Tissue Regenix Group plc

("Tissue Regenix" or "the Group")

Exclusive distribution agreement for OrthoPure® XT with Geistlich Biomaterials Italia

Tissue Regenix Group (AIM:TRX), the regenerative medical devices company, announces that it has signed an exclusive distribution agreement with Geistlich Biomaterials Italia ("Geistlich"), a subsidiary company of Geistlich Pharma AG, a global company with a focus on regenerative products for bone, cartilage and tissue, for the distribution of OrthoPure XT in Italy.

The OrthoPure XT decellularised xenograft ligament utilises Tissue Regenix's patented dCell® technology and is the only available non-human biologic graft indicated for certain ligament reconstruction procedures. OrthoPure XT was commercially launched in December 2020 after being awarded a CE Mark for revision of anterior cruciate ligament (ACL) reconstruction procedures and reconstruction of other knee ligaments, including multiligament and primary procedures when the autograft is unacceptable. The biocompatible implant provides a biomechanically appropriate tissue scaffold for cellular repopulation and eventual regeneration.

The multiyear distribution agreement covers Italy currently but also has the potential for extension to wider geographies. As part of the agreement, Geistlich has also committed to advance the clinical science surrounding OrthoPure XT which will be conducted at some of the leading institutions by clinicians in Italy.

Filippo Baldini, National Sales Manager for Geistlich Biomaterials Italia, commented: "Geistlich is excited to bring this new technology to the Italian market and serve the patient's needs with this innovative solution."

Prof. Stefano Zaffagnini of the Istituto Ortopedico Rizzoli in Bologna, Italy stated: "Our centre has demonstrated an interest in xenograft options for our patients and the OrthoPure XT has the potential to address needs in knee surgeries."   

Daniel Lee, Chief Executive Officer of Tissue Regenix, commented: "We are pleased to partner with Geistlich for our commercial efforts in Italy. Geistlich is a leader in regenerative products, so our commitments are aligned in delivering innovative products to advance patient care. We are excited to work with them to build the clinical experience with OrthoPure XT and introduce this transformative product to the Italian medical community."

Market Abuse Regulation (MAR) Disclosure

The information contained within this announcement is deemed by the Group to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 ('MAR'). Upon the publication of this announcement via Regulatory Information Service ('RIS'), this inside information is now considered to be in the public domain.

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About Tissue Regenix (www.tissuergenix.com)

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 soft tissue leaving an acellular tissue scaffold which is not rejected by the patient's body and can then be used to repair diseased or damaged body structures. Current applications address many critical clinical needs such as in sports medicine, foot and ankle, and wound care.

In August 2017 Tissue Regenix acquired CellRight Technologies®, a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease. CellRight's human osteobiologics may be used in spine, trauma, general orthopaedic, dental, and ophthalmological surgical procedures.

About Geistlich Pharma AG and Geistlich Biomaterials Italia s.r.l.

Geistlich Pharma AG develops, manufactures and markets medical devices for restoring bone, cartilage and soft tissue as well as drugs. The Swiss company Geistlich Pharma is part of the Geistlich Group and has been family-owned since 1851. Geistlich Pharma has a worldwide sales and distribution network with twelve subsidiary companies and more than 70 distributors. Geistlich Biomaterials Italia s.r.l. is a subsidiary company of Geistlich Pharma AG and markets products in regenerative dentistry, in orthopaedic and sports medicine within the territory of Italy.