CVRx Signals Major Growth with Strong Revenue and Breakthroughs in Access

MINNEAPOLIS, MN – April 13, 2026 – Medical device company CVRx, Inc. today signaled a period of significant momentum, reporting strong preliminary first-quarter revenue and highlighting two critical developments poised to expand the reach of its Barostim heart failure therapy: improved insurance approval rates and the launch of a landmark clinical trial.

The Minneapolis-based company announced preliminary Q1 2026 revenue is expected to reach between $14.7 million and $14.8 million, a roughly 20% jump from the $12.3 million reported in the same quarter last year. The strong topline performance, coupled with operational advancements, suggests that CVRx's strategic investments are beginning to yield substantial returns, setting a positive tone for the company's trajectory in the competitive cardiovascular device market.

"The investments we made in our team and programs in 2025 are beginning to pay off, allowing us to deliver strong revenue growth in the first quarter,” said Kevin Hykes, President and Chief Executive Officer of CVRx, in the company's press release. He noted the company's "positive momentum" heading into the rest of the year.

Unlocking Patient Access with Reimbursement Breakthrough

Perhaps the most significant operational news is the tangible impact of a recent change in medical billing codes for the Barostim procedure. As of January 1, 2026, the therapy transitioned from temporary Category III codes to permanent Category I Current Procedural Terminology (CPT) codes. This seemingly administrative change represents a monumental step in establishing Barostim as a standard, accepted medical procedure.

Category III codes are typically assigned to emerging technologies to track their use, but they do not guarantee payment from insurers and often lead to automatic denials. This creates a significant administrative and financial burden for hospitals and physicians, often referred to as the "prior authorization" battle. For years, this has been a major barrier to the adoption of many innovative medical devices.

In contrast, a Category I code signifies that a procedure is supported by strong clinical evidence, is FDA-approved, and is performed by many physicians nationwide. This designation fundamentally changes the conversation with insurance payers, moving from a question of "if" a procedure should be covered to "how" it will be reimbursed.

CVRx is already seeing the results. The company reported that the 30-day approval rate for Medicare Advantage prior authorizations, managed by its internal market access team, has climbed to 50% in the first two months of 2026. This is a dramatic increase from the 44% approval rate seen in 2025 and just 31% in 2024. By effectively eliminating the automatic denials associated with the old codes, the new CPT designation provides the payment predictability that hospitals and doctors need to confidently offer the therapy to eligible patients. This improvement directly addresses one of the most persistent challenges in commercializing novel medical technology.

Charting the Future with the BENEFIT-HF Trial

While improved reimbursement smooths the path for its current patient population, CVRx is also making a bold move to dramatically expand it. The company announced the activation of the first clinical site for its BENEFIT-HF trial on March 31, with patient enrollment set to begin in the second quarter of 2026.

This landmark randomized controlled trial is designed to be one of the largest ever conducted for a therapeutic cardiac device, aiming to enroll 2,500 patients across 200 centers in the U.S. and Germany. Its goal is to evaluate Barostim's impact on all-cause mortality and heart failure decompensation events in a much broader group of patients.

Currently, Barostim is approved for heart failure patients with a left ventricular ejection fraction (LVEF) — a key measure of the heart's pumping ability — of 35% or less. The BENEFIT-HF trial will include patients with an LVEF up to 50%, encompassing a category of patients with what is known as "mildly reduced" ejection fraction. Furthermore, the trial will include patients with NT-proBNP levels, a biomarker for heart stress, up to 5,000 pg/mL, a significant increase from the current indication's 1,600 pg/mL limit.

If successful, CVRx projects the trial could expand the indicated patient population for Barostim by approximately three times. This would transform the device from a niche therapy for a specific subset of severe heart failure patients into a mainstream option for a much larger segment of the heart failure population, potentially redefining care pathways and significantly growing the company's addressable market beyond its prior $2.2 billion annual estimate. The Centers for Medicare & Medicaid Services (CMS) has already granted coverage for the device within the trial, facilitating patient recruitment and access.

A Cohesive Strategy for Market Leadership

These developments, taken together, paint a picture of a cohesive and aggressive strategy. The strong Q1 financial performance, with an expected gross margin of 87% and a solid cash position of $72.3 million, provides the stability needed to fund ambitious growth initiatives. The company is not just growing; it is growing more profitably.

The resolution of the reimbursement bottleneck via the new CPT code directly fuels this financial engine by converting patient demand into recognized revenue more efficiently. At the same time, the company continues to expand its commercial footprint, adding five new active implanting centers and three new sales territories in the first quarter alone, bringing the U.S. totals to 257 and 56, respectively.

Barostim occupies a unique space in the heart failure treatment landscape. It is the first FDA-approved device to use neuromodulation—specifically, stimulating the body's natural baroreceptors in the carotid artery—to improve heart failure symptoms by restoring balance to the autonomic nervous system. This mechanism is distinct from other device-based therapies. It does not compete directly with implantable cardioverter-defibrillators (ICDs), which are designed to prevent sudden cardiac death, or with cardiac resynchronization therapy (CRT), which coordinates the heart's contractions. Instead, it offers a complementary approach focused on symptom relief and improving quality of life, which could now be proven to impact mortality.

By systematically dismantling the barriers to adoption—first through clinical evidence, then through regulatory approval, now through reimbursement, and finally by pursuing a vastly expanded patient population—CVRx is executing a textbook strategy for medical device commercialization. The positive early results in 2026 suggest this multi-pronged approach is not just a plan on paper but a strategy delivering tangible results.