CVRx, Inc.
Medical Devices & Tech
9201 West Broadway Avenue, Suite 650
Minneapolis, MN 55445 USA
phone: 763-416-2840
fax: 763-416-2841
Symbol Private
Exchange Private
Founded 0
Employees
www.cvrx.com
Research Sector Medical Devices & Tech
Summary Description
Active Implantable Technology to Treat Refractory Hypertension
Management
Nadim Yared, CVRx, Inc., President and CEO of CVRx; John Brintnall, CFO; Michael Sweeney, InterWest Partners, Director; Dale Spencer, ev3, Director; James Shapiro; Michael Selzer, Optobionics; John Nehra, New Enterprise Associates; Robert Kieval, CVRx, Inc, Chief Technology Officer of CVRx; A. Jay Graf
Keywords
cardiology, medical, device, heart, disease, cardio, drug refractory hypertension

Comment | Printable Version | Oct. 13, 2008
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Description
CVRx is a private, Minneapolis-based company that has developed proprietary active implantable technology to treat high blood pressure (hypertension) that cannot be regulated with medications (drug refactory or resistant hypertension).
Products / Services
The Rheos Hypertension (HT) Therapy system consists of three major components: the Rheos Implantable Pulse Generator, Rheos Carotid Sinus Leads, and the Rheos Programmer System. The Rheos Implantable Pulse Generator provides control and delivery of the activation energy through the Rheos Carotid Sinus Leads. These leads conduct activation energy from the Rheos Implantable Pulse Generator to the left and right carotid arteries. The Rheos Programmer System facilitates non-invasively communication with the pulse generator.
Technology / Differentiation
The Rheos HT System uses CVRx's patented Baroreflex Activation Therapy (TM) technology, designed to trigger the body's natural blood pressure regulation system. In effect, it allows the brain to independently direct the body's control mechanisms. The pulse generator is surgically implanted under the skin near the collarbone. When the baroreflex-the system that regulates blood pressure- is activated by the Rheos system, signals (e.g., activated stress hormones) are sent to the central nervous system and are interpreted as a rise in blood pressure. The response of the nervous system counteracts this perceived rise in blood pressure by dilating blood vessels to permit increased blood output. This reduces the heart rate and stimulates fluid release from the kidneys.
Market / Customers
Hypertension affects over 73 million people in the United States and is the cause of approximately one out of every eight deaths worldwide. It is a major risk factor for cardiovascular disease and stroke. Yearly costs to treat hypertension in the United States are currently estimated at $69.4 billion. Nevertheless, approximately 25 percent of people with hypertension cannot adequately control their hypertension with medications and lifestyle modifications. 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.
Status
The Rheos System received CE Mark approval in Europe and is being evaluated in a global pivotal trial designed to obtain FDA approval. CVRx reported positive two-year results from its European clinical trial of the Rheos System in June 2008; systolic blood pressure was reduced by an average of 35 mmHg and diastolic blood pressure by an average of 24 mmHg. CVRx announced that it had secured $84 million in private equity financing in July 2008; New Enterprise Associates, Inc. (NEA) and Johnson & Johnson Development Corporation were the co-lead investors. The company intends to use this funding to complete its hypertension pivotal trial (which has received investigational device exemption from the FDA), as well as for product development, sales and marketing. CVRx will also launch clinical research initiatives in the use of Rheos for the treatment of heart failure.


2008-11-20-383