CVRx awaits a regulatory verdict

The failure of CVRx’s Barostim Neo to prove a mortality and morbidity benefit in its postmarket trial last week leaves the company’s plan to expand the use of the heart failure device in tatters. Whether the product might actually be withdrawn from market, however, is unclear. Barostim Neo was approved by the FDA in 2019 based on six-month data from the Beat-HF trial, showing that it improved patients’ quality of life, exercise capacity and blood biomarker levels. As part of the approval the FDA required that CVRx expand Beat-HF, enrolling more patients with the aim of proving that Barostim Neo could cut death rates, hospitalisations and ER visits. CVRx's share price has fallen 36% since 21 February in the wake of the study's failure. The group plans to submit the new data to the FDA in the hope that subgroup analyses might persuade the agency to add the claim anyway. CVRx expects the agency’s verdict in seven or eight months’ time. An FDA spokesperson declined to comment when asked whether the Beat-HF failure would mean Barostim being pulled from market entirely, but added: “The FDA is aware of these results and will determine what actions may be warranted.”

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