Mesothelioma Survey Project

New Implantable Device Designed to Lower High Blood Pressure May Offer Hope for Millions of Patients

Early Hypertension Clinical Trial Results Show Significant Reduction in High Blood Pressure

May - Hypertension Awareness Month - Recognizes High Blood Pressure as a Top Risk Factor for Stroke, Heart and Kidney Disease

-- April 28, 2008 --CVRx:

WHAT: May is Hypertension Awareness Month, and a new device for high blood pressure now in clinical trials is showing promise for treating U.S. hypertension (high blood pressure) patients whose condition is not controlled by drugs. Rheos® Hypertension (HT) Therapy is the only implantable device designed to lower high blood pressure. It uses the body's natural blood pressure sensor (the baroreflex) to reduce blood pressure. Early hypertension clinical trial results showed a 39 mmHg reduction in systolic blood pressure at one year of use. High blood pressure is the number one risk factor for stroke, heart and kidney disease.

The Rheos HT Therapy is designed to electrically activate the carotid baroreceptors, the body's natural pressure sensors. When the baroreceptors are activated, signals are sent through the neural pathways to the brain and interpreted as a rise in blood pressure. The brain works to counteract this perceived rise in blood pressure by sending signals to various parts of the body-including the blood vessels, heart and kidneys. The Rheos HT System was developed by Minneapolis-based CVRx, Inc. (www.cvrx.com). The Rheos pivotal trial is currently under way. To learn more about the trial, patients can call 1-(888) 8BP-RISK (1-888-827-7475) or visit www.bloodpressuretrial.com.

WHY: Hypertension affects approximately 73 million people in the United States alone. High blood pressure is the number one risk factor for stroke and causes an estimated one in 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.

According to the National Institutes of Health, approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications. These patients may not respond to drugs, or they may not be able to maintain their complex medication regimens. Early Rheos HT clinical results have shown the device has the potential to significantly reduce blood pressure in patients who cannot control their blood pressure with medications. One-year results from 13 patients showed a 39 mmHg average decrease in systolic blood pressure and a 26 mmHg average decrease in diastolic blood pressure.

HYPERTENSION STROKE FACTS:

May is Hypertension Awareness Month, sponsored by the U.S. Department of Health and Human Services. In the United States:

    * High blood pressure is the number one stroke risk factor and accounts for an estimated 70 percent of all strokes. It is also one of the most important controllable risk factors for stroke prevention.
    * Stroke is the number three cause of death.
    * Twice as many women die from stroke each year than from breast cancer.
    * Approximately 750,000 Americans suffer a stroke each year and 80 percent of strokes are considered preventable, according to the National Stroke Association.

INTERVIEW OPPORTUNITIES:

    * Rheos study physicians
    * Nadim Yared, president and CEO of CVRx

ADDITIONAL EVENTS DURING HYPERTENSION AWARENESS MONTH:

    * May 4: ISHIB Worship Site Health Education Program (WSHEP)
    * May 17: World Hypertension Day

CVRx BACKGROUND AND MEDIA KIT: CVRx is a private company founded in 2001 and headquartered in Minneapolis. For more information and a media kit, visit www.cvrx.com.

* CAUTION: The CVRx Rheos System is an investigational device and is limited by Federal law to investigational use only.

CVRx, Rheos, Baroreflex Activation Therapy, and BAT are registered trademarks of CVRx, Inc. © CVRx, Inc. 2008.

Contacts

CVRx
John Brintnall, 763-416-2853
Chief Financial Officer
jbrintnall@cvrx.com
Mary McGrory-Usset, 651-308-8225
Corporate Communications
mmcgroryusset@comcast.net
or
Padilla Speer Beardsley
Nancy Johnson, 612-455-1745
njohnson@psbpr.com
Nick Banovetz, 612-455-1705
nbanovetz@psbpr.com

// posted by (hris @ 9:40 AM 0 Comments

Findings from a multi-center clinical trial sponsored by the National Cancer Institute and led by the Eastern Cooperative Oncology Group (ECOG) demonstrated that lowering the dose of the steroid dexamethasone when paired with REVLIMID® to treat newly diagnosed myeloma, not only reduces side effects, but also improves long-term survival. The data are being discussed and evaluated at the 49th annual meeting of the American Society of Hematology (ASH) in Atlanta. According to the Mayo Clinic Cancer Center, lead institution for the study, the data show a "distinct survival benefit" with lower doses of the dexamethasone combined with REVLIMID. S. Vincent Rajkumar, M.D., hematologist and lead investigator of the study at the Mayo Clinic added, "This is a major advance in the treatment of cancer, and also gives researchers a new direction to explore - that more is not necessarily better when it comes to fighting the cancer."

North Hollywood, CA, and Atlanta, GA  -  December 14 -- The International Myeloma Foundation (IMF) - supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said new data being reported at a global cancer conference require a new approach to evaluating cancer treatments. Findings from a multi-center clinical trial sponsored by the National Cancer Institute and led by the Eastern Cooperative Oncology Group (ECOG) demonstrated that lowering the dose of the steroid dexamethasone when paired with REVLIMID® to treat newly diagnosed myeloma, not only reduces side effects, but also improves long-term survival. The data are being discussed and evaluated at the 49th annual meeting of the American Society of Hematology (ASH) in Atlanta.

According to the Mayo Clinic Cancer Center, lead institution for the study, the data show a "distinct survival benefit" with lower doses of the dexamethasone combined with REVLIMID. S. Vincent Rajkumar, M.D., hematologist and lead investigator of the study at the Mayo Clinic added, "This is a major advance in the treatment of cancer, and also gives researchers a new direction to explore - that more is not necessarily better when it comes to fighting the cancer."

The data showed REVLIMID, an oral medication from Celgene, plus low-dose dexamethasone improves one year survival compared to the standard high-dose dexamethasone, 96% to 88%. Over two years the benefit continues with an 87% survival rate for low-dose dexamethasone compared to a 75% survival rate for high-dose dexamethasone. While lowering the dose of the steroid also lowers some immediate measures of response that is offset by better, long-term disease control.

"Lowering the doses of the steroid dexamethasone with REVLIMID gives us a new paradigm of treatment," said Brian G.M. Durie, M.D., chairman and co-founder of the International Myeloma Foundation. "When we combine REVLIMID with lower dose dexamethasone, we are seeing reduced side effects so patients stay on the drug longer, and, above all, significant survival benefits. These are the outcomes that patients and physicians find most important, and take precedence over the traditional ways we have used to evaluate new therapies."

Last April the independent committee monitoring the trial found the preliminary results so compelling that the trial was stopped and all patients in the trial were moved to lower dose dexamethasone. Because of the overwhelming positive response to REVLIMID plus low-dose dexamethasone in the ECOG study, a trial from the other large cancer cooperative, SWOG, was also stopped prematurely. This trial compared REVLIMID plus high-dose dexamethasone to dexamethasone alone. Because this SWOG trial stopped early, and because nearly half of the patients on the dexamethasone-alone-arm of the study crossed over to the REVLIMID-plus-dexamethasone-arm of the study within the first year, overall impressions regarding survival could be misleading.

According to Dr. Durie: "We do not want patients confused by statistics. In fact, the SWOG trial concluded that REVLIMID with low-dose dexamethasone is among the most active up-front combination regimens against myeloma. These results demonstrate that REVLIMID plus dexamethasone is definitely better than dexamethasone alone, and is an excellent treatment in newly diagnosed multiple myeloma."

The International Myeloma Foundation concludes that overall findings presented at this conference about multiple myeloma in all ages, and across all categories of patients (newly diagnosed, relapsed, patients proceeding to bone marrow transplants and so on) is positive and encouraging and represents major advances in the treatment of blood cancers beginning with myeloma.

ABOUT The International Myeloma Foundation
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 165,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses in four key areas: research, education, support and advocacy. To date, the IMF has conducted more than 120 educational seminars worldwide, maintains a world-renowned hotline, and operates Bank on a Cure®, a unique gene bank to advance myeloma research. The IMF was rated as the number one resource for patients in an independent survey by the Target Research Group. The IMF can be reached at (800) 452-CURE, or out of the United States at +1 (818) 487-7455. More information is available at www.myeloma.org.

Media Contact: Stephen Gendel or Jennifer Anderson +1 (212) 918-4650.

Press Contact: Flaherty Chelsey
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Phone: 212-445-8274
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