Conformal Medical Announces First Patient Enrollment in the E.U. for CONFORM Pivotal Trial with The CLAAS® AcuFORM™ LAAO Device

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Expanded partnerships with leading European centers create a strategic pathway to accelerate market adoption and drive future commercialization opportunities

NASHUA, N.H., Oct. 14, 2025 /PRNewswire/ -- Conformal Medical, Inc., a medical device company developing next-generation technology for left atrial appendage occlusion (LAAO), today announced the initiation of patient enrollment in the European Union for the CONFORM Pivotal Trial. The first E.U. procedure was successfully performed at the Institut Cardiovasculaire Paris Sud (ICPS) in France by Philippe Garot, MD, FESC, Head of the Interventional Cardiology.

The CONFORM Pivotal Trial is evaluating the CLAAS^® AcuFORM^™ LAAO device, a novel foam-based implant designed to provide a simplified, anatomy-conforming solution for stroke prevention in patients with non-valvular atrial fibrillation (AFib).

"The CLAAS AcuFORM system represents an important innovation in LAAO, with the potential to simplify procedures, expand access, and improve outcomes for patients with non-valvular AFib," said Dr. Garot. "We are excited to participate in the CONFORM Pivotal Trial and to help bring this next-generation therapy to patients across Europe."

The expansion of the CONFORM trial into the E.U. marks a significant milestone for Conformal Medical, underscoring both the scalability of the study and the global opportunity for the CLAAS AcuFORM system. Leveraging Europe's diverse healthcare systems and well-established clinical networks, this phase of the trial is designed to generate robust real-world evidence, drive physician adoption, and lay a strong foundation for future commercialization.

"Partnerships with leading European centers strengthen our global presence, accelerate innovation, and position us to deliver the benefits of our differentiated technology to patients worldwide," said James Reinstein, President and CEO of Conformal Medical. "We believe the CLAAS AcuFORM system will be a competitive offering, with its ability to conform to individual anatomies, simplify procedures with just two device sizes, and provide reliable seal confirmation."

About CONFORM Pivotal Trial
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. 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 https://conformalmedical.com/patient/enroll-in-trial.

The CONFORM Pivotal Trial is an ongoing study designed to comply with EU MDR Chapter VI, Article 62 4(i).

About Conformal Medical
Conformal Medical, Inc. 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 https://conformalmedical.com/.

Caution: Limited by federal law (United States) to investigational use. Exclusively for clinical investigation outside the United States. Not approved for commercial use.

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