Dive Brief:
- Artivion has taken certain systems offline in response to a cybersecurity incident, the company said Monday in a filing with the Securities and Exchange Commission.
- The heart device manufacturer said the incident, which involved the acquisition and encryption of files, “has caused disruptions to some order and shipping processes, as well as to certain corporate operations.”
- Those disruptions have “largely been mitigated,” Artivion said, but continued risks such as the potential for “delays in restoration” mean the company cannot rule out larger impacts.
Dive Insight:
Artivion identified the cybersecurity incident on Nov. 21. In response, the company took certain systems offline, began an investigation and engaged external advisers including legal, cybersecurity and forensics professionals. Artivion and its advisers are working to assess, contain and remediate the incident.
The company said it will “securely restore its systems as quickly as possible” but has yet to publish a timeline.
When Artivion shared details of the incident Monday, it believed the event had not had a material impact on its overall financial condition or results of operations and was “not reasonably likely” to have such an impact.
The incident has affected operations, though, and Artivion said it will continue to incur expenses related to its response. Artivion believes it has “adequate insurance coverage” but still expects to face costs that will not be covered by insurance. The company outlined its cybersecurity risk management and strategy in its annual report in February.
Artivion published details of the cybersecurity incident on the day it released an update on its AMDS Hybrid Prosthesis. The Food and Drug Administration granted humanitarian device exemption to the aortic arch remodeling device. The exemption allows Artivion to distribute the device in the U.S. ahead of an anticipated premarket approval (PMA) in patients with a type of tear in the aorta.
The company filed the first module of its PMA application earlier this year and is aiming to win approval in the fourth quarter of 2025, CEO Pat Mackin said on a third-quarter earnings call in November.
PMA would open up a $150 million addressable market with no competitive alternatives in the U.S., according to the CEO. Mackin outlined the case for the device and plans for the launch on the earnings call.
“We saw strokes cut in half with the acute Type A dissections,” Mackin said. “I think the fact that the mortality is so much lower, the stroke is so much lower, [distal anastomotic new re-entry] is so much lower, that we’re hopeful that we can get through these value analysis committees faster, but I’ll know it when we do it. I’ll have better visibility once we’ve launched it.”