Cvrx Inc

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.

HF is one of the most prevalent and devastating cardiovascular diseases. We estimate that there are approximately 64 million people worldwide suffering from HF, including approximately 6.7 million people in the U.S. HF is characterized by the heart’s inability to effectively circulate blood throughout the body resulting in insufficient levels of oxygen and nourishment to various body parts. This impacts a patient’s ability to function and leads to a variety of symptoms such as shortness of breath, extreme fatigue, exercise intolerance, swelling, and fluid retention that affects the patient’s quality of life, both physically and emotionally. HF worsens over time due to maladaptive responses from the body’s control systems, mediated by the ANS, that lead to excessive neural and hormonal activation. Autonomic activation is also a significant mechanism involved with multiple other cardiovascular diseases, such as hypertension, angina pectoris, and cardiac arrhythmia, as well as other diseases, such as chronic kidney disease.

We are currently focused on the treatment of patients with HF with reduced Ejection Fraction ("HFrEF"), which represent approximately 31% of the patients with HF. In HFrEF, the left ventricle loses its ability to contract properly, resulting in insufficient power to pump and push the necessary quantities of blood into circulation. Approximately 75% of HFrEF patients die within five years of being admitted to the hospital for HFrEF. Patients with HFrEF are typically placed on a treatment progression plan during which they are initially given GDMT to help manage symptoms, and then progress to more invasive and costly treatment options involving other implantable devices with the most severe patients often requiring Left Ventricular Assist Devices ("LVADs") or heart transplants. These other implantable devices mostly target different HFrEF patient populations, may require an invasive procedure that places hardware directly inside the heart, and are not designed to address the imbalance of the ANS that causes the disease. We believe there is a significant need and market opportunity for a safe, effective, and minimally invasive device-based treatment option for HFrEF.

We believe Barostim offers meaningful benefits for patients, physicians and payers that will continue to drive adoption of our therapy. The primary benefits include: