24 Aug Kuros Biosciences’ MagnetOs Bone Graft Successfully Achieves Three Key Milestones

• Completion of enrolment in PARTNER clinical trial, comparing MagnetOs to autograft
• First patient treated with MagnetOs Flex Matrix
• 10,000 patients now treated with MagnetOs worldwide

Schlieren (Zurich), Switzerland, August 23, 2022 – Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today that its MagnetOs bone graft has successfully achieved three key clinical and commercial milestones, with completion of enrolment in the PARTNER clinical trial, the first patient treated with MagnetOs Flex Matrix and reaching a total of 10,000 patients treated with MagnetOs worldwide.

Joost de Bruijn, Chief Executive Officer of Kuros, said: “The truly significant progress of MagnetOs is underlined by these three major milestones. The PARTNER trial marks an important advance in Project Fusion, which aims to create an unprecedented combination of scientific, pre-clinical and clinical studies to validate MagnetOs as a quality and reasonably priced alternative to cell-based allografts, bone morphogenetic proteins and premium-priced synthetic bone grafts. 

“MagnetOs Flex Matrix rounds out the MagnetOs family, providing Kuros with solutions to meet most user needs and a tool to target the 62% of U.S. spine surgeons who mix their bone graft with bone marrow aspirate, significantly de-risking of our U.S. commercialization plans. And reaching the impressive number of 10,000 patients treated is an important achievement in the growth of the brand.”

PARTNER is the first of five Level 1 randomized controlled trials for MagnetOs to be fully enrolled and conducted under the umbrella research program known as Project Fusion, which compares MagnetOs to the gold standard of autograft bone. A total of 30 patients with leg pain and/or back pain, requiring up to three-level instrumented posterolateral lumbar fusion (L2 – S1), were included in the study and an interim analysis will be performed once the first 15 patients have completed their Month 6 visit with available measurements for the endpoints.

The first patient was treated with MagnetOs Flex Matrix, which opens up an opportunity for the 62% of all U.S. spine surgeons who routinely mix their bone graft of choice with bone marrow aspirate, by Dr. Terrence Crowder at the Arizona Spine and Joint Hospital. MagnetOs Flex Matrix was mixed with autograft and used in a posterolateral fusion over the facets in a patient with degenerative disc disease. MagnetOs Flex Matrix is a new open matrix bone graft with a unique fibrillar and flexible structure that optimizes the effect of Kuros’ established NeedleGrip™ surface technology and is extremely convenient to use with strength and flexibility. 

Dr. Crowder said: “I am pleased to have had the opportunity to conduct this first treatment with MagnetOs Flex Matrix. I found the flexibility and versatility of the product very impressive and based on this evidence, I am already planning to use this new product with more patients in the coming weeks.”

Reaching 10,000 patients globally is an important commercial milestone, following launch in the UK in 2017, the US in 2019 and Australia and several EU countries in 2021, demonstrating the proven technology of MagnetOs in the real world of clinical practice as well as in controlled trial environments.

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About MagnetOs

MagnetOs isn’t like other bone grafts. It grows bone even in soft tissue thanks to its unique NeedleGrip surface technology which provides traction for our 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 one thing: a more efficient and predictable fusion. ^*†‡1-3

Indications statement

Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.

About Project Fusion

Today, nearly 1 in 5 spinal fusions fail. So, what can we do to change this situation – 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 across three continents to unlock the hidden secrets of bone healing through our research, development & technology program: Project Fusion. To deliver the ideal bone graft, we believe you need the highest quality & quantity of scientific evidence behind it. Which is 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 fast-growing leader in the development of 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 unique synthetic bone graft that has already been used successfully across three continents and in over 10,000 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 U.S. For more information on the company, its products and pipeline, visit kurosbio.com.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background 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. 
 

1. Van Dijk, et al. eCM. 2021;41:756-73

2. Duan, et al. eCM. 2019;37:60-73.

3. Van Dijk, et al. Clin Spine Surg. 2020;33(6):E276-E287.

*Results from in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com.

†MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft.

‡MagnetOs has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion. 

SOURCE: Kuros Biosciences, August 23 2022.

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