News release: CVRx® Receives FDA Approval for World’s First Heart Failure Neuromodulation Device

BAROSTIM NEO™ provides significant clinical benefit to heart failure patients

MINNEAPOLIS, Aug. 16, 2019 /PRNewswire/ — CVRx, Inc., a private medical device company, announced today that it has received Premarket Approval (PMA) from the United States Food and Drug Administration (FDA) to market its BAROSTIM NEO device for heart failure in the United States. The FDA’s Center for Devices and Radiological Health (CDRH) approved the Company’s submission after a thorough review of the clinical trial data from the Baroreflex Activation Therapy for Heart Failure Pivotal Trial (BeAT-HF).

“With the FDA’s approval of the BAROSTIM NEO, we finally have an effective neuromodulation therapy for advanced heart failure patients who are not indicated for Cardiac Resynchronization Therapy (CRT),” said Michael Zile, M.D., Professor of Medicine at the Medical University of South Carolina and Chair Person of the BeAT-HF Executive Steering Committee. “The BAROSTIM NEO improves the quality of life and the exercise capacity of heart failure patients who previously did not have access to a device-based therapy.”

Designed to address a significant unmet medical need in heart failure with reduced ejection fraction, the BAROSTIM NEO was one of the first therapies to receive the FDA’s “Breakthrough Device” designation. The “Breakthrough Device” designates therapies that offer a more effective treatment for life-threatening or irreversibly debilitating diseases. As a result of the BAROSTIM NEO receiving this designation, the BeAT-HF Trial received prioritized review by the FDA, which helped accelerate the development and approval process, resulting in expedited patient access to the Company’s unique therapy.

“After many decades of research in the field of neuromodulation, the BAROSTIM NEO is the first device approved in the United States that uses the power of the brain and nervous system to target cardiovascular disease,” said Nadim Yared, President and CEO of CVRx. “We are thrilled to transition to the next stage of our company’s growth, shifting our focus to the successful adoption of BAROSTIM NEO in the United States and bringing an innovative solution to chronic heart failure patients.”

About the BeAT-HF Pivotal Randomized Controlled Trial
The BeAT-HF phase III randomized clinical trial confirmed the safety of BAROSTIM NEO and its effectiveness in improving symptoms in patients suffering from chronic heart failure. The trial analysis included results from 264 patients randomized to two arms: 130 subjects randomized to receive a BAROSTIM NEO were compared to 134 subjects randomized to stay on guideline-directed medical therapy. The positive safety and effectiveness results were presented in Late Breaking Clinical Trial sessions at the Heart Rhythm Society and the European Society of Cardiology Heart Failure conferences in May 2019.

Key BeAT-HF Trial Eligibility Criteria:

  • NYHA Class III or Class II (with recent history of Class III)
  • Left ventricular ejection fraction ≤ 35%
  • On current heart failure guideline-directed medical therapy
  • NT-proBNP < 1600 pg/mL
  • Excluded patients indicated for CRT according to AHA/ACC/ESC guidelines

Key Results:

  • BAROSTIM NEO is safe to use for patients in heart failure with reduced ejection fraction
  • BAROSTIM NEO demonstrated clinically significant improvements in patient-centered symptomatic endpoints as compared to the control group:
    • Improved their quality of life score by 14 points using the Minnesota Living with Heart Failure Questionnaire,
    • Improved their exercise capacity by 60 meters as measured by the standardized 6-minute hall walk test, and
    • Improved their functional status as assessed by their NYHA classification.
  • These results were supported by objective evidence of significant reduction of NT-proBNP.
  • These clinically significant differences in treatment effect were observed despite an increase in the number of medications in the control arm.

Supporting Evidence 
Positive BAROSTIM NEO safety and efficacy results were previously reported from HOPE4HF, a 146-patient randomized, controlled phase II clinical trial. Results at six months showed that quality of life, 6-minute hall walk test and cardiovascular function were significantly improved in BAROSTIM NEO patients compared to control patients. Results were published in JACC-HF and European Journal of Heart Failure.1, 2

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 6.5 million adults.3 Overall, heart failure was associated with one in 8 deaths and close to half the people that develop heart failure die within 5 years of diagnosis.3 Projections suggest that by 2030, the total cost of heart failure will increase to $69.7 billion.3

About BAROSTIM NEO
BAROSTIM NEO uses CVRx-patented technology designed to trigger the body’s main cardiovascular reflex to treat patients suffering from chronic heart failure. It is designed to electrically activate 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 autonomic balance.

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 approved for use in heart failure in over 30 countries and approved for use in resistant hypertension in the European Economic Area, Colombia and New Zealand.

Footnotes:

  1. Abraham W, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction. JACC: Heart Failure 2015;3(6):487-496.
  2. Zile M, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction: Safety and Efficacy in Patients with and without Cardiac Resynchronization Therapy. Eur J Heart Fail. 2015;17(10):1066-1074.
  3. Benjamin EJ, et al. Heart Disease and Stroke Statistics—2018 Update. Circulation. 2018;137:e67–e492.

News release: CVRx® Announces Expedited Access Pathway Designation by FDA

Minneapolis – November 19, 2015 – CVRx, Inc., a private medical device company, announced that it received Expedited Access Pathway (EAP) Designation by FDA for Barostim Therapy® for the treatment of heart failure.  The EAP designation is based on Barostim Therapy being intended to treat a life-threatening or irreversibly debilitating disease where there is no available treatment alternative.  This groundbreaking initiative, recently launched by FDA, is intended to significantly accelerate access for US patients and their physicians to innovative medical treatments.

The EAP Designation applies to CVRx’s Phase III randomized, controlled clinical trial, Baroreflex Activation Therapy for Heart Failure Pivotal Clinical Trial (BeAT-HF).  CVRx is currently completing the selection and training of clinical investigative centers to participate in the trial.

“We applaud FDA for creating the EAP Designation.  This comes at a critical time for heart failure physicians, who are actively looking for treatment options for patients who are not adequately managed with current guideline-directed therapies”, said Dr. William Abraham, Director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center.  “Barostim Therapy is designed to activate the Baroreflex through the afferent (sensory) pathway causing a simultaneous reduction in sympathetic activity and increase in parasympathetic activity.  Restoring autonomic balance leads to a reduction in symptoms and has the potential to significantly improve cardiovascular function and patient outcomes.  This mechanism of action is unique to Barostim Therapy when compared to other neuromodulation-based therapies.”

About Barostim Therapy for Heart Failure

Positive safety and efficacy results from a 146-patient randomized, controlled clinical trial were presented at the American College of Cardiology, Heart Rhythm Society, European Society of Cardiology Heart Failure, and Transcatheter Cardiovascular Therapeutics Annual Scientific Sessions in 2015. Results at six months showed that patient symptoms, functional capacity, and cardiovascular function were significantly improved, while heart failure hospitalization days were significantly reduced in Barostim Therapy patients compared to control patients.  The favorable data are now published in JACC-HF and European Journal of Heart Failure.¹ ²

About the BeAT-HF Phase III Clinical Trial

The BeAT-HF Phase III clinical trial is designed to demonstrate the safety of Barostim neo and its effectiveness on symptoms and clinical outcomes in patients suffering from chronic heart failure. The trial is intended to provide the basis for market approval in the US. Key provisions of the EAP designation intended to streamline the clinical trial could accelerate this process by up to one to two years.

Key Eligibility Criteria:

  • NYHA Class III
  • Left Ventricular Ejection Fraction ≤ 35%
  • Elevated NTproBNP
  • On current heart failure guideline directed therapy

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 autonomic 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, as 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 devices³
  • It is now MR Conditional, or safe for use under specified conditions 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.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 2013.3

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
jbrintnall@cvrx.com
Phone: 763.416.2853

Tom Moore
Vice President of Sales Operations, Market Development, and the Americas
tmoore@cvrx.com
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; 3(6):487-496
  2. Zile M, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction: Safety and Efficacy in Patients with and without Cardiac Resynchronization Therapy, European Journal of Heart Failure (2015), doi: 10.1002/ejhf.299
  3. Madershahian N, et al. Baroreflex activation therapy in patients with preexisting implantable cardioverter-defibrillator: Compatible, complementary therapies.  Europace Feb, 2014
  4. 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.

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
jbrintnall@cvrx.com
Phone: 763.416.2853

Tom Moore
Vice President of Sales Operations, Market Development, and the Americas
tmoore@cvrx.com
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.

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

Minneapolis – May 26, 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 2015 annual Scientific Sessions of the Heart Rhythm Society (HRS) in a Late-Breaking Clinical Trial Session. Results were presented by Dr. Michael Zile from the Medical University of South Carolina.

Safety and efficacy results comparing patients previously treated with Cardiac Resynchronization Therapy (CRT) to patients without CRT (no-CRT) were presented. At six months in the no-CRT group, Dr. Zile reported that Quality of Life scores significantly improved, six-minute hall walk distance and left ventricular ejection fraction significantly increased, and heart failure hospitalizations were significantly reduced in Barostim Therapy patients compared to controls. “The results of the study are remarkable”, Dr. Zile said. “These data are not sufficient to rule out a therapeutic effect in CRT patients, but the effect was more pronounced in patients without CRT.”

“The positive results from our randomized, controlled clinical trial were well-received at HRS”, said Nadim Yared, CEO and President of CVRx. “There is a significant unmet medical need for patients with advanced, chronic heart failure despite having received guideline-directed therapies, and in particular, for those patients who are not candidates for CRT.”

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

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
jbrintnall@cvrx.com
Phone: 763.416.2853

Tom Moore
Vice President of Sales Operations, Market Development, and the Americas
tmoore@cvrx.com
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

News release: CVRx® Barostim Therapy™ for Heart Failure Clinical Trial Results Presented in a Featured Clinical Research Session of the American College of Cardiology Annual Conference

Minneapolis – March 17, 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 American College of Cardiology (ACC) in a Featured Clinical Research Session. Results were presented by Dr. William Abraham from The Ohio State University, who served on the trial’s Steering Committee.

“We are very encouraged by the results from the Barostim neo™ – Baroreflex Activation Therapy for Heart Failure Study”, said Dr. Abraham. “Barostim proved to be safe and significantly improved patient functional status, quality of life score, exercise capacity, serum biomarkers of heart failure severity (NT-proBNP), and suggested that the burden of heart failure hospitalizations may also be reduced with Barostim Therapy.”

“The positive results from our randomized, controlled clinical trial were well received at ACC”, said Nadim Yared, CEO and President of CVRx. “The safety and effectiveness data presented simultaneously with the online publication of the manuscript in JACC-HF, will further support our commercial success in Europe.”

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. Promising results from an earlier study demonstrating clinical improvement and reduced hospitalizations have been presented and published.1

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 patients suffering from chronic heart failure. The therapy is also a treatment option for patients with resistant hypertension. The system works by electrically activating the baroreceptors, the body’s natural sensors that regulate cardiovascular function. By activating this afferent pathway, Barostim restores sympatho-vagal balance by reducing sympathetic activity and increasing parasympathetic activity.

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;
  • It provides 100 percent adherence to treatment by continuously activating the baroreflex;
  • It is compatible with and complementary to implantable cardiac rhythm management devices; and
  • It is now MR Conditional, or safe for use under specified conditions in Europe

About Heart Failure

In heart failure, heart function is impaired, resulting in shortness ofbreath, 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. The company has developed the second generation Barostim neo, an implantable system designed to treat heart failure and hypertension (high blood pressure). Barostim neohas received CE marking for the treatment of heart failure. Barostim neo has also received CE marking for the treatment of hypertension. It is under clinical evaluation for the treatment of heart failure and hypertension in the United States.

CVRx Contacts:

John Brintnall
Chief Financial Officer
jbrintnall@cvrx.com
Phone: 763.416.2853

Tom Moore
Vice President of Sales Operations, Market Development, and the Americas
tmoore@cvrx.com
Phone: 763.258.9039

Footnotes:

  1. Gronda E, et al. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function and cardiac haemodynamics in heart failure: a proof of concept study.   European Journal of Heart Failure 2014; 16(9):977-983
  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. 2014. All rights reserved.

News release: CVRx® Granted Humanitarian Device Exemption Approval from FDA for Barostim neo legacy™ Hypertension Therapy Device

Minneapolis – December 16, 2014 –CVRx, Inc., a privately held medical device company, announced today that it has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for its Barostim neo legacy device. This milestone represents CVRx’s first commercial approval in the United States and is based on a determination by the FDA that neo legacy is safe and can be used in U.S. patients who were defined as responders to the Rheos Carotid Sinus Lead System.

“We are excited that our early clinical subjects who are actively being treated in our hypertension feasibility and pivotal studies will be able to maintain access to continued therapy through the HDE approval. All of these patients have been treated for over five years with Barostim Therapy, said Nadim Yared, CEO of CVRx. “During that time, CVRx has remained committed to providing access to Barostim Therapy for patients. My team and I want to thank our investigators, clinical research coordinators, investors, and especially our pioneering patients for their commitment to the therapy. We also want to thank FDA for interactively working with us on this unique approval.”

About Barostim Therapy™

Five-year results of the 322-patient sham-controlled Rheos Hypertension Trial were presented at the American Society of Hypertension and the joint European and International Societies of Hypertension annual scientific conferences in May and June of 2014. The results showed a persistent and statistically significant reduction of systolic and diastolic blood pressure in excess of 32mmHg and 17mmHg, respectively, over the course of 5 years. In addition, the long term safety profile of the therapy proved to be excellent with very low rates of stroke, myocardial infarction and worsening of carotid stenosis in this population of patients with advanced hypertension.1,2

Barostim Therapy is included in the joint European Society of Hypertension and European Society of Cardiology guidelines for the treatment of resistant hypertension that were published in June, 2013.3

CVRx has completed 6 month follow-up in a 146 patient randomized, controlled clinical trial to demonstrate the performance of Barostim Therapy in patients suffering from chronic heart failure with advanced symptoms. Promising results from an earlier study demonstrating clinical improvement and reduced hospitalizations have been presented and published.4 The six month results from the randomized, controlled trial are being prepared for publication.

About Barostim neo

Barostim neois 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 patients suffering from chronic heart failure and resistant hypertension. The system works by electrically activating the baroreceptors, the body’s natural sensors that regulate cardiovascular function. By activating this afferent pathway, Barostim restores sympatho-vagal balance by reducing sympathetic activity and increasing parasympathetic activity.

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 provides 100 percent compliance to treatment by continuously activating the baroreflex;
  • It is compatible with and complementary to implantable cardio-defibrillators and cardiac resynchronization therapy5; and
  • It is now MR Conditional, or safe for use under specified conditions in Europe

About Hypertension

In Europe, the prevalence of hypertension is estimated to be between 30-45% of the general population.In the United States, hypertension affects 77.9 million people.6 Worldwide, hypertension is estimated to cause one in every eight deaths.It is a major risk factor for cardiovascular disease, morbidity and mortality. Twenty-five percent of people with hypertension cannot adequately control their hypertension with medications and lifestyle modifications.6,7 It is a disease that needs new treatment solutions.

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.8 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 2013.8

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 heart failure and hypertension (high blood pressure). Barostim neohas received CE Marking for the treatment of heart failure in addition to CE Marking for hypertension in Europe. Barostim neo legacy has received CE Marking for hypertension in Europe and HDE in the United States. It is under clinical evaluation for the treatment of heart failure and hypertension in the United States.

CVRx Contacts:

John Brintnall
Chief Financial Officer
jbrintnall@cvrx.com
Phone: 763.416.2853

Tom Moore
Vice President of Sales Operations, Market Development, and the Americas
tmoore@cvrx.com
Phone: 763.258.9039

Footnotes:

  1. Bakris G, et al. Baroreflex activation therapy reduces blood pressure for at least five years in a large resistant hypertension cohort. J Am Soc Hypertens. 2014; 8(4S) e9-e10
  2. de Leeuw P, et al. Validation of long-term blood pressure control with baroreflex activation therapy in a large cohort of resistant hypertension patients. Journal of Hypertension. 2014; Vol 32, Suppl. 1; 27
  3. Mancia G, et al. 2013 ESH/ESC Guidelines for the management of arterial hypertension. European Heart Journal 2013 34 (28): 2159-2219
  4. Gronda E, et al. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function and cardiac haemodynamics in heart failure: a proof of concept study.   European Journal of Heart Failure 2014; 16(9):977-983
  5. Madershahian N, et al. Baroreflex activation therapy in patients with preexisting implantable cardioverter-defibrilator: Compatible, complementary therapies. Europace Feb, 2014
  6. Chobanian AV. JNC 7: Complete Report. JAMA 2003;289:2560-2572
  7. Prospective Studies Collaboration. Lancet 2002;360:1903-1913
  8. 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 oheartfailure and resistant hypertension in Canada.

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

© CVRx, Inc. 2014. All rights reserved.

News release: CVRx® Granted CE Marking of the Barostim neo System™ for Conditional MRI Compatibility

Minneapolis – December 11, 2014 – CVRx, Inc., a privately held medical device company, announced today that CE Marking has been granted to expand labeling of the Barostim neo System™ as MR Conditional, or safe for use in Magnetic Resonance Imaging (MRI) systems under specified conditions. By enabling access to MRI scans, the expanded labeling will benefit patients receiving Barostim Therapy for heart failure or resistant hypertension.

“This approval has the potential to benefit many patients and their health care providers as MRI is critical in the diagnosis of serious conditions which can occur in the populations served by Barostim Therapy. We are pleased to enable access to this diagnostic option for our current and future patients,” said Nadim Yared, CEO of CVRx.

About Barostim Therapy™

CVRx has completed 6 month follow-up in a 146 patient randomized, controlled clinical trial to demonstrate the performance of Barostim Therapy in patients suffering from chronic heart failure with advanced symptoms. Promising results from an earlier study demonstrating clinical improvement and reduced hospitalizations have been presented and published.1 The six month results from the randomized, controlled trial are being prepared for publication.

Five-year results of the 322-patient sham-controlled Rheos Hypertension Trial were presented at the American Society of Hypertension and the joint European and International Societies of Hypertension annual scientific conferences in May and June of 2014. The results showed a persistent and statistically significant reduction of systolic and diastolic blood pressure in excess of 32mmHg and 17mmHg, respectively, over the course of 5 years. In addition, the long term safety profile of the therapy proved to be excellent with very low rates of stroke, myocardial infarction and worsening of carotid stenosis in this population of patients with advanced hypertension.2,3

Barostim Therapy is included in the joint European Society of Hypertension and European Society of Cardiology guidelines for the treatment of resistant hypertension that were published in June, 2013.4

About Barostim neo

Barostim neois 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 patients suffering from chronic heart failure and resistant hypertension. The system works by electrically activating the baroreceptors, the body’s natural sensors that regulate cardiovascular function. By activating this afferent pathway, Barostim restores sympatho-vagal balance by reducing sympathetic activity and increasing parasympathetic activity.

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;
  • It provides 100 percent compliance to treatment by continuously activating the baroreflex;
  • It is compatible with and complementary to implantable cardio-defibrillators and cardiac resynchronization therapy5; and
  • It is now MR Conditional, or safe for use under specified conditions

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.6 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 2013.6

About Hypertension

In Europe, the prevalence of hypertension is estimated to be between 30-45% of the general population.In the United States, hypertension affects 77.9 million people.8 Worldwide, hypertension is estimated to cause one in every eight deaths.It is a major risk factor for cardiovascular disease, morbidity and mortality. Twenty-five percent of people with hypertension cannot adequately control their hypertension with medications and lifestyle modifications.7,8 It is a disease that needs new treatment solutions.

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 heart failure and hypertension (high blood pressure). Barostim neohas received CE Marking for the treatment of heart failure in addition to CE Marking for hypertension in Europe. It is under clinical evaluation for the treatment of heart failure and hypertension in the United States.

CVRx Contacts:

John Brintnall
Chief Financial Officer
jbrintnall@cvrx.com
Phone: 763.416.2853

Tom Moore
Vice President of Sales Operations, Market Development, and the Americas
tmoore@cvrx.com
Phone: 763.258.9039

Footnotes:

  1. Gronda E, et al. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function and cardiac haemodynamics in heart failure: a proof of concept study.   European Journal of Heart Failure 2014; 16(9):977-983
  2. Bakris G, et al. Baroreflex activation therapy reduces blood pressure for at least five years in a large resistant hypertension cohort. J Am Soc Hypertens. 2014; 8(4S) e9-e10
  3. de Leeuw P, et al. Validation of long-term blood pressure control with baroreflex activation therapy in a large cohort of resistant hypertension patients. Journal of Hypertension. 2014; Vol 32, Suppl. 1; 27
  4. Mancia G, et al. 2013 ESH/ESC Guidelines for the management of arterial hypertension. European Heart Journal 2013 34 (28): 2159-2219
  5. Madershahian N, et al. Baroreflex activation therapy in patients with preexisting implantable cardioverter-defibrilator: Compatible, complementary therapies. Europace Feb, 2014
  6. Go A, Heart Disease and Stroke Statistics. American Heart Association – 2013 Update. Circulation 2013;127:e6-e245
  7. Prospective Studies Collaboration. Lancet 2002;360:1903-1913
  8. Chobanian AV. JNC 7: Complete Report. JAMA 2003;289:2560-2572

CAUTION: Barostim neo™ is an investigational device and is limited by United States law to investigational use. Exclusively for Clinical Investigations for the treatment oheartfailure and resistant hypertension in Canada.

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

© CVRx, Inc. 2014. All rights reserved.