Healthcare Industry News: angiotensin II
News Release - June 13, 2007
CardioDynamics Announces New ICG Hypertension EvidenceAmerican Society of Hypertension Meeting Presentations Provide Framework for New Hypertension Research Strategy
SAN DIEGO, June 13 (HSMN NewsFeed) -- CardioDynamics (Nasdaq: CDIC ), the innovator and leader of BioZ® impedance cardiography (ICG) technology, today announced the presentation of three new hypertension studies at the American Society of Hypertension's 22nd Annual Scientific Meeting in Chicago.
The three clinical studies offer new insights into ICG's value in hypertension (also referred to as high blood pressure) and provide the rationale and framework for the Company's new hypertension research strategy. This strategy is targeted to address the questions raised in the 2006 Centers for Medicare and Medicaid Services (CMS) reconsideration of ICG coverage for hypertension. Currently, ICG is covered nationally by CMS for five indications, including patients with heart failure and shortness of breath, and CMS allows local carrier discretion for drug resistant hypertension. The Company's new research strategy has three primary objectives: 1) identify which ICG parameters provide the most additive information to traditional blood pressure measurements in the development and perpetuation of hypertension; 2) identify which ICG parameters will best predict a favorable blood pressure reduction in response to hypertension drug therapies to develop a new ICG-based treatment algorithm for hypertension; 3) demonstrate that using the new ICG-based treatment algorithm results in long-term improvements in blood pressure control rates compared to other approaches.
In the first study, Drs. Ronald Smith and Carlos Ferrario from Wake Forest University presented data from the CONTROL trial on 164 patients from over 790 patient visits. The study demonstrated that the traditional blood pressure measurement offered little ability to identify which specific ICG hemodynamic abnormalities were present in an individual patient. The investigators concurred that the variation in ICG parameters, within and between blood pressure categories, may indicate vascular and hemodynamic risk that is not apparent with blood pressure alone and that knowledge of these abnormalities is significant because they are targets for antihypertensive drug therapy.
In the second study, Dr. John Flack from Wayne State University presented data from the CONTROL trial on 164 patients in 492 patient visits in which antihypertensive medications were adjusted. In these visits, patients with a higher ICG-determined systemic vascular resistance were more likely to benefit from vasodilating therapies that reduced systemic vascular resistance, such as ACE inhibitors, angiotensin II receptor blockers, and calcium channel blockers. Dr. Flack stated, "ICG may allow better individualization of antihypertensive therapies by identifying which patients will receive the most benefit from each of the various hypertensive drug classes."
In the third study, Dr. Julio Chirinos of the University of Miami presented preliminary data from 590 patients from the PREVENCION study, a large population-based study being conducted in Peru. The study demonstrated that ICG abnormalities were directly associated with obesity and the development of hypertension. When completed, PREVENCION will include ICG measurements on at least 1,600 patients with a multi-year follow-up period. Dr. Chirinos commented, "ICG hemodynamic profiling will likely help clinicians identify which specific circulatory abnormalities are involved in specific populations or individual patients with high blood pressure, thereby improving our ability to target therapeutic interventions."
The Company also announced that Dr. Flack will be the principle investigator for a new company-sponsored observational study called BETTER-HTN (Bioimpedance Evaluation of Therapeutic Titration in Essential Resistant Hypertension). The BETTER-HTN study is projected to commence near the end of 2007 and will evaluate up to several thousand hypertensive patient visits at multiple sites in support of the Company's new research objectives.
"We are very encouraged by the new hypertension evidence presented at the American Society of Hypertension meeting," stated Michael K. Perry, Chief Executive Officer. "We already know that ICG can play an important role in the evaluation and treatment of hypertension, the most prevalent cardiovascular condition in the United States. We believe the results from PREVENCION and BETTER-HTN will allow us to strategically design a randomized controlled trial to answer the remaining scientific questions and, upon success completion, allow CMS and private insurers to cover ICG more broadly for patients with hypertension."
CardioDynamics (Nasdaq: CDIC ), the ICG Company, is the innovator and leader of an important medical technology called impedance cardiography (ICG). The Company develops, manufactures and markets noninvasive ICG products and medical device electrodes under its patented and proprietary BioZ® brand of ICG products. The Company's ICG Systems are being used by physicians around the world to help battle the number one killer of men and women -- cardiovascular disease. Partners include GE Healthcare and Philips Medical Systems. For additional information, please refer to the company's Web site at www.cdic.com.
Forward-Looking (Safe Harbor) Statement
Except for historical and factual information contained herein, this press release contains forward-looking statements, such as publication of clinical trials and commencement and anticipated benefits of new clinical trials, the accuracy of which is necessarily subject to uncertainties and risks including the Company's primary dependence on the BioZ product line, and various uncertainties characteristic of early growth companies, as well as other risks detailed in the Company's filings with the SEC, including its 2006 Form 10-K. The Company does not undertake to update the disclosures contained in this press release.
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