A second bone graft has been authorized for standalone use in the spine.

The U.S. Food and Drug Administration (FDA) has cleared Kuros Biosciences’s MagnetOs Granules for expanded spinal indications, based on radiographic data, clinical outcomes and safety data. The clinical evidence came from 50 patients who participated in a Level 1 randomized controlled multicenter trial that compared MagnetOs Granules to autograft, the gold standard for posterolateral fusion. The clearance for standalone use proves MagnetOs to be an augmented graft that can be used in place of, as well as in combination with, autograft bone. The data package used in the FDA submission is the first Level 1 data to emerge from the company’s Project Fusion.

Standalone use requires the body to rely on the implanted bone graft product and not on combined autograft from the patient.
 
“Almost all of the more than 400 bone grafts cleared by the FDA via 510(k) were done so based on preclinical evidence alone. In an environment in which there is increasing focus on value-based medicine, our clearance for standalone use based on human clinical data positions MagnetOs above most other 510(k)-cleared bone grafts being offered to providers and surgeons,” CEO Joost de Bruijn said. “There is a clear need for bone grafts that are supported by Level 1 evidence and cleared for multiple uses, including the most challenging such as standalone use.” 
 
Very few bone grafts (other than MagnetOs Granules) are supported by Level 1 evidence from a randomized controlled trial. The current market-leading synthetic is supported by only one Level 1 pilot study, in which 20 patients were treated as opposed to the 50 patients treated in Kuros Biosciences’s multicenter trial. Across all published studies for the market-leading synthetic, 90 percent of patients were from studies by a single investigator, and conducted at a single clinical site, and 96 percent of all patients were from non-randomized Level III/IV studies which provide a lower evidence base for clinical decision-making than Level I studies. 
 
MagnetOs unlike other bone grafts because It grows bone even in soft tissue due to its NeedleGrip surface technology, which provides traction for the body’s vitally important ‘pro-healing’ immune cells (M2 macrophages). This in turn, unlocks previously untapped potential to stimulate stem cells—and form new bone throughout the graft. The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients it means a more efficient and predictable fusion.
 
MagnetOs Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis and posterolateral spine. MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. MagnetOs Granules resorbs and is replaced with bone during the healing process.
 
Kuros Biosciences develops spinal fusion biologics that ease the burden of back pain. With locations in the United States, Switzerland, and the Netherlands, the company is listed on the SIX Swiss Exchange. The company’s first commercial product, MagnetOs, is a synthetic bone graft that has already been used successfully across three continents and in over 5,000 spinal fusion surgeries. The next candidate in the Kuros pipeline is Fibrin-PTH—the first drug-biologic combination for interbody spinal fusions, currently undergoing a Phase 2 clinical trial in the United States.