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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
14th Feb 20137:00 amRNSSuccessful safety study of dCELL® Meniscus
11th Feb 20132:57 pmRNSDirectorate Change
9th Jan 20137:15 amRNSHolding(s) in Company
30th Nov 201211:21 amRNSTissue Regenix board changes
26th Nov 20127:00 amRNSSets up US subsidiary
19th Nov 20127:00 amRNSAdds new patent global licence portfolio
4th Oct 20127:00 amRNSInterim data from clinical trial of dCELL® Dermis
4th Oct 20127:00 amRNSHalf Yearly Report
1st Oct 201210:57 amRNSTissue Regenix - senior development appointment
28th Sep 20123:30 pmRNSNotice of Results
7th Sep 20127:00 amRNSdCELL(R) vascular patch is safe and effective
2nd Aug 20122:31 pmRNSTissue Regenix makes appointment to Cardiac team
31st Jul 20123:02 pmRNSDirector/PDMR Shareholding
19th Jun 20122:39 pmRNSHolding(s) in Company
14th Jun 20127:00 amRNSResearch Update
11th Jun 201212:35 pmRNSResult of AGM
25th May 20127:00 amRNSExpands scope of development activities with NHSBT
10th May 20127:00 amRNSFinal Results
19th Apr 20121:49 pmRNSPoster shown at SAWC
16th Apr 20123:18 pmRNSNotice of Results
7th Feb 20124:00 pmRNSIssue of Equity and Total Voting Rights
11th Jan 201211:36 amRNSHolding(s) in Company
6th Jan 20125:05 pmRNSHolding(s) in Company
3rd Jan 20125:45 pmRNSHolding(s) in Company
3rd Jan 20125:43 pmRNSHolding(s) in Company
3rd Jan 20128:49 amRNSHolding(s) in Company
28th Dec 201112:00 pmRNSResult of General Meeting
8th Dec 201112:53 pmRNSIssue of Equity
25th Nov 20112:23 pmRNSUniversity Partner wins Queen's Anniversary Prize
4th Nov 20112:16 pmRNSHolding(s) in Company
14th Oct 20112:33 pmRNSHolding(s) in Company
10th Oct 20117:00 amRNSHalf Yearly Report
26th Jul 201111:04 amRNSIssue of Equity
7th Jul 20113:52 pmRNSIssue of Share Options
5th Jul 20111:30 pmRNSIssue of Equity
22nd Jun 20118:35 amRNSReceives EUR280,000 Grant Funding
13th Jun 20117:00 amRNSDirectorate Appointment
3rd Jun 201110:02 amRNSAGM Statement
11th May 20117:00 amRNSPositive Results in Clinical Evaluation of dCELL
4th May 20117:00 amRNSFinal Results
21st Apr 20117:00 amRNSTissue Regenix enters commercialisation agreement
29th Mar 20117:00 amRNSDirectorate Change
10th Mar 20117:00 amRNSNotice of allowance of patent received
4th Jan 201111:27 amRNSHolding(s) in Company
30th Dec 20109:05 amRNSHolding(s) in Company
23rd Dec 201012:44 pmRNSChange of Adviser
21st Dec 201010:12 amRNSAdviser - Change of Name
16th Dec 20107:00 amRNSResearch Update
10th Dec 20109:20 amRNSChange of Adviser
26th Nov 20103:12 pmRNSChange of Registered Office

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