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SYS-CON MEDIA Authors: Liz McMillan, Elizabeth White, Lori MacVittie, Carmen Gonzalez, Srinivasan Sundara Rajan

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Boston Biomedical Associates Adaptive Bayesian Study Design Results in FDA Approval

Boston Biomedical Associates (BBA) is proud to have supported our client and colleagues at Benvenue Medical, Inc. during The Kiva® System as a Vertebral Augmentation Treatment or KAST trial, and recent 510(k) clearance of the Kiva® VCF Treatment System.

The Kiva System is a novel implant-based solution for vertebral augmentation and a departure from balloon kyphoplasty (BKP), making it the first new approach to the treatment of vertebral compression fractures (VCFs) in over a decade. “We are excited to bring the Kiva System and its clinical benefits to the large and growing population of VCF patients in the US market,” said Robert K. Weigle, CEO of Benvenue Medical, Inc. “The VCF segment has little Level I clinical data, and we are proud to have sponsored one of the largest randomized studies in this space to date,” he added.

BBA partnered with Benvenue Medical Inc. to execute KIVA utilizing a Bayesian Adaptive Design. With this innovative trial design, Benvenue Medical was able to minimize trial sample size needed to demonstrate product safety and effectiveness, thus delivering this new technology to the marketplace sooner. “Benvenue is the kind of client BBA is proud to partner with. They have demonstrated their commitment to strong science, incredible diligence and careful attention to the success of the KIVA program,” said Michelle Michela, Group Leader of Consulting Services at BBA and project lead for the Benvenue Kiva Trial. “We couldn't be prouder of our successful partnership and trial outcome.”

“We are delighted to have worked with a company like BBA that offered us the full spectrum of clinical and data management services, with an integrated approach to study design, data management, statistical analysis and report generation. BBA’s team of industry leading experts was committed to servicing our needs and delivered high-quality results,” said Barbara S. Lindsay, Vice President at Benvenue Medical, Inc.”

Boston Biomedical Associates is a leading Clinical Research Organization known for its comprehensive approach to the clinical trial process. BBA serves as a strategic partner with those involved in the medical device, biotech and pharmaceutical industries, working with them throughout the entire medical product lifecycle to help them bring new technologies to market.

For more information about BBA, visit their website, www.boston-biomedical.com or contact Mack Rubley, PhD, BBA’s Director of Business Development: [email protected] or 508-351-8632.

Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. develops next-generation, minimally invasive expandable implants for the spine. The company is privately held and funded by Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $1.6 billion globally. For more information, visit http://www.benvenuemedical.com.

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