Five Companies Tap Hot Orthopedic-Biomaterials Market

The global orthopedic biomaterials market, valued at $4 billion in 2006, is projected to more than double by 2012, to $8.8 billion. That’s according to a recently released report by Kalorama Information, Orthopedic Biomaterials: World Market, which attributes the expected growth to the aging population and technological advances.

According to the report, by 2050, there will be two billion people who are 60 years or older. That growing segment is demanding improved longevity and higher quality-of-life, which is driving the number of diagnosed musculoskeletal conditions: One out of every seven Americans reports a musculoskeletal impairment; in Europe, 15-20% of all primary care consultations are for musculoskeletal conditions.

The bone morphogenetic proteins (BMP) segment is expected to fare especially well, says the report. These products are expected to grow at a CAGR of 25% to $2.9 billion by 2012, accounting for 39% of the ortho biomaterials market. Ceramic product sales, which made up 25% of the market in 2006, are projected to grow at a steady CAGR of 10% between now and 2012, but their portion of the orthopedic-biomaterials pie is expected to drop to 21%.

“As a result of evolving technology, a number of biomaterials have been introduced to the market over the past several years, all of which are biologically active substances intended to extend, enhance, or even replace autologous graft,” said Anne Anscomb, the report’s author, in a statement. Anscomb noted, though, that recent developments in recombinant BMPs and synthetic ceramic products stand out as particularly promising.

Here are some companies working in this fast-growing space:

Integra LifeSciences/IsoTis In August, Integra LifeSciences, of Plainsboro, NJ, announced plans to acquire Irvine, CA-based IsoTis in a $51 million deal that would create one of the largest orthobiologics companies in the world. The merger, which would make IsoTis a wholly owned subsidiary of Integra, would create a comprehensive product portfolio.

Integra will bring to the table the following: Integra Dermal Regeneration Template, a tissue-engineered product for burn and reconstructive surgery; DuraGen Dural Graft Matrix, a collagen matrix for dural closure; Integra Mozaik, an osteoconductive scaffold designed to create an environment favorable for the binding, migration, and growth of cells; and NeuraGen Nerve Guide, an absorbable collagen tube designed to be an interface between the nerve and the surrounding tissue and to create a conduit for axonal growth across a nerve gap.

IsoTis will contribute its demineralized bone matrix products, DynaGraft II and OrthoBlast II.

ISTO Technologies This St. Louis-based firm is developing implantable biomaterials for the repair and regeneration of musculoskeletal tissues, including bone-grafting and cartilage-regeneration products.

Just this week, the company received 501(k) clearance for its InQu bone-grafting technology, for use as an extender in the spine and as a bone-graft substitute in the extremities and pelvis. ISTO plans to launch InQu at the North American Spine Society conference in Austin, TX, happening in late October. In May, the company closed an $8.8 million financing to assist with the launch and to help finance the development of other pipeline products.

In the cartilage-regeneration space, ISTO has DeNovo ET, a tissue engineered cartilage for the repair of damaged or injured cartilage in the knee, and NuQu, an injectable cell-based therapy for the regeneration of the nucleus of the spinal disc.

FzioMed This San Luis Obispo, CA-based firm makes synthetic, resorbable surgical biomaterials for spine, abdominal and pelvic surgeries.

FzioMed’s product platform is a polymer technology called Oxiplex. The technology is being used to develop products for adhesion prevention and tissue healing, as injectables and coatings, and for drug delivery.

Products include Oxiplex/SP Gel, an adhesion barrier for spine surgery approved for sale in 45 countries outside the U.S.; Oxiplex/AP Gel, an adhesion barrier for abdominal and pelvic surgery that has CE Mark approval; and Laresse Dermal Filler, also CE Marked, a clear, smooth gel formulated for use in the correction of facial soft tissue contours.

Pegasus Biologics Based in Irvine, CA, Pegasus makes bioimplants for use in orthopedic musculoskeletal applications.

The company’s OrthADAPT Bioimplant is a FDA-cleared, Type I collagen scaffold that fortifies and supports tissue ingrowth. It is intended for the reinforcement, repair and reconstruction of soft tissue in orthopedic procedures. The DermADAPT Biomatrix Wound Dressing is a biocompatible, Type I collagen matrix for the local management of exuding wounds.

Pegasus is targeting its products to two markets: orthopedics and sports medicine, and neurosurgical and spine.

ETEX This Cambridge, MA-based firm is developing calcium phosphate-based bone-graft substitutes, implant surface coatings, and resorbable orthopedic devices.

ETEX’s first product, alpha-BSM Bone Substitute Material, is used for the treatment of bone voids resulting from fractures and other medical conditions. Other products in the pipeline include bone-graft substitutes suitable for reconstruction of skeletal defects, and carrier formulations for delivering recombinant human Bone Morphogenic Protein-2 (rhBMP-2) for various orthopedic and spine indications.

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