SOLANA BEACH, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced FDA Clearance and first-in-human cases using the ClearPoint 2.2 Software with integrated Maestro Brain Modeling, and also the publication of a key validation study for its ClearPoint Maestro® Brain Model in the peer-reviewed journal NeuroImage.1 “Leadership and innovation in any medical field requires not only practical product development to deliver value for clinicians, but also robust validation and peer review to show how and why those products work,” commented Joe Burnett, President and CEO at ClearPoint Neuro.

加利福尼亚州索拉纳海滩，2024年2月21日（环球通讯社）--ClearPoint Neuro，Inc.（纳斯达克：CLPT）（“公司”）是一家全球设备、细胞和基因治疗公司，能够提供精确的大脑和脊柱导航，今天宣布FDA批准，并首次在人类病例中使用具有集成Maestro大脑建模的ClearPoint 2.2软件，以及在同行评审的期刊NeuroImage上发表的ClearPoint Maestro®大脑模型的关键验证研究。1“任何医学领域的领导力和创新不仅需要实用的产品开发才能为临床医生带来价值，还需要强大的验证和同行评审来展示这些产品的工作方式和原因，”乔·伯内特评论道，ClearPoint Neuro总裁兼首席执行官。

“The Maestro Brain Model, and its integration into the recently FDA cleared ClearPoint 2.2 navigation software, is our latest example of just that. The ClearPoint system can now offer fast, peri-procedural segmentation of the cortical structures of the brain to identify both targets and safety zones for cell and gene therapy delivery, laser ablation, biopsy and deep brain stimulation.

“Maestro大脑模型及其与最近FDA批准的ClearPoint 2.2导航软件的集成是我们最新的例子。ClearPoint系统现在可以提供大脑皮层结构的快速，围手术期分割，以识别细胞和基因治疗传递，激光消融，活组织检查和深部脑刺激的目标和安全区域。

At the same time, we are pleased to announce that one of many planned validation studies has been published online in the journal NeuroImage to give surgeons confidence in the performance and accuracy of the Maestro Tool. The first clinical cases using ClearPoint 2.2 were completed successfully this quarter, and we expect full market release in the second half of this year.” MRI-guided neuro interventions require rapid, accurate, and reproducible segmentation of anatomical brain structures for identification of targets during surgical procedures.

同时，我们很高兴地宣布，许多计划中的验证研究之一已在NeuroImage杂志上在线发布，以使外科医生对Maestro工具的性能和准确性充满信心。第一批使用ClearPoint 2.2的临床病例已于本季度成功完成，我们预计将于今年下半年全面上市。”MRI引导的神经干预需要对解剖大脑结构进行快速，准确和可重复的分割，以在外科手术过程中识别目标。

This manuscript introduces the methodology for shape-constrained deformable brain segmentation behi.

该手稿介绍了形状约束可变形大脑分割behi的方法。