Tissue Regenix Share Discussion Threads

[bamboo2] 26/1/2016 17:28

From the German perspective...[made possible by google translate]



Tissue bank MV cooperates with companies of Regenerative Medicine
Rostock tissue bank cooperates with a leading international company in the field of regenerative medicine and seeks better care of patients with innovative tissue transplants to
January 26, 2016


This cooperation will not only strengthen Mecklenburg-Vorpommern as a recognized site of tissue medicine. The main effort is to improve the care of patients of all ages with innovative tissue transplants without long waiting times. The non-profit tissue bank founded in Rostock last year Mecklenburg-Vorpommern (GBM-V gGmbH) goes to a cooperation agreement with the British medical company Tissue Regenix. The Tissue Regenix Group plc is a leading international company in the development of regenerative implants on the basis of cell-free tissue scaffolds. For the first time presents Tissue Regenix its licenses of a European tissue bank.

"The cooperation is a European milestone," said the CEO of Tissue Regenix, Antony Odell, today in Rostock. "The timely provision of high-quality tissue transplants is one side. On the other hand, we want to explore together with the other partners on new Rostockers and transplants, which allow for the receiver a much better long-term results through higher quality and significantly lower or lack of rejection. "
The care of patients with high-quality tissue transplants is unsatisfactory even eight years after the entry into force of the legal framework. The waiting times for replacement of a cornea are about three months, in cardiovascular tissues, ie heart valves and blood vessels, it is similar. Still tissue transplants must be imported from abroad. In an emergency, the lack of suitable donor tissue can potentially lethal or permanent deterioration of the quality of life lead (z. B. amputations of limbs).


In July 2007, the law on donation, removal and transplantation of organs and tissues (Transplantation Act) was amended and adopted in a separate tissue Act. The Tissue Law regulates the use of human tissues and cells, as well as medical grafts made from human tissue. Nevertheless, the potential application of innovative technologies in the field of extraction and processing of tissues is still largely in its infancy. That should change with the pioneering Anglo-German co-operation.

The cornerstone was laid last year with the creation of non-profit tissue bank Mecklenburg-Vorpommern (GBM-V) and the non-profit Society of transplantation medicine Mecklenburg-Vorpommern (GTM-V gGmbH) in Rostock. The GBM-V, the first multi-tissue bank of its kind in Germany, is located in the Biomedical Research Center Rostock (BMFZ) and Member of Biocon Valley eV initiators of the new path in the tissue medicine in Mecklenburg-Vorpommern are the Rostock Doctors Dr. Frank -Peter Nitschke (55) and Dr. Axel Manecke (46) with years of experience in the field of transplantation medicine. The companies pursue exclusively charitable purposes in the field of tissue medicine.

Inform improve and demand of donor tissues: Objective 1

The cooperating GTM-V served with the tissue bank Mecklenburg-Vorpommern in Rostock as one of the few institutions in Germany the full range of post-mortem donation (removal of corneas, bones, tendons, skin, heart valves, blood vessels after death) and a part of the living donor (heart valves). "Also, the area of ​​living tissue donations in future we will fully insure," Nitschke announced. This applies to donations from the Geburtsplanzenta (amnion - caul of the amniotic sac) and musculoskeletal tissues (muskuloskelettal). "The removal of the post-mortem donation is basically with their own medical professionals and in close cooperation with the hospitals."

Last year, in a very short time into an agreement with the Society of transplantation medicine Mecklenburg-Vorpommern (GTM-V) have already eleven hospitals closed in MV. Three clinics them new integrated into the network. The donation program the GTM-V was launched in July 2015. The number of donations or removed tissue is steadily rising. "We attach great importance to comprehensive information about the tissue donation and transparency in dealing with human transplants," underlined Dr. Frank-Peter Nitschke.

The removed tissue preparations are being processed even in cooperating tissue banks for transplants. In the field of corneal transplantation production capacity currently stands at 78 percent. A new method to increase the Transplantabilität to over 95 percent. In the area of ​​cardiovascular and musculoskeletal tissues this already amounts to 100 percent. "In principle it is possible to meet the demand for tissue donation," the transplant physicians firmly believe.

"Due to the new manufacturing technologies, the number of transplants rises, particularly in corneas, heart valves, blood vessels and skin. We assume that the number of currently about 8,000 corneal transplants will increase in the future to about 12,000, in cardiac or vascular grafts, there are approximately 1,000 be nationwide annually. The need for skin grafts is enormous, especially in chronic wounds, after burns, accidents and cancer surgeries. "

Objective 2: Innovative method to avoid rejection reactions

The collaboration with Tissue Regenix to secure especially access to regenerative transplants on the basis of cell-free tissue scaffolds for affected patients. "Core point is the patented technology of dCELL® Tissue Regenix" said Antony Odell. "Tissue Regenix works internationally with leading research institutions in this field, such as with the University of Leeds, which is one of the most respected research institutions in the field of bioengineering worldwide. Company headquarters is in Yorkshire with a US subsidiary in San Antonio, Texas (Tissue Regenix Woundcare, Inc.). The current focus of Tissue Regenix lies in the areas of wound care, orthopedics and cardiac and general surgery. "

The dCELL® technology removes the genetic material (DNA) and the cellular material from the donor tissue and leaves a cell-free scaffold, on which is the patient's cells colonize and regenerate so that the new tissue is not recognized by the body as foreign and therefore not rejected ,

It all started with the development of dCELL® heart valves made from human tissue. The current possibilities of valve replacement in particular for younger patients is not satisfactory because either a lifetime with many risks anticoagulant drugs have to be taken or because of the high immune reactions, the biological grafts have only a limited shelf life and reoperations are necessary. Even the older generation is benefiting by increasing their life expectancy of this technology. dCELL® heart valves are implanted ten years now. More than 1,500 patients have so far been supplied successfully with these transplants. The most recent publications in the European Journal of Cardio -Thoracic Surgery, one of the most prestigious cardiac surgery journals, the advances show (: 10.1093 / ejcts / ezu013, DOI: DOI 10.16 / jathoracsur.2010.08.022). Patients with a fresh decellularized pulmonary valve had not yet be reoperated fold due.

Another application is "DermaPure" decellularized skin Tissue Regenix has recently introduced in the United States. DermaPure originally served specifically the treatment of diabetic wounds, but also proves to be in the treatment of other chronic wounds to be very effective. In orthopedics the focus is on partial Meniskusersatz and injuries of the anterior cruciate ligament. Currently running the first clinical trials in Europe, based on porcine dCELL® tissue (porcine derived).

"The development of innovative transplants is an important part of our work", emphasized Dr. Frank-Peter Nitsche. One partner, for example, the Leibniz Institute for Plasma Science and Technology eV Greifswald (INP). By means of the application of physical plasma is to be bacterial contamination of tissue or reduced almost completely excluded in order to prevent the transmission of infections. Furthermore, in addition to the cooperation with Tissue Regenix researches in the field of increase of tissue sampling and quality, among others, corneas, planned.

Outlook - what happens next?

Following the acquisition of licenses of Tissue Regenix authorizations for patient care with corneas, heart valves and vessels are requested by conventional and innovative manufacturing processes when Paul Ehrlich Institute in Langen this year. For the new technologies (dCELL®) necessary for the application procedure and preparatory studies are carried out. "Next year we want to start with the production of better tolerated grafts and the first patient enough to supply," says Nitschke.

The basis for the work of the tissue bank is a functioning donation program and collaborations with tissue banks. Here partnerships will be with other facilities closed. Gradually also want to come to the team now seven-member another ten employees.
The tissue bank Biomedical Research Center Rostock has about 90 square meters of production area of ​​the clean room class AD. With increasing production capacity, the plant will be too small in about three years. The development of additional clean room capacity is in the planning.

"The educational work and transparency in dealing with human donations is an important concern to us", emphasized the CEO of the tissue bank, Nitschke and Odell. "The GBM-V will constitute a scientific advisory board with far-reaching control rights among others. The members will be experts in the subject areas of ophthalmology, general surgery, cardiac and vascular surgery. Trust is the foundation of our work. With this high estate from the beginning we want to be very careful. "

Background information

Tissues Medicine represents a significant portion of transplantation medicine. It is estimated that more than 52,000 tissue transplantation are performed annually in Germany, far more than organ transplants. 2015 received nationwide 3,083 patients a donor organ.

In contrast to donate organs, tissues are not the same transplanted. In tissue banks quality tissue grafts are prepared from the removed tissue preparations. In medical care especially corneas, heart valves, bones, tendons and fascia, as well as blood vessels and skin are used as tissue grafts.

In Germany there are currently about 26 tissue banks with a permit for the extraction of tissue in the area of ​​post-mortem donation. The donor programs are organized universitär (11), in gGmbH (6) or GmbH (2). The tissue bank Mecklenburg-Vorpommern is cooperating in the field of tissue donation with the GTM-V.

The main tissue donations

Tissue transplantation lead primarily to an improvement in the quality of life and to accelerate social reintegration and working capacity of patients and save lives in emergency situations.

Heart / heart valves
Damage to the heart valves are the result of calcification, infection, or heart attacks. Rarely is an injury since birth. Damaged heart valves can eventually lead to a functional weakness of the heart, which reduce the efficiency of those affected dramatically. Possible therapies are the reconstruction of the heart valve in the context of a surgical operation on the heart or the replacement of the heart valve through a transplant.

Blood vessels
Narrowing vessels in the course of life due to deposits or clogging completely, this is particularly dangerous for the heart and extremities (legs). At the heart of the blockages can lead to a heart attack. On the legs vasoconstrictions or -verstopfungen lead to pain and restricted movement, in advanced cases, threatened with amputation. In vascular surgery human blood vessels are used to replace narrowed or clogged blood vessels (bypass surgery). Likewise, grafts for vascular reconstructions, especially the replacement of infected prosthetic plastic used. The latter are often life-saving emergency surgery.

Tendons and ligaments
Tendons and ligaments are transplanted to maintain or restore the stability and flexibility of the joints and to prevent artificial stiffening of the joints. Bone material replaces lost tissue among others by accident or tumor operations and preserves the patient from amputation. Rarely, however vital, is the use of the connective tissue sheath of the anterior thigh muscle (fascia lata) for the immediate surgical closure of congenital defects, for example, the abdominal wall in newborn babies.

Eye donation
The cornea of ​​the eye (cornea) is also referred to as the windshield of the eye. A smoothly curved and completely clear cornea leads to a clear vision. Diseases of the cornea (corneal curvature or corneal opacities) may have different causes and cause untreated for a reduced visual acuity ultimately to blindness. A corneal transplantation (keratoplasty) can save patients from blindness or give them back their sight. The diseased cornea of ​​the patient or parts will be replaced by it by a donor cornea.

skin
The skin is the largest human organ. Skin grafting is often necessary for the care of patients with severe defects such as large-scale skin after burns and chronic non-healing wounds. This can save the skin donation life in extensive burns (> 70% body surface area). Conditional loss of soft tissue tumors and hernias are successfully treated with skin preparations.

For more information visit www.organspende-info.de/organ-und-gewebespende/organe/gewebe

25 years of experience in transplantation medicine

Dr. med. Frank-Peter Nitschke was born in Rostock and has studied human medicine in the Hanseatic city. This was followed by a residency at the Department of Urology at the University of Rostock. From 1995 to 2000 the 55-year-old worked as a urologist. Since 1992 to 2000 he was also the coordinator of organ donation and transplantation at the Department of Urology and Surgery at the University of Rostock for the state of Mecklenburg-Vorpommern and then from 2000 to 2007 Medical Coordinator of the German Organ Transplantation Foundation (DSO) for MV. From 2003 organized Nitschke building the tissue donation for Mecklenburg-Vorpommern (DSO-G). From 2007-2015 he served as Medical Director of the German Society for Tissue Transplantation (DGFG). Since 2015 he is the managing doctor of the Society of transplantation medicine Mecklenburg-Vorpommern gGmbH (GTM-V) and managing director of the tissue bank gGmbH Mecklenburg-Vorpommern (GBM-V).

Dr. med. Axel Manecke also studied medicine at the University of Rostock and went through a residency at the Department of Urology at the University of Rostock. From 1998 to 2000, the native of Rostock coordinator for organ donation and transplantation at the Department of Urology and Surgery at the University of Rostock for the state of Mecklenburg-Vorpommern and from 2000 to 2008 Medical Coordinator of the German Organ Transplantation Foundation (DSO) for MV. Together with Nitschke he has built the tissue donation in Mecklenburg-Vorpommern from 2003 onwards. In period from 2008 to 2015, the urologist and experienced transplant physicians acted as Regional Director tissue donation in Mecklenburg-Vorpommern at the German Society for Tissue Transplantation (DGFG). The 46-year-old is as Dr. Frank-Peter Nitschke Managing Doctor of the Society for Transplantation Medicine Mecklenburg-Vorpommern gGmbH (GTM-V).

Source: GBM-V tissue bank Mecklenburg-Vorpommern gGmbH, Photos: GBM-V / Joachim Kloock

[bamboo2] 26/1/2016 14:49

Ig, yes, this JV, and all the talk about starting to see the co as three seperate entities suggests to me that any potential cash raising will be for specific products, rather than company wide refinancing.

[igbertsponk] 26/1/2016 14:32

Nice that they're already in discussions to do this in other countries too. Should reduce the cash needed to roll out worldwide.

[bamboo2] 26/1/2016 14:17

26 January 2016

Tissue Regenix Group plc

Joint Venture Agreement

York, 26 January 2016 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix" or "The Group") announces first step towards the commercialisation of human dCELL(R) heart valves and DermaPure(R) in the EU through a Joint Venture Agreement with German tissue bank.

Highlights

-- Joint Venture Agreement ("JVA") entered into with GTM-V to form GBM-V gGmbH ("GBM-V"), a tissue bank based in Rostock, Germany

-- Non-exclusive licences granted to GBM-V for human dCELL(R) heart valves & DermaPure(R) covering the EU

-- First licence granted for dCELL(R) heart valves
-- Regulatory submissions to German authorities being prepared by GBM-V
-- First products targeted to be launched in 2017 subject to regulatory approval

-- The Group anticipates replicating this business model in other countries, with initial discussions already held

The establishment of the JVA is an important milestone in the Group's overall commercialisation strategy, allowing Tissue Regenix to licence its patented dCELL(R) technology process for human tissue for the first time in the EU, in anticipation of bringing to market a portfolio of decellularised human tissue treatments subject to regulatory approval. Entering the JVA with GTM-V, who will be responsible for sourcing the donated tissue, the Group will be making an initial investment of EUR250,000 under the JVA to fund development and distribution.

The JVA allows Tissue Regenix to work with an accomplished group of individuals at GBM-V, with over 20 years of tissue medicine experience, who will produce and distribute the Group's decellurised tissue treatments in accordance with German regulations. The regulatory submissions to the German authorities to obtain approval are being prepared by GBM-V and the Group currently anticipates launch of its treatments under the JVA initially in Germany in 2017, with European wide distribution to follow.

Importantly, this is the first licence Tissue Regenix has granted for decellularised human heart valves, which is supported by 10 years of clinical data from Professor Francisco da Costa's pioneering work at the Pontifical Catholic University of Paraná (PUCPR), Brazil, validating the safety and success of the treatment. GBM-V's experience will also be important to the Group in developing improvements to human tissue applications of the dCELL(R) technology.

Antony Odell, CEO of Tissue Regenix said:

"This is a key agreement for Tissue Regenix, because it is an important step forward towards establishing dCELL(R) as a truly global brand. We see this as a business model that the Group can replicate elsewhere and we have already begun discussions with a number of potential tissue bank partners in other countries.

The establishment of this JVA will ultimately allow European clinicians and patients access to two clinically proven treatments. Germany is particularly stringent with its human tissue regulations, which provides a high benchmark from which wider EU approvals can follow.

We feel that this agreement reiterates the strength of our technology base and offers us a unique commercial opportunity. GBM-V is an important partner for the future of Tissue Regenix and we greatly look forward to working with the team."

Dr Frank Peter Nitschke, Managing Director, GBM-V said:

"We see this joint venture as an exciting opportunity to utilise Tissue Regenix regenerative medical technology, dCELL(R), and bring to European patients a portfolio of products that have the potential to change the treatment and recovery of many.

We believe that with our expertise dealing with human tissue, and Tissue Regenix's experience we will build a strong and successful partnership."

[luminoso] 26/1/2016 14:14

Another 500k sell or perhaps a matching trade with the earlier one ?
Might see a holdings rns soon, maybe.

[rayrac] 26/1/2016 13:52

Yes, and I was expecting to hear/see a comment from bamboo?

Anyway, it's more validation for TRX!

[igbertsponk] 26/1/2016 12:34

Nice little JV launched for heart valves with Germans.

[channel pirate] 26/1/2016 12:16

Wow, a 500,000 sell this morning - wish I had that many in my portfolio

[rayrac] 25/1/2016 11:14

Didn't mention I sold 30,000 about 8/10mths ago... 70k remaining...might regret selling those!

[rayrac] 25/1/2016 11:07

Rights issue would be fine, but not going to happen?

[igbertsponk] 25/1/2016 08:34

Hmm... paid for report signalling additional cash needed this year. Can't see the share price rising for a while with that hanging over it.

[rayrac] 25/1/2016 08:12

That's the one, bamboo.

[bamboo2] 25/1/2016 08:01

Tissue Regenix Group PLC

25 January 2016

Hardman & Co issues research report on Tissue Regenix Group plc

From development - into the commercial world: Tissue Regenix is no longer an R&D play. Its dCELL(R) technology allows for the production of 'like-for-like' tissue specific, structure-preserving scaffolds that have been validated in multiple clinical settings. Following the US launch of DermaPure(R), we expect a series of further product launches over the next two years in Orthopaedic Sports Medicine and heart valve replacement, substantial markets with significant unmet medical need. The Company continues to build long term value despite short term monthly cashburn of () GBP0.8m. An NPV of 42p is driven by three core product areas; the true value of the platform and product streams has still to be elucidated.

Please click here for the full report:

[rayrac] 25/1/2016 07:59

No longer an R&D company! But we are 'unsophisticated retail customers' so probably are not aware that kind of fact?

[luminoso] 23/1/2016 19:59

From Edison in my in box recently

[igbertsponk] 21/1/2016 08:53

Grizzly, but miraculous outcome. How are we stuck at a measly $1m sales ??!!!

[rayrac] 21/1/2016 07:45

That's a great find bam! Could it be used for skin cancer, post op? I have 2 friends who have had facial skin grafts taken from their hip area. I'm not impressed with the results, would it be better with Dermapure?

[bamboo2] 20/1/2016 23:14

Interesting case here of Dermapure used in a post MOHS patient...
[graphic]

68 year old male with Bilateral Basal Cell Carcinoma Excision. DermaPure applied with 100% healing in 4 weeks.

[rayrac] 20/1/2016 17:41

Well put Andrew!

The only blue among more than 50shares I have on watch.

Becoming a true bear market! At least 2 years of pain in the making....

[andrewbaker] 20/1/2016 13:15

When markets are like they are now, businesses like TRX are a welcome haven. They are producing new innovative product that will always be in demand, and barriers to entry for competitors are so high. They suffer when nothing much is happening, because holders get stale/bored and sell; but ultimately, barring a black swan happening, they will succeed regardless of general stock market ups and downs. This is truly a bottom-up business in which to invest.

Disclosure: long, and staying so.

[rayrac] 20/1/2016 09:11

Well I did see that... But it's a new one to me.

Anyway, I still got my usual rns email. Info enough?

[igbertsponk] 20/1/2016 09:05

Its only an RNS NON.

[rayrac] 20/1/2016 09:04

Could someone explain why there's no rns showing on advfn?

[rayrac] 20/1/2016 08:14

Dropping? Bits of news has to occur if it's a fact. Whether that means even more than that, I wouldn't like to presume. But I cannot believe this co and its products, are not on someone's wish list!

[bamboo2] 20/1/2016 08:14

Ig, I'm pretty sure that the co is alright for cash over the next few years, particularly now that there is some sales income.