CVRx® Launches HOPE4HF™ Clinical Trial Evaluating Barostim neo™ in Heart Failure Patients

MINNEAPOLIS, April 29, 2013 /PRNewswire/ -- CVRx, Inc., a private medical device company, announced the first patient enrolled in the Barostim HOPE4HF clinical trial. The study is evaluating the effectiveness and safety of CVRx's Barostim neo in heart failure patients. Dr. Richard Abben, Director of Cardiac Intervention, with the Cardiovascular Institute of the South, in Houma, Louisiana is the Principal Investigator for the center. The prospective, randomized and controlled study will enroll 60 patients in multiple clinical centers throughout the United States.

According to Dr. Abben, "Getting this trial under way is great news for the many individuals who desperately need options beyond traditional drug therapy to manage their heart failure. Barostim therapy has been studied in over 500 patients, with promising results. The second generation Barostim neo being used in this study is small and easy to place in a short procedure. We anticipate positive results from this new system."

"The HOPE4HF trial is an important step toward making Barostim Therapy™ available as a treatment for heart failure patients," said Nadim Yared, president and CEO of CVRx. "Barostim neo has had a strong safety profile and excellent clinical results in European studies¹. We anticipate these positive outcomes to continue in this study. Heart failure affects millions of people, which provides CVRx the opportunity to significantly expand our patient population and market reach." Other HOPE4HF clinical centers have started to enroll patients into the trial. The Aspirus Heart and Vascular Institute (Wassau, Wisconsin) led by Dr. German Larrain, randomized the second, third, fourth and fifth patients in the study.

Early Positive Heart Failure Results Presented at American Heart Association Scientific Sessions
Barostim neo data on heart failure patients were presented in two sessions at the American Heart Association (AHA) Scientific Sessions 2012. Professor Edoardo Gronda, IRCCS MultiMedica Milano, Italy, and Professor Jochen Muller-Ehmsen, University of Cologne, Germany, shared study results showing significant improvements in quality of life, functional capacity, biochemical markers and NYHA Class, and a reduction in sympathetic tone using Barostim neo.^2,3

"These early results of Barostim Therapy in heart failure patients who have a reduced ejection fraction and who are already on optimal medical treatment and, in some cases, already receiving cardiac resynchronization therapy, are very promising. This study will provide further insight into the magnitude of the long-term benefits of the therapy in this patient population," said Dr. Michael Zile, Charles Ezra Daniel Professor of Medicine, at the Medical University of South Carolina. Dr. Zile is on the Executive Steering Committee for this study.

For Potential Study Participants
Key heart failure qualifications for the HOPE4HF clinical trial include having a left ventricular ejection fraction less than or equal to 35 percent and being classified as having New York Heart Association (NYHA) Class III Heart Failure. Individuals who are interested in learning more about the trial should visit www.HeartFailureTrial.com.

About Heart Failure
In heart failure, heart function is impaired, resulting in shortness of breath, exercise intolerance and fluid retention. In the United States, heart failure is estimated to affect 5.1 million adults.⁴ Overall, heart failure is associated with a four-fold increased risk of death and a six to nine times increased risk of sudden cardiac death. The direct and indirect costs of heart failure are estimated to be $32 billion in the United States in 2013.⁴

About Barostim neo
Barostim neo is a second generation device that uses CVRx-patented technology that is designed to trigger the body's own natural blood flow regulation system to treat heart failure. The 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 Barostim neo, 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 organ to fill with blood; and
• Kidneys to reduce fluid in the body, lowering both excessive blood pressure and workload on the heart.

This unique, patented technology has the potential to improve quality of life and reduce health risks associated with heart failure, including heart and kidney disease, stroke and death. Other key potential benefits of Barostim neo include that it:

• Can be adjusted to meet each patient's individual therapy needs;
• Is a reversible treatment; and
• Provides 100 percent compliance to treatment, by automatically and continuously activating the baroreflex.

About CVRx, Inc.
CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis. The company has developed the second generation Barostim neo, an implantable system designed to treat hypertension (high blood pressure) and heart failure. Barostim neo received CE marking for the treatment of hypertension in Europe. It is under clinical evaluation for the treatment of heart failure in Europe and the United States. It is under clinical evaluation for the treatment of hypertension in the United States. For more information on this trial go to www.BloodPressureTrial.com.

Footnotes:

1. Hoppe UC, Brandt MC,, Wachter R, Beige J, Rump LC, Kroon AA, Cates AC, Lovett EG, Haller H. Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. J Am Soc Hypertens. 2012;6(4):270-276. Click here for abstract
2. Gronda E, Grassi G, Costantino G, Brambilla G, Seravalle G, Staine T, Moneta A, Mancia G, Lovett E, Donatelli F. Acute baroreceptor activation therapy approves hemodynamics in heart failure with reduced ejection fraction: early results from a chronic pilot investigation. Circulation. 2012;126:A15570. (Click title for poster access)
3. Halbach M, Madershahian N, Brandt MC, Velden R, Lovett E, Hoppe UC, Muller-Ehmsen J. Baroreflex activation therapy significantly lowers NTproBNP in patients with symptomatic heart failure. Circulation. 2012;126:A15273. (Click title for poster access)
4. Heart Disease and Stroke Statistics. American Heart Association – 2013 Update.

CAUTION: Barostim neo™ is an investigational device and is limited by United States law to investigational use. Exclusively for Clinical Investigations for the treatment of heart failure (in the European Union and Canada).

CVRx, HOPE4HF, Barostim neo and Barostim Therapy are trademarks of CVRx, Inc. registered in the United States Trademark Office.

© CVRx, Inc. 2013. All rights reserved.

SOURCE CVRx, Inc.