Just before the holidays, Acutus Medical submitted for CE mark of its left-heart access portfolio, triggering a $17 million earnout payment from Medtronic.

Acutus sold its left-heart access portfolio to Medtronic last year for an upfront cash payment of $50 million. Medtronic also agreed to future payments tied to certain milestones and future sales. With this submission for CE mark, Acutus has achieved two such milestones under that agreement. The first milestone was qualification to become an original equipment manufacturer for Medtronic, which triggered a $20 million earnout payment. Acutus plans to continue selling the left-heart access portfolio until commercial distribution is transitioned to Medtronic.

The portfolio Medtronic bought included the AcQCross line of sheath-compatible septal crossing devices, the AcQGuide Mini integrated crossing device and sheath, the AcQGuide Flex steerable introducer with integrated transseptal dilator and needle, and the AcQGuide Vue steerable sheath. The deal gave Acutus a much-needed path forward.

Before COVID-19, Acutus was turning heads and getting noticed by some of medtech's most reputable analysts. But the pandemic has been tough on the Carlsbad, CA-based company.

Faced with ongoing macroeconomic headwinds and an evolving commercial strategy, investor sentiment toward Acutus had dropped to an all-time low by the end of 2021, according to Marie Thibault, a BTIG analyst and a former managing editor at MD+DI. In 2022, Acutus announced a restructuring plan that included a workforce reduction, but some analysts, including Thibault, questioned if those cuts would be steep enough.

The CE mark submission came about three to six months earlier than expected.

“We are very pleased to have achieved this important milestone ahead of schedule. This submission is a critical step in our partnership with Medtronic, and we are confident that Medtronic will be able to accelerate adoption and positive impact on patient care and physician practice,” said David Roman, president and CEO at Acutus Medical. “In addition to positioning the left-heart access portfolio for long-term success in Europe, achieving this key milestone bolsters our financial position and enables Acutus to continue to focus on our differentiated mapping and therapy platform.”

Starting Jan. 28, Acutus will be eligible to receive four years of revenue-based earnouts under the agreement, the company noted.