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Pin to quick picksTissue Regenix Group Regulatory News (TRX)

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CE Mark Grant

10 Aug 2010 07:00

RNS Number : 7947Q
Tissue Regenix Group PLC
10 August 2010
 



 

 

Tissue Regenix Group Plc

 

("Tissue Regenix" or the "Company")

 

Tissue Regenix receives approval to commence sales of it's lead product

The dCELL® Vascular Patch

 

 

YORK, 10 August, 2010 - Tissue Regenix, a medical technology company focused on the development and commercialisation of acellular tissue replacement products to address the chronic global shortfalls in donor tissue availability, today announces that it has received European CE Marking for its dCELL® Vascular Patch.

The dCELL® Vascular Patch is a sterile, non-cellular biological scaffold manufactured to the highest quality and safety standards from porcine pericardium which is intended to be permanently implanted into the human body for vascular repair.

Tissue Regenix, joined AIM in June via a reverse takeover of Oxeco plc, and will manufacture the dCELL® Vascular Patch at its York facility.

Tissue Regenix will now be simultaneously working towards receiving FDA approval for the US.

The next product on which Tissue Regenix intends to focus is the dCELL® Meniscus, for the repair of damaged knee meniscus.

John Samuel, Tissue Regenix Executive Chairman, said: "The granting of a European CE mark for the dCELL® Vascular Patch, our first product approved for launch, is an historic moment for Tissue Regenix. As well as providing access to some of the world's largest medical devices markets, today's announcement acts as a validation of our dCELL® technology platform."

The dCELL® Vascular Patch is manufactured using Tissue Regenix's proprietary technology platform, dCELL®, used to remove cells and other components from human and animal tissue allowing them to be used without anti-rejection drugs to replace worn out or diseased body parts.

Enquiries:

Financial Dynamics

Ben Atwell / John Dineen

+44 (0) 20 7831 3113

 

Tissue Regenix Group plc

Antony Odell

+44 (0) 1904 567 609

 

ZAI Corporate Finance Ltd

John Depasquale /Sarang Shah

 

+44 (0) 20 7060 2220

 

About Tissue Regenix

 

Tissue Regenix was incorporated in May 2006 to commercialise the academic research of Professor Eileen Ingham and Professor John Fisher from the University of Leeds in the field of tissue decellularisation. Its dCELL® Technology comprises a patented process which removes cells and other components from human and animal tissue allowing it to be used without anti-rejection drugs to replace worn out or diseased body parts.

 

About dCELL® Technology

 

The process comprised within the dCELL® Technology involves the production of biological scaffolds created by taking a piece of human or animal tissue that is equivalent to the diseased or damaged body part which is being replaced, treating such tissue with a series of gentle chemical washes and then sterilising it. The end product is a scaffold which can be stored under normal conditions at room temperature like any synthetic medical device and, when it is implanted into the body, it repopulates with the patient's own cells using natural biological repair mechanisms.

Tissue Regenix's strategy is to continue to use its core dCELL® Technology as a platform to develop a range of products using the established medical device regulatory pathway to deliver solutions to unmet clinical needs. The three priority markets for the application of the technology are: Vascular (e.g. Vascular Patches); Cardiac (e.g. Heart Valves); and Orthopaedics (e.g. Meniscus).

 

 

 

 

 

 

This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
REASSDFMUFSSEEA
Date   Source Headline
25th Apr 20242:27 pmRNSResult of AGM
10th Apr 20247:15 amEQSHardman & Co Research on Tissue Regenix (TRX): Six consecutive periods of >20% growth
5th Apr 20243:52 pmRNSHolding(s) in Company
19th Mar 20247:00 amRNSFinal results for the year ended 31 December 2023
1st Mar 20247:00 amRNSNotice of Results
6th Feb 20247:00 amRNSFirst EU shipment & new distributor agreements
29th Jan 20243:02 pmRNSHolding(s) in Company
25th Jan 20247:00 amRNSTrading update for 2023
23rd Jan 20245:24 pmRNS2023 LTIP Grant
22nd Nov 20234:36 pmRNSHolding(s) in Company
30th Oct 20237:00 amRNSHPRA approval & distribution agreement in Spain
18th Sep 202310:40 amEQSHardman & Co Research on Tissue Regenix (TRX): Continuing postive momentum 1H'23
15th Sep 20234:30 pmRNSDirector/PDMR Shareholding
5th Sep 20237:01 amRNSNew sports medicine product launch
5th Sep 20237:00 amRNSInterim results
31st Aug 20231:45 pmRNSExercise of Options and Total Voting Rights
21st Aug 20237:00 amRNSNotice of interim results
17th Jul 20237:00 amRNSHalf-Year Trading Update
10th Jul 20237:00 amRNSDistribution agreement for OrthoPure® XT in the UK
25th May 20237:00 amRNSDistribution agreement with Australian Allografts
9th May 202312:00 pmRNSHolding(s) in Company
27th Apr 202312:35 pmRNSResult of AGM, Share Reorganisation &TVR
18th Apr 20237:00 amRNSProposed Share Reorganisation Timetable
5th Apr 20232:55 pmEQSHardman & Co Research on Tissue Regenix (TRX): Turning profitable and cash-generative
5th Apr 20237:00 amRNSCEO and CFO Share Purchases
30th Mar 20237:00 amRNSHolding(s) in Company
21st Mar 20237:00 amRNSFinal results for the year ended 31 December 2022
6th Mar 20237:00 amRNSNotice of results and Investor presentation
31st Jan 20237:01 amRNSTrading update for 2022
31st Jan 20237:00 amRNSChange of Adviser
18th Jan 202310:06 amRNSHolding(s) in Company
18th Jan 20237:00 amRNSChinese distribution agreement for OrthoPure® XT
7th Dec 20227:00 amRNSProduct launch in dCELL® division
22nd Nov 20227:00 amRNSDistribution agreement - OrthoPure® XT in Germany
14th Nov 20226:05 pmRNSHolding(s) in Company
7th Nov 20222:35 pmRNSHolding(s) in Company
29th Sep 202210:13 amRNSDirector/PDMR Shareholding
27th Sep 20227:15 amEQSHardman & Co Research on Tissue Regenix (TRX): Operating leverage
7th Sep 20227:00 amRNSHalf-year Report
22nd Aug 20223:31 pmRNSHolding(s) in Company
18th Aug 20225:36 pmRNSHolding(s) in Company
18th Aug 20222:10 pmRNSHolding(s) in Company
11th Aug 20224:30 pmEQSHardman & Co Research: Q&A on Tissue Regenix Group plc: Significantly undervalued which should correct
11th Aug 202212:46 pmRNSHolding(s) in Company
11th Aug 202212:17 pmRNSHolding(s) in Company
11th Aug 20227:00 amRNSConfirmation of Interim Results
5th Aug 20223:19 pmRNSHolding(s) in Company
1st Aug 20223:14 pmRNSHolding(s) in Company
19th Jul 20222:30 pmEQSHardman & Co Research : Tissue Regenix (TRX): Strong 1H’22 sales suggest upside potential
19th Jul 20227:00 amRNSHalf Year Trading Update and Notice of Results

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