STILLWATER, Minn., Feb. 3 /PRNewswire/ -- Spineology Inc., a developer and manufacturer of spinal implant and instrumentation systems, announced today that it closed its third round of financing in a convertible debt offering resulting in net proceeds of $3,485,000 in new capital.
"Spineology is gaining momentum," said Douglas E. King, CEO. "This third and most successful round of financing follows soon after the FDA's 510(k) clearance of our OptiMesh 1500E for vertebral body defects, and certainly represents another very important milestone for the Company.
"This latest financing will provide the means for the initial launch of OptiMesh 1500E in the U.S. and allow the Company to reach other significant milestones," King added. "We believe we are in the right market at the right time with a product that will revolutionize the treatment of vertebral body compression fractures in acute trauma and osteoporotic patients."
About Spineology Inc.
Spineology is a developer of proprietary technologies manufactured and marketed to the global implant market. On November 26, 2003, the FDA granted 510(k) clearance of Spineology's OptiMesh 1500E for use in the U.S. for vertebral body defects, which includes treatment of trauma, osteoporotic compression fractures and tumors of the vertebral body. The Company anticipates the first 1500E procedures in the U.S. will commence in February 2004. OptiMesh 1500S, designed for interbody fusion, is currently the subject of a multi-center IDE study in the U.S. OptiMesh 1500E and 1500S are both CE Mark-certified in Europe for use in orthopaedic procedures, including those in the spine. To date, OptiMesh has been successfully implanted in approximately 200 patients in Europe.
Spineology's first product, the K-Centrum(R) Anterior Spinal Fixation System, is cleared for use in the U.S. and Europe for alignment, correction and stabilization of the anterior thoraco-lumbar spine and has been successfully implanted in over 60 patients. Additionally, Spineology is preparing 510(k) and CE Mark applications for its LOOP Tension Band System, designed for posterior stabilization of the spinous processes in conjunction with other devices, especially OptiMesh. The system has multiple uses in spine and orthopedic procedures.
This press release contains forward-looking statements by Spineology regarding its expectations as to its OptiMesh products and other aspects of its business. Such statements are based on its current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference include, but are not limited to, its history of operating losses and its need for additional funds, as well as the risks and uncertainties in preclinical and clinical trial results, gaining regulatory approvals, scaling-up manufacturing, market acceptance, the sales levels of its products, research and development, competition and other risk factors. Spineology undertakes no obligation to publicly update any forward-looking statements.
Douglas E. King, CEO, Spineology, 651-351-1011