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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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. "