Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

("Tissue Regenix" or "the Group")

Launch of DermaPure® Meshed and VNEWTM

Both line extensions to the Biosurgery division, utilising the dCELL® Technology platform

Tissue Regenix (AIM: TRX), the regenerative medical technology company, announces the launch of DermaPure® Meshed and VNEWTM, both line extensions to the Company's BioSurgery division, utilising Tissue Regenix's patented decellularisation ('dCELL®') Technology.

DermaPure® Meshed provides surgeons with a customised new DermaPure® option that eliminates time consuming manual meshing in the operating room, allows for wound fluid egress, thereby optimising patient outcomes and is meshed to provide an expansion area of 1.8X, allowing for greater surface area coverage. The product is targeted for use by general, plastic and trauma surgeons who treat patients with conditions that result in loss of integumental tissue (skin), requiring replacement, repair, or reconstruction. DermaPure® Meshed is a niche addition to our current portfolio for our customer base.

VNEWTM is available exclusively through the Company's distribution partner ARMS Medical ('ARMS'), which it entered into a multi-year exclusive distribution agreement (the "Agreement") with in 2018. The Agreement granted ARMS exclusive rights to distribute DermaPure® to hospitals and surgeons throughout the US for use in urology and gynecology procedures, focused on women's pelvic health issues. VNEWTM, the pre-shaped, pre-cut acellular dermal allograft, is designed to facilitate pelvic organ prolapse surgical procedures intended to repair, reconstruct, and reinforce damaged or weakened tissue. Approximately 300,000 women annually undergo surgery for pelvic organ prolapse1. Tissue Regenix has already fulfilled its initial stocking order for VNEWTM.

Both products utilise the Company's patented dCELL® Technology, which unlike alternative processes, removes 99% of DNA and other cellular debris with virtually no structural disruption, differentiating itself from other technologies, thus providing optimal repair, replacement, and / or reconstruction of the damaged extracellular matrix, as well as providing structural support, allowing the patient's living, native cells to populate and integrate ultimately achieving the surgeons' goal of soft tissue healing. 

Daniel Lee, CEO of Tissue Regenix, commented: "We are pleased to launch two new products using our patented dCELL® Technology, extending our product lines and helping drive market penetration with our diversified portfolio."

1Enemchukwu EA. Transvaginal Suture-Based Repair. Urol Clin North Am. 2019 Feb;46(1):97-102. doi: 10.1016/j.ucl.2018.08.004. PMID: 30466707.

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About Tissue Regenix (www.tissueregenix.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 worn-out body parts. Current applications address many critical clinical needs such as sports medicine, heart valve replacement 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 soft tissue scaffolds that enhance healing opportunities of defects created by trauma and disease. CellRight's human osteobiologics may be used in spine, trauma, general orthopaedic, foot & ankle, dental, and sports medicine surgical procedures.