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Frequently Asked Questions
What is the market potential for EECPr?
Although the potential applications for EECPr are many, and represent additional opportunities, currently, we are focused on establishing EECPr in the treatment of angina pectoris. There are more than seven million people with a diagnosis of angina pectoris in the USA and probably as many as four times this number in overseas healthcare systems.
Realizing full potential will depend on how quickly EECPr can become widely available and take its place alongside standard therapies like angioplasty and bypass grafting.
We expect growing acceptance, especially following the reporting of our multicenter trial results. Of course, reimbursement of treatment fees is a vitally important issue affecting the acceptance of EECPr. However, with annual US healthcare expenditures for coronary revascularization procedures now at nearly $48 billion, as we expand clinical experience, we expect a favorable response from third-party payers.
What is happening with insurance coverage?
Obtaining coverage is our number one priority. We have ongoing communications with a number of large healthcare insurers. Although it is unlikely that any major insurer will grant blanket coverage before the results of our multicenter study are published, we are, nevertheless, pursuing this goal vigorously. We are constantly engaged in opening dialogue and creating a pathway for rapid review of new data as it comes to hand. There have been a significant number of case-by-case reimbursements to-date and we believe that, during the coming months, there will be more. To assist in this process, we encourage patients to apply to their insurers in advance of beginning treatment. This allows insurance companies to gauge the level of interest and consider their positions with regard to each individual.
How is the multicenter study progressing?
As mentioned earlier, everyone is awaiting the results of this trial with great anticipation. The study is being conducted in respected university cardiology research centers. Patients were chosen randomly in a blinded fashion to be in one of two groups, with one group being the control for the other. Because the trial is being conducted under rigorous guidelines, patient recruitment and entry was not as rapid as we had hoped. For this reason we expanded the numbers of study sites in an effort to complete the study more quickly. Based on previous study results from SUNY Stony Brook, there is reason to be optimistic about a positive outcome. In addition to the clinical protocol, there are instruments for measuring quality of life factors as well for provision of important cost/effectiveness information. Patient enrollment has been completed. We hope to report the results during 1997.
What are Vasomedical's development plans for EECPr?
We are implementing plans both for the upgrading of our current Model MC2 and development of our new, more sophisticated, transportable Model MC3. It is important to recognize that while EECPr is dependent on our equipment, the equipment alone is not the product.
EECPr is a medical procedure that might benefit the whole of the vascular systems and therefore, vascular diseases of many kinds. As we mentioned earlier, there are numerous possible clinical applications for EECPr both within and beyond diseases of the heart. Potential uses in various organ problems are documented. Each potential use, however, will certainly require further clinical exploration, as well as better documentation . Needless to say, we intend to pursue every practical medical use for EECPr.
How long has EECPr been used to treat angina?
In 1989, researchers at State University of New York at Stony Brook began clinical studies of EECPr. Until the summer of 1995, EECPr was only available to patients participating in clinical studies. Today EECPr is available at treatment centers throughout the country. However, it has been used successfully for the past fifteen years in China.
Is EECPr cleared by the FDA?
Vasomedical received marketing clearance from the U.S. Food and Drug Administration for an upgraded version of EECPr in 1995. |