Key Developments For Orthovita Inc
Orthovita Inc (VITA.O) (Consolidated Issue listed on NASDAQ Global Market)
Orthovita, Inc. Announces Presentation of Cortoss Clinical Study Results At 2009 Congress of Neurological Surgeons Annual Meeting
Orthovita, Inc. announced that Dr. Pierce D. Nunley, Director of the Spine Institute of Louisiana, will present his abstract, A Comparison of Clinical Outcomes and Adjacent Level Fractures in Patients Receiving Vertebroplasty for Osteoporotic Compression Fractures Using CortossTM or PMMA. Key findings from the 256-patient clinical study include the following significant benefits for the Cortoss patient group: - Early patient outcomes assessed at three months: With a Visual Analogue Pain Scale (VAS) score success rate of 86.6%, the Cortoss patient group experienced a statistically significant benefit in pain success over the PMMA group, which had a VAS score success rate of 75.0%. - Long-term patient outcomes assessed at 24 months: With an Oswestry Disability Index (ODI) function assessment success rate of 96.7%, the Cortoss patient group experienced a statistically significant benefit in function success over the PMMA group, which had an ODI success rate of 88.4%. In addition, the Cortoss patient group experienced benefits over the PMMA cohort in the following outcomes: - A 43.4% reduction in subsequent, adjacent level fractures in Cortoss patients treated for a primary fracture at one level, as measured at the end of the 24-month follow-up period; - A 67.4% lower incidence of subsequent VCF procedures; - A 74.6% lower incidence of re-hospitalization for spinal fracture; and - The Cortoss patients required an average of 30% less material to achieve fracture fill.
Orthovita, Inc. Raises FY 2009 Guidance
Orthovita, Inc. raised financial guidance for fiscal 2009 and expects total product sales from all biosurgery and orthobiologics products to be between $92 and $95 million and net loss to be between $3 and $4 million, or $0.04 to $0.05 per common share, compared to previous guidance of a net loss of $5 to $6 million, or $0.07 to $0.08 per common share. The revised guidance reflects the stronger than anticipated sales performance of the business year-to-date and also includes anticipated sales from Cortoss in the U.S. According to Reuters Estimates, analysts on an average were expecting the Company to report net loss per share of $0.05 and net loss of $4 million on revenue of $94 million for fiscal 2009.
Orthovita, Inc. Receives FDA Clearance for CORTOSS Bone Augmentation Material in Treatment of Vertebral Compression Fractures
Orthovita, Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CORTOSS Bone Augmentation Material for treatment of vertebral compression fractures. CORTOSS is an injectable, bioactive composite that mimics the physiological properties of human cortical bone and is the first alternative to polymethylmethacrlyate (PMMA) cement that has been evaluated in a large-scale, multi-center, randomized, controlled clinical study and cleared in the United States for the treatment of vertebral compression fractures.
Nancy C. Broadbent To Join Orthovita, Inc. As Senior Vice President And Chief Financial Officer
Orthovita, Inc. announced that Nancy C. Broadbent will join the Company as Senior Vice President and Chief Financial Officer effective May 26, 2009.
Orthovita, Inc. Submits Additional Data to FDA in Support of 510(k) Application for the Use of CORTOSS Bone Augmentation Material in Vertebral Augmentation
Orthovita, Inc. announced that it has submitted additional data to the U.S. Food and Drug Administration in support its 510(k) filing for the use of its CORTOSS Bone Augmentation Material in vertebral augmentation. This 510(k) application is intended to demonstrate that the performance of CORTOSS is substantially equivalent to polymethylmethacrylate (PMMA) bone cement. The data submitted includes two-year follow-up data from Orthovita`s pivotal, prospective, randomized, multi-site clinical study conducted under an FDA investigational device exemption (IDE). In the pivotal study, a total of 162 patients were treated with CORTOSS and 94 patients were treated with PMMA. The two-year follow-up period has now been completed for the pivotal study. In addition to two-year follow-up clinical data for patients enrolled in the pivotal study, Orthovita has submitted to FDA data on patients from two pilot U.S. clinical investigations conducted under FDA IDEs and from several European studies with follow-up ranging from 11 months to over four years.
