• Rare clearance for bone grafting for stand-alone use in the spine based on human clinical data
• Clearance obtained with evidence from a level 1 randomized controlled trial
• Positions MagnetOs above most other 510(k) bone grafts on the market

SCHLIEREN (ZURICH), Switzerland, 03 Feb. 10, 2022 (GLOBE NEWSWIRE) — Kuros Biosciences (“Kuros” or the “Company”), a leader in next-generation bone grafting technologies, today announced that its MagnetOs granules have been approved by the Food and Drug Administration ( FDA) of the United States for expanded indications in the spine, making it the second bone graft to gain clearance for stand-alone use in the spine based on human clinical data.

FDA clearance was obtained using radiographic data, clinical results, and safety data from 50 patients enrolled in a Tier 1, randomized, controlled, multicenter trial in which MagnetOs Pellets were compared head-to-head with autograft, the gold standard for posterolateral fusion. The stand-alone use authorization proves that MagnetOs is an augmented graft that can be used instead of or in combination with bone autograft.

Joost de Bruijn, President and CEO of Kuros, said, “Nearly all of the more than four hundred bone grafts cleared by the FDA through 510(k) have been done on the basis of preclinical evidence alone. In an environment of increasing emphasis on value-based medicine, our standalone use authorization based on human clinical data positions MagnetOs above most other bone grafts licensed by 510 (k) offered to vendors and surgeons. There is a clear need for bone grafts backed by level 1 evidence and licensed for multiple uses, including the most challenging such as stand-alone use.

Stand-alone use requires the body to rely on the implanted bone graft product and not the patient’s combined autograft, which means the bar for proving stand-alone efficacy is higher than for expander efficacy bone graft.

Unlike MagnetOs granules, very few bone grafts are supported by level 1 evidence from a randomized controlled trial. For example, the current market-leading synthetic is supported by a single Tier 1 pilot study, in which 20 patients were treated versus 50 patients treated in the Kuros multicenter trial. In all published studies of the market-leading synthetic, 90% of patients were from single-investigator, single-clinical-site studies, and 96% of all patients were from non-randomized Level III/ IV studies that provide a weaker evidence base for clinical decision-making than Tier I studies. The dataset used in the FDA submission is the first Tier 1 data from the company’s Project Fusion (https ://kurosbio.com/project-fusion/).

About MagnetOs
MagnetOs is not like other bone grafts. It grows bone even in soft tissue with its unique NeedleGrip surface technology that provides traction for our body’s vital “pro-healing” immune cells (M2 macrophages). This in turn unlocks previously untapped potential to stimulate stem cells – and form new bone throughout the transplant. The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients, it means one thing: more efficient and predictable fusion.

Declaration of US Indications
MagnetOs Granules is an implant intended to fill bone voids or gaps in the skeletal system, i.e. extremities, pelvis and posterolateral spine. MagnetOs granules can be used alone or mixed with autograft, blood and/or bone marrow. These bone defects may be created surgically or result from traumatic injury to the bone and are not intrinsic to the stability of the bone structure. MagnetOs Granules resorbs and is replaced by bone during the healing process.

About Project Fusion
Today, nearly 1 in 5 spinal fusions fail. So what can we do to change this – for the benefit of patients, surgeons and our wider society? This is the question that drives us at Kuros Biosciences. Every day, our team works on three continents to unlock the hidden secrets of bone healing through our research, development and technology program: Project Merge. To deliver the ideal bone graft, we believe you need the highest quality and quantity of scientific evidence. That’s why Project Fusion brings together an unprecedented blend of scientific, preclinical and clinical studies – all aimed at making the unpredictable…predictable. For more information on Project Fusion, visit kurosbio.com/project-fusion.

About Kuros Biosciences
Kuros Biosciences is a rapidly growing leader in the development of spinal fusion biologics that relieve the burden of back pain. Present 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 unique synthetic bone graft that has already been used successfully on three continents and in more than 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 in a Phase 2 clinical trial in the United States. For more information about the company, its products and its pipeline, visit kurosbio.com.

Forward-looking statements
This press release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from historical results or any future results expressed or implied by such forward-looking statements. You should consider statements that include the words “will” or “expect” or the negative form of these words or other similar words to be uncertain and forward-looking. Factors that could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements include scientific, business, economic and financial factors. In the context of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.