|sp, Thanks for sharing the reply.
It does seem strange. We were told about the delay in the Meniscus clinical trial due to the change in the format, but a delay in date for Tendon was not made clear.
I always thought the Tendon [XT] was 2017 anyway!
I just checked and the Hardman report dicusses XT as being CE marked six months early in 2016. So I guess it has reverted to the original timescale?
Did you ask about Xenograft products being sold into the NHS?
|My learned colleague says thus
Response from TRX, confirms slippage due to administrative delays in CE process....
"Thank you for your email.
Yes, you are correct. The slight hold up is a procedural delay with the CE mark approval process, which is unfortunately outside of our control. However, we do still expect that launch of the product will go ahead in H1 2017. "
So, nothing to get too concerned about.
My thoughts are - is it Annual or FY 2017?|
|sp, The ACL [Orthopure XT] product always was 2017.
It's the Meniscus [Orthopure XM] that has gone astray for 2016 I think. This is because the format has been revised and trial patients are being implanted with the newer version. The trial is extended. This format will be the same as that offered in the US.
NHSBT has nothing to do with the xenograft products. They will be offered to the NHS in due course I would imagine.|
|erm that Holy Grail that you are on about - did they ever find it?
Nicked from the other shop
But the CE mark promised before 'year end 2016' six months ahead of schedule seems now to have slipped back into H1 2017.
So read the RNS
No mention of NHS B&T so is this targeted at European / USA or wherever. Or when the annual results come out will it be another expense line.|
|Ray, yes that right, using our xenograft saves a second operation, along with all the costs, reduced infection risk, faster rehabilitation etc etc.
There will be a sweet spot in the pricing of this product that will make its use a no-brainer. Obvs if they go too high it will not be as easy to sell.
The ACL is often repaired at the same time as meniscus, hence the two products go very well together. This is the Holy Grail of Ortho surgery that Houlihan-Burne referred to, off the shelf parts, stored at room temperature.
It's a shame that they are doing a new version of the meniscus as this will prob take another year to get to the same point as ACL.|
|Just found it!
Allograft vs. Autograft - DCIDS Tissue Bank - DCI Donor Services
tissuebank.dcids.org › patient-education
Allograft vs. Autograft. An autograft is a bone or tissue that is taken from a part of a person's own body and transplanted into another. Often, surgeons will use a person's own hamstring tendon to repair a damaged anterior cruciate ligament.
We have another winner!|
|Autograft? Is that one that requires two operations, ie, grafted from the same body?|
|More success with the xenograft that is used for the treatment and repair of anterior cruciate ligaments (ACL).
"removing the need for a second surgical site (for tissue harvest), therefore making the operation faster and easier."
It would be good to get some idea of the time and money saved using the xenograft rather than autograft. If it can be priced advantageously, it should sell itself.|
|28 November 2016
Tissue Regenix Group plc
OrthoPure(TM) XT update
- Early patient outcomes show statistically significant improvement over gold standard procedure
- First European distributors appointed
Leeds, 28 November 2016 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Group") the regenerative medical devices company today provides an update on OrthoPure(TM) XT (porcine tendon).
The early clinical data provided to support the CE mark application has shown results highlighting the clinical relevance of the product, with the outcomes at 6 months post-operation showing a statistically significant improvement when compared to the current gold standard treatment which uses the patients' hamstring tendons or patellar tendon (autograft).
Dr Gabriel Oliver who performed the first OrthoPure(TM) XT implant commented: "Clinically our patients have progressed very well, with a reduction in inflammation, pain and faster rehabilitation allowing for a return to normal life ahead of other techniques. OrthoPure(TM) XT also offers benefits to hospitals and surgeons, removing the need for a second surgical site (for tissue harvest), therefore making the operation faster and easier."
The launch of OrthoPure(TM) XT remains on track for H1 2017, with CE mark approval in the same period. The first distribution agreements within Europe have been signed, indicators of the strong commercial and clinical support for OrthoPure(TM) XT, in preparation for rapid commercialisation in key European markets once approval is granted.
Peter Hamer, Commercial Director TRX Orthopaedics Ltd: "We are extremely encouraged by the initial results returned from the study. Having entered our first distributor agreements, which highlight the demand and market opportunity for OrthoPure(TM) XT, we remain on track for launch of OrthoPure(TM) XT by the end of H1 2017."|
|Doesn't seem that way to me. Would it be any good at wound repair, or cancerous lesions of the skin?
Nope, it's not in the same area of healing IMO.|
|22 November 2016
Tissue Regenix Group plc
Leeds, 22 November 2016 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Company") the regenerative medical devices company announces Chief Financial Officer, Ian Jefferson, has notified the Board of his intention to leave the Company. He will remain available to support the Company whilst the search for a successor is completed, and throughout the transition period.
Antony Odell, CEO, Tissue Regenix Group plc: "We would like to thank Ian for his commitment to Tissue Regenix over the last 5 years, and we wish him all the best in the future"|
|I think the threat of a fund raising is the scary bit.|
|Well, the chart looks scary. Is it because we are being 'Trumped'?!|
|Plus the ever-extending horizons to significant turnover, coupled with the chance of a further fundraising should turnover fail to cover the additional capital needs.
Those two issues alone are probably deterring new investors as well as making some, less perceptive, current holders leave the field.
IMO still an excellent medium term investment.|
|Walking backwards....to Christmas?
Does the market know something? Or is it just lack of news?|
|Would be nice if Mr Odell & Co announced something positive right now in order to reverse this falling share price.|
|A slight drop today on increased losses, but they were expected. This is a sound early stage business that will grow going forward, and deliver very good returns when it goes into profit, IMHO. I'm still holding and staying long: and if I didn't already hold so many, I'd be buying more (and won't unbalance my portfolio, but will be pleased with the current good profits and future better one!) :)|
|The 1M trade on Friday and today's 200K trade can't be pi's as we wouldn't be able to get a price within the Bid / Ask spread as both of those trades were.
Fund / Institution selling in order to cover withdrawals or need funds to buy a "bargain" ....!!|
|Just joking bam. I'm not feeling a bit like selling. Would buy more if I didn't mind knocking my portfolio completely out of balance!|
|From the Interims 12-10-2016:
Alongside this, we continue to progress with our European market entry and expect to be in a position to launch our first orthopaedic product, OrthoPure(TM) XT, into this market in H1 2017, with CE mark submission expected to be made a full six months ahead of schedule.
The developing momentum behind our dCELL(R) Technology product portfolio brings us confidence that we will achieve our year end corporate goals. We look forward to reporting our progress in the coming months."
So more news in the coming months...............time to add, or at worse, just to sit tight imo and wait for the share price to increase. Personally I added 2 more small lots on the recent dip which has now exhausted all spare cash that was sitting in my ISA account.|
|No. I'm not selling. I still have my original holding.|
|So we should sell then, bamboo?!😜|
On the projected figs I think the co can last another approx 18 months. TRX will need a dilutive fund raising, another partnership or bid to absorb the costs of going into production for dCell Meniscus/ACL.
The new products that will be released next year, will take time to gain traction in the medical community.|
|Who is off loading a Million shares at 13-30pm today then ?????????????????|