Sparta Biomedical Receives FDA Breakthrough Device Designation for SBM-01 Biomimetic Implant

斯巴达生物医学公司获得FDA关于SBM-01仿生植入物的突破性设备指定

2021-03-18 09:00:03 BioSpace

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Sparta Biomedical Inc., a developer of orthopedic solutions, today announced that its SBM-01 Biomimetic Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration . SBM-01 is intended to replace damaged knee cartilage in patients having single or multiple chondral or osteochondral defects in the knee. The Breakthrough Device Program is designed to accelerate patient access to promising technologies that have the potential to provide more effective treatments for debilitating conditions. The Program provides patients and health care providers timely access to these medical devices by assisting sponsors in their development, assessment, and review, consistent with the FDA's mission to protect and promote public health. "The Breakthrough Device Designation reflects our team's drive to develop a truly unique solution to address a large clinical need," said Dushyanth Surakanti Co-Founder & CEO of Sparta Biomedical. "This new treatment option is designed for the hundreds of thousands of patients who experience persistent knee pain and compromised mobility after failing conservative care, but who are too young for a total knee replacement." "This Designation will enable us to interact with the FDA more frequently to accelerate preclinical and clinical development for SBM-01," Co-Founder and COO Dimitrios Angelis added. We look forward to making this game-changing technology available to orthopedic surgeons so they may help their patients suffering from knee pain and immobility." Osteoarthritis (OA) is one of the most common and debilitating joint disorders. The condition is characterized by progressive, irreversible articular cartilage degeneration, resulting in significant joint pain, joint motion limitations, and the formation of bony osteophytes. Most commonly, OA in the knee is first treated conservatively with non-pharmacological management, viscosupplementation injections, and anti-inflammatory medications. Patient-specific conditions, behaviors, or preferences make these options challenging to administer or achieve a high level of regimen compliance. Those who go through these interventions, often only achieve marginal temporary, palliative success. SBM-01 Biomimetic Implant is a minimally invasive treatment for chondral or osteochondral defects of the knee cartilage. It mimics the properties of native cartilage and provides a smooth articulating surface, providing support to surrounding cartilage while stabilizing subchondral bone, and thereby limiting further exacerbation of the disease. "SBM-01 has the potential to have a significant impact on patients who are suffering from knee cartilage damage," said Adam Yanke, MD, Ph.D., Assistant Director of the Cartilage Restoration Center for Rush University Medical Center and Assistant Professor, Department of Orthopedics. "I'm delighted that the FDA will be collaborating with us to bring this novel technology to the market as quickly as possible." About Sparta Biomedical, Inc Sparta's mission is to empower orthopedic surgeons with advancements that fundamentally restore movement for their patients. More information at www.sparta-biomedical.com View original content:http://www.prnewswire.com/news-releases/sparta-biomedical-receives-fda-breakthrough-device-designation-for-sbm-01-biomimetic-implant-301249628.html SOURCE Sparta Biopharma, Inc.
骨科解决方案开发商斯巴达生物医学公司今天宣布,其SBM-01仿生植入物已获得美国食品和药物管理局的突破性设备指定。SBM-01的目的是在膝关节有单个或多个软骨或骨软骨缺损的患者中替换受损的膝关节软骨。 突破性的设备计划旨在加速病人获得有潜力的技术,为衰弱的情况提供更有效的治疗。该计划通过协助赞助商开发、评估和审查这些医疗设备,为患者和卫生保健提供者提供及时获得这些医疗设备的机会,这与FDA保护和促进公众健康的使命是一致的。 斯巴达生物医学公司联合创始人兼首席执行官杜希扬斯·苏拉坎蒂说:“突破性的设备名称反映了我们团队开发一种真正独特的解决方案以满足大量临床需求的动力。“这一新的治疗方案是为几十万患者设计的,这些患者在保守治疗失败后经历了持续的膝盖疼痛和活动能力下降,但他们年龄太小,不适合进行全膝关节置换。” 联合创始人兼首席运营官迪米特里奥斯·安吉利斯补充说:“这一指定将使我们能够更频繁地与FDA互动,以加速SBM-01的临床前和临床开发。”我们期待着将这种改变游戏规则的技术提供给整形外科医生,这样他们就可以帮助那些膝盖疼痛和不能动的病人。“ 骨关节炎(Osteoarthritis,OA)是一种最常见的关节疾病。这种情况的特点是进行性、不可逆的关节软骨变性,导致明显的关节疼痛、关节活动受限和骨性骨赘的形成。最常见的是,膝部OA首先采用非药物治疗、粘液补充注射和抗炎药物等保守治疗。患者的特殊情况、行为或偏好使得这些选择在管理或实现高水平的方案依从性方面具有挑战性。那些通过这些干预措施的人,往往只取得微不足道的、暂时的、治标不治本的成功。 SBM-01仿生植入物是一种微创治疗膝关节软骨或骨软骨缺损的方法。它模仿天然软骨的特性,提供光滑的关节表面,为周围软骨提供支持,同时稳定软骨下骨,从而限制疾病的进一步恶化。 拉什大学医学中心软骨修复中心助理主任、骨科助理教授亚当·扬克(Adam Yanke)博士说:“SBM-01有可能对正在遭受膝盖软骨损伤的患者产生重大影响。”“我很高兴FDA将与我们合作,尽快将这项新技术推向市场。” 斯巴达生物医药公司简介 斯巴达的使命是增强骨科医生的能力,从根本上恢复他们的病人的运动。欲了解更多信息,请访问:www.sparta-biomedical.com 查看原文内容:http://www.prnewswire.com/news-releases/sparta-biomedical-receives-fda-breakthrough-device-designation-for-SBM-01-biomimetic-implant-301249628.html 来源斯巴达生物制药公司。

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