Tissue Regenix Group Regulatory News (TRX)

 14 June 2013

Tissue Regenix pioneering dCELL® technology to be presented at prestigious heart valve event

Tissue Regenix plc ('TRX'), the regenerative medical device company, announces that Professor Francisco da Costa, the internationally renowned cardiac surgeon from Pontifical University of Parana, Brazil, and one of the company's long term clinical collaborators, has been asked to present his decellularised 'dCELL®' heart valve findings at the 7th Biennial Congress of the Society for Heart Valve Disease & Heart Valve Society of America in Venice, Italy, on 23rd June, 2013.

The study, which presents the use of decellularised human heart valves emerging as a better alternative to common pulmonary valve substitutes, uses the patented 'dCELL®' technology of Tissue Regenix. The data in the report has been accumulated from over 400 patients over an eight year follow-up period.[1]

Key findings of the study include:

·; Less immunogenic reaction

·; Lower and stable gradients up to eight years

·; No calcification

·; Partial re-population of the grafts

·; Particularly good results in younger patients

Tissue Regenix's dCELL® technology decellularises the heart valve, producing an inert heart valve. This can be implanted into the patient to act as a mechanical scaffold that is populated by the patient's own cells. The dCELL® heart valve regenerates to become part of the patient's body, providing a more durable repair with proven significantly reduced risk of rejection and infection.

Antony Odell, Managing Director of Tissue Regenix said: "We are pleased to see recognition for dCELL® heart valve technology by this internationally distinguished congress. It is an important step towards the company's commercialisation in this key area."

Professor Francisco da Costa, Research Partner of Tissue Regenix said: "In this single institutional study, dCELL® allografts have demonstrated superior results when compared to conventional cryopreserved allografts. In our experience, the decellularised valves seem to be providing superior reconstruction in these patients. It has been very gratifying to see such excellent results."

In April 2011, Tissue Regenix obtained exclusive worldwide commercialisation rights (excluding Brazil) to the data, which supports the commercialisation of 'dCELL® Heart Valve' and facilitates the company's entry into the $1.0bn global tissue heart valve market.

-ENDS-

For Further Information

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company's patented decellularisation ('dCELL®) technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient's body which can then be used to repair diseased or worn out 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.

Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercialises academic research conducted by our partners around the World.

Abstract:Objective: Evaluate the mid-term clinical and echocardiographic results of decellularized versus cryopreserved pulmonary allografts for RVOT during the Ross operation.

Methods:Methods: Between August 2005 and July 2012, 151 Ross operations were performed using a decellularized pulmonary valve allograft. For comparison, we matched 156 patients that received a cryopreserved allograft. Conduit dysfunction was defined as any peak gradient greater than 40 mmHg or insufficiency grade III or IV. The influence of age, ABO compatibility and z-value of the implanted allograft were specifically analyzed.By CT scan, calcium content on the cusps and conduit were investigated. Comparisons were made with linear regression analysis.

Results:Results: In the decellularized group, early mortality was 1.3% and late survival was 96.1±1.7% at 7 years. Peak gradients at hospital discharge was similar between groups, but during follow-up late gradients were significantly lower for the decellularized group (p = 0,004). Moderate or severe regurgitation was present in two cases of the decellularized group and in five of the cryopreserved. Conduit dysfunction was also significantly smaller in the decellularized (90±3.8%) versus the cryopreserved (83±3%) group (p=0,03) at seven years. There was no reoperation due to primary valve failure in the decellularized group, while two patients had reoperations for this reason in the cryopreserved group. In addition, decellularization eliminated age, ABO compatibility and allograft z-score as risk factors for the occurrence of elevated late gradients.By CT scan, no calcification on the conduit wall neither is the valve cusps of the decellularized allografts were observed up to seven years.

Conclusions:Conclusions: Decellularized allografts were superior to conventional cryopreserved allografts for RVOT reconstruction during the Ross operation up to seven years of follow-up, with lower late gradients, less pulmonary insufficiency and lower overall incidence of conduit dysfunction. In addition, decellularized allografts did no calcify during the 7 years of follow-up.