Periodic Reporting for period 1 - iMUC (Improving the Management of Unexplained Chest-pain)
Reporting period: 2014-11-01 to 2015-04-30
The iMUC project is designed to validate the improvement of cardiovascular outcomes in patients with unexplained chest-pain using a novel methodology of endothelial function assessment and adjusting their treatment, including life style modification, accordingly. iMUC is focused on the validation of a new biomarker-based non-invasive novel technology which detects and scores endothelial function in cardiovascular disease through its different stages.
iMUC EndoPAT diagnostic technology is a non-invasive, robust and non-operator-dependent technology, providing an enhanced clinical tool to improve disease management.
iMUC aims to validate that scoring endothelial function using iMUC technology can help to better manage patients with chest pain and in specific those that undergo diagnostic angiography but released without intervention. In addition, iMUC aims to show and validate that adherence to and compliance with intensive life style changing is improved when progress is monitored with the novel iMUC technology.
iMUC EndoPAT diagnostic technology is a non-invasive, robust and non-operator-dependent technology, providing an enhanced clinical tool to improve disease management.
iMUC aims to validate that scoring endothelial function using iMUC technology can help to better manage patients with chest pain and in specific those that undergo diagnostic angiography but released without intervention. In addition, iMUC aims to show and validate that adherence to and compliance with intensive life style changing is improved when progress is monitored with the novel iMUC technology.
iMUC Phase I study is focused on a business plan development and a feasibility study of the project's concept. The study included 1) clinical market research quantifying the relevant market segments and their size, 2) related health care economic viability , and 3) review of the relevant scientific literature.
As part of the Phase I study, Itamar Medical has established a steering committee composed of internationally renowned key opinion leaders in the field. Together with this steering committee, a detailed design of the project’s multicenter clinical trial protocol was established, including the management of the various expected risks. We have connected with over 20 medical centers worldwide that are interested to participate in the iMUC Phase II clinical study. Finally we have established the necessary relationships with a CRO as well as a bio-statistic group focused on and experienced in the cardiovascular area.
As part of the Phase I study, Itamar Medical has established a steering committee composed of internationally renowned key opinion leaders in the field. Together with this steering committee, a detailed design of the project’s multicenter clinical trial protocol was established, including the management of the various expected risks. We have connected with over 20 medical centers worldwide that are interested to participate in the iMUC Phase II clinical study. Finally we have established the necessary relationships with a CRO as well as a bio-statistic group focused on and experienced in the cardiovascular area.
iMUC solution implementation for improving patient management is expected to exhibit an important prognostic value of the technology when incorporated in the patient' risk stratification, helping the physician's decision on treatment, thus promoting better cardiovascular diseases prevention.
We strongly believe that it is feasible to validate the clinical benefits of the iMUC project. We also believe that the project will provide substantial potential value and growth to Itamar Medical.
We strongly believe that it is feasible to validate the clinical benefits of the iMUC project. We also believe that the project will provide substantial potential value and growth to Itamar Medical.