Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

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

Chinese distribution agreement secured for OrthoPure® XT

Tissue Regenix (AIM: TRX), the regenerative medical device company, announces that it has signed an exclusive distribution agreement with Kingsung Medical Group (Kingsung Medical), a Hong Kong-based medical enterprise, for the distribution of OrthoPure® XT in China.

The initial agreement is for six years and requires Kingsung Medical to purchase a minimum unit volume each year to maintain its exclusive status. As part of the agreement, Kingsung Medical and Tissue Regenix are mutually committed to advancing the clinical study of OrthoPure® XT to further support the regulatory approval process in China. Kingsung Medical is a medical technology group that integrates production, development and sales to provide world-leading medical technologies with exclusive value and service. It has direct sales teams in 10 cities in China as well as channel marketing sales and agents in every province to support clinics.

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. The CE-marked OrthoPure® XT can be used for the revision of anterior cruciate ligament (ACL) reconstruction procedures and reconstruction of other knee ligaments, including multi-ligament and primary procedures when an autograft is not an option.

Daniel Lee, CEO of Tissue Regenix, commented: "In the last year, we secured significant geographical partnerships in Germany and Italy and now in China for OrthoPure® XT. The market for ACL reconstruction in China is estimated to be in the range of 200,000-250,000 procedures per year, and this market needs additional graft options. As part of the agreement, both parties are committed to the advancement of clinical science surrounding OrthoPure® XT as part of the regulatory approval process for this market. We are delighted to be partnering with Kingsung Medical and hope this will be the start of a strong relationship as we continue to expand our geographical footprint into new territories."

Echo Liu, Chairman and President of Kingsung Medical Group, stated: "Adhering to the development philosophy of 'professional and innovation-oriented', Kingsung Medical has always been committed to providing surgeons and patients with the world's leading new technologies and products with unique clinical value.

"With the rapid development of sports medicine in China, we are delighted to introduce OrthoPure® XT to the Chinese market. We will accelerate the registration and launch of OrthoPure® XT in China and promote its emergence as a new option to allow patients with knee ligament injuries to achieve excellent treatment results earlier.

"We firmly believe that this new technology will inject impetus into the development of China's healthcare industry and benefit more patients."

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About Tissue Regenix (www.tissueregenix.com)

Tissue Regenix is a leading medical device 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 in sports medicine, foot and ankle and wound care.

In August 2017, Tissue Regenix acquired CellRight Technologies®, a biotech company that specialises in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds, which 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.