
Officials from Benvenue Medical Inc., a developer of minimally invasive solutions for spine repair, announce that they have completed a $25 million Series D round of financing. The spine company intends to use the proceeds to sustain global commercialization of its three breakthrough minimally invasive products to treat degenerative disc disease (DDD) with spinal fusion and vertebral compression fractures (VCFs), as well as for additional initiatives to bring its fusion and VCF products to the US market.
The Series D financing was completed with existing investors DeNovo Ventures, Domain Associates, Technology Partners, and Versant Ventures.
"Our investors share our excitement about our rapid growth and positive momentum, and we are gratified by their continued support for our vision and progress," comments Robert Weigle, CEO, Benvenue Medical.
"Benvenue is an innovative spine company with a top-notch team. We expect this new infusion of capital will carry the company to the next level of growth and commercial success," states Nimesh Shah, principal at Domain Associates.
Benvenue Medical has entered a $9 billion global spine device market with its three minimally invasive products to treat VCFs and DDD.
- The Kiva VCF Treatment System, commercially available in Europe, has now been used to treat more than 800 VCFs globally. Kiva is distributed by Zimmer Spine in Europe. In the U.S., the Kiva VCF Treatment System is being evaluated in the KAST (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial) clinical trial, which is being conducted in support of 510(k) market clearance from the U.S. Food and Drug Administration (FDA). KAST is the largest randomized study to date versus the current standard of care, balloon kyphoplasty, in VCFs.
- The Blazer Vertebral Augmentation System, also used in treating VCFs, is the first clinical product in Benvenue Medical's portfolio to be commercially available in the U.S. Together, Kiva and Blazer will be able to address the majority of patients suffering from VCFs, which are common to osteoporosis. The National Osteoporosis Foundation estimates that there are 700,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone, yet 200,000 kyphoplasty procedures are done globally.
- Benvenue Medical's Luna Interbody Spacer System for spinal fusion procedures received CE Mark approval in 2010. It is currently enrolling patients in a European post-market study, the Luna Interbody System for Fusion Trial (LIFT). After the completion of enrollment in the LIFT study, the Luna Interbody Spacer System will be commercially available in the EU. Currently this device is not available in the United States, and the company intends to submit a 510(k) in the US later this year.
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