Risk factors
CVRx (CVRX) risk factors
Item 1A of every CVRx, Inc. 10-K on file, and what changed from one year to the next. Readings are automated and can be wrong; check the filing for the exact wording.
- FY2025 10-K risk factors56 risks2 new1 dropped4 reworded
CVRx added new risk disclosures addressing artificial intelligence and potential FDA enforcement regarding product recall records. Reimbursement timelines for Barostim were updated to reflect 2026 rules.
Filed Feb 13, 2026 - FY2024 10-K risk factors55 risks
CVRx faces continuous losses with an accumulated deficit of $537.3 million as of December 31, 2024. Commercial success relies heavily on marketing Barostim, securing hospital purchasing contracts, and Medicare reimbursement levels. Manufacturing depends on a single facility in Minneapolis, Minnesota, and limited third-party suppliers.
Filed Feb 18, 2025