Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic products for regenerative healing, today announced it is highlighting three procedure-specific MagniFuse(TM) bone grafting products for different spine therapy areas at the North American Spine Society (NASS) 2009 Annual Meeting, taking place November 10th through 14th in San Francisco, California. To date MagniFuse has been used in 40 spinal surgeries in the United States.
"Our strategy is to utilize our platform technologies to develop procedure-specific products to address critical unmet surgical needs and we are very excited to be highlighting our MagniFuse platform at NASS," said Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer. "By utilizing our MagniFuse product line in posterior cervical, posterolateral and spinal deformity procedures, Osteotech is targeting a significant segment of the spinal therapy area. Feedback from surgeons that have used MagniFuse to date indicates the differentiated characteristics and capabilities supported by our MagniFuse technology have been well received, and we believe we are strongly positioned to become a market leader."
MagniFuse is a patented, next-generation technology platform that supports a family of high-performance, procedure-specific products that provide for simplified, precision grafting when injury or disease creates a need for bone fusion or new bone growth.
"In addition, we are also looking forward to showcasing our leading-edge FacetLinx(TM) Fusion Technology and Plexur M(TM) Innovative Grafting at NASS," continued Mr. Owusu-Akyaw. "Similar to MagniFuse, these products have received very positive responses in the market and we believe they will both play an important role in our future success. Our goal at Osteotech is to continue to commercialize proprietary biologics designed to address the unmet needs of the surgeon community and we believe these introductions illustrate our ability to successfully execute this strategy. We are pleased to share them directly with the physician community through NASS this week."
New MagniFuse Technology Products
Osteotech is showcasing three procedure-specific forms for three different spine therapy areas in the Company's booth at NASS: PC (posterior cervical), SD (spinal deformity) and PL (posterolateral).
- MagniFuse PC (posterior cervical) - Posterior cervical fusion is a surgical procedure to stop motion between two or more vertebrae that may be causing neck pain or damage to the nerves that extend into the upper extremities.
- MagniFuse SD (spinal deformity) - Spinal deformities, or curves in the spine, often develop during growth in adolescence or as a result of aging. MagniFuse will be utilized in the treatment of scoliosis, a frontal spinal deformity where the normal straight alignment of the spine from the front is affected by a curve to the left or right.
- MagniFuse PL (posterolateral) - Posterolateral fusion involves placing bone graft in the posterolateral portion of the spine. This procedure may be recommended as a surgical treatment option for patients with a condition causing spinal instability, such as degenerative disc disease, spondylolisthesis or spinal stenosis, which has not responded to conservative treatment measures (rest, physical therapy or medication).
MagniFuse Technology Platform
Osteotech's MagniFuse technology platform and related products offer unique, differentiating features compared with other bone grafts on the market:
- As a result of Osteotech's proprietary manufacturing and processing technology, MagniFuse utilizes a highly active biologic material, derived from an allograft source material containing a higher concentration of multiple natural human growth factors.
- This formulation is delivered in a unique, resorbable, mesh bag delivery-containment system that is sized specifically for the procedure application, eliminating the graft migration-related issues facing competitive products. It is also radiopaque, enabling surgeons to confirm both intra- and post-operation placement of the graft.
- The combination of MagniFuse's formulation and delivery system provides an optimized scaffold comprised of 100% bone material that produces targeted bone formation, as evidenced by our clinical data to date.
- Osteotech worked with a team of recognized spine surgeons and used their feedback in the development of the specific procedural forms within the MagniFuse line of products based on sizing and surgical techniques used in spinal surgeries.
Plexur M Innovative Grafting
Plexur M, a biocomposite combination of cortical bone fibers and resorbable polymers, may be used in a variety of orthopedic procedures as a bone void filler. Developed utilizing the Company's proprietary Plexur® technology, Plexur M offers a number of unique characteristics for orthopedic surgeons:
- Plexur M is pliable and moldable when heated, and can be shaped to specifically fit most defects.
- Plexur M provides porosity for bone growth after implantation and is fully resorbed by the body during the remodeling process.
- Plexur M hardens at body temperature when applied within the body allowing surgeons to quickly move to the next step in the surgery.
The Plexur technology platform is a unique and patented combination of polymer and cortical bone fibers that supports a family of procedure-specific products targeted for use in a variety of orthopedic surgeries. Plexur technology-based products have been clinically shown to completely resorb into the body within six to twelve months and to be replaced by host bone. Plexur technology offers improved handling and an effective osteoconductive matrix with high levels of porosity that provides a broad surface area for new cell growth. Plexur is supported by more than 20 patents and patent applications and is the platform technology that supports Plexur P(TM) used in a variety of trauma and reconstructive surgeries and focused on foot and ankle procedures as well as Plexur M.
FacetLinx Fusion Technology
Facet joint disorders are among the most common of all the recurrent, disabling low back problems that have serious symptoms and disability. FacetLinx is a patent-pending spinal allograft product that treats mechanical and facet-driven back pain by fixating the facet joints or may augment standard instrumented and non-instrumented fusion, offering patients stability with minimum additional risks. FacetLinx offers a number of differentiating advantages over other facet fusion devices:
- FacetLinx is quick, simple and has immediate efficacy, with reduced potential complications.
- The FacetLinx system's less invasive design provides a cruciform shape that is more stable and will resist motion to thus aid in immediate back pain relief.
- The FacetLinx system facilitates direct access to the cancellous bone on both sides of the facet joint to facilitate fusion.