March 08, 2018
SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive expandable implant solutions for spine repair, today announced that positive interim results of a retrospective analysis of its Luna® 3D Multi-Expandable Interbody Fusion System will be presented at the Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves (Spine Summit) taking place March 14-17 in Orlando. The single center minimally invasive study evaluated the safety and efficacy of the Luna device when placed from a standard minimally invasive transforaminal lumbar interbody fusion (TLIF) approach.
“The brilliance of Luna is its ability to engage the disc space through a minuscule annulotomy, and then expand to cover the greatest expanse of any intervertebral device available,” said Richard Fessler, M.D., study investigator and professor of neurosurgery at Rush University. “In our analysis, minimally invasive TLIF placement of the Luna device was shown to be safe and effective, improving pain and disability scores as well as consistently restoring disc height, reducing spondylolisthesis and increasing lumbar lordosis.”
The retrospective analysis evaluated 31 patients treated with the Luna 3D System who had at least six months of post-operative follow up. All but one patient experienced improvement in pain scores from baseline, and disability scores improved for all patients. When present, spondylolisthesis was reduced significantly. No instances of graft subsidence or hardware failure occurred.
“These safety and efficacy results lay the groundwork for our ongoing evolution of the Luna 3D Interbody Fusion System,” said Robert K. Weigle, CEO of Benvenue Medical. “We are currently developing a 2.0 version of the system that leverages our original platform and vision, improves the user experience and is designed to be minimally invasive to improve outcomes for patients and for use in the growing, emerging outpatient ambulatory spinal surgery center setting. We expect to submit for FDA clearance on Luna 2.0 later this year.”
“Minimally invasive spinal surgery and procedures in the outpatient setting are forecasted to grow considerably in the near term, and we see Luna as an important technological advancement in advancing patient care, quality and economic outcomes for the patient suffering from degenerative disc disease,” said Luke Düster, managing director and partner at CRG, an investor in Benvenue Medical.
Dr. Fessler will present the analysis, “Minimally invasive transforaminal lumbar interbody fusion with a multi-directional expandable device,” in the sponsored What’s New 2 session on Thursday, March 15, from 2:52-3:02 p.m. Benvenue is also exhibiting at Spine Summit in booth #311.
About the Luna 3D Interbody Fusion System
The Luna 3D Interbody Fusion System is one of the largest footprint yet least invasive devices for posterior lumbar interbody spinal fusion. The Luna 3D System is comprised of a PEEK implant designed to expand in multiple dimensions within the disc space, first in footprint, second in height and third in lordosis, allowing surgeons to effectively restore sagittal balance and height via a MIS posterior approach while providing the stability of a larger construct more often associated with an anterior approach. After a discectomy is performed, the Luna 3D Implant is delivered through a small diameter cannula into the disc space. After expanding its footprint, it is then expanded in height and lordosis with the insertion of a middle section. When the cannula is removed, a large volume of bone graft is placed in the middle of the implant to facilitate an interbody fusion.
About Benvenue Medical, Inc.
Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by CRG. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $9 billion globally. For more information, visit www.benvenuemedical.com.
About CRG LP
CRG is a premier healthcare-focused investment firm that has committed over $3.0 billion of capital across more than 50 investments. The firm seeks to commit between $20 to $300 million in each company and invests across the healthcare spectrum, including: medical devices, biopharmaceuticals, tools and diagnostics, services and information technology. CRG provides growth capital in the form of long-term debt and equity to support innovative, commercial-stage healthcare companies that address large, unmet medical needs. The firm partners with public and private companies to provide flexible financing solutions and world-class support to achieve exceptional growth objectives with minimal dilution. CRG maintains offices in Boulder, Houston and New York. For more information, visit www.crglp.com.
Betsy Merryman, 310-560-8176