Bacterin International Holdings, Inc. develops, manufactures, and markets biologics products in the United States and internationally. Products and Services The company operates through Biologics and Medical Devices divisions. Biologics Division The biologics products include OsteoSponge, OsteoSpongeSC, OsteoWrap, OsteoLock, BacFast HD, OsteoSTX and hMatrix as well as certain other allograft products which are as follows: 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. 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 can wrap around non-union fractures to assist with fusion, can act as a biologic plate or can be used in conjunction with a hardware plate system. Additionally, this product provides the surgeon with superior handling characteristics as the allograft can be easily sized using surgical scissors or a scalpel, and will withhold sutures or staples for fixation. OsteoLock and BacFast HD are facet stabilization dowels made from human bone. The shape of its facet stabilization dowel is engineered to maximize 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 its proprietary demineralization technology. OsteoLock and BacFast HD can be used to augment spinal procedures, or as a stand-alone procedure for mild spinal conditions. OsteoSTX are demineralized cortical sticks processed from human allograft bone. Utilizing its patented demineralization technology, the grafts are flexible and feature osteoinductive properties. OsteoSTX are designed for posterolateral spine surgery applications ranging from one-level to multi-level fusions, including scoliosis procedures. hMatrix dermal scaffold is an extension of Bacterin'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. In addition, the company makes and sells sports allografts which are processed specifically for anterior and posterior cruciate ligament repairs, anterior cruciate ligament reconstruction and meniscal repair; milled allografts which comprise cortical bone milled to desired shapes and dimensions, also called milled spinal allografts; and traditional allografts for multi-disciplinary applications including orthopedics, neurology, podiatry, oral/maxillofacial, genitourinary and plastic/reconstructive. Medical Device Products The Medical Devices division researches, tests and develops coatings for medical devices. This division also produces and distributes OsteoSelect DBM putty, an osteoinductive and osteoconductive product used by surgeons as a bone void filler. OsteoSelect DBM putty is engineered with the surgeon in mind. With outstanding handling characteristics, OsteoSelect can 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. The Medical Devices division also develops custom surgical instruments for use with allografts processed by its biologics division. These instruments offer design based upon the needs and inputs of surgeons who desire to use advanced minimally invasive techniques. These instruments are intended to provide optimal placement of its proprietary allografts. Trademarks The company owns the following registered trademarks: OsteoSponge, OsteoWrap, OsteoLock, BacFast, OsteoSelect, Elutia, QuickScrew, hMatrix, and BACTERINSE. Sales and Marketing The company sells its product in the United States through a hybrid distribution network including direct employees and independent distributors. Strategy In an effort to capitalize on its core markets, as well as new market opportunities, the company has diversified its supply of donor tissue, expanded its production capabilities, developed its hybrid sales force and refined the message to its market. Regulations The company is registered with the FDA as a manufacturer of human cellular and tissue products (HCT/Ps) as well as medical devices, and the company is an accredited member of the American Association of Tissue Banks in good standing. The company meets all licensing requirements for the distribution of HCT/Ps in states with licensing requirements, including Florida, California, Louisiana, Maryland and New York. Competition The company’s competitors in the orthopedic biomaterials markets include Medtronic, DePuy/Synthes, Arthrex, Smith & Nephew, Nuvasive, OrthoFix, Biomet, MTF, Stryker, RTI Surgical, AlloSource, Lifenet Health, Integra, ConMed/Linvatec, Wright Medical, Exactech, KCI, Baxter and Alphatec.
bacterin international holdi
600 Cruiser Lane
Belgrade, MT 59714
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