CellRight Technologies

The industry leader of regenerative matrices, committed to providing clinicians and their patients with verified Osteoinductive implants known to positively impact patient and fusion outcomes. 

CellRight Technologies

The industry leader of regenerative matrices, committed to providing clinicians and their patients with verified Osteoinductive implants known to positively impact patient and fusion outcomes. 

CellRight Technologies® has developed processes that transform human bone  into a malleable type 1 collagen scaffold  in a manner which preserves native Bone Morphogenic Proteins (BMPs) and Growth Factors (GFs).

CellRight's bio-active regenerative scaffolds may be used in spine, trauma, total joint arthroplasty, foot & ankle, dental, and sports medicine surgical procedures.

In-vivo and in-vitro testing to verify osteoinductivity is performed post-sterilization by an independent testing laboratory using validated osteoinductivity test methods.

CellRight Technologies® is located in Universal City, Texas, and is housed in a state-of-the-art facility.

CellRight Technologies® is registered with the US Food and Drug Administration (FDA), accredited by the American Association of Tissue Banks (AATB), licensed in the states of NY, MD, FL, CA, and registered with the Canadian Ministry of Health (CTO) to distribute human osteobiologic implants.

All implants produced by CellRight Technologies are processed using CellRight's proprietary BioRinse™ sterilization technology, and in accordance with AATB standards and FDA federal regulations. BioRinse™ is CellRight Technologies® validated sterilization 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.

Products

    • CellRight® Technologies offers patients and surgeons advanced science in its comprehensive portfolio of dental biologics. Find out more...

    • Many general surgical indications, including breast reconstruction and pelvic floor reinforcement can involve the use of a graft to reinforce the damaged area and support the patients own tissue. Find out more...

      Products

      Matrix OI® Dermis | Amnion | DermaPure

Regulatory & Quality

CellRight Technologies® employs strict quality assurance and quality control procedures to ensure patient safety. Our Medical Director, a licensed physician, performs an extensive medical review of the donor medical/social history for donor eligibility. Only donors whose screening, serologic, and microbiologic tests meet or exceed current standards established by the US Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB) are accepted for processing and transplantation.

Accreditation & Licenses

Federal Food and Drug Administration (FDA) Registration # 3009234552 American Association of Tissue Banks (AATB) Accreditation # 00212 California Tissue Bank License # CNC 80949 New York Tissue Bank License # CP173TP141TS145 Maryland Tissue Bank License # TB1898 Florida Tissue Bank License # 212

BioRinse™ Processing

All products processed by CellRight Technologies® are processed aseptically using CellRight's proprietary BioRinse™ sterilization technology, and in accordance with AATB standards and FDA federal regulations.

BioRinse™ is CellRight Technologies® validated sterilization 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® osteoinductive in-vivo verified Matrix OI®, MatrixCellect® 100 DBM putty, MatrixCellect® 100 DBM Crunch, ConCelltrate® 100, sports medicine, and conventional products.

BioRinse™ in combination with our final low dose sterilization step under low-temperatures ensures a medical device sterility assurance level (SAL) of 10-6 in accordance with a Sterile "R" claim.

Safety

CellRight Technologies® employs strict quality assurance and quality control procedures to ensure patient safety.

CellRight’s medical director, a licensed physician, performs an extensive medical review of the donor’s medical/social history to determine eligibility.

CellRight Technologies® only accepts donors whose screening, serologic, and microbiologic tests meet or exceed the current standards established by the Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB). Donor blood samples are tested by a CLIA licensed facility and must be found negative against infectious diseases such as Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, Syphilis, HIV-1/2 antibody, HIV-1 (NAT), HCV (NAT), and HTLV-I/II antibody. CellRight Technologies® products are processed aseptic in accordance with AATB standards and FDA federal regulations.

Grafts are sterilized using low-dose gamma irradiation to achieve a medical device sterility assurance level (SAL) of 10-6 . Sports medicine grafts are stored frozen between -40˚C to -80˚C, and have a shelf-life of up to 5 years from date of packaging.