Conformal Medical Achieves Enrollment Milestone in the CONFORM IDE Trial

Company marks 500^th patient enrolled in the study and gains significant clinical experience with its next-generation CLAAS^® AcuFORM^™ Left Atrial Appendage Device

NASHUA, N.H., April 2, 2025 /PRNewswire/ -- Conformal Medical, Inc., a medical device company specializing in stroke prevention technology, announces the enrollment of its 500^th patient in the company's CONFORM IDE Trial. The prospective, multicenter, randomized controlled study is evaluating the safety and efficacy of the Conformal CLAAS AcuFORM System compared to other commercially available left atrial appendage (LAA) devices and aims to enroll approximately 1,600 patients. This marks a significant milestone, reaching close to a third of the intended enrollment, and is a major step forward in validating the CLAAS System for patients with non-valvular atrial fibrillation (NVAF).

Leading U.S. physicians including Christopher Ellis, MD, Professor of Medicine and Director of the Atrial Fibrillation and LAA Closure Programs at Vanderbilt Health Nashville, TN, Vikrant Jagadeesan, MD, Assistant Professor in Interventional Cardiology at West Virginia University, Morgantown, WV, and Devi Nair, MD, Clinical Adjunct Professor UAMS, Director of Cardiac Electrophysiology St. Bernards Medical Center and White River Medical Center and Director/CEO Arrhythmia Research Group were among the first operators to implant the next-generation CLAAS AcuFORM left atrial appendage occlusion (LAAO) device. The CLAAS System aims to provide patients and physicians with an alternative option to seal the LAA with only two sizes, to reduce stroke risk without needing long-term anticoagulant therapy.

"I am pleased with the performance of the next-gen CLAAS AcuFORM System. Enhancements to the delivery system and the implant, combined with the addition of a steerable sheath, have improved the performance and ease of use," said Dr. Nair. "I believe this system has the potential to be a meaningful advancement and I look forward to validating this as we continue enrollment for the CONFORM Trial."

Additionally, Conformal confirms that the next-generation CLAAS AcuFORM device has been implanted in 51 patients worldwide, garnering enthusiastic support from the physician community across the globe and underscoring the potential of the technology to benefit patients and physicians. The device is designed to naturally conform to the LAA instead of reshaping it, as seen with commercially available devices. The CLAAS AcuFORM implant features a self-expanding nitinol endoskeleton for flexibility and an adaptive foam matrix that is intended to fill gaps for a better seal, reducing complications and providing a more patient-friendly solution.

"Reaching the 500^th patient enrollment in the CONFORM IDE Trial is a testament to the dedication of the Conformal team and the trust our implanting physicians place in our technology," commented James Reinstein, President and CEO of Conformal Medical. "We are committed to advancing stroke prevention technology and look forward to delivering the CLAAS AcuFORM System to market in the coming years."

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/.  

About Left Atrial Appendage Closure
More than six million people in the United States suffer from Afib, placing them at an increased risk of stroke.¹ Current standard of care for stroke prevention is chronic oral anticoagulants, which are not well accepted by patients due to concern about associated risk of bleeding. Left Atrial Appendage Occlusion (LAAO) is emerging as an important alternative to blood thinners for preventing strokes in patients with non-valvular Afib. First-generation LAAO devices are an estimated $1.4B global market in 2023 and are expected to grow to over $6B by 2030.^2,3

CAUTION: Investigational Device.
The CLAAS System is limited by Federal (or United States) law to investigational use.

NCT05147792

1. Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20.
2. Piper Sandler Market Analyst Report, September 2023.
3. Boston Scientific Investor Update, September 2023.

SOURCE Conformal Medical, Inc.