Benvenue Medical Announces First Clinical Use of Blazer – a Novel System for Vertebral Augmentation Procedures

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SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced today that it has treated the first patient in the United States with the Blazer Vertebral Augmentation System – a new device for the treatment of vertebral compression fractures (VCFs). The case was performed by Francis Facchini, M.D., partner, VIR Chicago, at Adventist GlenOaks Hospital in Glendale Heights, Illinois.

“The first U.S. clinical use of the Blazer Vertebral Augmentation System demonstrates our commitment to be the innovative leader in the treatment of vertebral compression fractures. To that point, we have developed two novel treatments for VCFs”

“The first U.S. clinical use of the Blazer Vertebral Augmentation System demonstrates our commitment to be the innovative leader in the treatment of vertebral compression fractures. To that point, we have developed two novel treatments for VCFs,” said Robert Weigle, CEO of Benvenue Medical. “We are thankful for Dr. Facchini’s support and are pleased to have had the opportunity to work with the team at Adventist GlenOaks Hospital. Blazer is the first product in the Benvenue Medical portfolio to be used in the U.S. Separately, Blazer will soon be followed by our flagship product, the Kiva VCF Treatment System, the next generation implant for the treatment of vertebral compression fractures. Kiva will be introduced through the launch of our KAST trial this month, which is a Level-I randomized study comparing the Kiva Implant vs. balloon kyphoplasty. The Blazer and Kiva systems will give physicians two separate and novel options to improve patient care and the ability to treat a majority of patients with VCFs.”

The patient treated with the Blazer System is a 71-year-old male who developed acute, severe low back pain. His pain was so severe he had difficulty walking, was unable to drive and had severe functional impairment. He was diagnosed with two osteoporotic compression fractures and had failed conservative therapy. According to Dr. Facchini, “the case went exceedingly well. We achieved endplate-to-endplate cement distribution with good control which resulted in an excellent clinical outcome. The patient’s reduction in pain has allowed a return to his baseline functional capacity. I appreciate all the support from the staff of Adventist GlenOaks Hospital, Adventist Midwest Health, and Benvenue Medical in continuing to work toward excellence in the treatment of osteoporotic compression fractures.”

About Vertebral Compression Fractures and Blazer

The treatment of vertebral compression fractures (VCFs) represented a global market of over $640 million and over 200,000 procedures in 2009. The market remains under penetrated with roughly 700,000 additional VCF patients diagnosed each year worldwide. Currently, only a small percentage of patients benefit from minimally invasive techniques due to limitations of the existing technologies.

The Blazer Vertebral Augmentation System provides an innovative approach to the treatment of painful VCFs. It preserves cancellous bone architecture by using a percutaneously-introduced nitinol wire designed to create channels within the vertebral body. The channels created in the bone are intended to direct the flow of PMMA bone cement in an anterior fashion and away from the posterior cortex. Blazer enables bone cement to interdigitate into the cancellous bone and stabilize the fracture.

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).

About Benvenue Medical, Inc.

Founded in 2004 and headquartered in Santa Clara, California, Benvenue Medical, Inc. is advancing spine repair through the development of proprietary, minimally invasive surgical and interventional solutions. The company is privately held and funded by DeNovo Ventures and Versant Ventures.

Keywords: spine, spinal, radiology, interventional radiology, interventional neuroradiology, surgery, vertebral augmentation, kyphoplasty, vertebroplasty, VCF, vertebral compression fracture, minimally invasive surgery, back, back pain, lumbar, thoracic.

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