Development History of

What is Omnigen®?

Omnigen is a unique ‘off the shelf’, transportable biological matrix that can be used as an effective wound dressing for a range of indications including ocular surface indications. Omnigen will equip those civilian, military and veterinary surgeons tasked with treating damaged corneas with an immediately accessible, consistent high quality, and reliable product.

Developed in partnership with University of Nottingham

Why did we develop Omnigen?

The current method for storing amnion for clinical use is via cryopreservation at -80˚C. Unfortunately, preservation by freezing and the subsequent thaw process is known to damage the tissue and strip the soluble trophic factors contained within the membrane, potentially compromising the clinical benefit. Freezing the tissue also requires heavily regulated cold chain storage and costly logistics, which prevents storage at the hospital.

Amnion can only be distributed for scheduled surgery once ordered, taking up to 24 hours for delivery, on a named patient basis, and once its reached the destination it must be used within 48 hours or be discarded. These limitations greatly restrict end user access for scheduled surgery and as a result the market is massively under served. Furthermore, amnion cannot be accessed as an emergency therapy for the routine treatment of trauma injuries.

Until now, the practical limitations of amnion and variation in quality have greatly restricted the full clinical potential of existing amnion products.

NuVision and the Academic Ophthalmology group, University of Nottingham, have developed ‘Tereo®’, a patented manufacturing process supported by extensive proprietary know-how. Tereo allows us to standardise the processing of amnion, and preserve amnion’s properties in a unique dry and stable format.

How does Omnigen help?

Omnigen was developed to allow easy and direct dry application onto the ocular surface during conventional surgery and emergency and trauma situations. Its application will be a simple process requiring non-surgical and suture-free intervention that a non-ophthalmic medical specialist will ultimately be able to perform.

This entails a sterile Omnigen disc being placed on the ocular surface and a conformer contact lens will then be inserted to hold the membrane in situ. Rapid in vivo rehydration from eye moisture will initiate the prolonged release of repair inducing amnion constituents, and antibiotics, during the most destructive initial phase of an injury.

How effective is Omnigen?

Omnigen has been 13 years in development backed by £2 million research funding including significant support from the UK MOD, Defence Science and Technology Laboratory. The technology is dual-patented and meets the demand for a product that is both easy to store and accessible in the hospital. Omnigen is expected to be ready for use in eye surgery, and emergency medicine in Autumn 2015.

Initial clinical testing of Omnigen was carried out during the Autumn of 2015 via a post marketing surveillance clinical study. Omnigen can be provided free of charge to clinicians involved in the study for them to use the product on a named patient basis for a pre-agreed profile of indications. Results will be published as case studies. If you wish to be involved in the study, please contact Dr Hopkinson directly.

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