Tissue Regenix Share Discussion Threads

[rayrac] 09/3/2016 08:15

There seem to be very few companies offering an ambient temperature human dermis based ECM allograft. KCI with Graftjacket, also based in San Antonio is probably the first name I would suggest.

But there are strong competitors 'out there' then, bamboo! I'm not quite so bullish now.

What's the point of a tiddler like TRX? Let's face it, I thought we had a front line position. Virtually on our own?

[bamboo2] 09/3/2016 08:12

Tissue Regenix Group plc

510k market clearance granted for SurgiPure(TM) XD

York, 9 March 2016 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix") or ("The Group") the regenerative medical devices company, today announces that it has been granted 510k market clearance from the Food and Drug Administration ("FDA") for SurgiPure(TM) XD. This is the first FDA market clearance for a medical device developed by the Group and clears SurgiPure(TM) XD for a commercial launch within the US in 2016.

SurgiPure(TM) XD, a porcine dermis product which utilises the Group's patented dCELL(R) technology, will be used for the reinforcement of soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, which may include the repair of hernias or body wall defects. The hernia market is estimated to have a $2-3bn global market value, with an estimated $1bn market opportunity in the US alone, with biologic treatments accounting for around $300m of this.

SurgiPure(TM) XD will be manufactured at the Group's manufacturing site in Swillington, UK and Tissue Regenix Wound Care, Inc. , who have already established a market presence with the commercialisation of the Group's DermaPure(R) decellurised dermis product, will be responsible for managing the commercialisation of SurgiPure(TM) XD in the US.

Antony Odell, CEO, Tissue Regenix Group commented: 'We are delighted to have gained our first FDA market clearance for a dCELL(R) application. The US is a key market for us and we have proven that we can successfully commercialise product here already with DermaPure(R). We continue to anticipate that the first SurgiPure(TM) XD product will be available in the US in H2 2016.

Tissue Regenix dCELL(R) applications are quickly gaining clinical validation and demand on an international scale, through both the Wound Care and Cardiac sectors, a testament to the strength of our dCELL(R) technology platform.'

Further announcements will be made on distribution partners and launch in the coming months.

[rayrac] 09/3/2016 07:52

Another light is switched on. We may soon be dazzled by the glare!

[bamboo2] 06/3/2016 23:30

luminoso, There are three main types of skin grafts, Allograft, Xenograft and Cell based, bio engineered tissue.

Perhaps due to ease of procurement, many competitors in the Allograft field rely on amniotic material as the basis for their woundcare offering. We know from experience that many of these products require multiple applications, so I would not consider them competition for Dermapure. Others, like Smith and Nephew, have Xenografts.

There seem to be very few companies offering an ambient temperature human dermis based ECM allograft. KCI with Graftjacket, also based in San Antonio is probably the first name I would suggest.

Unfortunately I am currently unable to find my TRX notes where I keep this info.

[luminoso] 04/3/2016 12:00

Bamboo, you mentioned writing something about the competition a while ago. Who is our closest competitor in your opinion ?

[rayrac] 03/3/2016 18:57

Thanks Andrew. I'm here for the ride 'til the lights go on!

[andrewbaker] 03/3/2016 16:55

Woodford, Baillie Gifford and Invesco have all been adding more recently, and the chart looks interesting: if we close above 16p. today, that should be confirmation of the start of a new uptrend, with a trend-line drawn from the mid-January second double bottom.

Add in the fundamentals of the company, mentioned in my earlier post number 1547, and there's even more reason to be optimistic going forward. Time to buy or add for those watching and not yet fully committed. All IMHO.

[rayrac] 26/2/2016 16:44

Oh well, another week goes by. It's a route march to nowhere.💤
27939;🏻€584;🦃

[swiss paul] 23/2/2016 21:26

Ray - simples (like you) just filter - like I just did wiv u

[rayrac] 23/2/2016 14:35

What an inspiring reply sp! I remember you from another rotten thread, I believe.

You annoyed me then!🚾

[bamboo2] 19/2/2016 19:56

swiss, Aha. Thanks for taking the trouble to reply.

[bamboo2] 16/2/2016 17:44

swiss, what is IOTS at the end of yr post?

[bamboo2] 15/2/2016 08:33

TRX CEO, Antony Odell, discusses EU Joint Venture

[swiss paul] 11/2/2016 19:18

More Yanks - more noses in the trough. Lets see how well he converts 'posters to sales' eh
IOTS

[bamboo2] 11/2/2016 08:02

11 February 2016

Tissue Regenix Group plc

Appointment of Vice President of Tissue Regenix Orthopaedic, Inc. North America

York, 11 February 2016 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix") or ("The Group") the regenerative medical devices company, is pleased to announce the appointment of Drew Distin as Vice President ("VP") of the Group's recently established subsidiary, Tissue Regenix Orthopaedic, Inc. North America. Drew will commence the role as of March 1(st) 2016.

Drew is well respected within the Orthopaedic sector in the United States having held a number of senior sales and business development roles at Parkus Medical, LLC. Osiris Therapeutics, Inc. Nuortho Surgical, Inc. RTI Biologics, Inc. and CryoLife, Inc.

With specialist knowledge in maximising sales through targeted marketing, he joins Tissue Regenix as it embarks on the next stage of commercialisation with its dCELL(R) Orthopaedic applications. His focus will be to drive their entry into the US marketplace in the coming years, with the first step expected to begin in 2017.

Currently, the Group have ongoing clinical trials for the OrthoPure XM (Porcine meniscus) and OrthoPure XT (Porcine tendon) products within the EU and aim to achieve CE mark submission by the end of the year for XM.

In the US, it is expected that the market entry strategy will focus on human tissue applications, initially starting with the human tendon (OrthoPure HT). Tissue Regenix is currently in partnership with tissue bank Community Tissue Services (CTS) for the manufacturing of its wound care product DermaPure(R), and this licencing model is one which the Group expects to replicate with relevant Orthopaedic partners.

Peter Hamer, Commercial Director, Tissue Regenix Orthopaedic Ltd, said:

"We are delighted to welcome Drew to the Orthopaedic team. He brings with him a wealth of experience that will be advantageous throughout the next stages of our commercialisation and the expansion of our Orthopaedic portfolio. This is a very exciting time for Orthopaedics at Tissue Regenix as we continue enrolment of our OrthoPure XT clinical trial and await submission for the CE mark with OrthoPure XM. We are on course to complete these tasks within the timeline predicted and look forward to further expansion into the US with Drew on board."

[bamboo2] 03/2/2016 09:07

Hi Ray, the co is committed to using Advocates as part of the sales process. This kind of publicity will attract more candidates to try the product and see the numerous benefits over the majority of the competition.

The Dermapure stage IV trial should complete in the next 3-4 months. This will add further grist to the sales mill. There's quite some momentum building.

Ig, lol!

[igbertsponk] 03/2/2016 09:02

Posters, lovely.
They're doing colouring in tomorrow, then playdo on Friday.

[rayrac] 03/2/2016 08:56

No effect on the share price though!

I suppose it's a 'helper' on the way to acceptance though?

[bamboo2] 03/2/2016 08:11

03 February 2016

Tissue Regenix Group plc

("Tissue Regenix or "The Group")

DermaPure(R) selected to feature nine poster presentations at Woundcare Symposium

York, 03 February 2016 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix") or ("The Group") the regenerative medical devices company, is pleased to announce Tissue Regenix Wound Care, Inc. will display nine poster presentations at the Symposium on Advanced Wound Care (SAWC) Spring conference to be held in Atlanta, Georgia, April 13-17.

Focussed on the Groups first commercialised product DermaPure, the posters have been written by various key opinion leaders including Clinicians, Clinical Affairs and researchers. They were selected and approved by a peer review committee and will focus on areas such as; clinical efficacy in various types of wounds, pain reduction, a retrospective analysis of clinical outcomes and an analysis of DermaPure's Extracellular Matrix.

DermaPure was released to the US market in 2014, and has been used to treat wounds from diabetic or pressure ulcers through to Frostbite. The Medicare 'Q' code became effective January 2015 allowing clinics to be reimbursed for the product and is now available to c.65% of Medicare beneficiaries. Tissue Regenix announced in January 2016 that sales of DermaPure had surpassed $1m since launch.

Greg Bila, President Tissue Regenix Wound Care, Inc. commented "We are extremely proud of how DermaPure has performed within a competitive marketplace since it was launched in 2014. Having nine posters chosen by a peer review committee to appear at SAWC, I think, illustrates a deeper understanding and appreciation of the dCELL(R) technology platform, and the difference that a product like DermaPure can make to patient treatment and recovery. We look forward to discussing this further at this year's spring SAWC, and I would like to extend my thanks to all who have contributed to these presentations"

Poster titles


Author(s) Title
Constantine Demou DPM, Use of Regenerative, Decellularized
Brendan McCarty DPM Jennifer Skin Replacement*on Severe Acute Diabetic
Michael DPM Foot Wounds Involving Exposed Bone
and Tendon: A Three Case Series

Valarie Muehlenbruch, The Use of a Regenerative, Decellularized
RN, Kate Biasiolli, RN, Skin Replacement* to Close Partial
Patti Gary, RN, CWCN Foot Amputation Wounds and Contribute
to Diabetic Limb Salvage

Jake Lambert, MD The Effect of Pain in Patients Treated
with Decellularized Human Dermal Grafts
Howard Kimmel DPM, Arthur The Use of a Decellularized Dermal
Tallis DPM Allograft in the Treatment of Chronic
Venous Leg Ulcers

HowardKimmel DPM Retrospective Analysis of Utilizing
A Decellularized Dermal Allograft to
Treat Chronic Wounds

Anna LeMoine, BSc, MSC, Maintenance of Key Extracellular Matrix
PhD; Vassilis Vayianos, Components in a Decellularised Human
BSc, MSc, PhD and Patti Dermis Product*
Gary, RN, CWCN

Jaminelli Banks, DPM, Decellularized Human Dermis* Drives
Robert Frykberg, DPM Rapid Surface Area Reduction and Closure
for Neuropathic Ulcer

Michael Desvigne, MD Unique Combined Application of an Ovine
Collagen Dressing with an Intact Extracellular
Matrix (CECM) with a Decellularized
Dermis to Assist in Closure of a Radiated
Lower Extremity Wound

Michael Desvigne, MD Optimizing Wound Bed for Application
of Cellular Tissue Based Products Using
an Ovine Collagen Dressing with an
Intact Extracellular Matrix

[luminoso] 30/1/2016 13:36

Yes, bamboo, they are trying to tell us they are being conservative with their estimates, I think !

[bamboo2] 29/1/2016 21:52

luminoso, thanks for posting the Edison link...eg...

"We consider DermaPure HD to be well positioned by virtue of the indications of good efficacy in hard-to-heal chronic wounds and the fact that it is economic to store and use. For example, Dermagraft must be stored at -75°C ± 10°C, while DermaPure is stored and transported at room temperature. The absence of immunogenic substances such as silicon and glycosaminoglycan in the dCELL extraction process makes DermaPure a ‘cleaner’; alternative to many other skin substitutes. As the product launch is still at an early stage, we forecast <1% market share in the US in FY21 with $6m in sales. To contextualise our $31m peak sales estimate for Derma Pure in more than 10 years’ time, we note that MiMedx reached over $100m in sales with its amnion-based product only a few years after launch."

[bamboo2] 26/1/2016 22:52

I have only just had a chance to speed read the Hardman note and at first look it is not certain that cash will be raised.

It is dependant on the decision whether or not to commence a clinical trial of the meniscus and tendon xenograft for the US market.

IF the Company go for it, it will be a large scale, long term trial [200 patients].

Then costs will be EITHER funded through a cash raise OR a partnership/JV.

[swiss paul] 26/1/2016 20:21

Igbert they will do a cash call, read the brokers note.