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05/10/2007

CVRx, Inc. Closes $65 Million in Series D Financing

 

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 and U.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 recent American College of 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 and U.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). CVRx, Inc.

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 States and 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.

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