SEATTLE, WASHINGTON -- (Marketwired) -- 06/24/13 -- Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company") (TSX VENTURE: VPT)(OTCQX: VPTDF) announces that it has completed a first closing of the second of its two previously announced non-brokered private placements and is providing a corporate update.
The Company previously reported the Food and Drug Administration ("FDA") had asked for additional information concerning the Company's 510(k) submission for Pulmonary Arterial Hypertension ("PAH"). Through a dialogue with the FDA, the Company has prepared a detailed statistical plan to obtain the information required in collaboration with the Hospital for Sick Children, Toronto, which will be re-analyzing the clinical studies. The Company has completed the collection of an additional 21 clinical cases, which along with the 54 studies used in the first analysis, yields 75 total cases, as originally planned in the clinical trial. The new analysis, which will use all 75 cases, has begun and is expected to take six to eight weeks to complete. The PAH clinical trial is now completed and is closed.
The clinical trial for Tetralogy of Fallot (TOF) has finished recruitment with the 75 required clinical cases and the study is now completed and closed. The analysis of the data will begin as soon as the PAH analysis is completed. This will also be done by the Hospital for Sick Children as the Ventripoint Medical System ("VMS") core lab and Nationwide Hospital as the MRI core lab.
The Company has developed a clinical trial protocol in collaboration with a major cardiac center that is interested in evaluating if VMS assessment of right heart function and structure in patients admitted with congestive heart failure can predict hospital readmission within 30 days of discharge (see CEO blog on website http://ventripoint.com/index.php?Itemid=511). This study has the potential to revolutionize how cardiac patients are assessed and save the healthcare system billions of dollars.
Last week the Company exhibited, in collaboration with Toshiba Medical Systems Europe, at the 11th International Symposium entitled "Echocardiography Today and Tomorrow" in St. Wolfgang, Austria. The conference was focused on the right heart and included a workshop, where case studies using the Ventripoint VMS were presented by the group from Elisabethinen Hospital, Linz, Austria, which also organized the conference.
From June 29-July 2, 2013 the Company will be exhibiting at the 24th Scientific Sessions of the American Society of Echocardiology ("ASE") in Minneapolis, Minnesota. There will be three scientific papers presented by three groups of researchers discussing the clinical use of the VMS.
A multicentre group from the University of Chicago and Elisabethinen Hospital in Linz, Austria will present a study entitled "Three-dimensional Modeling of the Right Ventricle from Two-Dimensional Transthoracic Echocardiographic Images: Utility of Knowledge-Based Reconstruction in Pulmonary Arterial Hypertension". Dr. Lang from the University of Chicago and past President of the ASE stated; "The VentriPoint 3D system provides reproducible measurements of RV volumes in pulmonary arterial hypertension patients. The clinical accuracy of VMS helps obtain valuable information that can impact patient care".
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