Tissue Regenix, a medical technology company that develops acellular tissue replacement products, has received European CE Marking for its dCELL Vascular Patch.
The dCELL Vascular Patch is a sterile, non-cellular biological scaffold manufactured from porcine pericardium (a double-layered membrane around the heart) that is intended to be permanently implanted into the human body for vascular repair without the need for anti-rejection drugs.
Tissue Regenix, a Leeds University spin-out company, says it will now work toward receiving FDA approval for the US.
John Samuel, Tissue Regenix executive chairman, said: ‘The granting of a European CE mark for the dCELL Vascular Patch, our first product approved for launch, is a historic moment for Tissue Regenix.
‘As well as providing access to some of the world’s largest medical devices markets, today’s announcement acts as a validation of our dCELL technology platform.’
The next product on which Tissue Regenix intends to focus is the dCELL Meniscus, for the repair of damaged knee meniscus.
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