Acutus Medical completes enrollment in IDE trial with its AcQBlate® FORCE Sensing Ablation System

Rhea-AI Summary

Acutus Medical (Nasdaq: AFIB) has completed patient enrollment in its AcQForce Flutter IDE clinical trial, totaling 110 participants across 21 sites globally. The trial evaluates the safety and efficacy of the AcQBlate FORCE sensing ablation catheter for treating right atrial typical flutter. Catheter ablation for this condition is expected to reach 200,000 procedures annually in the US by 2025. The system, approved in Europe, aims for PMA submission in Q3 2022.

Positive

• Successful completion of enrollment for the AcQForce Flutter trial, enhancing therapeutic prospects.
• Strong market potential with catheter ablation procedures projected to grow significantly by 2025.

Negative

• The AcQBlate FORCE system is still under investigational use in the US, delaying commercial availability domestically.

CARLSBAD, Calif., May 13, 2022 (GLOBE NEWSWIRE) -- Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced successful completion of patient enrollment in the company’s AcQForce™ Flutter Investigational Device Exemption (IDE) clinical trial which enrolled 110 patients at 21 sites globally.

The AcQForce Flutter trial was designed to evaluate the safety and efficacy of the AcQBlate FORCE sensing ablation catheter and system in the treatment of right atrial typical flutter. Right atrial flutter occurs when rapidly firing electrical signals cause the muscles in the heart’s upper chamber (atria) to contract quickly, leading to a rapid heartbeat and can include symptoms such as chest pain, shortness of breath, dizziness, and fainting¹. A sustained rapid heartbeat can also put stress on the heart and slow the movement of blood through the atria, increasing the risk of stroke, among other comorbidities².

Catheter ablation procedures to treat right atrial flutter account for approximately 30% of ablations in the US and are expected to reach 200,000 by 2025². The complete AcQBlate FORCE sensing ablation catheter and system, which received full CE Mark in late 2020, is commercially available in Europe. The company anticipates final patient follow-up in June 2022 with Pre-Market Approval (PMA) submission of the AcQBlate FORCE sensing ablation catheter and system in the third quarter of this year.

Designed specifically to provide consistent, effective therapeutic solutions during cardiac ablation procedures, the AcQBlate FORCE 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 outcomes³.

Dr. Vijay Swarup, MD, FHRS, Director of Cardiac Electrophysiology at the Arizona Heart Rhythm Center, and one of the leading enrollers in the trial, said, “I am pleased with the performance of the AcQBlate FORCE Sensing Ablation System in the AcQForce Flutter trial. The integration of the ablation system into the AcQMap 3D Mapping System helps the incorporation of this new force sensing technology into my workflow. I am particularly impressed by the flexibility of the system to operate both in a standalone manner and when integrated into the Acutus mapping technology.”

“Completing enrollment in the AcQForce Flutter trial represents a significant advancement in our journey to enter the United States with a therapeutic technology for the treatment of atrial flutter,” said David Roman, interim Chief Executive Officer and Chief Financial Officer of Acutus Medical. “Acutus has a strong history of partnering with physicians to bring innovative technology to the market to treat atrial arrhythmias, and we are thankful to our clinical trial sites, specifically the dedication and commitment of investigators and their staff, and to our clinical team for their collaboration in reaching this milestone.”

For more information on this trial, please see NCT04658940 on https://www.clinicaltrials.gov. AcQBlate Force Sensing Catheter is limited by US Federal Law to investigational use.

References

1. American Heart Association
2. Boyer M and Kaplan B, Atrial Flutter, Circulation (2015); 112:e334-e336
3. Electrophysiology Mapping and Ablation Devices, Market Insights, US. Decision Resources Group M360EP0062, June 2020
4. 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
https://www.globenewswire.com/NewsRoom/AttachmentNg/40e845f8-3a99-40bb-9cba-0d280dd4ffba

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FAQ

What does Acutus Medical's recent press release about the AcQForce Flutter trial indicate for AFIB investors?

The press release highlights successful patient enrollment in a significant clinical trial for an innovative ablation catheter, which may enhance future market performance for AFIB.

How many patients were enrolled in the AcQForce Flutter trial?

The trial enrolled a total of 110 patients across 21 sites globally.

What is the expected market size for catheter ablation procedures in the US by 2025?

Catheter ablation procedures are projected to reach 200,000 annually in the US by 2025.

When does Acutus Medical plan to submit for Pre-Market Approval (PMA) for the AcQBlate FORCE system?

Acutus Medical anticipates submitting for PMA in the third quarter of 2022.

What condition does the AcQBlate FORCE sensing ablation catheter treat?

It is designed for the treatment of right atrial typical flutter.