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THIS PART OF THE DEVICE ALLOWS MEASUREMENTS TO BE TRANSMITTED IN REAL TIME TO
THE RECEIVER, LOCATED IN THE SHORTS.

THIS PART OF THE DEVICE CONTAINS THE SENSORS THAT MONITOR TEMPERATURE AND OXYGEN
LEVELS IN THE UTERUS.

THIS ELEMENT CONTROLS THE SENSOR ALLOWING COLLECTION, STORAGE AND TRANSMISSION
OF DATA.




The IRIS IUMD is similar in size to an intrauterine contraceptive device (IUD)
at 33.91mm in length and 32mm wide. The receiver will sit in the shorts
provided, that can be worn over your normal underwear.

Use the arrows to look at both parts of the device






About Verso Biosense
For HCPs
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FIND OUT WHAT'S REALLY GOING ON IN YOUR UTERUS WITH IRIS

We are embarking on a journey of discovery to understand more about the uterus,
and what uterine health means. We invite women interested in contributing to
research to take part. Our upcoming clinical trials of the IRIS system will see
us gather real time data on temperature and oxygen levels from within the
uterus. We have clinical trials set up for women with normal menstrual cycles,
and women undergoing IVF.

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Clinical trials



The clinical trials are taking place in four UK locations under the supervision
of gynecology consultants and their teams. The trial will provide data to
support future women's health treatment.



About You



Women between 18 and 42 are invited to participate in our clinical trials. By
participating, you'll be contributing much needed data that will improve our
understanding about uterine health.

The Future



Diagnosis and treatment for some female-specific conditions could be greatly
improved. At Verso Biosense, we want to revolutionise uterine health so women
can make empowered decisions.


BE PART OF THE FUTURE OF WOMEN'S HEALTH


OUR LOCATIONS

Women with normal menstrual cycles

Liverpool University Hospitals NHS Foundation Trust

Clarewell Clinics - Birmingham

Clarewell Clinics - London

Women undergoing IVF

London Women’s Clinic 113 Harley Street, London


FREQUENTLY ASKED QUESTIONS

In simple terms, what is the device?
The full name of the device is the IRIS system Intra Uterine Monitoring Device
(IUMD), and there are two main parts:

• The IUMD (the “IRIS”): This is similar to an intrauterine contraceptive device
(the coil) in shape, size and appearance. A trained healthcare professional will
insert the IRIS device into the uterus via an inserter tube and rod - just like
the copper IUD coil.
• The data receiver: a detachable, rechargeable reader which powers the device,
communicating signals and retaining data. It is provided with an accompanying
pair of form-fitting shorts (which you wear over your everyday underwear), and
sits in a pocket on the outside of the garment.
Are the two parts connected? Would there be wires coming out of me?
There are no wires – the two parts connect wirelessly. A miniature system within
the IRIS allows it to communicate with the data receiver, and to wirelessly
collect energy.
How do the two parts communicate wirelessly?
A Radio Frequency Identification (RFID) system is used to communicate with the
receiver and to transfer data. Readings take place every ten minutes for a
duration of less than a minute, for seven days. The readings stored on the
receiver are then processed and analysed by a health care professional (HCP).
Who is the device for?
As a monitoring device, the IRIS system is currently offered to all women
interested in contributing to the research on uterine health as well as women
who have problems conceiving.
What does the device actually do?
The Iris measures both the oxygen concentration and temperature of the uterus -
features considered to have an impact on uterine conditions and on embryo
development. The objective of the study is to collect data that will enable
clinicians to reference the parameters to uterine conditions.
Can I be intimate with my partner whilst the device is inserted?
While the device is designed to allow for as much of your regular daily activity
as usual, sexual intercourse is not permitted in the context of the clinical
study as it is important you do not become pregnant while using the device. In
case you have sexual intercourse, it is recommended you use barrier
contraception (condoms).
Why is it important to monitor oxygen and temperature levels inside the uterus?
Monitoring oxygen and temperature levels in the uterus can help to create a
complete picture of uterine health. Body temperature needs to be maintained
within a narrow range for optimal enzyme activity and other cellular processes.
Understanding the levels of these parameters and their relation to normal
activities could potentially assist women to plan for children or to explain
certain condition.
If I’m approved for inclusion in the study, what am I given?
In addition to full support from the clinic team; once you are approved for the
inclusion in the study, you will be given four pairs of shorts, the IRIS sensor
(which will be inserted by a medical professional), two receivers , and a
charger, in a package that will contain all information you need to understand
the process.
What are the shorts like that i need to wear?
We’ve designed the shorts (which are used to keep the receiver and power the
IRIS device) to be form-fitting against your skin, to avoid discomfort whilst
you’re continuing with your daily routine. They carry the receiver which sits in
a built-in pocket on the outside of the shorts.

We will provide you with four pairs in your chosen size (choose from Small,
Medium or Large). They’re made from the same material that you’d expect to find
in sportswear and can be worn over your everyday underwear.

Can I shower with the device inserted?
Yes – just remove the shorts as they shouldn’t be exposed to water. The IRIS
must stay inserted while you go about your daily life.
How comfortable will I be while the device is inserted? Does it hurt?
The IRIS device is very similar to a traditional contraceptive coil in shape and
method of insertion. The placement of the IRIS will be carried out by a
consultant gynaecologist and should take between 5-10 minutes.

There might be some mild cramping once the IRIS has been placed, however you
should be able to continue with your daily routine immediately.
Are there any activities not allowed while the device is inserted? Can I go
swimming? Can I take a bath?
Showering is perfectly fine, but please don’t immerse yourself in water while
the device is inserted. Things like swimming or taking a bath may damage the
device.

You should also refrain from overseas travel where it would be necessary to pass
through airport scanners.

It is important to note that the IRIS system is not suitable for use with MRI
scans and X-ray equipment.

Can I exercise while the device is inserted?
Yes, with the exception of water-based activities where you are likely to be
immersed in water, you may continue your regular exercise routine.
What if I wish to withdraw from the study before the seven days are up?
You are free to withdraw from the study at any time, If you decide not to
continue with the study at any time, please contact your Nurse/Clinician team as
soon as possible.
How do I remove the device?
Do not attempt to remove the IRIS device yourself.

Your doctor will remove the device to facilitate as quick and easy a process as
possible. Removal of the device is a simple outpatient procedure, and it will be
organised as part of the clinical study.


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Verso Biosense can be found on LinkedIn where you can see our journey

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