Bacterin International Holdings, Inc. develops, manufactures, and markets biologics products to various markets in the United States and internationally. Products and Services The company’s bone graft products are used in various applications, including enhancing fusion in spine surgery, relief of back pain through facet joint stabilization, promotion of bone growth in foot and ankle surgery, promotion of skull healing following neurosurgery and subchondral bone repair in knee and other joint surgeries. The company’s acellular dermis scaffolds are utilized in wound care and plastic and reconstructive procedures. The company also develops custom surgical instruments for use with its allografts, and produces and distributes OsteoSelect DBM putty, an osteoinductive product used by surgeons as a bone void filler in the extremities and pelvis. DBM putty is considered a combination product by regulatory agencies - both a tissue and a medical device. The company’s products include OsteoSponge, OsteoSpongeSC, OsteoSelect DBM putty, OsteoWrap, OsteoLock, BacFast HD, OsteoSTX, hMatrix, and its new line of 3Demin products, as well as other allograft products, such as: OsteoSponge is a form of demineralized bone matrix made from 100% human bone. Derived from trabecular (cancellous) bone, OsteoSponge provides a natural scaffold for cellular in-growth and exposes bone-forming proteins to the healing environment. The malleable properties of OsteoSponge enable it to conform to, and fill, most defects. Upon compressing the allograft, OsteoSponge springs back to completely fill the void. Its mechanical and biological properties make OsteoSponge an ideal bone graft for use in various orthopedic practices, including spine, neurology, cranial/maxillofacial, trauma, plastic/reconstruction and general procedures where new bone growth is needed. OsteoSpongeSC is a form of OsteoSponge designed to fill bony defects in the subchondral region of joints. The company has received permission from the FDA to market this product as a subchondral bone void filler and is marketing it as such. OsteoSelect DBM putty is engineered with the surgeon in mind. With handling characteristics, OsteoSelect could be molded into any shape and compressed into bony voids. Bacterin has validated a low-dose, low-temperature gamma sterilization process to provide maximum osteoinductive potential while still affording device level sterility. Every production batch of OsteoSelect is tested for osteoinductive bone growth characteristics allowing the company to make that marketing claim. OsteoWrap is 100% human cortical bone demineralized through a proprietary process to make the graft flexible while maintaining allograft integrity. This product has various applications in orthopedic, neurological, trauma, oral/maxillofacial and reconstructive procedures. OsteoWrap could wrap around non-union fractures to assist with fusion, could act as a biologic plate or could be used in conjunction with a hardware plate system. Additionally, this product provides the surgeon with superior handling characteristics as the allograft could be sized using surgical scissors or a scalpel, and would withhold sutures or staples for fixation. OsteoLock and BacFast HD are facet stabilization dowels made from human bone. The shape of the company’s facet stabilization dowel is engineered to improve osteoconductivity and surface area contact, as well as provide stability to prevent migration from the surgical site. BacFast HD, having the same design as OsteoLock, is optimized through the company’s proprietary demineralization technology. OsteoLock and BacFast HD could be used to augment spinal procedures, or as a stand-alone procedure for mild spinal conditions. OsteoSTX is demineralized cortical sticks processed from human allograft bone. Utilizing the company’s patented demineralization technology, the grafts are flexible and feature osteoinductive properties. OsteoSTX is designed for posterolateral spine surgery applications ranging from one-level to multi-level fusions, including scoliosis procedures. This is a new addition to Bacterin’s biologic products portfolio launched in 2014. hMatrix dermal scaffold is an extension of the company’s core biologics technology. hMatrix is an acellular matrix made from donated human dermal tissue that is used to replace a patient's damaged tissue. hMatrix provides a natural collagen tissue scaffold that promotes cellular ingrowth, tissue vascularization and regeneration. The hMatrix scaffold tissue reabsorbs into the patient's dermal tissue for a biocompatible, natural repair. The company’s new line of 3Demin products consists of 3Demin Cortical Fibers, 3Demin Boats, and 3Demin Strips. These 3Demin products are made from cortical bone and primarily used in spine procedures. The company also processes and sells sports allografts, which are processed primarily for anterior and posterior cruciate ligament repairs, anterior cruciate ligament reconstruction and meniscal repair; milled spinal allografts, which include cortical bone milled to desired shapes and dimensions; and traditional allografts for multi-disciplinary applications, including orthopedics, neurology, podiatry, oral/maxillofacial, genitourinary, and plastic/reconstructive. The company also develops custom surgical instruments for use with the company’s allografts. As of December 31, 2014, the company made the strategic decision to exit the craniomaxillofacial and medical device coatings businesses. Sales and Marketing The company sells its product in the United States through a hybrid distribution network, including direct employees and independent distributors. Intellectual Property Trademarks: The company owns various registered trademarks, such as OsteoSponge, OsteoWrap, OsteoLock, BacFast, OsteoSelect, Elutia, OsteoSTX, hMatrix, BACTERINSE, and Circle of Life. Government Regulation The company is registered with the FDA as a manufacturer of human cellular and tissue products, as well as medical devices; and is an accredited member of the American Association of Tissue Banks in good standing.
bacterin international holdi
600 Cruiser Lane
Belgrade, MT 59714
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To contact BACTERIN INTERNATIONAL HOLDI, please visit www.bacterin.com. Company data is provided by Capital IQ. Please use this form to report any data issues.