Kuros Biosciences announces enrollment of first patient in ASTRA study – A global, prospective, randomized, multi-center clinical trial in foot and ankle fusion Schlieren (Zürich), Switzerland, December 2, 2025 – Kuros Biosciences (“Kuros” or the “Company”) a leader in innovative biologic technologies, today announced that the first patient has been enrolled in its global ASTRA (Ankle Subtalar arThrodesis Randomized Assessment) study. ASTRA is a prospective, randomized, single-blinded, controlled, multi-cen ...

Kuros Biosciences to present at the Piper Sandler 37th Annual Healthcare Conference Schlieren (Zürich), Switzerland, November 26, 2025 – Kuros Biosciences (“Kuros” or the “Company”) a leader in innovative biologic technologies, will present at the Piper Sandler 37th Annual Healthcare Conference, taking place December 2–4, 2025 at The Lotte New York Palace in New York City. The Company’s presentation will highlight continued commercial momentum, clinical advancement across the MagnetOs portfolio, and ongoin ...

Core Viewpoint - Kuros Biosciences has reported a significant financial performance for the first nine months of 2025, with a 77% year-over-year revenue increase, prompting the company to raise its sales guidance for 2025 to at least 70% growth [1][3][10]. Financial & Operational Highlights - Total group revenue reached USD 101.1 million, up 77% compared to USD 57.2 million in the same period of 2024 [3][7]. - Revenue from Direct MagnetOs product sales increased by 76% year-on-year to USD 99.7 million, compared to USD 56.7 million in 9M 2024 [3][7]. - The Group achieved an EBITDA of USD 7.4 million for the first nine months of 2025, a significant increase from USD 1.6 million in the prior-year period [4][7]. - Adjusted EBITDA amounted to USD 12.2 million, with a margin of 12.1%, up from USD 6.5 million and a margin of 11.3% in 9M 2024 [4][7]. - Cash and cash equivalents increased to USD 20.0 million as of September 30, 2025, from USD 18.4 million as of June 30, 2025 [5][7]. Regulatory, Commercial & Clinical Highlights - Kuros has commenced the full commercial launch of the MagnetOs MIS Delivery System in the U.S. after receiving FDA clearance, designed for minimally invasive spine procedures [6][10]. - The MagnetOs MIS Delivery System is noted for its efficiency, delivering grafts three times faster than traditional methods, and is backed by Level I clinical evidence [6][10]. - The company received approval from the Saudi Food and Drug Authority (SFDA) for MagnetOs Putty and MagnetOs Granules, marking a key milestone in its expansion in the MENA region [8][9]. Outlook - The Group expects sales in the second half of the year to align with usual seasonal trends, reinforcing the raised sales guidance for 2025 [3][10]. - The CEO emphasized the company's focus on organic growth initiatives and expansion into new markets, including the spinal market and regions like Saudi Arabia [10].

Core Insights - Kuros Biosciences has launched the MagnetOs™ MIS Delivery System, designed for minimally invasive surgical procedures, which will be showcased at the SMISS Annual Meeting on October 3, 2025 [1][4]. Product Features - The MagnetOs MIS Delivery System is the only sterile, prefilled, and human tissue-free bone graft delivery system, supported by Level I clinical evidence [2]. - It utilizes proprietary NeedleGrip™ submicron surface technology to enhance bone formation by harnessing the immune system, ensuring efficient and precise graft placement [2][8]. - The system allows for graft placement that is three times faster than traditional methods, and it is ready-to-use without the need for refrigeration or thawing [7]. Clinical Evidence - A retrospective study showed a 94.4% fusion rate in patients undergoing minimally invasive and open transforaminal lumbar interbody fusions (TLIF) using MagnetOs, even among patients with comorbidities [6]. - MagnetOs demonstrated nearly double the fusion rate of autograft in posterolateral fusion procedures (79% vs. 47%) in a Level I clinical study [8]. Expert Endorsements - Dr. Matthew Maserati, a neurosurgeon, praised the MagnetOs MIS Delivery System for its efficiency and reliability in graft placement during his presentation at SMISS [3]. Company Vision - Chris Fair, CEO of Kuros Biosciences, emphasized that the launch of MagnetOs MIS reflects the company's commitment to redefining spine surgery through innovation, efficiency, and clinical evidence [4].

Core Viewpoint - Kuros Biosciences is currently investigating the resignation of former Board member Albert Arp, who allegedly resigned due to sharing price-sensitive information with a third party, but the company asserts this matter does not affect its strategic direction or financial performance [1]. Company Overview - Kuros Biosciences is focused on innovative biologic technologies and is listed on the SIX Swiss Exchange, with operations in the United States, Switzerland, and the Netherlands [5]. - The company's flagship product, MagnetOs, is an advanced bone graft used globally across four continents [5]. Product Information - MagnetOs has demonstrated a fusion rate of 79% in a Level I clinical study, nearly double that of autograft at 47% for posterolateral fusions [3]. - Among active smokers, the fusion rate difference was even more pronounced, although specific data for this subgroup was not statistically analyzed [3][7]. - MagnetOs utilizes NeedleGrip technology to stimulate bone growth without added cells or growth factors, and it is FDA cleared for use throughout the spine [3]. Regulatory and Usage Notes - MagnetOs is not cleared as an osteoinductive bone graft and must be used with an FDA-cleared intervertebral body fusion device [8].

Company Overview - Kuros Biosciences is a leader in next-generation bone healing technologies, with a mission to discover, develop, and deliver innovative biologic technologies [2][7] - The company is listed on the SIX Swiss Exchange and has locations in the United States, Switzerland, and the Netherlands [7] Board of Directors Changes - Albert Arp has resigned from the Board of Directors for personal and professional reasons, effective immediately [2] - Oliver Walker has been appointed as Chair of the Audit and Risk Committee [2] - Kimberley Elting has been appointed as a member of the Audit and Risk Committee and as Chair of the Compensation and Nomination Committee [2] Product Information - Kuros's first commercial product, MagnetOs, is an advanced bone graft that has been used across four continents [7] - In a Level I human clinical study, MagnetOs achieved a fusion rate of 79%, nearly double that of autograft at 47% in posterolateral fusions [5] - Among active smokers, the fusion difference was even more pronounced, although specific data for this subgroup was not statistically analyzed [5][9] - MagnetOs utilizes NeedleGrip technology to stimulate bone growth without added cells or growth factors, and it is FDA cleared for use throughout the spine [5]

Core Insights - Kuros Biosciences reported a significant revenue growth of 78% in H1 2025, reaching USD 63.5 million, driven primarily by Direct MagnetOs product sales [4][6][8] - The company achieved its first-ever operating profit of USD 3.5 million, a notable improvement from an operating loss of USD (0.2) million in H1 2024 [4][11] - Kuros anticipates continued strong growth, projecting sales of USD 220 million to USD 250 million by 2027, with a minimum sales growth expectation of 60% for 2025 [8][14] Financial Highlights - Total group revenue for H1 2025 was USD 63.5 million, a 78% increase from H1 2024 [4][8] - Direct MagnetOs product sales rose by 77% year-on-year to USD 62.7 million [4][8] - EBITDA for H1 2025 reached USD 5.1 million, up from USD 0.8 million in H1 2024, with adjusted EBITDA totaling USD 7.8 million [4][8] - The company reported a net loss of USD (2.0) million for H1 2025, compared to a net loss of USD (0.2) million in H1 2024 [11][15] Operational Highlights - Kuros has established a five-year exclusive strategic sales agent agreement with Medtronic for MagnetOs in the U.S., enhancing commercial access [7] - The company received FDA clearance for its MagnetOs MIS Delivery System, which significantly improves graft placement efficiency [12] - Kuros is expanding its global presence, with recent approvals for MagnetOs products in Brazil and other international markets [12] Strategic Initiatives - The company is constructing a new U.S. headquarters and production facility in Atlanta to support operational expansion and meet rising demand [12] - Kuros hosted its inaugural Capital Markets Day in May 2025, showcasing its scientific leadership and global commercial strategy [12] - The company continues to invest in R&D and marketing to penetrate new markets and enhance brand awareness [10][12]

Core Insights - Kuros Biosciences is set to present its latest developments regarding MagnetOs and its strategic priorities during the Capital Markets Day on May 13, 2025, in Zürich, Switzerland [1][2] Company Overview - Kuros Biosciences is a leader in innovative biologic technologies, focusing on bone healing solutions [1][9] - The company is expanding its global footprint and targeting both spinal and extremity markets, with anticipated growth in the U.S., Europe, and other regions [6] Product Insights - MagnetOs is a proprietary bone healing technology that has shown nearly double the fusion rate compared to autograft in a Level I human clinical study, particularly effective among active smokers [6][7] - The technology utilizes NeedleGrip™, a submicron surface technology that stimulates bone growth without added cells or growth factors [6][7] Strategic Priorities - Kuros aims to improve patient outcomes and drive shareholder value through innovation, strategic partnerships, and global growth [4][6] - The company is leveraging its alliance with Medtronic to enhance market access and accelerate product adoption [6] Clinical Insights - Seven Level I human clinical trials are currently underway to demonstrate MagnetOs' efficacy in promoting bone growth and fusion across various surgical applications [6] - Insights from Dr. Greg Berlet, a leading orthopedic surgeon, will be shared, highlighting the advantages of MagnetOs from both surgeon and patient perspectives [2][6]