Kuros Biosciences to present positive clinical data for MagnetOs at NASS 2022 Annual Meeting

Kuros Biosciences to present positive clinical data for MagnetOs at NASS 2022 Annual Meeting

 

• First clinical data from five planned randomized controlled trials
• Show favorable fusion rate compared to autograft
• Launch of MagnetOs Flex Matrix expands perioperative options for surgeons

 

Schlieren (Zurich), Switzerland, 11 October, 2022 – Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today that it will present compelling clinical data on MagnetOs bone graft at the 38^th Annual Meeting of the North American Spine Society (NASS), being held in Chicago October 12 to 15, 2022, in addition to completing a full commercial launch of MagnetOs Flex Matrix.

 

This first data, from the Company’s five planned randomized controlled trials for MagnetOs, compares MagnetOs Granules to the gold standard of autograft bone. The rate of posterolateral lumbar fusion of the first consecutive 50 patients in this preliminary analysis were assessed by CT-scan at Month 12 post-operation. The fusion rate for MagnetOs was 78% in comparison to 42% for autograft, comparing favorably to fusion rates of 55-71% reported for synthetic bone grafts evaluated in similar well-controlled studies.¹

 

The full commercial availability of MagnetOs Flex Matrix opens an opportunity for surgeons who routinely mix their bone graft of choice with bone marrow aspirate, to reap the benefits of MagnetOs’ NeedleGrip surface technology while continuing with their routine peri-operative practice. The MagnetOs Flex Matrix product is extremely convenient to use, with excellent granule retention, remaining strong yet flexible even when wet, allowing wide-ranging manipulation to fill bony spaces in whichever way surgeons require.

 

Joost de Bruijn, Chief Executive Officer of Kuros, said: "These exciting data mark a significant milestone in the clinical phase of Project Fusion, which brings together an unprecedented blend of scientific, pre-clinical and clinical studies. The interim data exceed expectations for performance and validate MagnetOs as an augmented bone grafting option.

 

“Furthermore, the launch of MagnetOs Flex Matrix rounds out the family of MagnetOs products, meaning we have solutions that meet user needs in most peri-operative surgical scenarios in posterolateral fusion.”

 

Details of the NASS presentations:

 

Dr. Katherine Sage, DO: Ongoing, Prospective, Randomized, Intra-Patient Controlled Trial Shows Favorable Results of MagnetOs Granules Used Standalone As Compared to Autograft in Instrumented Posterolateral Spinal Fusions

• Session Date: 10/13/2022
• Session Room: Red Theater
• Presentation Time: 1:00 PM - 1:07 PM CDT

 

Nathan Kucko, PhD: Evaluation of a calcium phosphate-collagen matrix bone graft with needle-shaped submicron surface topography in a clinically relevant sheep posterolateral lumbar spine fusion mode

• Session Date: 10/13/2022
• Session Room: Red Theater
• Presentation Time: 1:08 PM - 1:15 PM CDT

 

For further information, please contact:

Kuros Biosciences AG  LifeSci Advisors

Michael Grau Sandya von der Weid

Chief Financial Officer Investors

t:  +41 44 733 47 47 t: +41 78 680 0538

e: [email protected] e: [email protected]

 

 

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. ^*†‡2-4

 

Indications statement

MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. In the posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate and used as an extender to autograft bone. The osseous defects may be surgically created or the result of traumatic injury to the bone that are not intrinsic to the stability of the bony structure. MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process.

 

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. Lehr, et al. Spine. 2020; 45(14):944-951; Coughlan, et al. Spine (Phila Pa 1976). 2018;1-43(15):E860-E868.

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

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

4. 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.