Fertility
TMRW Life Sciences launches “unique” fertility specimen facility to reduce human error in IVF
The company has developed the only automated specimen management platform for frozen eggs and embryos used for IVF

TMRW Life Sciences has launched a “unique” fertility specimen cryostorage facility to provide more transparency into the safety of frozen eggs and embryos used in IVF.
The facility located in New York aims to deliver a new standard of care directly to patients and to fertility clinic partners by offering more transparency into the safety of frozen eggs and embryos.
The specimens are supported by round-the-clock monitoring and are stored with real-time data capture and reporting, in an effort to ease the pressure on patients and clinics.
TMRW’s system aims to reduce the number of opportunities for human error by automating processes and workflows in an integrated digital platform. It provides patients and clinics visibility into their entire cryospecimen inventory and helps embryologists focus on supporting aspiring parents.
The company says its technology has the ability to “uniquely” identify, track and trace cryopreserved fertility specimens, whether located in a clinic during active treatment, or offsite in one of their cryobanks after treatment has been completed.
“We are committed to providing a safe, transparent and digitally-enabled solution for both patients and clinics in the care and management of these incredibly precious specimens,” said said Tara Comonte, TMRW’s CEO.
“We believe the same level of visibility should exist in the care of frozen eggs and embryos as it does in almost all other aspects of our lives today.
“The extension of our technology from an in-clinic solution to a direct-to-patient offsite state-of-the-art facility has always been a natural evolution.
“Clinics, and now patients, have a choice, and we’re laser focused on making sure they all sleep better at night with their specimens under our watch,” Comonte added.
The CCRM Fertility network, Conceptions Reproductive Associates, and Illume Fertility are some of the first to collaborate with TMRW for its cryobank and digitally-connected specimen management platform.
Glenn Proctor, chief operating officer at Conceptions, said: “Partnering with TMRW means we’re using the highest standards of technology with a full digital chain of custody to track and trace specimens 24 hours a day, 365 days a year.
“TMRW’s platform represents a new standard in our field. This technology provides the most sophisticated, advanced level of control and visibility that exists today.”
The growing demand for fertility treatment has resulted in an increase in the number of frozen specimens under clinic management, each of which need to be accurately identified, managed and monitored.
TMRW says that while IVF clinics were not designed to be long-term cryobanks, this is what they have inadvertently become.
The growing uncertainty around the future of reproductive healthcare in the US since the Supreme Court’s recent decision to overturn Roe v Wade has left many fertility clinics and patients concerned, with the ability to deliver and receive care being put under threat in many parts of the country.
Joe B, one of the first patients moving their embryos to the TMRW cryobank, said: “The decision to transfer our frozen embryos was not one we took lightly.
“The process is seamless, organised and transparent. Their technology is bringing this industry into the modern world and I feel better knowing my future children are under their care.”
TMRW will be expanding its network of “technology-enabled” cryostorage facilities in both California and the UK over the coming months, with plans to expand its platform further across the US and Europe in 2023.
Insight
UK LGBTQ+ population faces barriers to fertility treatment, research finds

LGBTQ+ people across the UK face discrimination, funding inequalities and gaps in fertility care, research has found.
Eligibility for NHS-funded treatment varies across the country, while many services are still structured around heterosexual couples.
People with diverse sexual orientations and gender identities can be left navigating complex systems, paying more for treatment and explaining their needs to healthcare professionals.
Co-author Dr Chloe He, of the UCL Institute of Epidemiology and Health Care, said: “Legal access is not the same as equitable access. LGBTQ+ patients are forced to navigate a Kafkaesque fertility care system alone – researching, self-advocating, and often educating the doctors and nurses treating them.
“In our study, we saw clinicians with no formal LGBTQ+ training, gay men pressured into being relentlessly cheerful to prove parent-worthiness to surrogacy services, and patients travelling hundreds of miles for care after experiencing transphobia at local clinics.”
The University of Stirling-led research involved 54 participants and 36 in-depth interviews with people who had used fertility services and professionals working in or alongside fertility care across the UK.
Researchers from Stirling, SKEMA Business School and University College London examined the extra work undertaken by LGBTIQA+ people seeking to have children.
They called this “reproductive labour”, which includes researching treatment, advocating for themselves, covering additional costs and educating clinicians.
The researchers said this work was used to manage “reproductive bioprecarity”, a term describing the uncertainty and vulnerability people can face while seeking reproductive healthcare.
The study, funded by a Santander Universities Research Grant, primarily reflected the experiences of cisgender lesbian participants.
One participant, Amanda, said she and her partner, Amy, spent a long time trying to find a GP willing to discuss fertility with them.
The couple eventually underwent fertility tests through the NHS, but their private clinic rejected the results because they had not been referred by a GP.
They had to repeat the tests and pay for them privately.
The researchers said lesbian couples are often required to self-fund multiple rounds of intrauterine insemination before becoming eligible for NHS support.
Intrauterine insemination, or IUI, involves placing sperm directly into the womb.
Gay men usually have to pursue surrogacy, which is not funded or supported by the NHS, while transgender people can face long waits to save eggs and sperm to allow them to have children.
Lead author Dr Carolyn Wilson-Nash, senior lecturer at the University of Stirling Business School, began investigating the issue after she and her wife made multiple attempts to conceive and faced challenges throughout the process.
The couple funded almost the entire process themselves and consulted a GP who had no experience of supporting same-sex couples seeking fertility care.
The researchers called for clearer treatment pathways, more inclusive services and better training for healthcare staff.
Dr Wilson-Nash, who is now the mother of a three-year-old boy, said: “The way the current system for fertility services is set up in the UK can lead to unequal pathways for the LGBTIQA+ population.
“For example, heterosexual couples can access NHS-funded in vitro fertilisation (IVF), whereas lesbian couples are often required to self-fund multiple rounds of intrauterine insemination (IUI) before becoming eligible for NHS support.
“Gay men usually have to pursue surrogacy, which is not funded by or supported by the NHS.
“And transgender individuals often face long waiting times to save eggs and sperm to allow them to have children. So legal access does not necessarily translate into equitable or inclusive care.
“Building a family should be neither exclusive nor this difficult. Fertility services should be available to all, regardless of their sexual orientation or gender identity.”
Laura-Rose Thorogood, founder of LGBT Mummies and part of the UK’s Fertility Justice Campaign, said: “Right now, intended LGBTQIA+ parents are being discriminated against because of who they are, and who they love.
“This is ultimately forcing them down alternative pathways which in turn put them at long-term risk physically, psychologically and socially.
“By providing access to treatment, our community can thrive and create the families they dream of by their chosen route.”
Entrepreneur
Impli wins £1.4m for hormone patch

Impli has secured a £1.4m grant to begin clinical use of a real-time hormone patch for infertility treatment.
The startup, which is working with innovations from Imperial College London, is developing a continuous hormone monitoring system for use in in vitro fertilisation, known as IVF.
IVF is a fertility treatment in which eggs are fertilised outside the body before an embryo is transferred to the womb.
Timing is critical in IVF, the most common form of infertility treatment, but most patients are still monitored through blood tests taken every other day at best.
Hormone levels can change within hours, meaning important shifts may be missed.
These can include hormone surges linked to egg release, dips that may contribute to implantation failure and early signs of ovarian hyperstimulation syndrome.
Ovarian hyperstimulation syndrome is a potentially serious reaction to fertility medicines, where the ovaries over-respond and become swollen.
In a treatment with low success rates, these uncertainties can affect patient outcomes and wellbeing.
Impli’s system is based on research by Dr Salzitsa Anastasova in the department of mechanical engineering at Imperial.
The technology uses electrochemical biosensors to sample hormones in the fluid between cells.
These can be used in a subcutaneous implant, meaning one placed under the skin, or in Impli’s Bio-Endocrine Analysis Monitor, known as BEAM, which uses microneedles that pierce the skin.
Microneedles are tiny needles designed to enter the upper layers of the skin with minimal discomfort.
The biosensors continuously measure oestradiol, luteinising hormone and progesterone, which are hormones involved in the menstrual cycle and fertility treatment.
Data is transmitted wirelessly to a smartphone, where AI software converts raw signals into real-time hormone trends.
Sotirios Saravelos, consultant gynaecologist and reproductive medicine subspecialist at the Wolfson Fertility Centre, part of Imperial College Healthcare NHS Trust, said:
“Continuous hormone monitoring has the potential to change the landscape of fertility treatment, both in terms of clinical care and patient experience. Rather than snapshots taken at fixed points in time, with Impli we will have access to a live feed of each patient’s hormonal response, allowing us to personalise care in a way that has not been possible before.”
Saravelos is part of the research consortium that has won a £1.4m grant to take Impli’s BEAM device from prototype to its first human clinical validation for IVF.
The project was designed with support from Dr Simon Hanassab as part of a PhD on how AI can support decision making for IVF.
The work was carried out at the UKRI Centre for Doctoral Training in AI for Healthcare at Imperial, a collaboration between the department of computing and the department of metabolism, digestion and reproduction.
Hanassab is now working part-time as Impli’s head of AI.
The grant comes from the National Institute for Health and Care Research Invention for Innovation programme.
It will support a 30-month project bringing together Impli, Imperial College Healthcare NHS Trust, the London Institute for Healthcare Engineering at King’s College London and the patient advocacy network Fertility Europe.
Specialist medical device manufacturer TTP is also involved.
BEAM is the first step in Impli’s plan to develop a broader platform of fully implantable, long-duration monitoring systems.
Anna Luisa Schaffgotsch, founder and chief executive of Impli, said:
“We are not just building a device, we are building the evidence base to show that continuous hormone monitoring is possible, clinically meaningful and ready for the real world. With an exceptional consortium behind us, we now have the funding, the expertise and the clinical pathway to do that properly.”
According to the company, the same core technology could later have applications in hormonally driven cancers, polycystic ovary syndrome, endometriosis and menopause.
Polycystic ovary syndrome is a common hormonal condition that can affect periods, fertility and metabolism.
Endometriosis is a condition where tissue similar to the lining of the womb grows outside the uterus, often causing pain.
BEAM’s development builds on more than 15 years of biosensor research at Imperial, with intellectual property covering the sensing approach, device architecture and data interfaces.
Impli has so far delivered three functional prototypes, completed pre-clinical laboratory trials and begun animal trials, which the company said have shown positive results.
It also has a strategic partnership with Bayer on real-time hormone biosensing and relationships with IVF clinics internationally.
Fertility
Vipoglanstat trial reaches recruitment halfway point

Vipoglanstat has reached the halfway point for patient recruitment in a phase 2 endometriosis trial.
Gesynta Pharma said 50 per cent of the target of 190 patients have been randomised in the NOVA trial.
The study is evaluating vipoglanstat, described by the company as a novel, non-hormonal, non-opioid drug candidate for the treatment of endometriosis.
Endometriosis is a chronic inflammatory condition where tissue similar to the lining of the womb grows outside the uterus, often causing severe pain and, in some cases, infertility.
The condition affects more than 10 per cent of women of reproductive age.
Top-line results from the study are expected in 2027.
The NOVA trial is a randomised, double-blind, placebo-controlled phase 2 proof-of-concept study evaluating vipoglanstat in women with endometriosis across Europe.
This means patients are assigned to treatment groups by chance, neither participants nor researchers know who receives the drug or placebo during the study, and the results are intended to show whether the treatment has enough evidence to move into later testing.
The trial is assessing the efficacy and safety of two dose levels of vipoglanstat and will provide information for the design of a subsequent phase 3 programme.
Eva Johnsson, chief medical officer and vice president of clinical development at Gesynta Pharma, said:
“Reaching the halfway point in patient recruitment marks a major milestone for our Phase 2 clinical trial in endometriosis. Achieved well ahead of schedule, the rapid progress reflects strong participation from clinical sites and great interest among eligible participants. This momentum highlights the urgent need for better treatments.
“We are now eager to complete enrolment and proceed to the next phase of evaluation.”
Patric Stenberg, chief executive of Gesynta Pharma, said:
“The NOVA trial is a significant advancement in a field with few ongoing clinical trials, and a key step toward establishing a strong foundation for a future Phase 3 programme for vipoglanstat.
“Given the immense medical need, our focus remains on delivering a treatment that is highly effective, safe, and well-tolerated.”
Vipoglanstat is an orally active drug candidate designed to reduce pain and inflammation by targeting mPGES-1, an enzyme that produces prostaglandin E2, a substance linked to inflammation in endometriotic lesions.
A preclinical proof-of-concept study in an advanced endometriosis model found that vipoglanstat significantly reduced pain-related behaviours and endometriotic lesion burden.
Gesynta said previous clinical studies have supported the drug candidate’s safety, tolerability and pharmacodynamic effects in humans. Pharmacodynamic effects refer to how a drug acts in the body.
NOVA stands for the Non-hormonal Option, a Vipoglanstat Assessment trial.
Endometriosis commonly presents with severe period pain, known as dysmenorrhoea, pain between periods, pain during sexual intercourse, gastrointestinal symptoms and infertility.
Current management is typically limited to painkillers, hormonal therapies and surgery.
Despite its prevalence, Gesynta said endometriosis remains a critically underserved area of women’s health.
The company said the disease is significantly underdiagnosed and undertreated, with few new treatment options available to patients.
Approximately 190 patients aged 18 to 45 will receive vipoglanstat or placebo over four menstrual cycles.
The primary objective is to evaluate the effect of vipoglanstat on endometriosis-related pain during non-menstrual days.
Secondary objectives include assessing the effect on menstrual pain, known as dysmenorrhoea, pain during sexual intercourse, known as dyspareunia, use of opioid rescue medication and quality-of-life measures.
Changes in endometriotic lesions, areas of tissue linked to the condition, will also be explored using MRI scans.
Gesynta Pharma said its research on targeting mPGES-1 began at Karolinska Institutet in Sweden.
The company said a second drug candidate, GS-073, is ready to enter clinical phase 1 for the treatment of chronic inflammatory pain.
Gesynta Pharma’s shareholders include Hadean Ventures, Industrifonden, Innovestor Life Science, Linc, HealthCap, XGen Venture and other specialist investors.
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