A revolution in women’s health through advanced sensor technology

Verso Biosense, an innovative women's health business, is on a mission to revolutionise women’s health with its unique, battery-less intra-uterine device (IUD) embedded with sensor technology that has the potential to change the landscape of women's health globally.

The Verso smart IUD technology holds significant promise for extensive applicability, with a distinct focus on addressing existing unmet needs in early diagnosis and intervention. Fertility monitoring, endometriosis diagnostics, smart contraception, menopause tracking, and PCOS diagnosis are applications that exemplify the versatility and potential impact of this first-in-class smart monitoring product.

A unique power source

The foundation of Verso's technology was laid back in 2014 by two visionary professors at the University of Southampton in England. With expertise in wireless technology and sensors, they developed a wearable device with wireless capabilities and battery-less powering, making it safe for the user.

Power is sourced from specially designed wearables (undergarments), allowing for continuous 8-hour monitoring of basal body temperature. Future iterations are expected to draw power from various sources, expanding the device's potential.

Targeted application

The first iteration of this revolutionary device is based on an electrochemical sensor capable of measuring intrauterine temperature and dissolved oxygen, sending data to an external garment wirelessly. The initial applications will be in fertility monitoring and endometriosis diagnosis.

Verso envisions the next logical evolution of their device as a smart contraceptive IUD, which would also provide women with personalised relevant health data. Beyond contraception, the technology's potential applications include menopause tracking, intrauterine glucose sensing for diabetes management, and in the diagnosis of polycystic ovary syndrome (PCOS).

This versatile platform technology holds promise for addressing multiple unmet needs in women's health.

Fertility monitoring

Verso's preliminary clinical studies have illuminated significant variations in intrauterine  conditions that may be implicated in the outcome of IVF treatment. Verso's IUD device provides a personalised screening tool that gives crucial insights into uterine parameters before and during embryo implantation and incubation. With accurate and continuous monitoring, Verso's device aids in optimising in-vitro fertilisation (IVF) procedures, potentially leading to higher success rates and reduced emotional and financial burdens for individuals and couples seeking fertility solutions.

Endometriosis diagnosis

Endometriosis, a prevalent and debilitating medical condition, involves the abnormal growth of endometrial tissue beyond the uterus, causing severe pain and infertility. It affects millions of women globally and poses significant challenges in diagnosis and management. Verso's device presents an adjunct diagnostic tool by offering early monitoring and temperature anomaly detection associated with endometriosis. By accelerating the diagnosis process, Verso aims to minimise the suffering and uncertainty often experienced by women affected by endometriosis.

Wearable smart IUD

Verso envisions the future of contraceptive IUDs as revolutionary smart, wearable technology. With an estimated 159 million women utilising contraceptive IUDs globally, a stagnant design since its inception in 1967, the time is ripe for innovation. Verso sees future, smart contraceptive IUDs as wearable devices, empowering women with personalised insights into their bodies' dynamics and overall well-being. Similar to contemporary wearables, this device will not only serve its primary contraceptive function but also could also offer valuable data on, for example, peri and menopausal symptoms. Verso's commitment lies in advancing the capabilities of this vital contraceptive tool to enhance women's health and provide actionable information for informed decision-making.

Menopause tracking

The onset of menopause can be unpredictable, emerging suddenly and catching individuals off guard. Symptoms encompass a spectrum from hot flushes and sleep disruptions to heightened anxiety and depression. Verso's innovative smart IUD holds promise as a valuable tool in monitoring and indicating peri- and menopausal symptoms. This proactive approach enables timely interventions, whether through targeted hormone replacement therapies, pharmaceuticals, or dietary supplements, improving overall health and well-being during this transitional and often traumatic phase of a woman's life.

Intrauterine glucose sensor for diabetes

Diabetes is an escalating global health problem impacting 223 million women worldwide and needs innovate healthcare solutions to mitigate its impact on patients and health budgets. Verso's pioneering approach to this problem involves incorporating an intrauterine glucose sensor into smart IUDs. Verso’s technology enables accurate internal monitoring of blood glucose levels, facilitating precise disease management for women. Notably, existing blood glucose monitoring devices are mandated by the FDA to be within 15-20% of the actual level.  This lack of precision can be significantly improved upon with Verso's device giving patients and their clinicians better actionable data and ultimately better disease management.

PCOS diagnosis

Polycystic Ovary Syndrome (PCOS) affects a significant proportion of women within childbearing age, ranging from 4-20%, and currently lacks a definitive cure. The syndrome stems from a hormonal imbalance prominently characterised by an excess of male hormones, and has an important and damaging impact on fertility in women. Verso's innovative smart Intrauterine Device (IUD) holds promise as a potential diagnostic tool for PCOS. This technology will empower both patients and healthcare providers by identifying hormonal imbalances and enabling timely interventions to ameliorate the impact of PCOS.

Advancing toward approvals

The Verso device underwent its first clinical study in Southampton in 2021, involving 12 women, demonstrating the technology's commercial viability. Building on a successful proof of concept study in 2015, this study specifically focused on validating the device's capacity to gather temperature and dissolved oxygen data.

Following a rigorous evaluation, the MHRA granted approval for its safety in 2022, further solidified by ethical committee clearance in the same year. In 2023, the business successfully completed an ISO accreditation audit and awaits certification. The upcoming year marks the initiation of multiple planned clinical studies, commencing in Liverpool, targeting baseline intrauterine temperature data in 30 women. Additionally, a study at the London Women’s Clinic will investigate the impact of raised dissolved oxygen levels (by taking Viagra) on 30 women who have experienced failed fertility treatments. Verso’s proprietary technology will be employed to monitor the uterine environment and evaluate its correlation with successful IVF outcomes over a 3-4 day period. Future research will encompass exploring the uterine microbiome by monitoring pH and temperature and correlating these variables with IVF success. This study will. be conducted at a large fertility clinic in Barcelona.

Regulatory approval

The initial priority is to obtain a CE mark approval which will enable commercialisation in the EU, EFTA, and Turkey, and now also in the UK due to recent changes. This regulatory standard is also recognised in other geographies around the world. The CE application was meticulously prepared during the summer and has since been officially submitted, triggering a six-month review period. In the US, the regulatory approval process is via a 510K De Novo device process given the absence of a legally marketed predicate device. This process is expected to take a year to 18 months once the submission is completed, which should happen before the end of 2023.

A new era in women's health

Verso Biosense's groundbreaking smart intrauterine technology has the potential to significantly enhance the delivery of women's healthcare across a number of areas where existing best practise has failed to deliver better outcomes or where there is significant unmet need. Verso's innovative wireless technology is unique, and after years of painstaking development is now poised for commercialisation in multiple settings in multiple  geographies once appropriate regulatory approvals have been secured.