Acutus Medical Receives FDA Approval to Initiate US Atrial Fibrillation IDE Trial with the AcQBlate® FORCE Sensing Ablation System

Rhea-AI Summary

Acutus Medical (Nasdaq: AFIB) has announced FDA approval to initiate its Atrial Fibrillation Investigational Device Exemption (IDE) clinical trial for the AcQBlate Force Sensing Ablation Catheter and System. This trial aims to enroll 350 subjects and evaluate safety and efficacy for treating both paroxysmal and persistent atrial fibrillation, a condition affecting many patients. With AF ablation procedures projected to increase to 375,000 annually by 2025, Acutus aims to expand its market presence and address a significant need in arrhythmia management.

Positive

• FDA approval to begin Atrial Fibrillation IDE trial, allowing for expanded market opportunities.
• Projected increase in AF ablation procedures to 375,000 annually by 2025, indicating significant market growth potential.
• Innovative AcQBlate Force system designed to enhance patient outcomes through real-time contact force information during ablation.

Negative

• Trial enrollment expected to begin in the second half of 2021, indicating potential delays before product commercialization.
• AcQBlate Force Sensing Catheter and System limited to investigational use under US Federal Law, restricting its current market access.

CARLSBAD, Calif., May 27, 2021 (GLOBE NEWSWIRE) -- Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced FDA approval for the company to initiate its Atrial Fibrillation (“AF”) Investigational Device Exemption (IDE) clinical trial for the AcQBlate Force Sensing Ablation Catheter and System. In the US, AF ablation procedures total approximately 190,000 per year and are projected to reach 375,000 annually by 2025¹. This trial is expected to enroll 350 subjects in leading centers globally and will evaluate the safety and efficacy of the system in the treatment of both paroxysmal and persistent atrial fibrillation.

Designed specifically to provide consistent, effective therapeutic solutions during cardiac ablation procedures, the AcQBlate Force gold-tipped catheter and system shows physicians, in real-time, how much contact force is being applied to the heart during ablations. Studies have shown the utility of real-time contact force information in helping physicians guide safe and effective therapy, which may improve patient outcomes².

In contrast to most contemporary ablation systems, the AcQBlate Force Catheter and System can operate both in a stand-alone manner or in conjunction with compatible 3D mapping systems. The new ablation system is comprised of Acutus’ AcQBlate Force Catheter and Qubic Force module and seamlessly integrates with the Qubic RF generator and Qiona irrigation pump. This state-of-the-art system received a key CE Mark in late 2020 and is now commercially available in Europe. In addition to ongoing US IDE and European commercial activities, the AcQBlate Force Catheter and System is planned to serve as the work-horse delivery platform for the company’s Pulsed Field Ablation (PFA) program.

“The AF IDE trial will expand on our entry into the US with a therapeutic technology for the treatment of the most common of arrhythmias, atrial fibrillation,” said Vince Burgess, President & CEO of Acutus Medical. “In April, we kicked off our efforts to add therapy to our US portfolio with our right atrial flutter IDE trial, and that trial is enrolling on plan. Pursuing an atrial fibrillation indication represents a critical step forward in our strategy to become a comprehensive partner to electrophysiologists in the treatment of complex arrhythmias. We look forward to offering the benefits of a force sensing ablation system to electrophysiologists and patients in the United States once we complete clinical trials and gain regulatory approval.”

Enrollment for the AcQBlate Force AF trial is expected to begin in the second half of 2021, once participating sites gain necessary institutional review board (IRB) approvals.

More information on the AcQBlate AF trial is available at https://www.clinicaltrials.gov under NCT04904354. The AcQForce Flutter trial is ongoing, and the company is actively working with selected sites to initiate cases under the IDE (reference: NCT04658940 on https://www.clinicaltrials.gov). AcQBlate Force Sensing Catheter and System is limited by US Federal Law to investigational use.

References
1. Erik J. Bracciodieta, Electrophysiology Mapping and Ablation Devices, Market Insights, US. Decision Resources Group M360EP0059, June 2019.
2. Ariyarathna N. et al., Role of Contact Force Sensing in Catheter Ablation of Cardiac Arrhythmias: Evolution or History Repeating Itself? JACC: Clinical Electrophysiology (2018); 707-723

About Acutus Medical
Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.

Follow Acutus Medical on:

• Twitter: @AcutusMedical
• LinkedIn: www.linkedin.com/company/acutus-medical-inc-/
• Facebook: @AcutusMedical
  

Media Contact
Holly Windler
619-929-1275
holly.windler@acutus.com

Investor Contact
Caroline Corner
415-202-5678
caroline.corner@westwicke.com

Photos accompanying this announcement are available at:

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FAQ

What is the purpose of Acutus Medical's Atrial Fibrillation IDE clinical trial?

The trial aims to evaluate the safety and efficacy of the AcQBlate Force Sensing Ablation Catheter and System for treating both paroxysmal and persistent atrial fibrillation.

How many subjects will the AcQBlate Force trial enroll?

The trial is expected to enroll 350 subjects from leading centers globally.

When is the enrollment for the AcQBlate Force AF trial expected to start?

Enrollment is expected to begin in the second half of 2021, pending necessary institutional review board approvals.

What are the future market prospects for AF ablation procedures?

AF ablation procedures are projected to increase from approximately 190,000 per year to 375,000 annually by 2025.

What are the key features of the AcQBlate Force Sensing Ablation Catheter?

The catheter provides real-time contact force feedback during ablation, enhancing the safety and effectiveness of the procedure.