York,
11
May
2015
|
08:25
Europe/Amsterdam

Preliminary results for the year ended 31 January 2015

Summary

Successful launch of DermaPure®

EU approval for start of OrthoPure XM clinical trial

Continued strong cash position

Tissue Regenix Group plc (AIM:TRX) (“Tissue Regenix” or “the Group”), the regenerative medical devices company, today announces its unaudited preliminary results for the year ended 31 January 2015.

Operational Highlights

During the year, the Group:

  • Launched DermaPure® (decellularised human dermis) in June into the US acute care chronic wound market.
    • Outstanding clinical results from DermaPure® from initial US clinical use
    • Secured ‘Q’ code as a preliminary to obtaining Medicare reimbursement for non-acute care
    • Deployed direct salesforce to work alongside distributor network
    • Peer-reviewed paper published showing superior healing compared to competition in acute (surgical) wounds
    • Clinical trials for DermaPure® in other geographies continue to be encouraging
  • Gained approval to start OrthoPure™ XM (porcine meniscus) clinical trial in the EU
  • Secured grant of several important patents including meniscus in the US
  • Board and Company structure reflects growing commercial focus

Financial Highlights

  • Strong cash position with a balance of £10.3m at the year-end (2014: £18.5m)
  • Operating loss for the year of £8.4m as expected (2014: £6.6m) reflecting the ramp up of infrastructure to support US commercial activities and progression of product development
  • Ongoing submission of enhanced research and development tax claims – expected refund for the year of £620k (2014: £710k)
  • £19.0m, net of expenses, raised post year-end via share placing
Antony Odell, CEO of Tissue Regenix
“The year ended 31 January 2015 was a year of real progress for Tissue Regenix. We are delighted, not only with the continued drive towards the commercialisation of DermaPure®, but also the highly encouraging early-stage results from our portfolio of other products.

These developments validate our strong belief that our dCELL® technology has the capacity and capability to address significant markets and improve the treatment and recovery of millions of patients per year.

We have continued this strong momentum into the new financial year, with approval from Novitas for usage and reimbursement of DermaPure® for Medicare patients in the post-acute and outpatient setting being a significant development in the US. Similarly the commencement of the UK arm of the EU clinical trial for OrthoPure™ XT represents an important step in bringing our tendon and meniscus products to market.

I look forward to the coming year with real confidence. DermaPure® looks set to repay the considerable financial & intellectual capital investment that has been made in its development, and current progress give us confidence that our pipeline of other products will progress successfully through clinical trials.”
Antony Odell, CEO of Tissue Regenix