Fertility
First-in-human study of fallopian endoscopic system has positive results
FemDx Medsystems has announced the successful completion of its first-in-human clinical study of its miniaturised endoscopic system designed to visualise the fallopian tube lumen via the uterine route.
In this initial study, patient cases were performed with direct visual access to the tubal ostium and lumen. Physicians reported satisfaction with overall performance.
The procedure was performed in February 2025 and yielded highly encouraging results, according to the company, marking a significant milestone toward improving early detection and access to fallopian tubes under direct visualisation.
The device, called FalloView, is the first falloposcope incorporating a CMOS chip endoscope, designed to provide direct visualisation and access to the fallopian tubes. The device has received FDA 510(k) clearance.
Dr. Jose Garza, who led the study in Monterrey, Mexico, said: “This technology has the potential to revolutionise how we assess and access fallopian tubes for fertility evaluations and early detection of gynaecologic pathology.”
“The successful first-in-human study of the device marks a significant advancement in women’s health.” Ashlee Francis, CEO and Co-founder of FemDx Medsystems, commented on the milestone.
“Our team is dedicated to developing innovative solutions and this achievement brings us closer to providing clinicians with effective tools.”
FemDx Medsystems plans to continue clinical validation and expand its study cohort in preparation for regulatory submissions to support commercial launch.
Insight
IVFmicro raises £3.5m to boost IVF success
IVFmicro has raised £3.5m to advance its microfluidic device designed to improve IVF success rates in routine clinic use.
The Leeds-based spinout from the University of Leeds, founded in 2024, aims to increase the quality and number of embryos in an IVF cycle.
IVF, or in vitro fertilisation, combines eggs and sperm in a lab before transferring embryos to the womb. A microfluidic device is a chip with tiny channels that move very small volumes of fluid.
The company says its device could raise the number of viable embryos available for transfer and the likelihood that an embryo will implant.
Currently, IVF leads to a successful pregnancy in about 30 per cent of cases for women under 35. A single cycle typically costs around £5,000 in the UK.
“My career has focused on understanding the reproductive biology of eggs and embryos, how they develop and, crucially, why things sometimes go wrong,” said IVFmicro co-founder and scientific director Helen Picton.
“At IVFmicro, we are harnessing years of research into reproductive biology to create a practical, accessible solution that can improve outcomes for patients undergoing fertility treatment. Our goal is to make IVF more effective, more predictable, and ultimately more hopeful for those striving to start a family.”
The investment was led by Northern Gritstone, with support from Innovate UK’s Investment Partnership Programme.
“IVFMicro is a brilliant example of the world-class innovation emerging from the Northern Arc’s universities, combining scientific excellence with a clear commercial vision to tackle the societal challenge of infertility,” said Northern Gritstone chief executive Duncan Johnson.
“Millions worldwide require fertility treatment, but new solutions are needed to overcome the high costs involved and low success rates. We are especially proud that IVFMicro’s journey has been supported through our NG Studios programme and our Innovation Services, which exist to help founders like Virginia and Helen turn pioneering research into real-world impact.”
Features
University of Leeds IVF spinout raises £3.5m
University of Leeds IVF spinout IVFmicro has raised £3.5m in pre-seed funding.
The investment is led by Northern Gritstone, with support from Innovate UK Investor Partnerships Programme, and will be used by IVFmicro for its next verification and validation phase, leading to trials on human embryos in fertility clinics.
Helen Picton is scientific director and co-founder of IVFmicro.
She said: “My career has focused on understanding the reproductive biology of eggs and embryos, how they develop and, crucially, why things sometimes go wrong.
“At IVFmicro, we are harnessing years of research into reproductive biology to create a practical, accessible solution that can improve outcomes for patients undergoing fertility treatment.
“Our goal is to make IVF more effective, more predictable, and ultimately more hopeful for those striving to start a family.”
Globally, 1 in 6 couples will face fertility issues, yet IVF success rates are suboptimal, with only 25-30 per cent succeeding in women under 35 years of age.
This is due in part to limitations of the embryo culture process, which typically involves repetitive handling, subjective selection of the best embryo, and the expense of highly skilled operators.
IVF is an expensive process, costing on average £5,000 for a patient in the UK for one cycle, accompanied by long NHS waiting lists that have selective criteria.
IVFmicro provides the first microfluidic device (a device for safely managing embryo culture and handling with very small amounts of nutrient-rich fluid) that can be used in any IVF treatment cycle.
This precision-engineered solution improves both the number of viable embryos available for transfer and the likelihood that an embryo will implant and result in a pregnancy.
IVFmicro provides a 10-15 per cent improvement in embryo quality and quantity, a significant leap that increases the potential to fall pregnant.
IVFmicro was founded in 2018 by Virginia Pensabene, Ph.D, and Helen Picton, Bsc, Ph.D., both professors at the University of Leeds.
Pensabene has published scientific advancements in microfluidics and brings her technical and scientific expertise to the product design.
Picton is a non-clinical expert in female reproductive biology and embryology, and has generated over £8m in research grant income.
IVFmicro recently took part in the NG Studios life sciences programme, which supports pre-seed life science businesses, and is delivered by accelerator KQ Labs, the Francis Crick Institute, and Northern Gritstone.
Virginia Pensabene, CEO and co-founder, IVFmicro, said: “As a biomedical engineer, I began exploring the potential of this technology in 2017, when Helen and I first met at the University of Leeds.
“From the start, our goal was to translate our research into a real solution for patients.
“Thanks to the combination of grant funding and Northern Gritstone’s support — both through investment and its innovation programmes — we have been able to grow our team in Leeds and take a major step toward bringing this precision-engineered IVF solution to market.”
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