预防房颤患者中风器械研发商Conformal Medical完成3200万美元D轮融资，推进其下一代左心耳封堵技术的发展-动脉网

Conformal Medical Closes $32 Million Series D Extension to Advance its Next-Generation Left Atrial Appendage Occlusion Technology

CISION 等信源发布 2025-08-13 01:33

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New partner reinforces confidence in the company's progress and future potential.

新合作伙伴增强了对公司进展和未来潜力的信心。

NASHUA, N.H.

新罕布什尔州纳舒厄市

，

Aug. 12, 2025

2025年8月12日

/PRNewswire/ --

/美通社/ --

Conformal Medical, Inc.

共形医疗公司

, a medical device company developing next-generation left atrial appendage occlusion (LAAO) technology, announced the successful closing of its Series D extension financing, with a new partner joining inside investors to raise a total of

，一家开发下一代左心耳封堵（LAAO）技术的医疗设备公司，宣布成功完成了其D轮融资扩展，新合作伙伴加入内部投资者行列，共筹集了

$32 million

3200万美元

。

继续阅读

Conformal Medical's CLAAS® AcuFORM™ Left Atrial Appendage Device (PRNewsfoto/Conformal Medical, Inc.)

康福特医疗的CLAAS® AcuFORM™ 左心耳装置 (PRNewsfoto/Conformal Medical, Inc.)

The funds will support the enrollment of the company's ongoing CONFORM Pivotal Trial and fund key pre-commercialization initiatives for CLAAS

这笔资金将支持公司正在进行的CONFORM关键试验的注册，并为CLAAS的关键预商业化计划提供资金。

AcuFORM™ LAAO system. The CONFORM Pivotal Trial is the company's clinical trial evaluating the safety and efficacy of the CLAAS

AcuFORM™ LAAO系统。CONFORM关键试验是该公司评估CLAAS安全性和有效性的临床试验。

System compared to other commercially available LAAO devices and will support U.S. Food and Drug Administration (FDA) pre-market approval. The CLAAS AcuFORM System is designed to seal the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AFib) to reduce the risk of stroke without the need for anticoagulants..

系统与其他商业可用的LAAO设备相比，并将支持美国食品药品监督管理局（FDA）的上市前批准。CLAAS AcuFORM系统旨在封闭非瓣膜性心房颤动（AFib）患者的左心耳（LAA），以降低中风风险，且无需抗凝剂。

'We are pleased to have treated over 100 patients with the next-generation AcuFORM™ System, with impressive deliverability and safety performance to date,' said

“我们很高兴已经使用下一代AcuFORM™系统成功治疗了100多名患者，迄今为止其输送性能和安全性表现令人印象深刻，”

James Reinstein

詹姆斯·雷因斯坦

, President and CEO of Conformal Medical. 'We look forward to building upon this robust body of evidence to further validate our one-size strategy, and the promising experience from our GLACE trial, demonstrating successful use of ICE guidance as it would eliminate the need for general anesthesia and intubation for these procedures.'.

Conformal Medical的总裁兼首席执行官表示：“我们期待在这一有力的证据基础上，进一步验证我们的单一尺寸策略，以及GLACE试验的令人鼓舞的经验，证明了ICE引导的成功应用，因为它将消除这些手术对全身麻醉和插管的需求。”

Conformal Medical's proprietary CLAAS AcuFORM technology features a foam-based architecture designed to conform to a broad range of LAA anatomies with only two sizes. The AcuFORM device may also accelerate the shift to ICE-guided LAAO closure due to simplified sizing and seal confirmation, thereby potentially eliminating the need for a procedural transesophageal echocardiogram and general anesthesia.

康福特医疗公司专有的CLAAS AcuFORM技术采用基于泡沫结构的设计，能够以仅两种尺寸适应广泛的左心耳解剖结构。AcuFORM装置还可能通过简化的尺寸选择和密封确认加速向ICE引导的左心耳封堵术转变，从而可能消除对经食管超声心动图和全身麻醉的需求。

This is a significant advancement with the potential to shift clinical practice to a single-operator procedure that is less invasive for patients. The company remains focused on completing the CONFORM and GLACE clinical trials to demonstrate its safety profile and ability to offer breakthrough solutions that address unmet clinical needs and transform the way Left Atrial Appendage Occlusion is treated..

这是一个重要的进步，有可能将临床实践转变为对患者创伤更小的单人操作程序。公司仍专注于完成CONFORM和GLACE临床试验，以证明其安全性，并能够提供突破性的解决方案，满足未被满足的临床需求，改变左心耳封堵术的治疗方式。

Piper Sandler

派珀·桑德勒

acted as exclusive financial advisor, and

担任独家财务顾问，并且

Gunderson Dettmer

贡德森·德特默律师事务所

acted as legal counsel to Conformal Medical in this transaction.

在此交易中担任Conformal Medical的法律顾问。

About CONFORM Pivotal Trial

关于CONFORM关键试验

The CONFORM Pivotal Trial is a prospective, multicenter, randomized controlled study evaluating the safety and efficacy of the Conformal CLAAS AcuFORM System compared to other commercially available left atrial appendage (LAA) devices. The trial plans to randomize approximately 1,600 patients at sites worldwide and is now >30% enrolled.

CONFORM 关键试验是一项前瞻性、多中心、随机对照研究，评估 Conformal CLAAS AcuFORM 系统与其他市售左心耳 (LAA) 装置相比的安全性和有效性。该试验计划在全球各地的站点随机分配约 1,600 名患者，目前已完成超过 30% 的入组。

It aims to generate pivotal data supporting next-generation stroke prevention therapies for individuals with non-valvular atrial fibrillation (AFib) who are seeking an alternative to long-term oral anticoagulation. For more information, visit .

该研究旨在生成关键数据，以支持非瓣膜性心房颤动（AFib）患者寻求长期口服抗凝治疗替代方案的下一代卒中预防疗法。欲了解更多信息，请访问。

https://conformalmedical.com/patient/enroll-in-trial

。

About Conformal Medical

关于Conformal Medical

Conformal Medical, Inc.

共形医疗公司

is a medical device company developing devices to prevent stroke in patients with non-valvular atrial fibrillation. The company's proprietary technology is intended to make left atrial appendage closure a same-day, single-operator procedure. For more information, visit

是一家医疗设备公司，正在开发用于预防非瓣膜性心房颤动患者中风的设备。该公司的专有技术旨在使左心耳封堵术成为当天、单人操作的程序。欲了解更多信息，请访问

https://conformalmedical.com/

。

CAUTION: Investigational Device

注意：研究用装置

。

The CLAAS System is limited by Federal (or

CLAAS系统受联邦（或

United States

美国

) law to investigational use.

`) 法律用于调查用途。`