York-based Tissue Regenix secures new 12-month US distribution contract

York-based Tissue Regenix Group, the regenerative medical devices company, has signed a new US distribution contract with TRX Wound Care Inc. for DermaPure® - a product used in the treatment of chronic and acute wounds.

Commercial interest in Dermapure® significantly increased after Tissue Regenix received notice of Local Coverage Determination (LCD) from Novitas, as announced on 5 March 2015 and effective from 9 April 2015.

Novitas is a Medicare Administrative Contractor covering US states representing 8.9 million Medicare beneficiaries and is responsible for product coverage and reimbursement. Novitas is the largest of the eight reimbursement groups covering Medicare and Medicaid reimbursement claims in the US.

This major new contract, which has been signed with an experienced surgical and wound care distribution network, covers 2 of the 12 states that included in the region covered by the Novitas reimbursement LCD notice and represents approximately 11% of the Medicare patients addressed by the notice.

Worth a minimum of $600k, the contract covers the next 12 months and provides for additional areas to be covered by mutual agreement.

Building on the increasing clinical awareness of the outstanding results being achieved in the US by Dermapure®, Tissue Regenix is also continuing to deploy its direct sales representatives as part of its ‘hybrid’ distribution strategy of both direct and indirect sales representation.

This announcement comes less than a week after Tissue Regenix secured approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for the first clinical trial of its decellularized tendon device, Orthopure™ XT.

Antony Odell, CEO of Tissue Regenix, said: “Our US team has done an outstanding job in achieving commercial traction for DermaPure® and signing this regional distribution agreement.This agreement validates the hard work put in since the launch of DermaPure® in June 2014, as well as the remarkable clinical results that we are seeing from the product.”