YORK medical-device specialist Tissue Regenix is moving closer to the commercialisation of its latest product after being granted approval for clinical trials.
The York Science Park-based firm, which has been growing a sales base in the US for its DermaPure product, is now advancing the development of its latest device dCELL mensical, designed to aid knee repairs.
Yesterday the Medicines and Healthcare Products Regulatory Agency (MHRA) announced formal approval for Tissue Regenix to start the first UK clinical trial of its dCELL mensical device.
Following completion of rigorous final tests and preparations, it is anticipated the trial will start in the fourth quarter of 2014. Bosses say the trial approval marks a “critical stage” towards gaining EU clearance which will enable full commercialisation.
The dCELL® meniscus will be used to repair damage from “tears” in the meniscus knee cartila ge by encouraging tissue growth.
Speaking yesterday Antony Odell, chief executive of Tissue Regenix said: “Today’s decision by MHRA will allow Tissue Regenix to commence the first UK trial of the dCELL meniscus and marks a significant step for the group towards bringing this pioneering device to market.
“We feel the dCELL meniscus has the potential to provide a ground breaking new approach to help permanently replace damaged meniscus and return patients to full mobility.”
The UK trial for the dCELL meniscus will be conducted at The Hillingdon Hospitals NHS Foundation Trust, in Uxbridge, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, in Oswestry and at the Clifton Park Hospital, in York.
In addition to receiving clinical trials approval, Tissue Regenix has seen sales activity for its DermaPure product steadily increasing after its US launch in June in conjunction with Tissue Regenix’s partner CTS (Community Tissue Services).
Initial orders have been received, and are being shipped to customers as the company works to obtain new product approvals from hospitals.
Mr Odell said orders have been received and added: “We are equally encouraged by the early interest in DermaPure, since its US launch in June.”
“We have already received orders and are encouraged by progress in the enrolment of patients into human trials in the US.
“We look forward to gaining additional hospital new product evaluation committee approvals as a trigger for further product adoption. This is further validation of the quality of our product pipeline.”