CVRx, Inc. (NASDAQ: CVRX) is up in today’s trading session. CVRx stock went up 17.53% to $29.37 at the time of the recent check. The increase in CVRX shares comes on the heels of regulatory clearance.
CVRx (CVRX) announced today that the FDA has authorized amended Barostim Instructions For Use (IFU) that incorporate significant long-term clinical results from the BeAT-HF randomized studies.
CVRX saw it as a crucial affirmation from the FDA of the long-term findings of the BeAT-HF clinical trial’s post-market phase. This enables the corporation to share this information with clinicians and patients. CVRX continued to undertake this major study for seven years, despite obstacles during the COVID-19.
Barostim provides Baroreflex Activation Therapy to patients in order to enhance their functional status, six-minute hall walk, and quality of life. The new Clinical Summary part of the IFU now contains the primary endpoint outcomes, symptomatic data at 6, 12, and 24 months, the win ratio, and all-cause mortality data.
In summary, the key safety endpoint was reached in the Pre-Market Phase and reaffirmed in the Post-Market Phase. All efficacy objectives were previously fulfilled in the Pre-Market Phase, exhibiting 6-month gains in 6MHW, overall quality of living, NYHA Class, and NT-proBNP.
The primary endpoint of Post-Market Phase efficacy of CV mortality and hospitalization for HF was not fulfilled. Additional Post-Market Phase efficacy assessments indicated that Barostim treatment had a positive impact. The combined 6-, 12-, and 24-month results showed symptomatic enhancements for cardiac failure patients in NYHA Class III or Class II.
Based on this new long-term safety and efficacy data, as well as its commercial experience, CVRX estimates that the annual market opportunity for Barostim in the United States is currently amended to increase the number of patients considered by physicians, and to take into consideration the new reimbursement assignment for Barostim.
Thus CVRX considers the yearly market opportunity in the United States is now $2.2 billion, or 76,000 new patients, up from $1.4 billion, or 55,000 new patients, reflecting growth of nearly 60% and 38%, respectively.