Results & Update 13 May 2013 12:23
Tissue Regenix (LON:TRX) had made significant progress towards commercialisation of its regenerative medical technology over the past year.The company, which has a patented technology, dCELL, that allows human or animal tissue to be used again for skin or body part replacement in other patients, added that the market for tissue engineering is large and growing quickly.In the area of wound repair and following on from a successful chronic ulcer trial in the UK, discussions have begun on initiating a clinical study in the US.
Approval was also received in April for a UK clinical research trial of dCELL dermis matrix in treating acute wounds.In cardiac, a porcine pulmonary valve is being translated from the work done at the University of Leeds, and pre-clinical work is planned for this half-year.In the vascular area, a pilot study for the AV graft is now in progress and is on course for a pre-clinical study in the second half of this year.In orthopaedics, regulatory application to start a clinical trial in Europe for its knee cartilage replacement will be submitted in the first half of 2014 when biomechanical testing and refinement of the suturing technique has been completed.The ligament repair product will be in pre-clinical studies by the end of 2013 with discussions underway with the US Food and Drug Administration in respect of approval requirements for the US market.
Antony Odell, Tissue Regenix’s managing director, added: “We are also moving ahead with our expansion into the US, and are currently in discussions with prospective product manufacturers and distributors, as well as exploring the possibility of clinical trials with major academic institutions and key opinion leaders to support marketing efforts in the US in 2014.“Tissue Regenix has a portfolio of dCELL Scaffolds, enabling clinicians to get the right tissue for the application area rather than trying to make one tissue type perform a multiplicity of clinical roles that it was not designed to do. As we roll out this portfolio, this clear distinction from other approaches will become an important factor in our future success.”The group posted a loss of £3.5mln (£2.7mln) in the year to January, with a closing year end cash position of £24.2mln.
http://tinyurl.com/d832u7w