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news.Point Biomedical has submitted a new drug application to the FDA for approval to market CardioSphere, a myocardial perfusion agent used with ultrasound imaging for the detection and localization of obstructive coronary artery disease.
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The NDA submission is based on the results of 11 clinical trials, involving more than 1300 patients and subjects including two multi-center phase III clinical trials conducted in the US.
The phase III trials were designed to evaluate the performance of CardioSphere for the assessment of myocardial perfusion using ultrasound imaging compared to radionuclide imaging, the current standard of care. If approved, CardioSphere will allow cardiologists to diagnose coronary artery disease in the office or hospital using standard ultrasound equipment and without the need for radioactive isotopes.
“The submission of this NDA is an important milestone for Point,” said Point CEO Dr Jerry Griffin. “We are now looking forward to working with the FDA to ultimately be able to bring this procedure to patients as a non-invasive, non-radioactive means of assessing coronary artery disease.”