Profile: Orthovita Inc (VITA.O)

Orthovita, Inc. (Orthovita), incorporated in 1992, is an orthobiologics and biosurgery company, which develops and markets medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. The Company’s fusion and regeneration products are based on its VITOSS Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Its CORTOSS Bone Augmentation Material, an injectable, polymer composite, which mimics the structural characteristics of human bone, provides the basis for its fixation portfolio. CORTOSS Bone Augmentation Material is approved for certain uses in certain countries outside the United States and is under review for regulatory clearance in the United States for vertebral augmentation. Orthovita’s hemostasis portfolio includes VITAGEL Surgical Hemostat, a collagen-based matrix that controls bleeding and facilitates healing, and VITASURE Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery. It also markets accessories and delivery products, which complement its orthobiologics and biosurgery platforms.

In the United States Orthovita has assembled a field sales network of direct sales representatives and independent non-stocking distributors in order to market VITOSS, VITAGEL, VITASURE, the IMBIBE Bone Marrow Aspiration System and the CELLPAKER Plasma Collection System. Outside of the United States., it primarily utilizes a network of independent stocking distributors to market VITOSS, CORTOSS, ALIQUOT Delivery System, VITAGEL and CELLPAKER.

VITOSS Bone Graft Substitute

VITOSS is an ultra- porous resorbable beta-tricalcium phosphate bone void filler used to help the body guide the three-dimensional regeneration of the patient’s own bone. The Company had sold approximately 275,000 units during the year ended December 31, 2008. VITOSS’s ultra-porosity allows it to soak and hold its own volume in blood and bone marrow aspirate and has been shown to perform well in a range of applications in the spine, extremities and pelvis, such as spinal grafting and the treatment of bone defects due to trauma, degenerative disease and tumors, including posterolateral spine fusion procedures. VITOSS integrates well into existing bone and allows for bone in-growth and maturation. The Company has developed and is developing a number of VITOSS-based products and related delivery devices that are designed to expand the market for its VITOSS products by broadening the range of surgical indications and by addressing additional surgeon preferences and needs.

Orthovita launched its VITOSS Bioactive FOAM strip product as part of a controlled rollout during 2008, and fully launched the product during 2008. It launched its VITOSS Bioactive FOAM pack product during 2008. In addition to its VITOSS beta-tricalcium phosphate bone graft substitute and Kensey’s resorbable biomaterials, VITOSS Bioactive FOAM products also contain its combeite bioactive glass. VITOSS has been used in bone grafting procedures as a bone graft substitute to provide a synthetic scaffold in a variety of applications, including those of the extremities, spine and pelvis. Autograft, cadaver allograft, as well as synthetic scaffolds like VITOSS, are used for trauma related bone graft repairs. VITOSS has been used as a bone graft substitute in a variety of trauma applications, including those of the extremities, spine and pelvis.

VITAGEL Surgical Hemostat and Accessories

VITAGEL is a United States Food and Drug Administration (FDA)-approved, CE-marked, plant-based hemostat product that can be deployed throughout surgery. Through microporous polysaccharide hemosphere technology, VITASURE acts as a molecular sieve to quickly extract fluids from blood, creating an osmotic action that causes the VITASURE particles to swell and concentrates serum proteins, platelets, and other elements on the surface. It launched the VITASURE product in the United States in 2008 and in certain non- United States territories in January 2009.

Near-Term Product Development

The Company has developed new products under its approved VITOSS, VITAGEL and IMBIBE product platforms. It may seek to bring VITOSS, VITAGEL and/or IMBIBE product line extensions to market in the United States through the 510(k) or pre-market approval (PMA) regulatory process. These product line extensions will be in addition to its United States CORTOSS investigational device exemption (IDE) clinical program.

CORTOSS Bone Augmentation Material

CORTOSS is a self-setting glass ceramic polymeric composite engineered specifically to mimic the characteristics of human bone and to provide fixation for vertebral compression fractures (“VCFs”). Laboratory tests demonstrate that CORTOSS exhibits compressive strength similar to human bone. For patients with poor bone healing, as seen in osteoporotic patients, CORTOSS may be used in a variety of surgical procedures to quickly provide structural stability and reinforcement of the bones after surgery. The surgeon’s goal is to repair the patient’s bone and enhance the patient’s mobility as quickly as possible since prolonged bed rest or inactivity may result in decreased overall health for older or osteoporotic patients.

ALIQUOT Delivery System

The Company's ALIQUOT Delivery System facilitates delivery of materials to bony sites, including delivery of its CORTOSS product directly to the surgical site. A coaxial system of catheter and syringe dispenser is designed to assure effective delivery of material in vertebral augmentation of VCFs and screw augmentation procedures. The ALIQUOT system was used as part of its European multi-center prospective clinical study for CORTOSS in vertebral augmentation of VCFs and was used in the United States clinical studies for CORTOSS in vertebral augmentation of VCFs. ALIQUOT is exempt from 510(k) clearance.