Acutus Medical Archives - Medical Design Sourcing

Acutus Medical is laying off more than half of its workers

Acutus Medical (Nasdaq:AFIB) announced today that it will lay off 65% of its workforce as part of a major restructuring.

The Carlsbad, California–based company’s most recent annual report lists 225 workers at the end of 2022, which means the layoff could involve roughly 146 workers.

Restructuring will involve winding down Acutus Medical’s EP mapping and ablation business, including the AcQMap mapping system, the AcQMap 3D mapping catheter, the AcQBlate force-sensing ablation catheter, the AcGuide Max 2.0 steerable sheath, and associated accessories. (The company said it will support AcQMap procedures with a small group of therapy managers through Nov. 30.)

Acutus Medical’s main remaining focus will be the manufacturing of left-heart access products for Medtronic. It sold its left-heart access portfolio to Medtronic for $50 million last year, and has brought in tens of millions of dollars worth of milestone payments from the deal since …

Acutus posts Q2 beats, expects AcQBlate ablation catheter approval by end of 2023

Acutus Medical (Nasdaq:AFIB) reported positive second-quarter results with some plans for the future 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 le…

Acutus Medical stock is down despite Street-beating Q4, raised guidance

Acutus Medical (Nasdaq:AFIB) shares took a hit today despite fourth-quarter results that came in ahead of the consensus forecast.

Shares of AFIB fell 11% to 89¢ apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 0.8%.

The Carlsbad, California-based arrhythmia management company posted profits of $15.1 million. That amounts to 41¢ per share on sales of $4.96 million for the three months ended Dec. 31, 2022.

Acutus posted a massive bottom-line gain from deep in the red on sales growth of 13%. The company attributed improvements to a higher production volume and lower manufacturing variances. It also cited a positive impact from restructuring actions taken earlier in the year. Acutus enacted layoffs in January 2022 as part of this restructuring. The company noted that the reduce headcount contributed to lower operating expenses.

Adjusted t…

Acutus Medical picks new CFO from within, announces 2023 guidance

Takeo Mukai. [Image from Acutus website]Acutus Medical (Nasdaq:AFIB) announced today that it promoted Takeo Mukai to senior vice president and chief financial officer (CFO).

Mukai joined Acutus in July 2021 as VP, finance. He expanded his responsibilities over the past 18 months, most recently serving as interim CFO.

“Takeo has led our strategic priority to drive operational excellence at Acutus since taking over as interim CFO in August,” said Acutus President and CEO David Roman. “Takeo’s strategic mindset, operating discipline, and extensive corporate finance experience has made him a key business partner as we drive gross margin improvement initiatives, optimize operating expenses, and ensure prudent cash management.”

Before joining Acutus, he held roles of increasing responsibility over 14 years at Medtronic, with whom Acutus recently executed a major asset sale.

“I am excited to move into the CFO role on a permanent basis,” said Mukai. “We have…

The top 10 cardiac device stories of 2022

[Image from Pixabay]From pulsed-field ablation to non-invasive monitoring, this was an exciting year for cardiac device tech.

Here are the top 10 cardiac device stories from MassDevice and its sister sites:

10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio

Earlier this year, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million.

9. Abbott confirms first implants of its dual-chamber leadless pacemaker system

The company designed its i2i technology to provide beat-by-beat communication between two leadless pacemakers, with one positioned on the right ventricle and the other in the right atrium.

8. Boston Scientific completes $1.75B Baylis Medical acquisition

The deal expanded Boston Scientific’s electrophysiology and structural heart product portfolios to include the radiofrequency (RF) NRG and VersaCross transseptal platforms. It also gained a family of guidewires, sheaths an…

Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio

[Image from the Acutus Medical website]Acutus Medical (Nasdaq:AFIB) announced today that it achieved its second milestone under an asset purchase agreement with Medtronic (NYSE:MDT).

The milestone covers submission for CE mark of the Acutus left-heart access portfolio under EU MDR. Hitting the milestone triggered a $17 million earnout payment from Medtronic to Acutus.

Earlier this year, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million. In June, the company completed the first two closings of its deal to sell the devices to Medtronic. In October, Acutus completed the first $20 million milestone under its asset purchase agreement with the medtech giant. Beginning Jan. 28, 2023, Acutus becomes eligible to receive four years of revenue-based earnouts under the deal.

The Acutus left-heart access portfolio includes the AcQCross line of sheath-compatible septal crossing devices. It also features the AcQGuide Mini, AcQGuide Flex an…

Acutus Medical fully launches next-gen heart ultrasound software

Acutus Medical (Nasdaq: AFIB) today announced the full commercial release of its next-gen AcQMap 8.5.

Its latest heart ultrasound platform includes software improvements that further leverage the system’s capabilities for non-contact anatomy reconstruction, according to Carlsbad, California–based Acutus.

“AcQMap 8.5 represents an important step forward in our technology roadmap with a specific focus on improving procedure workflow and physician experience,” said Derrick Chou, Acutus Medical’s SVP and CTO.

“This release enables physicians to further leverage AcQMap’s differentiated non-contact ultrasound capabilities for higher anatomical accuracy while providing a workflow that fits with existing clinical practice,” Chou said in a news release. “The full market release of AcQMap 8.5 is an important driver of our growth plans in 2023 and thereafter.”

More about Acutus Medical’s AcQMap 8.5 software

Acutus Medical first launch…

Medtronic begins distributing Acutus AcQCross sheath-compatible septal crossing devices

[Image from the Acutus Medical website]Acutus Medical (Nasdaq:AFIB) announced today that Medtronic (NYSE:MDT) intends to begin distributing its left-heart access devices.

In April, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million. That portfolio includes the AcQCross line of sheath-compatible septal crossing devices. It also features the AcQGuide Mini, AcQGuide Flex and AcQGuide VUE technologies.

Acutus said in June that it completed the first two closings of its deal to sell the devices to Medtronic. Last month, Acutus completed the first $20 million milestone under its asset purchase agreement with the medtech giant.

Beginning today, Medtronic intends to initiate distributing the products, having provided notice to Acutus of its intentions. Pursuant to the distribution agreement, Acutus ceased all distribution and sales of the left-heart devices to third parties, according to a news release. It now intends to manufacture …

Acutus Medical faces Nasdaq delisting

Acutus Medical (Nasdaq:AFIB) announced that it received a letter from the Nasdaq stock market indicating unsatisfied listing requirements.

The Carlsbad, California-based company said it received notification from Nasdaq that it has failed to maintain a minimum bid price of $1 per share for 30 consecutive business days. The notification of noncompliance has no immediate effect on Acutus Medical’s listing or trading of the company’s common stock on the Nasdaq Global Market.

Acutus has 180 calendar days until May 1, 2023, to regain compliance with the minimum bid price requirement, which is $1 per share for a minimum of 10 consecutive business days. Shares in AFIB were up 5.89% this afternoon to 96¢ apiece.

The company may be eligible for an additional 180-calendar day compliance period to satisfy the requirement.

The delisting notification follows news that Acutus Medical completed the first milestone under its asset purchase agreement w…

Acutus Medical achieves $20M milestone in Medtronic deal

Acutus Medical (Nasdaq:AFIB) announced today that it completed the first milestone under its asset purchase agreement with Medtronic (NYSE:MDT).

Carlsbad, California-based Acutus announced in April that it agreed to sell its left-heart access portfolio to Medtronic for $50 million.

It completed the first of two closings in its portfolio sale in June.

The achievement of the first milestone triggers a $20 million earnout payment from Medtronic. It allows Acutus to become an original equipment manufacturer (OEM) for Medtronic as well. Acutus plans to continue selling its left-heart access portfolio until its commercial distribution transitions to Medtronic.

“We are very pleased with the partnership we have built with Medtronic, with both teams working diligently to ensure a smooth transition for all stakeholders. We are excited about the potential to accelerate this innovative product line’s impact on patient care with Medtronic’s global reach, and w…

Acutus Medical ticks up on revenue beat, missed EPS in Q2 results

Acutus Medical (Nasdaq:AFIB) this week posted second-quarter results that beat the revenue consensus on Wall Street and missed earnings estimates.

The Carlsbad, California-based company reported profits of $5.7 million, or 16¢ per share, on sales of $4.1 million for the three months ended June 30, for a bottom-line gain of 119.9% on sales loss of 13.44% compared with Q2 2021.

Adjusted to exclude one-time items, earnings per share were -93¢, 17¢ behind The Street, where analysts were looking for sales of $3.97 million.

Acutus Medical said global mapping procedure volumes increased 20% year-over-year, which contributed to its profit growth.

“Our teams continued to execute our strategy in the second quarter, as we intensify focus on utilization and procedure volume as the key drivers of our business,” President and CEO David Roman said in a news release. “We registered another quarter of record procedure volumes with year-over-year growth worldwide. …

Acutus Medical’s chief translational science officer is stepping down

Acutus Medical (Nasdaq:AFIB) Chief Translational Science Officer Dr. Steven Mickelsen recently announced he is stepping down to focus on patient care and new cardiac innovation.

Mickelsen has been with the company for three years and led the design team to create a pulsed field ablation waveform to expand the capabilities of the company’s AcQblate contact-force ablation catheter. The announcement comes at the same time Acutus Medical appointed David Roman as its new president and CEO, taking the “interim” out of his title.

Upon his departure from the company, Mickelsen will dedicate his additional time to caring for heart-rhythm patients at his clinical practice in La Jolla, California and will continue educating as an associate professor of internal medicine at the University of Iowa.

Later this year, Mickelsen announced he will begin a new business venture called Field Medical to create the next generation of cardiac ablation technology. The vent…