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Acutus expects AcQBlate ablation catheter approval by end of 2023

August 8, 2023 By Sean Whooley

This image shows the logo of Acutus Medical.Acutus Medical (Nasdaq:AFIB) reported positive second-quarter results, with some future plans that got analysts excited.

Shares of AFIB rose 0.8% at 68¢ apiece in mid-afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 2.1%.

BTIG analysts Marie Thibault and Sam Eiber maintained a “Buy” rating for Acutus. They cited a few coming milestones in the near future. The company plans to submit a premarket approval response letter to the FDA regarding its AcQBlate ablation catheter by the end of the third quarter. It anticipates approval, focused on cybersecurity, by the end of the year.

Additionally, with FDA clearance garnered for its AcQMap 9.0 software, it expects a broad launch in the fourth quarter.

“AFIB has consistently demonstrated improved utilization,” the analysts wrote. “This, combined with clear demand for the left-heart access products and gradual user expansion, leads us to believe AFIB’s improvements can be sustained.”

The rest of the quarterly results for Acutus

The Carlsbad, California–based arrhythmia management company posted losses of $18.4 million in the quarter. That amounts to 63¢ per share on sales of $5.3 million for the three months ended June 30, 2023.

Acutus recorded a massive bottom-line slide into the red on sales growth of 29.8%.

Adjusted to exclude one-time items, losses per share totaled 60¢, landing 4¢ ahead of expectations on Wall Street. Sales beat the analysts’ forecasts for $4.53 million in revenue, too.

The company said its sales growth came primarily through disposables sales, higher capital conversions, increases in service, and rent. Additionally, sales through Acutus’ distribution agreement with Medtronic drove growth.

Among highlights for the quarter, Acutus achieved record procedure volumes thanks to a handful of drivers. That included the AcQMap 8.5 software launch and positive results from its RECOVER AF study.

“Our second quarter performance reflects significant progress on our key strategic initiatives to return our business to growth while driving further operational improvement,” said David Roman, president & CEO of Acutus Medical. “The strategic actions we have successfully undertaken over the past year, along with our team’s crisp execution, are driving momentum in our business and enabling our mission to create a new paradigm for the diagnosis and treatment of complex cardiac arrhythmias.”

Acutus expects 2023 revenues to range between $20 million and $22 million.

Filed Under: Catheters, Regulatory Tagged With: Acutus Medical

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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