Overview
Orthopaedics
A regenerative approach to tissue repair and return to pre-injury activity, using 2 innovative technology platforms:
- dCELL® for soft tissues
- BioRinse™ for bone products
An acute soft tissue joint injury can significantly affect the quality of life of a previously healthy and active individual.
The team at TRX Orthopaedics are changing the way health care professionals are able to treat these injuries.
Our patented dCELL® Technology products provide a natural and biologic alternative to harvesting and transplanting the patient’s own ligaments or tendons, eliminating any donor site complications (a second surgical site), supporting a replicable surgery, saving operating room time and simplifying rehabilitation.
Our dCELL® Technology is being used to develop new regenerative approaches to repairing damaged knees.
With an aging population, increasing number of sports related injuries and rising levels of obesity, the global orthopaedic market is currently valued at an estimated $46bn with the sports medicine sector valued at $4.5bn.
Tissue Regenix is addressing these problems through their portfolio of biological regenerative solutions.
Applying the dCELL® technology to various tissues; OrthoPure™ XT (porcine tendon) produces a scaffold to replace the damaged tissue that will re-populate with the patient’s own cells.
dCELL® Technology also offers the surgical team a strong and consistently sized scaffold with makes surgical planning simpler and the surgery faster and more reproducible. The OrthoPure™ XT implant requires no special storage conditions, it is transported and stored at ambient temperature which helps improve operating room efficiencies and logistics.
The company is currently conducting clinical trials within the EU and data has been submitted for CE approval.
OrthoPure™ XT is currently not available in the US under FDA regulations.
BioRinse™
All products processed by CellRight Technologies® are processed using CellRight's proprietary BioRinse™ sterilisation technology, and in accordance with AATB Standards and FDA federal regulations. BioRinse™ is CellRight Technologies® validated steriliszation process that uses proprietary rinsing agents in multiple combinations designed to kill pathogenic microorganisms, vegetative bacteria and spores. These steps include the removal of debris, blood, bone marrow and lipids, components associated with disease transmission. The BioRinse™ process is a technologically advanced science developed by CellRight Technologies® for use in product families including CellRight Technologies® verified* osteoinductive Matrix OI®, MatrixCellect® 100 DBM putty, MatrixCellect® 100 DBM Crunch, ConCelltrate® 100; and its sports medicine, dental, and conventional products. BioRinse™ in combination with our final low dose sterilisation step under low-temperatures ensures a medical device sterility assurance level (SAL) of 10 -6 in accordance with a Sterile "R" claim.
*Each lot, post-sterilisation is verified for osteoinductivity.
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