Tissue Regenix is a company that focuses on delivering practical solutions to real clinical issues using its patented dCELL process.

Products
The dCELL Technology comprises a patented process which removes cells and other components from animal and human tissue
allowing it to be used without anti-rejection drugs to replace worn out or diseased 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.
Vascular Patch
The dCELL Vascular Patch provides a highly biocompatible patch for peripheral vascular reconstruction that supports infiltration
of the patients own cells allowing host tissue regeneration. The dCELL Vascular Patch is manufactured from porcine pericardium
using the proprietary dCELL process. The dCELL process removes cellular material from tissues while maintaining the structural
and biomechanical properties.

Positive points
Chairman has a good track record
Have recently received a EUR280,000 Grant Funding
Positive Results in Clinical Evaluation of dCELL
Recent high volume has got the share into a BREAKOUT
At 13.75p market cap is 64M


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UPDATE: Tissue Regenix produces impressive results in leg ulcer trial
5:34 pm by Giles Gwinnett and Philip Whiterow All 20 patients treated with Tissue Regenix’s dCELL Dermis saw a significant reduction in their wounds while nine were completely healed, it said ---Adds share price and quotes from managing director---

Shares in Tissue Regenix (LON:TRX) were lifted more than 12% today as its replacement skin continued to generate impressive results in a UK trial to treat chronic leg ulcers.

All 20 patients treated with Tissue Regenix’s dCELL Dermis saw a significant reduction in their wounds while nine were completely healed, it said.

The firm's Regenix's dCELL Dermis is human skin that has been treated with its dCELLprocess - a patented technology that involves taking human or animal tissue and “washing” it so that it can be used again to replace worn out or diseased body parts without the risk of rejection.

The ongoing trial is being carried out in conjunction with the NHS Blood and Transplant division and is focused on people who have suffered with chronic ulcers for more than four years.

As well as the nine patients being healed, the surface area of all of the patient’s ulcers had halved in size, with volume also reduced significantly. The results were after six weeks.

The study also showed that the new skin could be applied in 30- 40 minutes without hospital admission in out-patient clinics and potentially GP surgeries.

Dr Ardeshir Bayat, the trial's principal investigator at the University Hospital of South Manchester said: "Chronic wounds of the lower leg are a clinical challenge and their on-going treatment costs the NHS in excess of £400m per annum.

"Therefore a novel solution that can both reduce these costs and simultaneously offer a more effective treatment strategy has been long overdue."

Antony Odell, Tissue Regenix’s managing director, added: "People who suffer with chronic leg ulcers often do so for many years.

"Traditional treatments using compression bandages are not effective in many cases and require regular hospital visits and the associated disruption to their daily lives."

He told Proactive Investors the firm was "very encouraged" by these results.

"It's another demonstration of the utility of the dCELL technology in another indication," he said.

The next step, he said, would be to carry out a larger clinical study, but also to begin to look at commercialising CELL Dermis.

Tissue is keen to see it launched outside the UK and has begun talks in the US about a clinical trial there, he said.

"We are quietly confident that we'll get some people to be interested enough to pick it up and want to do this clinical work."

Earlier, Odell told investors that the company expects to publish the results of a pre-clinical knee cartilage replacement trial before the end of the year, while a number of different products including the ligament and cardiac patch are due to enter preclinical studies.

Tissue Regenix has also been selected as one of only twenty UK healthcare companies to attend the Future Healthcare Mission to showcase the best in UK medical and healthcare science and technology to US investors and business partners, he said.

“We believe Tissue Regenix is an excellent example of a British company with world-beating technology, which is based on research conducted in UK universities and pioneered through patient treatment in the NHS."

Tissue had net cash at the end of July of £26.1 mln. The company raised £25m through a share placing in December.

Losses in the half year rose to £1.87 mln from £1.34 mln reflecting the heavy product development currently underway, it said.

Shares rose today 12.22%, to stand at 12.50 pence.

Tissue Regenix sets up new subsidiary to tackle US market

http://www.proactiveinvestors.co.uk/companies/news/50778/tissue-regenix-sets-up-new-subsidiary-to-tackle-us-market-50778.html

http://www.proactiveinvestors.co.uk/companies/news/56536/tissue-regenixs-commercialisation-plans-boosted-by-impressive-trial--56536.html

Tissue Regenix's commercialisation plans boosted by impressive trial

By Philip Whiterow May 06 2013, 12:36pm

Tissue Regenix’s (LON:TRX) plans to commercialise its novel regenerative technology for the human body took a big step forward with impressive results from a NHS trial in Manchester.

Twenty patients suffering from chronic leg ulcers were treated with a skin graft that used Tissue Regenix’s dCELL process.

Of these, more than half, 12, were completely healed while the remaining eight people saw their wound shrink by more than 50% in all but one case.

In any trial the results would have been good, but were especially eye-catching given it was carried out in a hospital clinic, without anaesthetic, on actual patients.

Antony Odell, Tissue’s managing director, was understandably pleased with the results, especially as the patients had been selected for the long-term nature of their condition he told Proactive Investors.

“The average age of the ulcer for the trial was five years. These were things that had had everything else thrown at them already and we managed to heal over half of them.”

The trial was for a new clinical product, dCELL Human Dermis, for the NHS' Blood and Transplant Tissue Service (NHSBT).

After the success of the trial the product will now become available for use by the NHS from the middle of summer.

dCELL technology uses a process that “washes” the donor tissue. It removes the DNA and cells and leaves a scaffold for the recipient patients' own cells to re-populate and regenerate living, functional skin tissue.

Because the tissue has been re-populated by a patient’s own cells, it is not rejected by their immune system.

Odell said the dCELL Dermis has the potential to help many patients but was also a critical part of its plans to commercialise other treatments that use dCELL technology.

Care and treatment of ulcers takes up 1% of the NHS’s total budget, costing £400mln per year, while the total global market is predicted to be worth £16bn by 2015.

The next step will see a paper on the trial results presented at the Symposium on Advanced Wound Care (SAWC) in Denver this week by Dr Ardeshir Bayat, who led the study in Manchester.

Odell says Dr Bayat is very interested in how wounds heal and this was a key part of the trial in Manchester.

“One of the things we did was to monitor the depth of the wound and how it was healing so we could understand why it healed and why what we are doing that is different.

“Understanding when you have to use these treatments and how you use them is very important and in this regard Tissue Regenix is going into much greater depth than almost anybody else.

"We think this will give us a unique position in the market place. When people ask why should we pay money for this treatment, we can then explain why they should.”

Even though the recent tiral was with the NHS, Odell sees the US as potentially the major source of revenue going forward.

“Treating these type of wounds cost everyone’s healthcare system lots of money.“ he said.

dreamcatcher, are you still following trx ?

Gaynor

I must say TRX do look worth some further research :-)

square miler,you might find this article of interest too showing the target market for
the company.

http://bdaily.co.uk/entrepreneurship/30-04-2013/21bn-market-targeted-as-trx-receives-trial-approval/


$21bn market targeted as TRX receives trial approval

30 Apr 2013

York-based Tissue Regenix (TRX), the regenerative medical device company, has announced that approval has been given for a clinical research trial of its dCELL dermis matrix, which will examine its effectiveness in treating acute wounds, in addition to chronic wounds which was previously evaluated in a clinical study.

This trial marks an important milestone in Tissue Regenix’s plans to target the global market for chronic and acute wound care, which research firm Kalorama estimates could be worth around $21 billion by 2015.

Finding more effective ways to treat acute wounds, including surgical incisions and traumatic injuries such as lacerations, abrasions, avulsions, penetrations, bites or burn injuries, would save the NHS significant sums of money, improve patient recovery times and promote more successful healing.

The clinical study will be conducted by University Hospital of South Manchester NHS Foundation Trust and will involve a series of six-week trials on 50 healthy human patients, to investigate the responsiveness of acute wounds to Tissue Regenix’s dCELL dermis matrix and to clarify if dCELL dermis improves the closure of acute wounds compared to “normal” wound healing and other options.

Tissue Regenix’s dCELL dermis works by taking human donor skin and removing the DNA and cells, using the patented dCELL process to leave a dermis matrix that can be placed over the wound to aid natural healing by attracting the patient’s own cells to the wound area.

Antony Odell, managing director of Tissue Regenix Group plc, commented: “We are delighted that this clinical trial can now proceed.

“Finding more effective ways to treat acute wounds could significantly improve the efficacy and speed of patient recovery times and save the NHS and other healthcare providers’ significant sums of money.

“This builds on the work we have already been undertaking in collaboration with Dr Bayat and his team in Manchester on chronic wounds, with a clinical study which investigated successfully the efficacy of Tissue Regenix dCELL dermis matrix in healing chronic wounds such as venous ulcers.”

Gaynor that sure is a big potential market for them,i was looking around
the net this morning and came across this fairly recent piece on the
bbc news channel.

http://www.bbc.co.uk/news/business-21776285

NEWS TODAY looking very positive


Tissue Regenix (LON:TRX) had made significant progress towards commercialisation of its regenerative medical technology over the past year.The company, which has a patented technology, dCELL, that allows human or animal tissue to be used again for skin or body part replacement in other patients, added that the market for tissue engineering is large and growing quickly.In the area of wound repair and following on from a successful chronic ulcer trial in the UK, discussions have begun on initiating a clinical study in the US.

Approval was also received in April for a UK clinical research trial of dCELL dermis matrix in treating acute wounds.In cardiac, a porcine pulmonary valve is being translated from the work done at the University of Leeds, and pre-clinical work is planned for this half-year.In the vascular area, a pilot study for the AV graft is now in progress and is on course for a pre-clinical study in the second half of this year.In orthopaedics, regulatory application to start a clinical trial in Europe for its knee cartilage replacement will be submitted in the first half of 2014 when biomechanical testing and refinement of the suturing technique has been completed.The ligament repair product will be in pre-clinical studies by the end of 2013 with discussions underway with the US Food and Drug Administration in respect of approval requirements for the US market.

Antony Odell, Tissue Regenix’s managing director, added: “We are also moving ahead with our expansion into the US, and are currently in discussions with prospective product manufacturers and distributors, as well as exploring the possibility of clinical trials with major academic institutions and key opinion leaders to support marketing efforts in the US in 2014.“Tissue Regenix has a portfolio of dCELL Scaffolds, enabling clinicians to get the right tissue for the application area rather than trying to make one tissue type perform a multiplicity of clinical roles that it was not designed to do. As we roll out this portfolio, this clear distinction from other approaches will become an important factor in our future success.”The group posted a loss of £3.5mln (£2.7mln) in the year to January, with a closing year end cash position of £24.2mln.

http://www.proactiveinvestors.co.uk/companies/news/56817/tissue-regenix-makes-significant-progress-on-commercialisation-56817.html

SM,some comments from Panmure Gordon yesterday


13th May 2013

City broker Panmure Gordon has hailed the cash balance of Tissue Regenix (LON:TRX), whose patented technology allows human or animal tissue to be used again for skin or body part replacement in other patients.

Looking back over the year just gone, the company said it has made significant progress towards commercialising its regenerative medical technology.

Panmure said that at £24.2mln the cash balance was slightly higher than forecast and while the addition of US infrastructure will accelerate cash burn, it demonstrates that Tissue Regenix remains on a good trajectory for growth.

The company has also received good data on its dermis product, while there is growing evidence of stem cells being attracted to re-populate the company’s dCELL matrix in vascular patches, said the broker.

The marquee product, its heart valve technology that is already on the market in Brazil, now also has eight years’ worth of supporting data.

Panmure believes that if Tissue’s technology platform becomes successfully commercialised it will become a bid target.

“It has multiple shots at goal and a strong balance sheet to execute its strategy. Therefore, we remain buyers and re-iterate our price target of 18p,” said the broker.

Panmure Gordon note:
Terrific news this morning, with some 40 new sales representatives ‘engaged’ to detail the company’s dCELL human dermis product DermaPure in the US. This should allow a strong entry into the US market with the company having set up very detailed commercialisation plans in this market. Disruptive technology, taking on the incumbents head on. This allows us to upgrade our price target to 22p (from 18p) and retain our overall Buy recommendation.
Setting up new sales channels is not celebrated enough, in our view. Today’s news that the company has signed agreements empowering some 40 regional sales reps in the US serves as a reminder that this company is on the cusp of exploding in a commercial sense. The recipe includes great new products, exciting pipeline and a robust commercialisation plan with attention paid to precise routes to market and targeting of payers as well as a more traditional ‘marketing’ efforts.
Tissue Regenix is a regenerative medicine company, a space which is currently attracting a lot of interest from the majors and will likely result in a trade sale. Its platform is relatively de-risked in that it utilises a low-tech method of tissue engineering which should allow faster access to market than more hi-tech approaches like stem-cell migration etc.
The tissue engineering market is currently worth c.$1bn and is forecast to grow at a CAGR of 6%, driven by a shortage in donor organ supply and the need to treat chronic wounds. The company’s platform is essentially lower risk than many biopharmaceutical companies as it looks to solve well defined shortcomings in the tissue engineering field without relying on risky breakthrough technologies such as stem cell technologies or biomolecules (e.g. growth factors and proteins that stimulate cell growth). The company’s platform is essentially a materials play in this exciting new field. Overall, development in recent months seems to be taking slightly longer than had previously been anticipated but the platform remains valuable and, in our view, will ultimately attract a trade bid.
Ultimately, we see the company becoming a bid target if its technology platform becomes successfully commercialised. It has multiple shots at goal and a strong balance sheet to execute its strategy. Looking at near neighbour’s Tissue Science Laboratory trade sale (with an overlap these days in some of its employees) and Advanced BioHealing, we conclude Tissue Regenix will also likely be a trade sale of anything up to $325m by 2020 (or 22p per share in today’s money). Therefore, we remain buyers and re-set our price target at 22p (from 18p previously).

Unaudited Interim Results for the six months ended 30 June 2018

Group sales grow +61% (pro forma) year on year

Gross margin increased by 12.1 percentage points to 56%



Leeds, 03 September 2018 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Group") the regenerative medical devices company today announces its unaudited interim results for the six months ended 30 June 2018.



Financial Highlights

• Group sales increased to £5.6m (H1 2017: £1.3m) +61% pro forma, driven by;

o DermaPure® sales grew by 73% on a reported basis, 96% in constant currency, to £1.5m (H1 2017: £0.9m)

o CellRight contribution of £3.2m under orthopaedics and dental, +46% pro forma

o Increased sales from GBM-V by 70% to £0.9m (H1 2017: £0.5m)

• Gross margin increased by 12.1 percentage points to 56%

• Significantly narrowed Group EBITDA loss for the period £3.5m (£5.1m)

• Cash balance at 30 June 2018 £12.2m (H1 2017: £3.6m)

• Overall cash outflow reduced £4.3m (H1 2017: £4.6m)



Operational Highlights



• Distribution agreements signed with Arthrex, inc. ARMS medical and Pennine Healthcare

• Human Tissue Authority licence granted for the import of the BioRinse portfolio into the UK

• DermaPure® manufacturing successfully transferred into CellRight facility ahead of schedule

• Additional GPO coverage for DermaPure, with an additional 3 year contract under Premier, Inc.

• Premier, Inc. 'Supplier Horizon Award' granted

• R&D portfolio review undertaken, and operational efficiency initiatives implemented



Post Period

• Appointed Gareth Jones as Chief Financial Officer, to commence Q4 2018

• First commercial manufacture of SurgiPure XD for distribution into the US



Steve Couldwell, CEO, Tissue Regenix Group: "We have delivered a strong first half performance. I am pleased with the growing momentum across our business and we increased market penetration in our key clinical areas as a result of the good progress against our refined strategy. Central to our commercial success has been the strategic distribution agreements with Arthrex, for US distribution of the BioRinse portfolio, ARMS medical for the exclusive distribution of DermaPure in the Urogynaecology space and Pennine Healthcare, the first UK distribution agreement for our enlarged Group. We continue to increase our focus on commercial execution to drive the sales of both dCELL®, through DermaPure, and the growing demand for the BioRinse portfolio from direct and OEM customers.

We recently passed the first anniversary of the CellRight acquisition and have navigated through the integration process, successfully transferring the processing of DermaPure into the CellRight San Antonio facility, and leveraging the development, operational and commercial experience of the combined companies.

As the demand for our products continues to increase we are proactively reviewing our capacity capabilities to ensure that we can scale the business to meet future production requirements. We have identified a number of potential new commercial opportunities which we are actively pursuing and anticipate our current momentum will continue. We remain committed to our objective of being break-even in 2020. "