Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group Plc

Tissue Regenix's dCELL® aortic heart valve technology presented at prestigious EACTS congress

YORK, 20th October 2014 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix" or "the Group"), the regenerative medical devices company, has had a patient study into the efficacy of its dCELL® aortic heart valves showcased at the 28th Annual Meeting of the European Association of Cardio Thoracic Surgery (EACTS) in Milan.

Tissue Regenix's long-term clinical collaborator, Professor Francisco da Costa, presented an update based on nearly nine years of research data.

Professor da Costa has pioneered the use of decellularised aortic heart valve implants in human patients and the findings presented at the EACTS congress suggest that decellularised human aortic heart valves, developed using Tissue Regenix's patented dCELL® technology, could provide a more effective treatment than cryopreserved aortic valve substitutes.

Professor da Costa's study is the largest and longest-running study conducted globally into patient outcomes based on treatment with decellularised aortic heart valves, with aortic implants remaining the most commonly undertaken heart valve operation.

Professor Francisco da Costa, an internationally renowned cardiac surgeon from Pontifical University of Parana, Brazil, has amassed the data in his report from 86 patient implants undertaken at his institution between 2005 and 2014 with follow-up review and patient monitoring up to the present date. 

The study is also notable because the patients treated are in younger and harder to treat age groups, with the mean age of the cohort averaging 44 years-old, with patients ranging in age from children to older adults. All patients in the study are considered high risk due to conditions including recurrent endocarditis and third or fourth redo operations.

Key findings of the study include:

· The gradients, a first indicator of dysfunction, stayed very low and stable over the study period

· 94% of patients were free from more than moderate regurgitation (where blood leaks back through the aortic valve because the valve does not close properly. With each heartbeat, more blood than usual enters the heart and so it needs to work harder sometimes leading to failure)

· The patient´s diseased heart valve led to a pathological increase of the left heart chamber. After treatment this chamber remodelled towards normal

· Freedom from reoperation in this high risk group was 94% after 7 years

· Scans showed essential absence of calcification, a particular problem in younger patients

Professor Francisco da Costa stated: "We are very happy with the results in this young, high risk patient population, the incidence of reoperation is very low and the results are promising. The evaluation continues and we hope to see on-going progress based on this dCELL® regenerative medicine treatment."

Tissue Regenix's dCELL® technology decellularises human donor heart valves, producing an inert scaffold which is implanted into the patient to act as a mechanical scaffold that is partially 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 significantly reduced risk of rejection and degeneration.

The dCELL® heart valve technology is being developed to target a global tissue heart valve market which is worth in excess of $1.0bn a year. Aortic valve replacements represent the majority of heart valve replacement procedures currently undertaken.

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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.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States- 'Tissue Regenix Wound Care Inc.', as part of its commercialisation strategy for its dCELL® technology platform.