Just because pulsed field ablation therapy has yet to make its mark in the U.S. by clearing the FDA, that doesn’t mean there’s any reason to wait on developing version 2.0.

仅仅因为脉冲场消融疗法尚未在美国通过清理FDA而取得标志，这并不意味着有任何理由等待开发2.0版。

Field Medical is already working to redefine the nascent approach, with what it describes as the “next generation of pulsed electric field ablation technology.” The catheter-based procedure for atrial fibrillation aims to spare certain surrounding tissues from the damage that can come with traditional thermal ablation..

Field Medical已经在努力重新定义新生的方法，它被称为“下一代脉冲电场消融技术”。基于导管的心房颤动手术旨在使某些周围组织免受传统热消融可能带来的损害。。

The California-based startup was founded last year by Steven Mickelsen, who previously helped launch the pulsed field ablation developer Farapulse—a company that was acquired by Boston Scientific for $295 million upfront in mid-2021, based on a system that is now approaching an FDA green light after previously claiming a European approval and a recent win in a U.S.

这家总部位于加利福尼亚州的初创企业去年由Steven Mickelsen创立，该公司此前曾帮助推出脉冲场消融开发商Farapulse-a公司，该公司于2021年中期以2.95亿美元的价格被Boston Scientific收购，该公司基于目前正在接近的系统FDA在之前声称获得欧洲批准并在美国最近获胜后发出绿灯。

pivotal trial..

关键试验。。

But Field Medical believes there’s still room for improvement. While pulsed field ablation treats an irregular heartbeat using short bursts of electric energy tuned to disrupt contracting cardiac muscle cells without overheating tissues—and without harming nearby nerve cells and organs such as the esophagus—the company aims to hone the technology further by shaping and concentrating those electric fields, while also addressing other safety challenges..

但现场医疗认为仍有改进的余地。虽然脉冲场消融治疗不规则的心跳，使用短时间的电能调节来破坏收缩的心肌细胞而不会过热组织，也不会损害附近的神经细胞和器官，如食道，但公司的目标是通过塑造和集中这些技术进一步完善技术。电场，同时也解决其他安全挑战。。

To support its plans, Field Medical has collected a $14 million seed round consisting of convertible note funding backed by private and strategic investors, the company said in its announcement. Those plans include a goal of launching first-in-human clinical trials in early 2024, as well as eventually tackling electrophysiology procedures and arrhythmias outside of intermittent afib..

该公司在公告中表示，为了支持其计划，Field Medical已经收集了1400万美元的种子轮，其中包括由私人和战略投资者支持的可转换债券资金。这些计划包括在2024年初启动首次人体临床试验的目标，以及最终在间歇性afib之外解决电生理程序和心律失常。。

“In today’s uncertain investment climate, we are thrilled to have attracted such strong attention from the investor community and strategic partners,” said Mickelsen, who serves as CEO.

担任首席执行官的米克尔森说：“在当今不确定的投资环境中，我们很高兴能够引起投资者界和战略合作伙伴的如此强烈关注。”。

Field Medical estimates it will enter a $3.6 billion cardiac catheter ablation market that is already growing about 14% annually.

现场医疗估计，它将进入36亿美元的心脏导管消融市场，该市场每年已经增长约14%。

In August, Boston Scientific’s Farapulse system showed it can operate on par with traditional ablation methods while demonstrating fewer complications in a head-to-head trial. Meanwhile, Medtronic’s PulseSelect ablation device posted a study earlier this year showing that 70% of patients with paroxysmal afib and 62% with persistent afib went arrhythmia-free for one year..

8月份，波士顿科学公司的Farapulse系统显示它可以与传统的消融方法相媲美，同时在头对头试验中表现出较少的并发症。与此同时，美敦力公司的PulseSelect消融装置今年早些时候发布了一项研究，显示70%的阵发性afib患者和62%的持续性afib患者无心律失常一年。。

Additionally, this week Johnson & Johnson MedTech’s Biosense Webster division declared the start of a 135-patient clinical trial in Europe of its Omnypulse pulsed fiedl ablation catheter, featuring heart mapping technology.

此外，本周Johnson＆Johnson MedTech的Biosense Webster部门宣布在欧洲开始使用Omnypulse脉冲fiedl消融导管进行135例患者临床试验，该导管采用心脏标测技术。

Previously, Field Medical announced a collaboration with CardioNXT to develop a “purpose-built system” integrating its focal pulsed field ablation technology with the latter’s 3D heart mapping and navigation platforms—with the goal of minimizing the use of X-ray imaging during procedures.

此前，Field Medical宣布与CardioNXT合作开发一种“专用系统”，将其焦点脉冲场消融技术与后者的3D心脏测绘和导航平台相结合，目的是最大限度地减少手术过程中X射线成像的使用。

“[Pulsed field ablation] has generated much excitement in the treatment of atrial fibrillation due to an improved safety profile and procedural workflow. However, most of the first generation PFA technologies today are repurposed from other applications and suffer from significant limitations outside a subset of afib procedures,” Mickelsen said in the December 2022 release.

[脉冲场消融]由于安全性和程序工作流程的改善，在心房颤动的治疗中引起了极大的兴奋。然而，目前大多数第一代PFA技术都被其他应用重新利用，并且在一个子集之外受到显着限制。afib程序，“Mickelsen在2022年12月发布时说。

“This collaboration brings together second-generation focal PFA and AI-based cardiac mapping—a combination set to revolutionize catheter ablation across the full spectrum of treatable arrhythmias.”.

“这项合作汇集了第二代局灶性PFA和基于AI的心脏标测-这是一套组合，可以在全方位可治疗的心律失常中彻底改变导管消融。”。