Benvenue Medical said its Kiva implant for vertebral compression fractures held its own against balloon kyphoplasty in a pivotal clinical trial, the results of which were published online in the journal Spine.
The 300-patient, randomized, controlled Kast study enrolled patients with 1 or 2 osteoporotic vertebral compression fractures. Researchers compared balloon kyphoplasty to Benvenue’s Kiva VCF, a flexible implant made from a biocompatible polymer that is physician-customized and used in conjunction with the company’s bone cement kit.
The Kiva system was on par with balloon kyphoplasty, based on a composite primary endpoint of pain, function and serious device-related adverse events. There were no device-related serious adverse events, although Kiva patients had higher risk factors such as prior spinal surgeries and a history of smoking.
Benvenue said the KAST trial is the largest randomized study of its kind to compare Kiva with the current standard of care in vertebral compression fractures.
Santa Clara, Calif.-based Benvenue raised $3.5 million in March 2014 through the sale of debt, options and securities, with 9 unnamed investors participating.
"Kiva is the only VCF treatment with the highest level of head-to-head comparison data, and the spine community is excited about Kast because there’s so little Level I data in the VCF segment," CEO Robert Weigle said in prepared remarks. "Publication of Kast results in a peer-reviewed journal further validates the benefits of, as well as adds to the body of evidence for, Kiva."