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Pin to quick picksTissue Regenix Group Regulatory News (TRX)

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HPRA approval & distribution agreement in Spain

30 Oct 2023 07:00

RNS Number : 6125R
Tissue Regenix Group PLC
30 October 2023
 

Tissue Regenix Group plc

('Tissue Regenix', the 'Company' or the 'Group')

 

HPRA approval & distribution agreement in Spain

 

HPRA approval to provide an Irish logistics hub for the distribution of allograft products in the EU

New exclusive distribution agreement for Tissue Regenix's allograft products in Spain

 

Tissue Regenix Group plc (AIM: TRX), the regenerative medical devices company, announces that it has received approval from the Irish Health Products Regulatory Authority ('HPRA'), allowing the Company to set up a logistics hub in Ireland for the distribution of its allograft products within the European Union ('EU').

 

The HPRA regulates medicines and devices in Ireland for the benefit of people and animals, inspecting companies and facilities which test, make or distribute health products to ensure that they comply with relevant standards and legislation.

 

Tissue Regenix has also signed an exclusive distributor contract with Spineart España SLU ('Spineart') for the distribution of its allograft products in Spain. Spineart is a privately held medical device company that operates in over 60 markets, focused on simplifying surgery by designing, developing and promoting safe and efficient solutions to spine surgeons, operating room teams and patients.

 

Daniel Lee, Chief Executive Officer of Tissue Regenix, commented: "Receiving HPRA approval is a great step for Tissue Regenix, as it will provide a logistics hub for the distribution of our allograft products to the European market. Following this, we are delighted to be partnering with Spineart to bring our allograft products to more customers in the EU. Spineart have a large global footprint that we hope in time can be leveraged to bring our products to more customers internationally."

 

For more information:

 

Tissue Regenix Group plc

www.tissueregenix.com

David Cocke, Chief Financial Officer

via Walbrook PR

Cavendish Capital Markets Limited (Nominated Adviser and Broker)

Emily Watts/Geoff Nash/George Dollemore - Corporate Finance

Nigel Birks/Harriet Ward - ECM

Walbrook PR (Financial PR and IR)

Tel: +44 (0)20 7933 8780

Alice Woodings

TissueRegenix@walbrookpr.com

 

About Tissue Regenix (www.tissueregenix.com)

Tissue Regenix is a leading medical device company in regenerative medicine. The Company's patented decellularisation technology (dCELL®) removes DNA and other cellular material from animal and human soft tissue, leaving an acellular tissue scaffold not rejected by the patient's body that can be used to repair diseased or damaged body structures. Current applications address many crucial clinical needs in sports medicine, foot and ankle injuries, and wound care.

 

In August 2017, Tissue Regenix acquired CellRight Technologies®. This biotech company specialises in regenerative medicine and is dedicated to developing high-quality, innovative tissue scaffolds to enhance healing opportunities in defects created by trauma and disease. CellRight's human tissue products may be used in spine, trauma, general orthopaedic, dental and ophthalmological surgical procedures.

 

 

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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
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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
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18th Jan 20237:00 amRNSChinese distribution agreement for OrthoPure® XT
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22nd Nov 20227:00 amRNSDistribution agreement - OrthoPure® XT in Germany
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29th Sep 202210:13 amRNSDirector/PDMR Shareholding
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7th Sep 20227:00 amRNSHalf-year Report
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11th Aug 202212:17 pmRNSHolding(s) in Company
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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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