Omnigen®: An effective and unique ocular surface regenerative therapy solution (#2849)

Idea Description
Supplementary Information
Innovation 'Elevator Pitch':
Omnigen® is a unique ‘off-the-shelf’ transportable biological matrix that can be used as an effective surgical and in clinic regeneration therapy for a range of wound care and ocular surface disorders.
Overview of Innovation:
The ocular surface comprises the cornea, conjunctiva, eyelids and lacrimal glands, and any disorder in these structures can be classified as an ocular surface disorder (OSD). Though the prevalence of OSD is quite high, unfortunately, cases often go undiagnosed or undertreated, due to a lack of understanding of symptoms and inaccurate evaluation. As people are living longer, these disorders are becoming more prevalent, but awareness about them is limited.

Omnigen is an innovative sight saving and wound care regenerative therapy that retains the natural regenerative properties of fresh amniotic membrane (amnion) in a dry and stable transplant matrix. Omnigen equips civilian and military clinicians with an easy accessible and easy to use regenerative therapy, allowing them to effectively treat OSD and trauma in surgery, in the clinic or in the emergency room.

Omnigen is supplied in a bespoke delivery tray. It is easy to manipulate and applied dry, directly to the eye, where it can be rapidly rehydrated by ambient in vivo moisture of the eye. The epithelial side is marked for confident orientation.

Omnigen contains no viable cells. It is stored and shipped at room temperature (25˚C) and is ready to use straight from the sterile pack. There is no longer any need to be concerned with keeping amnion frozen, thawing it, having to pre-plan use or risk wastage.

Omnigen retains the originality of amnion. It is manufactured using a patented preparation and drying process (Tereo®). This process allows retention of the natural trophic components present in fresh amnion; an element believed to be linked to wound healing performance (Allen C.L., et al 2013).

Omnigen is a stable matrix developed so that it may be stored at the point-of-care. As a stock product, it is therefore ready to use immediately when clinically required. Omnigen can thus be routinely accessed in emergency situations to treat the diseased ocular surface.

Omnigen is processed from amnion donated by UK donors undergoing elective caesarean section births at NHS hospitals. Donor eligibility is assessed via the donor’s history, a face-to-face medical/social history interview and mandatory blood tests. Omnigen is aseptically processed under Grade A clean room conditions and undergoes antibiotic decontamination. The culture negative microbiological status of the processed product is validated by an independent laboratory prior to release.

Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
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