Omnigen^®

Information for clinicians

What is Omnigen?

Omnigen is a dry and stable human amniotic membrane-derived matrix. Amnion can be used to improve healing in ophthalmic wounds and soft tissue-damage settings.

Supplied in a convenient range of shapes and sizes
Shipped and stored at room temperature
Applied to the wound dry for in-vivo rehydration
Ready for use at point-of-care
Accessible in an outpatient setting by ambulatory application

NuVision use a patented and unique process called Tereo to produce Omnigen which ensures the bioactive components and healing benefits of amnion are retained.

Omnigen can be applied in a suture free or ambulatory setting, as an onlay-graft (patch) to treat superficial disease or surgically as a:

Permanent inlay-graft (graft): supports the structure and re-growth of natural tissue; or
Temporary onlay-graft (patch): biological dressing to protect the wound, reduce inflammation and facilitate healing

Omnigen is approved for treatment on the National Health Service (NHS) and at certain private clinics. Your healthcare professional will have information on how to access Omnigen.

Omnigen application allows for the natural benefits of amniotic membrane to be delivered to the ocular surface.

The benefits of amniotic membrane include:

Reduces inflammation
Promotes healing
Reduces pain
Provide tectonic support
Provides pain relief
Can remove the need for surgery

OmniLenz application of Omnigen can be used to treat conditions that affect corneal and limbus or for more serve situations that require full ocular or mucosal surface coverage. Larger pieces of Omnigen can be applied in a suture free setting.

Together, these strategies provide total ocular surface coverage options that can be applied as part of early acute and prophylactic treatment strategies.

Applications of Omnigen

Omnigen can be used as an onlay graft (patch) or inlay graft (graft).

Patch applications are applied epithelial side down for wound healing. This approach delivers immuno-regulatory benefits, promotes epithelial healing and acts as a temporary biological bandage.
Graft applications are applied epithelial side up, providing a basement membrane for epithelial re-growth and a scaffold for tectonic support of damaged stroma. The graft is permanent and integrates over time.

Patch and graft applications can be used in a range of circumstances, including:

Onlay-graft (patch) indications	Inlay-graft (graft) indications
Acute and persistent epithelial defects	Corneal ulcers
Chemical/thermal injury	Limbal stem cell transplantation
Cicatrising conjunctivitis (SJS, TEN, Sjögren’s, Pemphigoid, Rosacea, GvHD)	Oculoplastics
Keratitis	Procedural adjunct – pterygium, glaucoma, neoplasia

Omnigen comes in a range of pre-cut sizes for ease of use and reduced waste

The science

The amniotic membrane – amnion - is the inner, foetal-derived, avascular layer of the foetal membrane. It surrounds, protects and nurtures the foetus. Amnion produces important proteins which are responsible for normal growth and development of the foetus.

During pregnancy, amnion acts as a physical anti-inflammatory barrier between the mother and foetus, inhibiting maternal immune responses that could harm the foetus. These immunoregulatory and immune-privileged properties of amnion are believed to protect against tissue rejection and inflammation when amnion is used as a tissue transplant

These biological features give amnion regenerative properties including:

Immunoregulation
Anti-inflammatory
Wound healing
Anti-fibrotic
Antiangiogenic

When amnion is delicately processed using the Tereo technique the components that drive these properties are preserved meaning Omnigen.

How to use Omnigen

Omnigen is pliable and easy to manipulate and cut, if necessary in its dry format

It is supplied in bespoke packaging and can be applied directly to the wound where it rehydrates from ambient and ocular moisture. The epithelial side is marked for confident application.

Omnigen comes in a range of convenient pre-cut sizes for ease of use and reduced waste.
Where appropriate, Omnigen can be applied in the outpatient setting using our bespoke contact lens OmniLenz.

How to store Omnigen

Omnigen should be stored at room temperature (2 – 25°C) and out of direct sunlight.

If you are based in the United Kingdom, please consult the Omnigen storage guide to see if you are able to store Omnigen at your centre.

Omnigen^® natural wound dressing

Information for patients

What is Omnigen?

Omnigen is manufactured from a naturally sourced material used to improve your body’s wound healing. Omnigen can be used on eye wounds caused by trauma, infection or disease. It is applied using a special bandage contact lens during an outpatient appointment or in surgery. It may be used as a graft that permanently supports the structure and re-growth of your natural tissue or as a temporary bandage that can be removed.

You may be treated with Omnigen if damage has been caused to your eye by disease or trauma.

A key benefit of Omnigen is how easy it is to use, meaning it is a fast and effective option for your treatment. Certain wound types benefit considerably from Omnigen, sometimes allowing for surgery-free treatment.

Omnigen is approved for treatment on the National Health Service (NHS) and at certain private clinics. Your healthcare professional will have information on how to access Omnigen.

Key benefits of amniotic membrane treatment

Omnigen is approved for treatment on the National Health Service (NHS) and at certain private clinics. Your healthcare professional will have information on how to access Omnigen.

What is Omnigen?

Omnigen is a natural material derived from the amniotic sac that surrounds a baby in the womb. The amniotic membrane has natural wound healing properties, preventing problematic inflammation and supporting your body’s wound-healing process.

We source our amniotic sac from women who choose to give birth by elective caesarean section and have given full voluntary informed consent for their amniotic sac to be collected and used in the manufacture of Omnigen. Donors are screened to ensure they are healthy.

To create Omnigen the amniotic sac is delicately processed under stringent regulations to ensure it is safe to use.

What can Omnigen be used for?

Biological dressing

For large superficial eye wounds

Reconstructive graft

Used to support the repair of damaged tissue

With OmniLenz contact lens

For surface eye wounds

Donation and safety testing

Women who donate their amniotic sac for the manufacture of Omnigen give voluntary informed consent for their amniotic sac to be used and receive no payment or benefit for doing so.

We screen potential donors’ medical history for information of infectious and autoimmune diseases and lifestyle choices that could increase the risk of contracting an infectious disease. Donors undergo blood tests for diseases including:

HIV I & HIV II
Hepatitis B
Hepatitis C
HTLV-I
Syphilis
Cytomegalovirus

All of NuVision donors are tested negative for COVID-19, at the point of consent.

Processing Omnigen

NuVision manufacture Omnigen by delicately processing and preserving the amniotic sac.

NuVision’s patented process is regulated and audited by the United Kingdom Human Tissue Authority (HTA) (Licence No. 22656). These regulations apply the following Acts of Parliament:

The Human Tissue Act 2004
The Human Tissue (Quality and Safety for Human Application) Regulations 2007
HTA Guide to Quality and Safety Assurance for Human Tissue and Cells for Patient Treatment, v3 Directions 001/2021 § (2021)

During processing the amniotic membrane undergoes thorough treatment to reduce transmission of potential infections, including treatment with antibiotics and antimycotics. As there are trace elements of these antibiotics and antimycotics in Omnigen, you should inform your clinician if you are allergic to any antibiotics/antimycotics (gentamycin, imipenem, polymyxin B, vancomycin, nystatin).

How does Omnigen work?

Omnigen promotes regeneration of tissue and wound healing.

The amniotic sac used to manufacture Omnigen surrounds, protects and nurtures the foetus during pregnancy. This is a complicated biological task, as the baby is nurtured while being protected from the mother’s immune system which could recognise the baby as a threat.

The amniotic sac plays a key role in foetal development, producing essential proteins that facilitate normal growth and development of the foetus. These properties also have important function in wound healing and recovery:

Immuno-suppressive to reduce long term complications
Anti-fibrotic to stop excess tissue growth
Anti-angiogenic to prevent inappropriate development of blood vessels

Retention of amniotic membranes natural properties allow for its transplantation to promote the regeneration and recovery of healthy tissue.

How will my treatment with Omnigen be carried out?

Omnigen is thin, meaning you will barely notice it is there.

If you have an eye condition treated with Omnigen, it may be applied in surgery or using a special contact lens in an outpatient setting – read about OmniLenz to find out more. Your healthcare professional will decide the best method of application for your eye wound.

Use of Omnigen to dress wounds may not require surgery or sutures, depending on the condition being treated. Omnigen can be an excellent option for conditions where rapid treat is required or when surgery is not immediately available.

Once your condition has healed, Omnigen will either naturally resorb or will be removed by your healthcare professional. This depends on the condition your condition and duration of treatment.

If you would like specific information around your treatment, please ask your clinician for guidance.

What makes Omnigen different?

Omnigen provides a natural aid to wound healing.

Tereo® preservation protects and retains the important structural, composition and biological healing properties of fresh amniotic membrane to aid ocular healing.

Omnigen can be stored dry on site and is ready to use immediately unlike other products derived from the amniotic sac. This reduces the time it takes for your wound to be treated and means Omnigen is available for use in emergency and unplanned routine settings. The faster wounds receive treatment with Omnigen the more likely they are to heal well.

As there is the option to apply Omnigen in an outpatient setting with OmniLenz, this treatment is very accessible for many different diseases.

How to access treatment with Omnigen

Omnigen is an available treatment on the National Health Service (NHS) and at certain private clinics. Your healthcare professional will have information on how to access Omnigen.