York’s Tissue Regenix Group secures further approval for US move

York-based Tissue Regenix Group, the regenerative medical devices company, has secured approval from the Noridian Healthcare Solutions and Palmetto GBA Medicare administrators for DermaPure®reimbursement.

Noridian Healthcare Solutions and Palmetto GBA’s approval means that DermaPure®, a product used in the treatment of chronic and acute wounds, is now available to 20.7 million Medicare beneficiaries across 30 states in the US.

Securing Medicare approval is also a significant development for Tissue Regenix’s strategy to access the largest potential group of US patients who would be unable to benefit from Tissue Regenix products without it.

The Medicare programme in the United States is a national social insurance programme which provides health insurance for citizens aged 65 and over. It is administered by bodies such as Noridian Healthcare Solutions and Palmetto GBA, each one with their own jurisdiction of states.

Being approved enables medical establishments to purchase and seek reimbursement for products used to treat post-acute and outpatients who are beneficiaries of the Medicare initiative.

Early last month, the York-based company signed a new US distribution contract with TRX Wound Care Inc. for DermaPure®.

Antony Odell, CEO of Tissue Regenix said: “We are thrilled with DermaPure’s® performance in 2015. In the space of just four months the product has gained approval for coverage in over half of the American states via what is a highly rigorous and intensive selection process.

“This is further evidence of both the continued strong clinical performance of DermaPure® and Tissue Regenix delivering on its clearly defined strategy for full commercialisation of the product in the US.

“While it is hard to predict the time frame for further approvals, we are confident that the successful clinical outcomes of DermaPure® across an ever widening pool of patients stands us in good stead for gaining additional coverage.”

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