Cambridge Heart's CH 2000 Cleared To Include SCA Prognostic Indication
This article was originally published in The Gray Sheet
Executive Summary
Cambridge Heart, Inc., expects its proprietary high-resolution electrode leads to generate additional revenue following FDA clearance of the CH 2000 T-wave alternans stress test 510(k) April 13 for the prognosis of sudden cardiac arrest.
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Cambridge Heart
Equity capital of $5.1 mil is raised via private placement, "primarily with a group of institutional investors," the firm reports. The financing included about 1.45 mil. unregistered common shares and 291,428 warrants. The Bedford, Massachusetts company will use a portion of the proceeds to further promote clinical adoption of its CH 2000 T-wave alternans test, cleared by FDA via 510(k) in April as the first non-invasive test to identify patients at risk of arrhythmia (1"The Gray Sheet" April 19, p. 11). Funds are also earmarked for additional clinical studies, pursuit of third-party reimbursement and "other operational needs"
Cambridge Heart
Equity capital of $5.1 mil is raised via private placement, "primarily with a group of institutional investors," the firm reports. The financing included about 1.45 mil. unregistered common shares and 291,428 warrants. The Bedford, Massachusetts company will use a portion of the proceeds to further promote clinical adoption of its CH 2000 T-wave alternans test, cleared by FDA via 510(k) in April as the first non-invasive test to identify patients at risk of arrhythmia (1"The Gray Sheet" April 19, p. 11). Funds are also earmarked for additional clinical studies, pursuit of third-party reimbursement and "other operational needs"
Boost In Clinician Confidence Could Back Bid For CH 2000 CPT Code
Cambridge Heart is ready to present its case to the American Medical Association Feb. 11 to secure a current procedure terminology (CPT) code for the firm's CH 2000 T-wave alternans test.