KURN Kuros Biosciences AG

Kuros Biosciences completes enrolment in Level 1 clinical study of MagnetOs Granules

Kuros Biosciences AG / Key word(s): Study
Kuros Biosciences completes enrolment in Level 1 clinical study of MagnetOs Granules

02.11.2022 / 07:00 CET/CEST


  • Preliminary data shows 78% fusion rate vs 42% for autograft and 55-71% for other synthetic bone grafts 
  • Level 1 clinical study compares MagnetOs Granules to local autograft in patients undergoing posterolateral lumbar fusion 
  • First of five randomized controlled Level 1 trials for MagnetOs to complete enrolment 

Schlieren (Zurich), Switzerland, November 2, 2022 – Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today the completion of enrolment in the Level 1 clinical study, comparing MagnetOs Granules to the gold standard of autograft bone in patients undergoing posterolateral lumbar fusion.

Data from the prospective, multi-center, intra-patient controlled trial showed a fusion rate for MagnetOs of 78%, compared to 42% for autograft. This compares favorably to fusion rates of 55-71% reported for other synthetic bone grafts evaluated in similar well-controlled studies of posterolateral fusion.1,2

The first consecutive 50 patients (from a total of 100) requiring up to four-level instrumented posterolateral lumbar fusion (T10 – S2), were included in this preliminary analysis. The rate of posterolateral lumbar/thoracolumbar fusion was assessed by CT-scan 12 months after surgery. Data can  be downloaded from the .

Joost de Bruijn, Chief Executive Officer of Kuros, said: "We are pleased to complete enrolment in the trial and take another step forward in the clinical phase of Project Fusion with MagnetOs, with the aim of delivering the ideal bone graft. Previous bone grafts have been sold on the premise of improved clinical outcomes but based on benchtop or preclinical data, so we are excited to demonstrate MagnetOs’ effect in a high-level clinical setting. This further demonstrates our commitment to converting our ground-breaking research to Level 1 evidence of efficacy in humans, and to fund research in spine surgery for the benefit of patients, surgeons, and our wider society.”

For further information, please contact:

Kuros Biosciences AG 
Michael Grau
Chief Financial Officer
Tel 7
LifeSci Advisors 
Hans Herklots
Investors
t:

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. *†‡3-5

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 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 US. 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; 

2. Coughlan, et al. Spine (Phila Pa 1976). 2018;1-43(15):E860-E868.

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

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

5. 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.



End of Media Release


Language: English
Company: Kuros Biosciences AG
Wagistrasse 25
8952 Schlieren
Switzerland
Phone:
Fax:
E-mail:
Internet:
ISIN: CH0325814116
Valor: 32581411
Listed: SIX Swiss Exchange
EQS News ID: 1476877

 
End of News EQS News Service

1476877  02.11.2022 CET/CEST

fncls.ssp?fn=show_t_gif&application_id=1476877&application_name=news&site_id=research_pool
EN
02/11/2022

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Kuros Biosciences AG

Kuros Biosciences AG: 2 directors

Two Directors at Kuros Biosciences AG sold 650,000 shares at 18.280CHF. The significance rating of the trade was 100/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years ...

 PRESS RELEASE

Kuros Biosciences Announces Peer-Reviewed Publication of MagnetOs MAXA...

Kuros Biosciences AG / Key word(s): Study results/Scientific publication Kuros Biosciences Announces Peer-Reviewed Publication of MagnetOs MAXA Level 1 Study Outcomes in Spine, Indicating Superiority Over Autograft 25.06.2024 / 07:00 CET/CEST Schlieren (Zurich), Switzerland, June 25, 2024 – Kuros Biosciences, a leader in next generation bone healing technologies, today announced the publication of a peer-reviewed manuscript that details the clinical data of its MAXA Level 1 prospective, multi-center, randomized, intra-patient controlled clinical study in Spine1.   Published clinica...

 PRESS RELEASE

Annual General Meeting of Kuros Biosciences approves all resolutions

Kuros Biosciences AG / Key word(s): AGMEGM Annual General Meeting of Kuros Biosciences approves all resolutions 17.04.2024 / 14:05 CET/CEST Schlieren (Zurich), Switzerland, April 17, 2024 – Kuros Biosciences (SIX:KURN), a leader in next generation bone graft technologies, held its Annual General Meeting today.  The Annual General Meeting approved the Annual Report, the Annual Financial Statements, and the Consolidated Financial Statements for the year 2023 and took note of the Reports of the Auditors. Shareholders granted discharge to the Board and the Executive Committee, voted i...

 PRESS RELEASE

Kuros Biosciences to Report Full Year Financial Results for 2023 and P...

Kuros Biosciences AG / Key word(s): Annual Results Kuros Biosciences to Report Full Year Financial Results for 2023 and Provide Corporate Update 08.03.2024 / 07:00 CET/CEST -    Company to host conference call and webcast on March 13, 2024, at 3pm CET/10am US EST Schlieren (Zurich), Switzerland, March 8, 2024 – Kuros Biosciences (“Kuros” or “the Company”), a leader in next-generation bone graft technologies, today announced that it will report its full-year financial results and provide a corporate update on its business on March 13, 2024.  Following the announcement, the company w...

 PRESS RELEASE

Kuros Biosciences to Present at the CG 2024 Musculoskeletal Conference

Kuros Biosciences AG / Key word(s): Conference Kuros Biosciences to Present at the CG 2024 Musculoskeletal Conference 01.02.2024 / 07:00 CET/CEST Schlieren (Zurich), Switzerland, February 1, 2024 – Kuros Biosciences (“Kuros” or “the Company”), a leader in next generation bone graft technologies, today announced it will present at the CG 2024 Musculoskeletal Conference, to be held in San Francisco on February 12, 2024. At the conference, management will discuss its novel MagnetOs portfolio of products and its application to spinal fusion.  Presentation details are as follows: Pres...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch