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CVRx, Inc. Fact Sheet
CVRx, Inc., a private company based in Minneapolis, Minnesota, has developed a proprietary active
implantable technology for the treatment of high blood pressure, also referred to as hypertension, and
heart failure.
CVRx received CE marking for its Barostim neo™ System for the treatment of resistant hypertension and
it is currently available for sale in Germany, Italy, The Netherlands, Switzerland and Austria. Barostim
neo is currently under clinical evaluation in the United States and Canada for the treatment of high blood
pressure and heart failure. It is under clinical evaluation in Europe for the treatment of heart failure.
CVRx Background and Financing
CVRx was founded in 2001 to develop a proprietary active implantable technology to treat high blood
pressure and heart failure. The senior management and technical teams have many years of experience
commercializing implantable medical devices. CVRx has proprietary technology protected by an
expanding portfolio of U.S. patents. CVRx has received private equity financing totaling $209 million.
New Enterprise Associates, Inc. (NEA) and Johnson & Johnson Development Corporation are the lead
investors.
Hypertension and Heart Failure: Two Large, Growing Market Opportunities
Hypertension
In Europe, hypertension affects an estimated 40 percent of adults, or 154 million people.1 In the United
States, hypertension affects 76.4 million people.2 Worldwide, hypertension is estimated to cause one in
every eight deaths.2 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 modifications3,4 It is a disease that needs new treatment solutions.
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 5.7 million adults.2 On a
worldwide basis, heart failure is estimated to affect 23 million people.5 Overall, heart failure is
associated with a four-fold increased risk in death and a six to nine times increased risk of sudden
cardiac death.6, 7 The direct and indirect costs of heart failure are estimated to reach $44.6 billion
annually in the United States by 2015.2
Barostim neo™ System
Barostim neo uses CVRx-patented technology that is designed to trigger the body's own natural blood
flow regulation system to treat hypertension and 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:
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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 and improving cardiovascular function.
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Barostim neo can be adjusted to meet each patient’s individual therapy needs, making it the only
personalized medical device therapy for the treatment of hypertension with a CE marking.
Barostim neo is a fully reversible treatment. The mechanism of action is electrical stimulation of the
baroreceptors, which does not alter or destroy the structure of the baroreflex. For this reason, physicians
can, if needed, turn the therapy OFF by simply pressing a button. This means that physicians can easily
observe the difference Barostim neo makes in blood pressure and other hemodynamic parameters simply
by turning it OFF and ON.
In addition, Barostim neo provides 100% compliance to treatment, by automatically and continuously
activating the baroreflex .The system does not rely on patients to be compliant to using their treatment,
which is a significant problem with medications.
Company Milestones
Continued Investment in Hypertension and Heart Failure Clinical Studies
 The company initiated a 310 patient study in the U.S. with the Barostim neo System for the treatment
of hypertension in 2012.
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The company initiated a 60 patient study in the U.S. with the Barostim neo System for the treatment
of heart failure in 2012.
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The company initiated a 500 patient European Registry to monitor hypertension patients treated with
Barostim neo in 2012.
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The company initiated a 150 patient study in Europe and Canada with the Barostim neo for the
treatment of heart failure in 2011.
CE Marking for Hypertension Indication for CVRx Products
 CVRx received CE marking for the treatment of hypertension for Barostim neo in 2011, and in 2007
for the Rheos® System.
Continued Positive Hypertension and Heart Failure Clinical Results for CVRx Products
 The first Barostim neo System clinical study documented similar effectiveness results to the Rheos
System and improved safety results.8
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Promising long-term results from the Rheos Pivotal study were reported with 55% of resistant
hypertension patients being able to reach their goal blood pressure of < 140 mmHg systolic blood
pressure, among patients who responded to the treatment.9
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Physicians have reported promising improved heart function and heart structure results from heart
failure patients from European and U.S. feasibility studies at numerous cardiology meetings
(American Heart Association, American College of Cardiology, Heart Failure Society of America)
since 2008.
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CVRx has received several prestigious awards for excellence in research from the American Heart
Association and the International Society for Vascular Surgery.
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CVRx Contacts:
John Brintnall
Chief Financial Officer
[email protected]
Phone: 763.416.2853
Mary McGrory-Usset
Corporate Communications
[email protected]
Phone: 651.308.8225
CVRx, Inc.
9201 West Broadway Avenue
Suite 650
Minneapolis, MN 55445
www.cvrx.com
Footnotes:
1. Estimated based on data from Dymedex Consulting.
2. Heart Disease and Stroke Statistics. American Heart Association - 2012 Update.
3. Prospective Studies Collaboration. Lancet 2002;360:1903-1913.
4. Chobian AV, et al. JAMA 2003;289:2560-2572.
5. McMurray JJ, et al. Eur Heart J 1998;1Suppl P:P9.
6. Lloyd-Jones DM, et al. Circulation. 2002;106:3068-3072.
7. Owan TE, et al. N Engl J Med 2006;355:251-259.
8. Hoppe C, et al. J Am Soc Hypertens. 2012;6(4):270-276.
9. Bakris GL et al. J Am Soc Hypertens. 2012;6(2):152-158.
CAUTION: Barostim neo™ System 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).
CVRx, Rheos, and Barostim neo are trademarks of CVRx, Inc. registered in the United States Trademark
Office.
© CVRx, Inc. 2012. All rights reserved.
October 2012
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