Acutus Medical Inc. posted strong results for the third quarter of 2020, despite the ongoing uncertainties of the COVID-19 pandemic. Sales for the quarter totaled $3.2 million, up 180% sequentially and 391% when compared with the same period in 2019.

Driving the increase were direct sales of Acutus disposables, sales of Acqmap consoles and distributor sales via partner Biotronik Inc., the company said. Carlsbad, Calif.-based Acutus, which focuses on cardiac electrophysiology (EP), made its Wall Street debut in August.

During the quarter, Acutus expanded its installed base of next-generation Acqmap consoles to 37, up from 21 in the prior quarter. The combination of new installs and upgrades from the first-generation 3D imaging and mapping systems brought the total installed base to 49 as of Sept. 30.

“In the third quarter, we saw strong execution by our commercial team and made considerable progress on key development and operational fronts,” CEO Vince Burgess said. “Despite headwinds from COVID-19, we continued to add new customers and aggressively upgraded existing customers to our groundbreaking second-generation electrophysiology mapping system, Acqmap.”

Broad portfolio of products

During its Nov. 12 earnings call, Burgess also touted Acutus’ broad portfolio of products, citing growing interest in its transseptal access line – not just in EP ablation procedures but in structural heart applications as well, due to workflow and safety advantages. “We believe our commercial team will facilitate traction in this space, both in accounts where we have already an Acqmap console installed and in accounts that do not yet have an Acqmap console.”

William Blair’s Margaret Kaczor rated the company’s stock Outperform. “Though we believe the pandemic is likely to be a larger headwind to fourth-quarter results, the recent IPO allowed the company to accelerate its investments in its salesforce and mappers, which should set up the company for performance in 2021-plus,” she wrote.

With its third-quarter results, Acutus continues to provide proof that it has a disruptive technology and a commercial strategy to drive sustained growth, she added.

Marie Thibault, of BTIG, also gave Acutus a thumbs up, noting revenue beat consensus’ estimate. “Utilization trends continued to improve, with September marking a record for procedural volume,” she said.

During the call, Burgess pointed to early signs that Acqmap is being used as a workhorse station, not only for complex arrythmias but for more straightforward ones as well. He noted, for example, a major southern California hospital that is routinely scheduling days with three or four cases, including conventional contact mapping and noncontact mapping. The system also is seeing use in cryoballoon and ablation cases that are performed without X-ray-based fluoroscopy, an emerging trend with EP physicians, he said.

Pipeline delays

Turning to product development, Burgess said the company expects to nab the CE mark for its Acqblate force sensing ablation catheter in the current quarter. The milestone originally had been expected in the third quarter.

COVID-19 has caused other delays as well. In the U.S., several IDE trials are facing one-quarter delays. The first of those, for a right atrial flutter indication, is expected to take about two years to complete, putting the timeline for PMA approval and commercialization in late 2022 or early 2023, Burgess said.

U.S. availability of the force sensing catheter also will be delayed until later 2022 or early 2023, while indications for paroxysmal and persistent atrial fibrillation are now slated for late 2023 or early 2024.

Private label versions of Biotronik-sourced and CE-marked platinum-iridium and gold-tipped ablation catheters, also heading into U.S. trials, are expected in the first half of 2023.

To aid in the pipeline effort, Acutus has hired Steve Mickelsen, a practicing EP and technologist, as chief translational science officer.

Pressed by J.P. Morgan Chase’s Robbie Marcus on catheter competition, Burgess declined to talk specifics. “Our plan is to come out of the gate initially, having pulsed field ablation right on the back of our force sensing gold-tipped ablation catheter,” he said. “We think that is a nicely differentiated strategy as compared to what some other folks are doing. And we obviously will have other … catheter products in that portfolio as well.”

Guidance withheld

With coronavirus cases again on the rise, Acutus withheld guidance for the remainder of the year. While the company doesn’t expect a return to the large-scale lockdowns and lab shutdowns seen in the spring, it is seeing regional slowdowns in elective procedures, notably in France, Belgium, the Netherlands and U.K.

“Presently, we don’t believe it’s going to impact materially the ramp of the installed base,” Burgess said. “The utilization per console, absolutely.” He noted that one European country has come down hard on elective procedures, but Acutus only has one console in that country so the impact may be small.

That said, patients and physicians are eager to treat arrythmias, and hospitals have learned ways to adapt to the pandemic – signs that bode well for the industry, he said.

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