Press Release

News release: CVRx^® Barostim Therapy^® for Heart Failure Clinical Trial Results Presented in the Late-Breaking Clinical Session of the ESC-Heart Failure 2015 Annual Conference

Seville– May 27, 2015 – CVRx, Inc., a private medical device company, announced that positive results from the ‘Barostim Therapy for Heart Failure’ randomized, controlled clinical trial were presented at the ESC-Heart Failure 2015 Annual Conference in a Late-Breaking Trial Session. Results were presented by Professor Jochen Müller-Ehmsen from Asklepios Hospital Altona in Hamburg, Germany.

Safety and efficacy results with Barostim therapy comparing patients not previously treated with Cardiac Resynchronization Therapy (no-CRT) to patients who continued to suffer from advanced heart failure despite prior treatment with CRT (CRT) were presented. At six months in the no-CRT group, Professor Müller-Ehmsen reported that Quality of Life scores improved significantly, six-minute hall walk distance and left ventricular ejection fraction increased significantly, and heart failure hospitalization days were significantly reduced in Barostim Therapy patients compared to controls.

“Based on our own experience with Barostim Therapy and the safety and efficacy data now published, we are very confident to offer this therapy to our heart failure patients who are still symptomatic despite receiving optimal heart failure therapy”, Professor Müller-Ehmsen said. “Based on results of this trial we have had the good fortune of presenting the data at three Late-Breaking Clinical Trial Sessions and generating two simultaneous publications over the last three months. This is unprecedented,” said Dr. William Abraham from The Ohio State University, who served on the trial’s Steering Committee.

“The positive results from our randomized, controlled clinical trial were well received at Heart Failure 2015”, said Nadim Yared, CEO and President of CVRx. “The safety and effectiveness data presented simultaneously with the online publication of the manuscript in European Journal of Heart Failure, will further support our efforts in Europe to provide a new therapeutic option for patients with advanced heart failure.”

About Barostim Therapy®
CVRx completed a 146-patient randomized, controlled clinical trial to determine the performance of Barostim Therapy for patients suffering from chronic heart failure with advanced symptoms. Aggregate results were recently presented at the American College of Cardiology’s (ACC) Annual Scientific Session and simultaneously published in JACC-HF. Barostim Therapy was shown to be safe and significantly improved patient functional and exercise capability, as well as quality of life, when compared to optimal medical therapy. Barostim Therapy also significantly reduced the plasma biomarkers of heart failure severity and the burden of heart failure hospitalizations in patients with heart failure.¹

About Barostim neo®
Barostim neo is a second-generation device that uses CVRx-patented technology designed to trigger the body’s own natural blood flow regulation system to treat patients suffering from chronic heart failure. The therapy is also a treatment option for patients with resistant hypertension. The system electrically activates the baroreflex, the body’s natural mechanism to regulate cardiovascular function. By activating this afferent pathway, Barostim Therapy reduces sympathetic activity and increases parasympathetic activity, ultimately restoring sympatho-vagal balance.

Key unique benefits:

• The Barostim neo can be turned on and off to demonstrate acute results
• It can be adjusted to meet each patient’s individual therapy needs
• It is a reversible treatment, the therapy can be turned off
• It provides 100 percent adherence to treatment by continuously activating the baroreflex
• It is compatible with and complementary to implantable cardiac rhythm management devices²
• It is now MR Conditional, or safe for use under specified condition in Europe

 

About Heart Failure
Heart failure is a serious condition that impairs heart function, resulting in shortness of breath, exercise intolerance and fluid retention. In the United States, heart failure is estimated to affect 5.1 million adults.3 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 2013.³

About CVRx, Inc.
CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis, Minnesota. The company has developed the second-generation Barostim neo, a minimally-invasive implantable system and the only device CE Marked for the separate indications of heart failure and resistant hypertension. Barostim neo is commercially available in over 20 countries and under clinical evaluation for the treatment of heart failure, hypertension, and chronic kidney disease in the United States. It is now MR Conditional, or safe for use under specified conditions in Europe. The company’s Barostim neo legacy™, holds Humanitarian Device Exemption (HDE) approval from the FDA, deeming it safe for use in hypertensive patients who were responders to the first-generation Barostim Therapy with Rheos Carotid Sinus Lead System.

CVRx Contacts:
John Brintnall
Chief Financial Officer
[email protected]
Phone: 763.416.2853

Tom Moore
Vice President of Sales Operations, Market Development, and the Americas
[email protected]
Phone: 763.258.9039

Footnotes:

1. Abraham W, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction, JACC: Heart Failure (2015), doi: 10.1016/j.jchf.2015.02.006 2. Madershahian N, et al. Baroreflex activation therapy in patients with preexisting implantable cardioverter-defibrillator: Compatible, complementary therapies. Europace Feb, 2014 3. Go A, Heart Disease and Stroke Statistics. American Heart Association – 2013 Update. Circulation 2013;127:e6-e245

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 and resistant hypertension in Canada.

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

© CVRx, Inc. 2015. All rights reserved.