AN "important milestone" has been marked by York medical science company Tissue Regenix as a new joint venture a with German firm sees licences for its transplant technology granted for the first time in the EU.
Tissue Regenix, based at York Science Park, announced yesterday it has agreed a joint venture arrangement (JVA) with German tissue bank GTM-V to create GBM-V.
The deal marks the first step towards the commercialisation of Tissue Regenix's heart valves, created using its patented dCELL technology, which works by taking donor tissue and removing the DNA and cells to leave a natural scaffold to treat patients.
This is the first licence Tissue Regenix has granted for decellularised human heart valves, which is supported by 10 years of clinical data from Professor Francisco da Costa's work in Brazil, validating the safety and success of the treatment.
The JVA also boosts the firm's wider commercialisation strategy, allowing Tissue Regenix to licence its dCELL technology process for human tissue for the first time in the EU, in anticipation of bringing to market a portfolio of decellularised human tissue treatments subject to regulatory approval.
Entering the JVA with GTM-V, which will be responsible for sourcing the donated tissue, Tissue Regenix will be making an initial investment of €250,000 to fund development and distribution.
Antony Odell, chief executive of Tissue Regenix says the deal bring the potential for similar arrangements elsewhere in the global market.
he said "This is a key agreement for Tissue Regenix, because it is an important step forward towards establishing dCELL as a truly global brand.
"We see this as a business model that the group can replicate elsewhere and we have already begun discussions with a number of potential tissue bank partners in other countries.
"The establishment of this JVA will ultimately allow European clinicians and patients access to two clinically proven treatments. Germany is particularly stringent with its human tissue regulations, which provides a high benchmark from which wider EU approvals can follow.
"We feel that this agreement reiterates the strength of our technology base and offers us a unique commercial opportunity. GBM-V is an important partner for the future of Tissue Regenix and we greatly look forward to working with the team."
The JVA allows Tissue Regenix to work with individuals at GBM-V, who have more than 20 years of tissue medicine experience, and will produce and distribute the group's decellurised tissue treatments in accordance with German regulations.
The regulatory submissions to the German authorities to obtain approval are being prepared by GBM-V and the group currently anticipates launch of its treatments under the JVA initially in Germany in 2017, with European wide distribution to follow.
Dr Frank Peter Nitschke, managing director, GBM-V said: "We see this joint venture as an exciting opportunity to utilise Tissue Regenix regenerative medical technology, dCELL, and bring to European patients a portfolio of products that have the potential to change the treatment and recovery of many.
"We believe that with our expertise dealing with human tissue, and Tissue Regenix's experience we will build a strong and successful partnership."