Core Insights - Kuros Biosciences announced significant milestones including health system approvals, regulatory certifications, and preclinical evidence supporting the global expansion of MagnetOs, to be presented at upcoming investor conferences [2][3] Recent U.S. Healthcare System Approvals - All five formulations of MagnetOs have received approval from multiple large Integrated Delivery Network (IDN) health systems in the U.S., facilitating broader access and adoption [4] - These approvals are based on comprehensive evaluations by multidisciplinary teams assessing efficacy, safety, and economic considerations, which will enhance surgeon access to MagnetOs [5] Regulatory Achievements - MagnetOs Granules and MagnetOs Putty achieved certification under the European Union Medical Device Regulation (MDR) on December 22, 2025, ensuring continued market access in the EU [6][7] - MDR certification is recognized as one of the most stringent regulatory frameworks globally, reflecting the strength of Kuros' clinical evidence [8] Preclinical Study Publication - A newly published preclinical study demonstrated that MagnetOs Flex Matrix achieved significantly higher fusion rates compared to various synthetic bone grafts in a sheep model, with 100% bilateral fusion in MagnetOs treated segments [9][10] - This study emphasizes the importance of robust multi-endpoint analysis in distinguishing true bone fusion outcomes, further differentiating MagnetOs from competing technologies [10] Ongoing Clinical Development - Kuros is continuing its clinical development efforts with the ASTRA study, a global, prospective, randomized, controlled trial evaluating MagnetOs against autograft in patients undergoing hindfoot or ankle fusions [10] Upcoming Events - Key upcoming events include the Octavian Seminar on January 15, 2026, and the Baader Bank Swiss Equities Conference on January 16, 2026, where the company will provide further updates [11]

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 ...

Core Insights - Kuros Biosciences will present at the Piper Sandler 37th Annual Healthcare Conference, showcasing its innovative biologic technologies and commercial momentum [1][2] - The presentation will focus on clinical advancements in the MagnetOs portfolio, expansion into new indications, and the company's path to sustainable profitability [2] Company Overview - Kuros Biosciences is dedicated to discovering, developing, and delivering innovative biologic technologies, with operations in the United States, Switzerland, and the Netherlands [7] - The company's first commercial product, MagnetOs, is an advanced bone graft used globally across five continents [7] Product Details - MagnetOs has demonstrated a fusion rate of 79% in a Level I clinical study, nearly double that of autograft at 47% [5] - The product utilizes NeedleGrip technology to stimulate bone growth without added cells or growth factors, and is FDA cleared for use throughout the spine [5] Presentation Details - The presentation will be led by Chris Fair, CEO of Kuros Biosciences, on December 3, 2025, at The Lotte New York Palace in New York City [3] - A live webcast of the presentation will be available for 30 days post-event [3]

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]