Tissue Regenix's devices a step closer to product launch

The AIM listed company is currently undertaking clinical trials within the European Union for OrthoPure XT and OrthoPure XM products.

The company said OrthoPure XT it is expected to gain a CE (Conformité Européene) mark for the product by the end of 2016, six months ahead of schedule.

Tissue Regenix also said positive food and drug administration (FDA) discussions in the US encouraged it to apply for a US clinical trial, with submission expected in the final quarter of 2016.

Tissue Regenix said that a 510k market clearance in the US could be possible for OrthoPure XM, which is a less expensive and time consuming option than the company previously thought. A 510k market clearance is premarket submission to the FDA to demonstrate that a device is to be marketed is at least safe and effective, which is substantially equivalent to a legally marketed device which is not subject to premarket approval.

The OrthoPure Xm implant was proven in an EU clinical trial to be biocompatible showing integration into the patient’s own tissues. The company said the trail was beneficial in highlighting improvements to the implant which Tissue Regenix are further investigating.

The company, which was formed in 2006, said it will bring to market only one version of the product and therefore the current EU trial would be superseded by a new study, with an identical protocol, using the updated implant.

However, the company said that the current clinical trial will continue to be closed out and the patients currently enrolled will continue to be monitored. Regulatory application for the second trial is expected to begin before the end of the year.

"The possibility of earlier EU approval for OrthoPure XT, and the potential for a US pilot study, would allow us to access these key markets via a more rapid regulatory route, where sales momentum can be quickly established, particularly with our off-the-shelf alternative to the existing approaches," said chief executive Anthony Odell.

“Positive data from the OrthoPure XM EU clinical trial, and the confirmation of a 510k route to the US market, means that we can undertake the additional study to implement improvements and pursue one common version of the product, expected for launch within the EU during 2018, and allow us to initiate the work required for US regulatory approval."

Tissue Regenix was spun out of the University of Leeds and commercialises academic research conducted by its partners internationally.

Its patented dCELL, or decellularisation, technology removes DNA and other cellular material from animal and human tissue, leaving an acellular tissue scaffold which is not rejected by the patient's body which can then be used to repair diseased or worn out body parts. The potential applications could address vascular disease, heart valve replacement and knee repair.

Shares in Tissue Regenix rose 11.43% to 19.5p at 1642 BST.