Barostim’s label upgrade caps off successful 2023 for CVRx, says Craig-Hallum

Craig-Hallum says “FDA slid down the chimney on Christmas with a Barostim label upgrade in hand,” ending an eventful 2023 on a definitive high note for CVRx. Combined with a reimbursement upgrade, 2024 and beyond looks especially promising, the firm says. The label now includes the 12- and 24-month symptomatic improvement of heart failure. The IFU also includes data and references to positive all-cause mortality and win ratio, but the label does not include the word “treatment” of heart failure. The new IFU states the BeAT-HF did not meet the primary endpoint, but “additional effectiveness analyses suggested a favorable effect of Barostim.” Now that BeAT-HF is concluded, the firm anticipates CVRx to spend more time on direct label expansion, including lower or higher-risk patients, different LVEFs, and then expanding beyond left-sided heart failure. Overall, Craig-Hallum believes Barostim’s label upgrade caps off a successful 2023 for the company. The firm has a Buy rating on the shares with a price target of $24.