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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
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3rd Oct 20197:00 amRNSDermaPure Product Line Extension Launched
10th Sep 20197:00 amRNSUnaudited Interim Results
28th Aug 20197:00 amRNSAppointment of CFO
15th Aug 20197:00 amRNSAdditional manufacturing capacity secured
1st Aug 20197:00 amRNSDirectorate Change
8th Jul 20195:03 pmRNSHolding(s) in Company
20th Jun 20192:23 pmEQSHardman & Co Research: Tissue Regenix (TRX): Credit facilities expand cash runway to 2021
7th Jun 20192:55 pmRNSIssue of Equity and Total Voting Rights
4th Jun 20197:00 amRNSNotice of AGM
4th Jun 20197:00 amRNSSecures Credit Facilities of up to $20m
4th Jun 20197:00 amRNSAnnual Results for the year ended 31 December 2018
21st May 20197:00 amRNSCEO to return to full time duties
10th Apr 20197:20 amEQSHardman & Co Research: Tissue Regenix (TRX): Expanded GPO coverage secured
4th Apr 20197:26 amRNSExpands US GPO coverage for DermaPure
18th Feb 20197:00 amRNSChange of Adviser
6th Feb 201911:05 amRNSSecond Price Monitoring Extn
6th Feb 201911:00 amRNSPrice Monitoring Extension
4th Feb 20197:00 amRNSTrading Update
17th Dec 201811:56 amEQSHardman & Co Research: Tissue Regenix (TRX): 2018 in review: foundations laid for osteobiologics
6th Dec 20187:00 amRNSInterim Management Change
13th Nov 20187:00 amRNSPan European distribution agreement with Arthrex
29th Oct 20187:00 amRNSGareth Jones commences position as CFO
14th Sep 20187:16 amEQSHardman & Co Research: Tissue Regenix (TRX): Strategy delivering growth above expectations
3rd Sep 20187:00 amRNSUnaudited Interim Results
2nd Aug 201810:10 amEQSHardman & Co Research: Tissue Regenix (TRX): 1H'18 preview: organic plus inorganic growth
2nd Aug 20187:00 amRNSNotice of Interim Results
4th Jul 20187:00 amRNSAppointment of CFO
25th Jun 20187:00 amRNSHTA License granted and UK distribution Agreement
21st Jun 20187:10 amRNSTRX BioSurgery wins GPO Supplier Horizon Award
18th Jun 20187:00 amRNSIssue of Equity
24th May 201812:12 pmRNSResult of AGM
2nd May 20187:00 amRNSTRX BioSurgery GPO agreement with Premier, Inc.
27th Apr 20187:00 amRNSPosting of Annual Report and Notice of AGM
24th Apr 20187:00 amRNSDermaPure manufacturing at CellRight Facility
19th Apr 20183:29 pmRNSHolding(s) in Company
5th Apr 20187:17 amEQSHardman & Co Research: Tissue Regenix (TRX): CellRight hits the right note
26th Mar 20187:00 amRNSAnnual results for period ended 31 December 2017
16th Mar 20183:40 pmRNSPublication of Financial Results
8th Mar 20187:15 amRNSHardman & Co: Full-year 2017 - what to look for
6th Mar 20187:00 amRNSLong term distribution agreement with Arthrex, Inc
26th Feb 20187:00 amRNSNotice of Results
26th Feb 20187:00 amRNSLaunch of BioSurgery and new distributor agreement
2nd Feb 20187:00 amRNSIssue of Equity
22nd Dec 20179:30 amRNSIssue of Equity
1st Dec 20177:00 amRNSDirectorate Change
1st Dec 20177:00 amRNSIssue of Equity
2nd Nov 20177:00 amRNSAppointment of CEO

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