A new treatment option for high blood pressure

Tag : Lead Wires
CVRx, a private medical device company, plans to use the funding to complete the hypertension pivotaltrial, as well as for product development and building a sales andmarketing organization in anticipation of product launch. Inaddition, CVRx will launch clinical research initiatives in the useof Rheos for the treatment of heart failure. Heart failure affects5 million patients in the United States. 1
New Enterprise Associates, Inc. (NEA) and Johnson & JohnsonDevelopment Corporation were the co-lead investors. Otherparticipants in this round included existing investors BBT FundL.P., Thomas Weisel Healthcare Venture Partners, InterWestPartners, Frazier Healthcare Ventures and SightLine Partners. Withthis financing, the total investment in CVRx exceeds $209 million.
“ The continuing support of our investors is a strong vote ofconfidence in our team, our technology, our results to date and ourfuture market opportunities, ” said Nadim Yared, CVRx president and CEO. “ We are especially optimistic about the two-year patient results,which showed a significant and sustained reduction in bloodpressure. We are also encouraged by the early data on improvedheart function with Rheos therapy. Hypertension and heart failure are complex conditions, and we arehopeful our technologies will provide much-needed new treatmentalternatives for patients around the world. ”
Two-Year Hypertension Data Show Sustained Patient Outcomes
The first-available two-year data from the European clinical trialevaluating the Rheos System were presented in June 2008 at aninternational hypertension conference in Berlin. Two-year resultsshowed that systolic blood pressure, a leading indicator of patientrisk, was reduced by an average of 35 mmHg (191 mmHg vs. 156 mmHg),and diastolic blood pressure declined by an average of 24 mmHg (116mmHg vs. 92 mmHg among patients who completed two years of RheosTherapy. Similar results were found at three months and one year. 2
Rheos Therapy Results Demonstrate Improved Heart Function
Additional data from the European and U.S. feasibility studiespresented at the Berlin conference showed heart function wasnotably improved. Blood pressure was reduced significantly and leftventricular hypertrophy (LVH) significantly regressed. 3 LVH, a process in which the heart becomes enlarged and does notwork efficiently, increases the risk of heart attacks, heartfailure and sudden cardiac death, and regression of LVH reducesthese risks.
The Rheos System: Working with the Body ’ s Own Mechanisms to Reduce High Blood Pressure and Treat HeartFailure
The Rheos System uses the CVRx-patented Baroreflex ActivationTherapy ™ technology that is designed to activate the carotid baroreceptors,central components of the body ’ s natural cardiovascular regulation system. When the baroreceptorsare activated, signals are sent through neural pathways to thebrain and interpreted as a rise in blood pressure. The brain worksto counteract this perceived rise in blood pressure by sendingsignals to other parts of the body (heart, blood vessels andkidneys) that relax the blood vessels and inhibit the production ofstress-related hormones. These changes enable the heart to increaseblood output, while maintaining or reducing its workload, therebyreducing blood pressure when it is elevated and alleviating thesymptoms of heart failure.
The Rheos System includes the following components: A small pulse generator that is implanted under the collar bone; Two thin lead wires that are implanted at the left and rightcarotid arteries and connected to the pulse generator; and The Rheos Programmer System, an external device used by doctors tonon-invasively regulate the activation energy from the generator tothe lead wires.
About Hypertension
Hypertension causes an estimated one in eight deaths worldwide. 3 In the United States alone, high blood pressure affectsapproximately 73 million people. 3 Approximately 25 percent of people with hypertension cannotcontrol their high blood pressure, despite the use of multiplemedications. 4, 5 Each incremental increase of 20 mmHg in systolic blood pressure or10 mmHg in diastolic blood pressure above normal levels isassociated with a two-fold increase in death rates from stroke,coronary heart disease and other vascular causes. 4,5
About the Co-Lead Investors
NEA, founded in 1978, is a leading venture capital firm focused onhelping entrepreneurs create and build major new enterprises. NEAfocuses on investments at all stages of a company ’ s development, from seed stage through IPO. With approximately $8.5billion in committed capital across its affiliated funds, NEA ’ s experienced management team has invested in over 600 companies.For additional information, visit www.nea.com .
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 carecompanies. Portfolio companies include those in the fields ofpharmaceuticals, biotechnology, medical devices, diagnostics andconsumer products. JJDC also leads and manages internal investmentsin selected promising technologies. For more information, go to www.jjdevcorp.com .
About the Rheos Hypertension Pivotal Trial
CVRx received investigational device exemption (IDE) approval fromthe FDA to conduct the Rheos Pivotal Trial to evaluate the safetyand effectiveness of the Rheos System. The trial is also evaluatingthe effectiveness of the Rheos System when medications change. Thetrial is currently enrolling patients at multiple clinical sites inthe United States and in Europe. Prospective patients can call(888) 8BP-RISK (888-827-7475) or visit www.bloodpressuretrial.com , to learn more about the clinical trial.
About CVRx, Inc.
CVRx, a private company located in Minneapolis, has developed thefirst proprietary active implantable technology to treat high bloodpressure. For more information, visit www.cvrx.com .
Editor ’ s Note : Blood pressure is typically recorded as two numbers − the systolic pressure (top number) over the diastolic pressure(bottom number). The systolic pressure is the pressure of blood inthe vessels when the heart contracts. Diastolic pressure is thepressure of the blood between heartbeats, when the heart is at restand is refilling.
1 Heart Disease and Stroke Statistics. American Heart Association – 2008 Update.
2 Journal of Hypertension 2008;26(Suppl 1):S19.
3 Journal of Hypertension 2008;26(Suppl 1):S471.
4 Lancet 2002;360:1903-1913.
5 JAMA 2003;289:2560-2572.
CAUTION: CVRx Rheos System is an investigational device and islimited by Federal (or United States) law to investigational useonly.
CVRx, Rheos, Baroreflex Activation Therapy and BAT are trademarksof CVRx, Inc.
© CVRx, Inc. 2008. All rights reserved.