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医疗器械公司CustomSurg获得CHMBR Partners领投融资,用于加速FDA监管申请流程、启动首次人体研究并确立其在美国市场的地位

Fresh capital to enhance bone surgeries

startupticker | 2024-03-20 | 翻译由动脉网AI生成,点击反馈

可切换为仅中文


CustomSurg, provider of data-driven, end-to-end solutions for faster surgeries on complex bone fractures, has obtained an undisclosed amount in its funding round led by US East Coast Fund CHMBR Partners LLC. The funds will be used to accelerate the FDA regulatory application process and launch the first-in-human study and establish its presence in the US market..

CustomSurg是一家数据驱动的端到端解决方案提供商,为复杂骨折的快速手术提供服务,在美国东海岸基金CHMBR Partners LLC领导的一轮融资中获得了一笔未披露的资金。这些资金将用于加速FDA监管应用程序,启动首次人体研究,并在美国市场建立业务。

Approximately 25% of surgeries following complex bone fractures lead to patients experiencing complications and enduring long-term disabilities. Despite advancements in implants enhancing fracture stabilization, treatment choices remain subjective, often relying on significant intraoperative experimentation for complex fractures.

复杂骨折后大约25%的手术会导致患者出现并发症和长期残疾。尽管植入物在增强骨折稳定性方面取得了进展,但治疗选择仍然是主观的,通常依赖于复杂骨折的重要术中实验。

Uncertainty surrounding the stability of a specific fracture construct results in patients being immobilized for as long as three months post-surgery..

围绕特定骨折结构稳定性的不确定性导致患者术后固定长达三个月。

Thomas Zumbrunn, Arvind von Keudell (medical lead) and co-founder), and Valentin Splett (commercial lead), founded CustomSurg in 2019, proposing a new approach to this challenge, starting with knee-joint surgeries. They devised a service model that provides a fully-customized solution for a personalized treatment strategy based on patient-specific, biomechanical data.

2019年,托马斯·祖姆布伦(Thomas Zumbrunn)、阿文德·冯·库德尔(Arvind von Keudell)(医学负责人)和瓦伦汀·斯普雷特(Valentin Splett)(商业负责人)成立了CustomSurg,提出了一种应对这一挑战的新方法,从膝关节手术开始。他们设计了一种服务模型,为基于患者特定生物力学数据的个性化治疗策略提供了完全定制的解决方案。

The startup’s technology uses a CT scan to generate 3D models and mimic daily activities through real-life load simulations, allowing for personalized surgical planning and operative implementation, and patient-specific implant design. By quantifying the stability of a specific fracture construct, patients can expedite their recovery process.

这家初创公司的技术使用CT扫描生成3D模型,并通过真实的负荷模拟来模拟日常活动,从而实现个性化的手术计划和手术实施,以及针对患者的植入物设计。通过量化特定骨折结构的稳定性,患者可以加速其恢复过程。

Surgeons on the other hand benefit from precise pre-operative planning and real-time guidance during surgery using 3D-printed bone models and augmented reality assistance..

另一方面,外科医生受益于使用3D打印骨骼模型和增强现实辅助的精确术前计划和手术期间的实时指导。

Supported by a team of ten people, the ETH Spinoff has obtained fresh funds from an investment consortium led by US East Coast fund manager CHMBR Partners LLC. The round also includes German-based HTGF | High-Tech Gründerfonds, Switzerland-based kickfund and and several international Medtech investors.

在十人团队的支持下,ETH分支机构从美国东海岸基金管理公司CHMBR Partners LLC领导的投资财团获得了新资金。这轮投资还包括总部位于德国的HTGF高科技Gründerfonds、总部位于瑞士的kickfund和几家国际医疗技术投资者。

The funds provide the startup the required resources to grow the team, invest in further clinical research, and obtain regulatory clearance to bring AI-guided trauma surgery to clinicians and patients around the globe. The startup plans to enter the US market upon obtaining approval from the US Food and Drug Administration.(RAN).

这些资金为初创公司提供了必要的资源,以发展团队,投资于进一步的临床研究,并获得监管许可,为全球临床医生和患者带来人工智能引导的创伤手术。这家初创公司计划在获得美国食品和药物管理局的批准后进入美国市场。

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