BACTERINⓇ International is located in Belgrade, Montana. BACTERIN holds the patent on OsteospongeⓇ, the world’s first demineralized cancellous bone sponge, and was first-to-market with this innovation in bone grafting. A vertically integrated tissue bank, BACTERIN is in full control of every step of donor selection, testing, processing, packaging, and distribution.
The company’s recent merger with X-Spine Systems has created an integrated company known as XTANTⓇ Medical, thereby expanding the company’s offering into unique surgical hardware. The Bacterin Biologics Division remains focused on the provision of innovative, market-leading tissue scaffolds for spinal fusion, foot and ankle, plastic surgery, and orthopedic reconstruction
BACTERINⓇ/ XTANTⓇ holds ISO 13485 certification, which requires highly standardized and efficient internal quality systems. CLIA certified, all processing is completed in ISO 5 (Class 100) clean rooms using the scientifically formulated “Bacterinse” protocol to insure effective decontamination and sterilization.
Their flagship product, Osteosponge, is absorbent, compressible, and both osteoconductive and osteoinductive. Although Osteosponge is regulated as a Human Cell and Tissue Product (HCTPs) for which the FDA does not require clinical evidence, the product has been the subject of multiple clinical studies supporting its efficacy. Please click “Download Published Literature” on the right.
The tissue portfolio also includes a robust DBM putty (lot-tested in vivo post-sterilization), cortical fiber products, acellular dermis, tendons, and traditional bone grafts. The company’s primary expertise has always been related to bone processing and demineralization, and since 2009 every lot of OsteoSelectⓇ DBM putty produced has been proven osteoinductive in a rat model, as a condition for product release.
All tissue products are terminally sterilized using ISO VDMax/Method 2B, and involve the administration of low-dose gamma radiation at ultra-low dry ice temperatures.
XTANTⓇ Medical has extensive national contracts with GPOs (including Vizient, Premiere, HCA, MedAssets, and others) and the company’s National Accounts Team works hand-in-hand with small hospitals and major IDNs alike to deliver cost-effective biologics solutions.