Legal

Benvenue Medical’s Kiva VCF Treatment System, Blazer, and methods are covered by U.S. Patent Nos. 7,785,368; 7,666,226; 7,666,227; 7,670,374; 7,670,375; 7,967,864; 7,967,865; 7,963,993; 7,955,391; and 8,057,544.

Europe — The Kiva VCF Treatment System is indicated for the reduction and treatment of pathological compression fractures of the thoracic and lumbar spine that may result from osteoporosis, benign lesions and/or malignant lesions. This is to be offered only when traditional medical therapy has not provided pain relief and pain is substantially altering the patient’s lifestyle. It is intended to be used with Benvenue Medical Vertebral Augmentation Cement Kit. The Kiva VCF Treatment System and the Benvenue Medical Vertebral Augmentation Cement Kit bear the CE mark and are available for sale in Europe.

Under the KAST study, the Kiva VCF Treatment System is being evaluated for the reduction and treatment of painful pathological compression fractures of the thoracic and lumbar spine that may result from osteoporosis. It is intended to be used with Benvenue Medical Vertebral Augmentation Cement Kit.

US — CAUTION — Investigational Device. Limited by United States Federal Law to investigational use.

Canada — Investigational Device. To be used by Qualified Investigators only. Investigational Device. To be used by Qualified Investigators only. Instrument de Recherche. Réservé uniquement à l’usage de chercheurs competent.

Blazer is indicated for the treatment of pathological compression fractures of the vertebral body that result from osteoporosis, benign lesions, or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA).

The Blazer Vertebral Augmentation System is available for sale in the United States, Canada, and Europe.

Advancing Spine Repair, Kiva, and Benvenue Medical are registered trademarks and Blazer and Kivaplasaty are trademarks of Benvenue Medical Inc.