VentriPoint Diagnostics today provided a corporate update and said that it has completed a first closing of the second of two non-brokered private placements.
As previously reported, the U.S. FDA had requested additional information concerning the company's 510(k) submission for Pulmonary Arterial Hypertension ("PAH"). In response, VPTDF said it has prepared a detailed statistical plan to obtain the information required in collaboration with the Hospital for Sick Children, Toronto, which will re-analyze the clinical studies.
In accordance with its original plans for the clinical trial, VPTDF 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. The new analysis will use all 75 cases and will take approximately six to eight weeks to complete. The PAH clinical trial has been completed.
The company also announced:
• Tetralogy of Fallot (NYSEMKT:TOF) clinical trial has finished recruitment with the 75 required clinical cases - the study is now completed and closed. The analysis of the data will begin upon completion of the PAH analysis.
• The development of a clinical trial protocol in collaboration with a major cardiac center 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 Web site ventripoint.com/index.php?Itemid=511).
• The company last week exhibited at the 11th International Symposium entitled "Echocardiography Today and Tomorrow" in St. Wolfgang, Austria.
• From June 29-July 2, 2013, VPTDF will exhibit 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."
• A group led by Dr. Laser from the Heart and Diabetes Center NRW (HDZ NRW), Bad Oeynhausen, Germany, will report on the first use of the prototype VMS-3DE™ software, which analyses 3D ultrasound cardiac images.
• A group led by Dr. Soriano from the Seattle Children's Hospital will report on their early experiences with the VMS in a number of children with a broad range of heart.
• VPTDF has been upgrading VMS systems to the new mobile VMS-Angelo™ model and installing new systems for customer evaluation. By the end of this quarter, there will be seven systems in clinical use, four of which are being placed for a 30-day trial period prior to purchase. Additionally, four institution-sponsored clinical research studies have been completed and favorable purchase terms are being negotiated. The company anticipates several sales agreements in the next quarter and has a number of new cardiac centers requesting a VMS-Angelo system for evaluation.
In regards to its private placement, VPTDF has issued an aggregate of 500 units for gross proceeds of $500,000. The company intends to use the proceeds from private placement for product and service commercialization of the VMS machines; clinical validation of VMS functionality, including applications for additional diagnoses and heart diseases; and for general working capital purposes and to repay debt and outstanding payables.
The company also said it has received approval from the Exchange and has issued 694,425 Common Shares at $0.099 per Common Share in payment of $68,748.09 of accrued interest owing to a holder of a debenture of the Company.
For more information, visit ventripoint.com
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