Benvenue Medical develops next-generation minimally invasive systems for spine repair, combining expandable implants with novel delivery instruments. Its two commercial products are the Luna 3D Interbody Fusion System (FDA cleared November 2014) and the Kiva VCF Treatment System (FDA cleared January 2014). Luna is a small-profile PEEK implant that expands three-dimensionally within the disc space to restore height via a posterior approach; Kiva is a cylindrical expandable implant shown in a randomized controlled study to restore kyphotic angle and reduce adjacent-level fractures versus balloon kyphoplasty. The company plans to use the financing to accelerate U.S. commercialization of both products. Benvenue is privately held and was founded in 2004; its stated investors include InterWest Partners, Versant Ventures, DeNovo Ventures, Domain Associates, Esquilime Partners and Technology Partners. The treatments the products address have combined global revenues of $9 billion, which the company cites as the market opportunity. Benvenue Medical develops next-generation, minimally invasive expandable implants for spine repair. Its product portfolio includes the Kiva VCF Treatment System, the Blazer-C Vertebral Augmentation System, and the Luna Interbody System. The Luna system has received the CE Mark and is not currently available in the U.S. The company targets a roughly $9 billion global spine device market with devices for degenerative disc disease and vertebral compression fractures. Founded in 2004 and led by CEO Robert Weigle, Benvenue plans to use new funds to build its U.S. commercial presence, scale manufacturing, expand administrative functions, and provide working capital. The Luna system incorporates Benvenue Medical’s proprietary implant technology. Benvenue Medical is a privately held spinal devices maker based in Santa Clara, California, founded in 2004. The company designs and manufactures minimally invasive spinal repair devices, with its flagship Kiva VCF system offering an implant‑based approach to vertebral augmentation for painful vertebral compression fractures. Benvenue announced data showing Kiva was non‑inferior to balloon kyphoplasty for managing pain associated with osteolytic vertebral body metastases and reportedly eliminated incidents of cement leakage. The Kiva System won FDA 510(k) clearance last month and is available in Europe through distribution by Zimmer. Financially, Benvenue recently closed a $3.5 million financing recorded in a regulatory filing. The funds were raised through sales of debt, rights and securities (or rights to acquire securities) from nine unnamed investors. Benvenue Medical develops minimally invasive solutions for spine repair, focusing on treatments for degenerative disc disease and vertebral compression fractures. Its product portfolio includes the Kiva VCF Treatment System, the Blazer Vertebral Augmentation System, and the Luna Interbody Spacer System. The Kiva system is distributed by Zimmer Spine in Europe and is being evaluated in the KAST clinical trial to support a U.S. 510(k) filing. The Blazer system is commercially available in the U.S., while the Luna spacer received CE Mark approval in 2010 and is enrolling patients in a European post-market study (LIFT). The company intends to use new financing to sustain global commercialization of its three products and to advance initiatives to bring its fusion and VCF products to the U.S. market. Benvenue Medical develops minimally invasive solutions for spine repair, including the Kiva system for treating vertebral compression fractures (VCFs). The company offers three minimally invasive products targeting VCFs and degenerative disc disease (DDD). The Kiva system has been used to treat more than 450 vertebral compression fractures globally. Benvenue intends to use new funding to complete enrollment and patient follow-up in the KAST trial (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial). The company also plans multiple spine product commercialization initiatives in the U.S. and Europe. Benvenue is led by CEO Robert Weigle and was founded in 2004 in Santa Clara, CA, and is entering a roughly $9bn global spinal device market.

Total raised

$188M

Funding rounds

7

Latest round

Debt Financing

Latest activity

Jan 2016