Tissue Regenix (LON:TRX) has agreed a joint venture in Germany that will use its patented technology to supply replacement heart valves and skin for grafts.
German firm GTM-V, a tissue bank based in Rostock, expects first products from the venture to be launched in 2017 subject to regulatory approval.
It is the first commercial application of Tissue Regenix’s cell washing technology, dCELL, in heart valves.
Dermapure, a skin graft product, was launched in the US last year and just recently passed the milestone of US$1mln worth of sales.
Up to now, though, development of replacement heart valves has taken place in Brazil under the control of Professor Francisco da Costa at the Pontifical Catholic University of Paraná.
Ten years worth of clinical data has been amassed through this work.
GTM-V will be responsible for sourcing the donated tissue for both products while Tissue Regenix will invest €250,000 to fund development and distribution.
A new joint venture company, GBM-V, will be set up and prepare the regulatory submissions to the German authorities.
Antony Odell, chief executive, said the venture will help establish dCELL as a truly global brand and establish a business model that can be replicated with other tissue banks elsewhere.
Talks are already underway with other companies in other countries, he added.
In addition, doctors and patients in Germany would gain access to two clinically proven treatments in a country that is particularly stringent with human tissue regulations.
“This provides a high benchmark from which wider EU approvals can follow,” said Odell.
The dCELL process removes DNA and other cellular material from animal and human tissue, but leaves an acellular tissue scaffold that can be populated by a patient’s own cells. This all but eliminates the risk of rejection.
As well as skin and heart valves, Tissue Regenix is working on cartilage and knee ligament replacements and vascular disease treatments.
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