Proceeds to Advance Pivotal Clinical Trial of Rheos™ Baroreflex Hypertension Therapy™ System
Minneapolis – May 9, 2007 – CVRx, Inc., a private medical device company, has completed a fourth round of private equity financing totaling $65 million. The company has developed the Rheos™ Baroreflex Hypertension Therapy™ System, the only implantable device designed to control hypertension, a leading cause of heart and kidney disease, stroke and death. Johnson & Johnson Development Corporation was the lead investor. In conjunction with the financing, Dr. Brad Vale, vice president, Johnson & Johnson Development Corporation joined the CVRx Board of Directors.
Other participants in this round included new investor BBT Fund L.P., and existing investors New Enterprise Associates, Thomas Weisel Healthcare Venture Partners, InterWest Partners, ABS Ventures, Frazier Healthcare Ventures and SightLine Partners. With this financing, the total investment in CVRx exceeds $125 million.
“We are excited to have the confidence and support of our investors. The early clinical trial results have been promising, and we look forward to providing a new treatment option to the millions of patients whose hypertension does not respond to drug therapy. We have a strong, experienced management team to execute our plan, and these funds will help us complete this important trial,” said Nadim Yared, president and CEO of CVRx.
Preliminary data from European andU.S.early clinical trials evaluating the safety and clinical effectiveness of the Rheos System were presented in a Late-Breaking Emerging Technologies Session at the recentAmericanCollegeof Cardiology conference. The findings showed a significant reduction in blood pressure in patients with drug-resistant hypertension who have a systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including a diuretic. The ACC presentation reported office measurement results after six months of active Rheos therapy for the first 21 European andU.S.patients enrolled in these trials. Systolic blood pressure was reduced by an average of 21 mmHg (187 mmHg vs.166 mmHg); and diastolic blood pressure was reduced by an average of 16 mmHg (112 mmHg vs. 96 mmHg).
Rheos Pivotal Trial in Progress
CVRx received investigational device exemption (IDE) approval from the Food and Drug Administration to begin a U.S.pivotal clinical trial that is evaluating the safety and effectiveness of the Rheos System in 300 patients. The blinded study is a prospective, randomized, placebo-controlled clinical trial that is being conducted at multiple medical sites in the United Statesand in Europe. To be enrolled in the trial, patients need to be resistant to treatment with at least three anti-hypertension agents, including a diuretic, and their systolic blood pressure must be greater than or equal to 160 mmHg. Study results are intended to support the Pre-Market Approval (PMA) application for the Rheos System to the FDA. . Individuals who are interested in participating in the trial can call 1-800-XXX to learn more about the trial qualifications and clinical sites who are recruiting patients.
The Rheos System: Working with the Body’s Own Mechanisms
The Rheos System provides a “physio-rational” method to reduce blood pressure. The system’s proprietary technology uses the body’s own natural blood pressure regulation system (the baroreflex) to control blood pressure.
The system electrically stimulates the baroreflex, which sends signals to the brain suggesting a blood pressure increase. Then, the brain acts to lower blood pressure by sending signals to various parts of the body, including the blood vessels, heart and kidneys.
The Rheos System includes:
• A small pulse generator that is implanted under the collar bone;
•Two thin lead wires that are implanted at the left and right carotid arteries and connect to the pulse generator; and
•The Rheos Programmer System, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.
Hypertension: The Need for a New Treatment Option
High blood pressure, also referred to as hypertension, affects about 72 million people in the United Statesalone.1 Hypertension causes an estimated one in every eight deaths worldwide. Each incremental increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal levels is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.2, 3
About Johnson & Johnson Development Corporation
Organized in 1973, Johnson & Johnson Development Corporation (JJDC) is the venture capital subsidiary of Johnson & Johnson. JJDC makes private equity investments in venture funded health care companies. Portfolio companies include those in the fields of pharmaceuticals, biotechnology, medical devices, diagnostics and consumer products. JJDC also leads and manages internal investments in selected promising technologies. For more information, go to www.jjdevcorp.com
About CVRx, Inc.
CVRx, Inc., is a private company founded in 2001 and headquartered in Minneapolis. Its senior management and technical teams have many years of experience commercializing implantable medical devices. For more information on CVRx and the Rheos pivotal clinical trial, visit www.cvrx.com
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1 Heart Disease and Stroke Statistics. American Heart Association – 2007 Update.
2 U.S. Renal Data System. USRDS 2003 Annual Data Report. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2003.
3 Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903-1913.
CAUTION: CVRx Rheos System is an investigational device and is limited by Federal (orUnited States) law to investigational use only.
CVRx, Rheos, Baroreflex Hypertension Therapy are trademarks of CVRx, Inc.
© CVRx, Inc. 2007