaginal suppositories, that can leak and may move during use.

The device is being developed by London-based Calla Lily Clinical Care, a medical technology company focused on women’s health. The trial is funded by the National Institute for Health and Care Research and run in collaboration with the Trial Management Unit at University Hospitals Coventry and Warwickshire NHS Trust.

According to the company, Callavid is positioned to become the world’s first drug-device combination product to support treatment of threatened miscarriage, as well as luteal phase support as part of assisted reproductive technologies, including in vitro fertilisation, or IVF.

The Government’s Renewed Women’s Health Strategy for England cites estimates ranging from 120,000 to 250,000 cases of miscarriage a year in the UK. Administering 400mg micronised progesterone twice daily is recommended by the National Institute for Health and Care Excellence for women who have suffered a previous miscarriage and experience bleeding during early pregnancy, known clinically as threatened miscarriage.

Current pessary delivery methods can result in uncertain placement and movement during use. These limitations can reduce the efficiency and consistency of drug absorption, potentially compromising delivery of the intended dose, and patients are regularly advised to lie horizontal for extended periods after each administration.

The FREEDOM trial is led by professor Siobhan Quenby MBE, an authority on miscarriage and preterm birth, and an honorary consultant at University Hospitals Coventry and Warwickshire NHS Trust. The study aims to evaluate safety, user acceptability and progesterone absorption, with the goal of providing evidence of improved usability in self-administration.

Quenby commented: “Through my clinical practice, I see the difficulties patients face with existing vaginal progesterone products at an already very stressful time. Callavid offers a promising new solution to ensure delivery of the correct progesterone dosage and give women greater confidence in their treatment. There is genuine excitement among both clinicians and patients at the prospect of Callavid progressing into clinical trials.”

Dr Lara Zibners, co-founder and chair of Calla Lily Clinical Care, added: “As a physician and entrepreneur, I believe we have a responsibility to create more effective, patient-centred solutions in women’s health. Having been through seven rounds of IVF myself, I have experienced how difficult progesterone treatment can be, and I am proud to be advancing an innovation shaped by both medical insight and lived experience.”

Thang Vo-Ta, co-founder and chief executive of Calla Lily Clinical Care, said: “Dosing the first patients in the FREEDOM study marks a critical milestone for Calla Lily Clinical Care. Callavid represents a differentiated delivery modality for a broad range of therapeutics in the pharma pipeline, and will create new opportunities to extend the lifecycle of existing drugs. This trial is a key step in demonstrating Callavid’s massive potential.”

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