12 Aug Auctus Surgical: FDA Breakthrough Device Designation, Key Patent for Non-Fusion Scoliosis System
SAN FRANCISCO, Aug. 11, 2021 /PRNewswire/ — Auctus Surgical, a company devoted to non-fusion options for scoliosis patients, is developing a one-of-a-kind vertebral body tethering (VBT) system to treat pediatric scoliosis with a non-fusion, dynamic approach. The company is announcing the recent Breakthrough Device Designation by the FDA, a recognition that the Auctus dynamic vertebral body tethering system is unique and will meet a clear clinical need. This FDA designation allows for priority review and interactive communication regarding device development. In addition, the company has just received a U.S. patent (US 11,065,037 B2) “spinal curvature modulation systems and methods. This comprehensive patent covers the specific technologies and methods of the Auctus System.
The Auctus team has designied a system from the ground up in order to give adolescents a viable, flexible option to complex fusion surgery. Necessitating only one treatment event, the Auctus System utilizes an external magnet controller for non-surgical adjustment of the spinal curvature over time.
“These back-to-back achievements continue the momentum in the development of this critical therapy,” states Auctus CEO and founder John Barrett. “I am proud of the tremendous efforts put forth by our team—efforts that will make a concrete difference in the lives of suffering adolescents and their families.”
“Spinal fusion for scoliosis is a century old operation that corrects deformity but eliminates movement of the spine,” states Mohammad Diab, M.D., Professor and Vice chair in the Department of Orthopaedic Surgery and the Department of Pediatrics at the University of California San Francisco. “The pediatric surgical community, as well as our patients, are eager for and welcoming of a fusionless option for the treatment of scoliosis. The Auctus Dynamic Tethering System will do just that and will do so in a modular manner that allows greater control of the spine.”
About Auctus Surgical:
Auctus Surgical is developing a Dynamic Vertebral Body Tethering System (VBT) to treat pediatric scoliosis with a non-fusion approach. A definitive therapy which straightens a spine without bracing and fusion surgery is one of the holy grails of spine surgery. Families and surgeons have been searching for an approach that will potentially spare a child years of ineffective bracing therapy as well as the trauma and permanent physical limitations of fusion surgery.