Four-year clinical study results show sustained effect that Rheos System has on reducing hypertension

CVRx, Inc. announced today the four-year Rheos clinical results from the European study evaluating the Rheos^® System at the European Society of Hypertension 20^th Meeting. The system is the first device designed to treat hypertension (high blood pressure), a leading cause of heart and kidney disease, stroke and death. This device is a future treatment option for the millions of people who cannot control their blood pressure with medications.

“These long-term results demonstrate the sustained effect that the Rheos System has on reducing blood pressure.”

Dr. Bram Kroon, Associate Professor, Vascular Medicine Specialist, Department of Internal Medicine, MUMC+, Maastricht, today presented the four-year results from the Device-Based Therapy of Hypertension (DEBuT-HT) study (Abstract 01, Oral Session 9D). The findings show a significant reduction in blood pressure in patients who have drug-resistant hypertension and had a systolic blood pressure above 160 mmHg prior to receiving the device. After four years of treatment, Rheos reduced systolic blood pressure by an average of 53mmHg (193 mmHg vs. 140 mmHg). Blood pressure was reduced significantly each year, with the largest decrease occurring in year four. Many of these patients were able to reach their blood pressure goal. Over this time period the number of medications that patients were taking to treat their hypertension decreased from an average of 5 at baseline to 3.4 medications at 4 years.

"These long-term results demonstrate the sustained effect that the Rheos System has on reducing blood pressure." Dr. Kroon said. "The Rheos System offers us a new treatment option for patients who have a very difficult to treat disease. We are also learning that the Rheos System has the potential to improve the function and structure of heart," he commented, referring to a second study presented earlier in the conference (poster presentation PP16 on June 19th).

Additional Rheos Data Presented at the European Society of Hypertension 20^th Meeting

Additional data from the DEBuT and US studies were presented in three poster sessions and one oral presentation. These studies support the Rheos blood pressure reduction results and show early signs that it can also improve heart function and structure; and preserve kidney function.

• Baroreflex activation therapy improves functional capacity and reduces left ventricular mass: results from European and United States Trials of Rheos System (Abstract No. 94; Poster Session PP16)
• Baroreflex Activation Therapy (BAT) acutely improves central arterial properties in resistant hypertension patients (Abstract No. 02; Oral Session 3A)
• Achievement of blood pressure goal in patients with resistant hypertension treated with baroreflex activation therapy. (Abstract No. 108; Poster Session PP16)
• Functional safety in resistant hypertensive patients with baroreflex activation therapy (Abstract No. 298, Poster Session PP33)

The Rheos System and Baroreflex Activation Therapy^®

The Rheos System uses Baroreflex Activation Therapy^® (BAT^®) that is designed to trigger the body's own natural blood flow regulation system to treat high blood pressure and heart failure. The Rheos System works by electrically activating the baroreceptors, the body's natural blood pressure sensors that regulate cardiovascular function. These baroreceptors are located on the carotid artery. When activated by the Rheos System, signals are sent through neural pathways to the brain, which responds by telling the:

• Arteries to relax, making it easier for blood to flow through the body and reducing cardiac exertion;
• Heart to slow down, allowing more time for the heart to fill with blood; and
• Kidneys to reduce fluid in the body, lowering both excessive blood pressure and workload on the heart.

This system includes three components:

• A small device that is implanted under the collar bone;
• Two thin lead wires that are implanted at the left and right carotid arteries and connected to the device; and
• The Rheos Programmer System, an external device used by doctors to noninvasively regulate the activation energy therapy from the device to the leads.

The therapy can be adjusted to meet each patient's individual needs as they change over time, providing personalized treatment.

The Rheos System is CE Marked and approved for sale for hypertension patients in Europe.