Tissue Regenix Share Discussion Threads

[swiss paul] 11/7/2016 20:01

Bamboo - oh I well and truly understand - have you? Did your read the annual report and accounts. Can you give me a breakdown of sales by geography? Can you tell me what the remuneration of our US sales force was based against how many sales - taking into consideration the geographical spread of where the insurance cover is?

Igbert - I was excited when I thought - eh up someone else is getting it. Show me a line in that statement that promises a delivery. Words such as:
Positive discussion with FDA
Initial clinical evidence (read the book Bad Pharma for interpretation)
is now expected to gain a CE mark.
The possibility of earlier EU approval for OrthoPure(TM) XT, and the potential for a US pilot study, would allow us to access these key markets via a more rapid regulatory route, where sales momentum can be quickly established, particularly with our 'off the shelf' alternative to the existing approaches.


So come on - be honest - what have they really told you - besides building up your expectations - trouble is they have don that considerably in the past.

Look at the NHS tissue deal - what has that really delivered. Tissue Ulcers a chuffing big problem - we allegedly have the solution - so why are the products not flying off the shelves?

I hold - but am coming to the conclusion that a commercial person needs to take this forward as its all research and possibilities. Look at IQE - same problem - run by boffins and not made a profit in a decade.

IOTS

[rayrac] 11/7/2016 17:28

So say eye!

[igbertsponk] 11/7/2016 08:45

I always get nervous when I see an RNS headline with the word "update" in it as 9 times out of 10 its bad news.
Glad to see this was the very opposite. Well done TRX !

[bamboo2] 11/7/2016 07:40

swiss paul, do you understand now?
ps expect more data imminently.

11 July 2016

Tissue Regenix Group plc

Orthopaedics Update

- Positive discussion with FDA regarding regulatory approval routes

- Initial clinical evidence renders OrthoPure(TM) XM biocompatible

- CE Mark application for OrthoPure(TM) XT brought forward

Leeds, 11 July 2016 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Group") the regenerative medical devices company today updates on its strategy for OrthoPure(TM) XT and XM (porcine tendon and meniscus) market clearance pathways.

The Group is currently undertaking clinical trials within the EU for both products, and due to the success of the clinical data for OrthoPure(TM) XT to date, is now expected to gain a CE mark for the product by the end of 2016, more than 6 months ahead of schedule. Positive FDA discussions have also encouraged the Group to apply for a US pilot clinical trial, with submission expected in Q4 2016, signalling a key milestone towards gaining regulatory approval for this product in the US.

Tissue Regenix has also established that 510(k) market clearance could be possible for OrthoPure(TM) XM - a considerably less expensive and time consuming option than previously thought. The EU clinical trial data has proven the implant to be biocompatible, showing integration into the patient's own tissues, and has been beneficial in highlighting improvements to the implant which Tissue Regenix are investigating further. The Group will only bring to market one version of the product and therefore the current EU trial will be superseded by a new study, with an identical protocol, using the updated implant. However, the current clinical trial will continue to be closed out and the patients currently enrolled will continue to be monitored. It is expected that the process to begin regulatory application for the second trial will begin before the end of 2016.

Antony Odell, CEO Tissue Regenix Group commented: "The possibility of earlier EU approval for OrthoPure(TM) XT, and the potential for a US pilot study, would allow us to access these key markets via a more rapid regulatory route, where sales momentum can be quickly established, particularly with our 'off the shelf' alternative to the existing approaches.

Positive data from the OrthoPure(TM) XM EU clinical trial, and the confirmation of a 510(k) route to the US market, means that we can undertake the additional study to implement improvements and pursue one common version of the product, expected for launch within the EU during 2018, and allow us to initiate the work required for US regulatory approval."

[igbertsponk] 08/7/2016 10:36

Think sometimes people forget how hard and expensive it is to introduce anything new to the medical world. I was involved with a drug testing company and they wanted to launch a new heart drug. They flew 200 UK doctors and their wives to Monaco for a weekend to show them how good it was. Their competitors used to do similar things so to get a toe in the door that's what they had to do.

[bamboo2] 08/7/2016 10:16

swiss, One of the surgeons leading the Meniscus trial in the UK has described our product as the 'Holy Grail' of orthopeadic surgery. Assuming the trial is a success, [we may get early results as soon as next week] I think it would be prudent to be able to make it available as widely as possible.

The US is the biggest market in the world, but it needs to be approached in the right way. As we have seen with Dermapure[dcell skin allograft], it is not just a case of setting up a shopfront. There are many rules and regulations, plus clinical and surgeon inertia to address.

We have already seen, in March 2016, that the FDA are happy for the co to start introducing xenografts to the market, with SurgiPure(TM) XD. This paves the way for a fastrack with the fda of the porcine derived meniscus and tendon.

This is a completely new product that deals with some of the fundamental problems associated with knee surgery. eg Shortage of viable human derived donor tissue, second operating site for autografts, etc

I really think you should get behind the co. Management seem to be delivering imo.

[bamboo2] 06/7/2016 22:39

A new type of heart valve could improve treatment for the thousands of patients who require replacements each year.

The manufacturer says it should be available on the NHS next year.

The implant is made from a donated human heart valve, which is ‘washed’ with gentle chemicals to remove the cells that the body could reject.
Results so far suggest the new valve ¿ named CardioPure dCELL ¿ ensures normal blood flow through the heart and does not harden over time as the manufacturer says it should be available on the NHS next year

Results so far suggest the new valve — named CardioPure dCELL — ensures normal blood flow through the heart and does not harden over time as the manufacturer says it should be available on the NHS next year

This means that, as well as preserving the valve’s mechanics so it functions as it should, there is less risk of rejection, which would mean patients need a second operation.

Washing the valve could also allow patients to avoid medication after surgery.

Every year, around 20,000 patients in the UK undergo surgery to replace or repair valves in their heart. Valves are tiny structures that help control the flow of blood through the heart.

Over time, or as a result of some diseases, valves can narrow or leak. The heart then pumps blood less efficiently.

The heart consists of four chambers — the left and right atria at the top, and the two ventricles underneath.

There are valves connecting the top and bottom compartments on each side, and two more in each ventricle where the blood leaves the heart and travels into large blood vessels.

The company behind the new valve, Tissue Regenix, says the implant could be applied to all valve replacements.

However, research has so far focused on the aortic valve — which controls the flow of blood out of the left ventricle into the aorta, the body’s main artery — and the pulmonary valve, which controls blood flow to the lungs.

There are many types of replacement heart valve. They can be mechanical, which are made from metal or carbon fibre, or from animals such as pigs or cows.

It is also possible to use human valves from donations, which means they are the exact shape patients need. Patients with mechanical valves need to take anti-clotting medication for life.

Human and animal valve replacements can cause the immune system to trigger a life-threatening reaction, so patients with these types of implants almost always need to take immunosuppressant drugs. The valves harden over time, too.

Until now, the techniques with human valves have involved freezing and storing the implants quickly to preserve the tissue.

The valves have had to be transported in liquid nitrogen, using specialised containers that not all hospitals have.
The heart consists of four chambers ¿ the left and right atria at the top, and the two ventricles underneath (computer artwork of aortic valve)

The heart consists of four chambers — the left and right atria at the top, and the two ventricles underneath (computer artwork of aortic valve)

Freezing in this way can also damage the cells and limit how long the valve can be used for.

Because the CardioPure dCELL has all of the active cells removed, with only the external ‘scaffold’ remaining, the implant can simply be transported in a pot of saline.

The human valves are taken from a tissue bank, where they are stored in special fridges.

Scientists start by washing them with enzymes and gentle chemicals in order to remove active cells that could trigger an immune reaction.

The washing process takes between four and six days, after which the valve is ready to be implanted.

So far, around 1,700 patients in Brazil have had CardioPure dCELL valves implanted by cardiac surgeon Professor Francisco da Costa.

‘The surgery requires specialist training, but it means patients won’t need any medicines afterwards,’ he says.

Results presented recently at the Heart Valve Society annual meeting in New York suggest that the valves are still effective after ten years, and do not harden over time.

Russell Millner, a consultant cardiothoracic surgeon at Blackpool Teaching Hospitals NHS Foundation Trust, says: ‘There is a spectrum of valves to choose from, and this offers a theoretical improvement on one of the options, but it is certainly not a universal panacea.

‘Based on the current evidence, the jury is still out as to whether it will offer a solution to patients in the UK.

‘It could lead to an improved way of using human donor valves, but this is a niche part of the overall heart valve market.

‘Generally, the knowledge and experience of human donor valves is limited, and artificial valves are still seen as more reliable.

[bamboo2] 06/7/2016 15:51

I expect a great deal more Ortho activity from the co in the near future.


July 05, 2016 09:24 AM Eastern Daylight Time

LEEDS, England--(BUSINESS WIRE)--Tissue Regenix Group (AIM:TRX) (“Tissue Regenix” or “The Group”) the regenerative medical devices company announces the appointment of an orthopedic clinical advisory board for the US as the Group continues to gain momentum within this key orthopedic market.

The clinical advisory board consists of 5 experts across varying orthopedic specialities, with special emphasis in ligament reconstruction, meniscal replacement, and cartilage restoration. Included on this Board are:

Steven Arnoczky, DVM—Director, Laboratory for Comparative Orthopedic Research, at Michigan State University, East Lansing, Michigan
David Caborn, MD—Clinical Professor, Orthopedic Surgery at University of Louisville, Louisville, Kentucky
Thomas Carter, MD—Team Physician for the NBA Phoenix Suns; member of The Orthopedic Clinic Association, Phoenix, Arizona
Philip Davidson, MD—founder of Davidson Orthopedics in Salt Lake City, Utah
Jack Farr II, MD— Knee restoration and Cartilage specialist at OrthoIndy in Indianapolis, Indiana

Tissue Regenix will work closely with this Board of esteemed individuals as it looks to commercialize its orthopedic products throughout the US. With the US sports medicine market valued at $3B, the appointment of this Board signifies the first major step towards a commercialization pathway in the US for the Group, with an initial focus on allograft (human tissue) applications.

While the initial focus will be to introduce allograft tissues treated with the proprietary dCELL® process, allowing them to be stored at room temperature, Tissue Regenix will look to address unmet clinical needs for ligament reconstruction and meniscal replacement through their portfolio of OrthoPure™ products. OrthoPure™ XM (meniscus) and XT (tendon), both porcine tissue based devices, are currently undergoing clinical trials in the EU for CE Mark approval.

Drew Distin, VP Tissue Regenix Orthopedics, Inc. commented “We are very excited to assemble an advisory board of some of the top minds in the sports medicine arena. These professionals are renowned in the industry not only for their clinical expertise, but also for their pioneering research into the use of tissue engineering for ligament reconstruction, meniscal replacement and cartilage regeneration. We look forward to working closely with this team, utilizing their expertise to help guide our launch into the US orthopedic market.”

Tissue Regenix will also exhibit at its first major orthopedic convention this month, attending The American Orthopedic Society for Sports Medicine Annual Meeting in Colorado Springs, July 7th-10th with a booth positioned at #321.

[igbertsponk] 01/7/2016 08:37

Sounds promising. Lets hope sales now begin to rise as they deserve.

[bamboo2] 01/7/2016 07:58

01 July 2016

Tissue Regenix Group plc

DermaPure(R) secures first GPO contract in US

York, 1 July 2016 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Group") the regenerative medical devices company announces that Tissue Regenix Wound Care, Inc. has secured a contract agreement with a national US Group Purchasing Organization (GPO) for the use of DermaPure(R).

A GPO negotiates contracts and pricing with an Integrated Delivery Network (IDN) on behalf of its members which can include; regional alliances, hospitals and individual physician offices.

Effective from today, Tissue Regenix Wound Care Inc. secured a 3-year contract agreement with a national GPO which spans across 43 states and is affiliated with 48 IDNs, with a membership comprised of more than 800 acute care hospitals, 186 different Health Systems and more than 1000 long-term care facilities. This agreement now makes it easier for physicians within these facilities to access DermaPure(R) for the treatment of their patients.

Greg Bila, President Tissue Regenix Wound Care, Inc. commented: 'This first GPO agreement marks another significant milestone for DermaPure(R), allowing a multitude of care settings and physicians to access the product. The results and clinical support that we have seen, to date, has been outstanding and we are pleased to be able to convert this into further market penetration and availability.'

[gersemi] 01/7/2016 07:06

Gaining traction now it seems

[andrewbaker] 30/6/2016 14:56

Woodford has said he's still holding TRX and sold some for cash raising purposes, the directors have foregone an instant reward for a deferred one in the future, and only then if the share price performs, so they are supportive; and the company sells much outside of the UK, so is an exporter who will benefit from the fall in the UK currency. So, how come the price falls!? Maybe there's shorter term profit taking happening; but, as I'm a long term investor, that doesn't concern me so much: this business is a long term success story, in my view. Buying in now, or adding to an existing holding, has to be a profitable strategy for future profits, IMHO.

[bamboo2] 30/6/2016 08:13

Could be interim results from Meniscus trial as soon as next week.

===========================================
30 June 2016

Tissue Regenix Group plc

Deferred Annual Bonus Scheme

Leeds, 30 June 2016 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Company") the regenerative medical devices company announces that an award has been made to Ian Jefferson, Chief Financial Officer and Antony Odell, Chief Executive Officer, pursuant to the terms of the Company's Deferred Annual Bonus Scheme.

Under the terms of the Deferred Annual Bonus Scheme, Ian Jefferson waived his entitlement to receive 50% of his annual cash bonus in return for an option over 209,677 ordinary shares of 0.5p each in the Company and Antony Odell waived his entitlement to receive 36% of his annual cash bonus in return for an option over 255,484 ordinary shares of 0.5p each in the Company (the "Deferred Allocation"). The number of shares comprising the Deferred Allocation (i.e. subject to option) was calculated by dividing the amount of cash bonus waived by the closing market value of the ordinary shares of the Company on the dealing day immediately prior to the date of deferral. The Deferred Allocation option is not capable of exercise until the vesting date has been reached, which is three years from the date of the award. By participating in the Deferred Annual Bonus Scheme Ian Jefferson and Antony Odell are entitled to receive a matching award at no additional cost (the "Matching Allocation"), being an option over 629,031 and 766,452 ordinary 0.5p shares in the Company respectively. The Matching Allocation is not capable of exercise until the vesting date has been reached, which is three years from the date of award. Additionally, the Matching Allocation is not capable of exercise until the Company's share price has reached the following target prices and remained at those prices for at least 30 consecutive days:

Performance criteria


% Of Interest .Share Price
To Vest ..........Criteria
-------------- ------------
33.33% .........20p
-------------- ------------
33.33%......... 25p
-------------- ------------
33.33%......... 30p
-------------- ------------

[channel pirate] 27/6/2016 11:46

Hi Luminoso, I have no idea that's why I asked the question, but I suppose it is down to TRX how they negotiated sales.

[luminoso] 27/6/2016 10:38

Surely if you sell in the US, as we do, revenue is initially in dollars, is it not ?

[channel pirate] 27/6/2016 10:33

Just a thought - with exposure going well in the USA, then would TRX have agreed to be paid in US dollars from there, or GBP. Same for Europe, but obviously in Euros. Would be good in the present economic climate if it was in Dollars and Euros

Anyone any thoughts ??

[luminoso] 22/6/2016 13:02

Sorry I wasn't clear, I meant Woodford as per bamboo's post.

[channel pirate] 21/6/2016 14:50

Maybe not cashing up as I have just done a "dummy buy" and was quoted 19.5p. So that looks like 2 x Buys totalling 100K !!

[luminoso] 21/6/2016 14:23

A bit of cashing up in case referendum vote throws up opportunities, I guess.
Nothing to worry about IMO.

[bamboo2] 18/6/2016 10:20

From Woodfords PCT update May 2016

"In terms of portfolio disposals, we sold the trust’s shares in Tissue Regenix, BTG and Midatech Pharma to raise cash. Positions in Abzena and IP Group were slightly reduced. We remain positive on the long-term potential of all of these businesses and continue to hold the shares across a range of our other portfolios."

[andrewbaker] 15/6/2016 15:13

Despite more sells than buys today, the price has increased, so it seems someone is unloading and there are plenty of willing buyers to absorb it all at current prices. I repeat my thought yesterday, that buying or adding TRX at these levels is pretty much a no-brainer, especially as only Close are selling in significant numbers (3.89m), and have only 3.47m left, whilst Jupiter, Woodford and Baillie Gifford have between them bought 38m in the past three months (source: FT).

And the bottom line is that the business should be rated on what it does and how long it's likely to be doing it successfully, and for my money, Tissue Regenix stacks up very well in that department.

[luminoso] 15/6/2016 11:49

Agree. Recent fall was reflected all over the market and was Brexit related IMO.

[channel pirate] 15/6/2016 09:09

Well I have added some more here yesterday, but decided to only use 40% of funds that I had set aside for a "top-up". In my opinion next week could possibly see our market initially react irrationally after the BREXIT results are announced before common sense prevails and it eventually settles. GLA

[andrewbaker] 14/6/2016 11:29

This is not a share with a big trade volume daily, so smaller sales adversely affect the price. Today's trading so far is low in overall volume, yet caused a disproportionate drop in price because sales started first; but now buys outnumber sales because, for my money anyway, buying this on the dips is a good thing to do. In short: Tissue Regenix is an investment over the longer term, and short term price movements are much more to do with trading the shares than to do with the trading that the business does, which is good, growing, and in an area where barriers to entry for any potential rival, are high. One could do worse than take a position at the current price, or add if already holding.