YORK, England, May 11, 2015 /PRNewswire/ --
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.
(Logo: http://photos.prnewswire.com/prnh/20150505/743321 )
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, Tissue Regenix’s Chief Executive Officer, commented:
“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.”
For the full release please visit: http://www.tissueregenix.com/investors/rns-announcements
About Tissue Regenix
Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company’s patented decellularisation (‘dCELL®') 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 of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.
Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercialises academic research conducted by our partners around the World.
In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States- ‘Tissue Regenix Wound Care Inc.’, as part of its commercialisation strategy for its dCELL® technology platform.
Tissue Regenix Group Plc: +44-19-0443-5176
Antony Odell
Ian Jefferson
Jefferies International Ltd: +44(0)20-7029-8000
Simon Hardy
Harry Nicholas
Tulchan Communications: +44(0)207-353-4200
Tom Buchanan
Victoria Huxster
Matt Low
SOURCE Tissue Regenix Group Plc
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