CVRx, Inc. CVRX

CVRx is a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative and minimally invasive neuromodulation solutions for patients with cardiovascular disease. Barostim is the first medical technology approved by the U.S. Food and Drug Administration (the "FDA") that uses neuromodulation to improve the symptoms of patients with heart failure ("HF"). Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery to counteract decreased baroreceptor signaling, which creates an imbalance in the brain's Autonomic Nervous System ("ANS") resulting in excess neurohormones that drive HF progression. Barostim provides Baroreflex Activation Therapy ("BAT," or "Barostim Therapy"), which links the cardiovascular system to the ANS. This therapy complements the pharmaceutical neurohormonal blockade, or Guideline Directed Medical Therapy ("GDMT"), by increasing the signaling of the baroreceptors, thereby, reducing symptoms of HF. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in HF patients in the U.S. We estimate our total market opportunity using both prevalence and incidence epidemiologic models in which prevalence reflects the total number of individuals indicated for therapy at a given time, while incidence captures the annual occurrence of new cases meeting the indication. Based on these distinct models, we estimate that our prevalence-based market opportunity for HFrEF is $10.5 billion in the U.S. Using an incidence-based model, we estimate an annual market opportunity of $2.4 billion in the U.S.