# Barostim by CVRx

Canonical page: https://technooptimist.io/neurotech/barostim
Frontier: [Neurotech](https://technooptimist.io/neurotech.md) · Field: Nerve stimulation · Company: [CVRx](https://technooptimist.io/companies/cvrx.md)
Stage: Scaling (5 of 5: Research → Proto → Pilot → Deploy → Scaling)
Updated: last update 2026-08-06, facts checked 2026-10-11
Goal: Treat heart failure through the nervous system: trigger the body's own blood-pressure reflex to cut the nerve drive that wears out a weak heart, improving how patients feel and, if BENEFIT-HF succeeds, survival.
Status: Sold at 258 US centres; 2,500-patient BENEFIT-HF outcomes trial enrolling since May 2026
Next milestone: Enrol 2,500 patients at ~150 US and German centres

## Milestones

| Status | Milestone | Date | Slip |
| --- | --- | --- | --- |
| Done | FDA approval for heart failure (BeAT-HF data) | 16 Aug 2019 |   |
| Done | Category I CPT codes replace Category III | 1 Jan 2026 |   |
| Done | First BENEFIT-HF patient enrolled | 4 May 2026 |   |
| Done | Humana and Devoted Medicare Advantage coverage | Jul 2026 |   |
| Current | Enrol 2,500 patients at ~150 US and German centres |   |   |
| Planned | BENEFIT-HF completes | 2032 |   |

## Upcoming events

- **2032**: BENEFIT-HF completes
- **2032**: BENEFIT-HF trial completion

## Most important updates

- **6 Aug 2026**: CVRx Q2 2026 revenue rises 16% to $15.7M but full-year guidance is cut to $58-60M. US revenue grew 21% to $14.8M while Europe fell 31% to $0.9M. ([our story](https://technooptimist.io/stories/cvrx-q2-2026-revenue-rises-16-to-15-7m-but-full-year-guidance-is-cut-to-2fd5d793.md) · [original source](https://finviz.com/news/379271/cvrx-reports-second-quarter-2026-financial-and-operating-results))
- **4 May 2026**: CVRx enrols first patient in BENEFIT-HF, a 2,500-patient trial of Barostim in a wider heart failure population. The first BENEFIT-HF patient was enrolled at North Central Heart in Sioux Falls, South Dakota. ([our story](https://technooptimist.io/stories/cvrx-enrols-first-patient-in-benefit-hf-a-2-500-patient-trial-of-b4fa2120.md) · [original source](https://citoday.com/news/cvrx-commences-benefit-hf-of-barostim-in-an-expanded-population-of-heart-failure-patients))
- **16 Aug 2019**: FDA approves CVRx's Barostim Neo, the first neuromodulation device for heart failure. The FDA approved Barostim Neo for heart failure with reduced ejection fraction in patients not indicated for cardiac resynchronisation therapy. ([our story](https://technooptimist.io/stories/fda-approves-cvrx-s-barostim-neo-the-first-neuromodulation-device-for-3f2a2e34.md) · [original source](https://www.biospace.com/cvrx-receives-fda-approval-for-world-s-first-heart-failure-neuromodulation-device))

## Current obstacles

- **Outcome evidence still missing**: Approval showed better symptoms and walking distance in 264 patients; mortality and hospitalisation benefit awaits BENEFIT-HF, running to 2032.
- **Sales execution and payer friction**: In August 2026 CVRx cut guidance, citing fewer sales territories, lower rep productivity and a long dispute with a large payer.

## Physics limits

- **Reflexes adapt**: The baroreflex is built to reset around new pressures; constant stimulation risks the body re-tuning its set point and blunting the effect over time.
- **One small nerve target, many systems**: Calming the sympathetic system helps the heart but also lowers blood pressure and heart rate, so dose is limited by what patients with weak hearts tolerate.

## How it works

### Implant: Generator under the skin

A pulse generator is implanted under the skin and a lead runs to an electrode on the carotid sinus, the pressure-sensing bulge in the neck artery.

### Signal: Pulses mimic high blood pressure

Electrical pulses activate the baroreceptors, which signal the brainstem as if blood pressure had risen.

### Response: Less sympathetic, more parasympathetic

The brain reflexively reduces sympathetic nerve activity and raises parasympathetic tone, easing the chronic stress response that worsens heart failure.

## Spec sheet

| Spec | Barostim | Provenance |
| --- | --- | --- |
| 6-minute walk gain vs control | +60 m (BeAT-HF) | reported |
| Quality-of-life score gain | 14 points (Minnesota questionnaire) | reported |
| Free of major adverse events, 6 mo | 94% (goal 85%) | reported |
| Active US implanting centres | 258 (June 2026) | reported |
| Revenue, Q2 2026 | $15.7M | reported |
| US indication | LVEF ≤35%, not a CRT candidate | reported |

Provenance: reported = stated by the company; estimated = our estimate; sample = a sample figure.

## About CVRx

CVRx is a Minneapolis medical device company, founded in 2001, that makes Barostim: an implant that stimulates pressure sensors in the neck artery so the nervous system eases the strain on a failing heart.

- Barostim won FDA approval in August 2019 for advanced heart failure patients not suited to resynchronisation pacing.
- Q2 2026 revenue $15.7M (+16%) from 258 US implanting centres; 2026 guidance cut to $58-60M.
- BENEFIT-HF, a 2,500-patient outcomes trial, could triple the eligible population if it succeeds.

- Founded: 2001
- Headquarters: US
- Status: public
- Listing: CVRX (NASDAQ)
- Website: https://www.cvrx.com
- People: Kevin Hykes (CEO)
- Partners, customers, investors: Humana (customer); Devoted Health (customer)

Company page: https://technooptimist.io/companies/cvrx.md

## Related programs

Everything in Neurotech: https://technooptimist.io/neurotech.md

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