SEATTLE, WASHINGTON--(Marketwired - June 24, 2013) - 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".
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 in a paper entitled; "Right ventricular volumetry in healthy children and young adults by RT3DE - New axis, new quantification tool with promising results".
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 problems in a paper entitled; "Echocardiographic 3D Reconstruction Accurately and Precisely Measures Right Ventricular End Diastolic Volumes: Preliminary Pediatric Experience in a Single Institution". Dr. Sorino commented "Our ongoing research experience with the Ventripoint equipment has been very positive and we look forward to applying it routinely once it is available for clinical usage in the USA".
The Company 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. In addition, four institution-sponsored clinical research studies have been completed and we are working on favorable purchase terms with each of them to maintain clinical usage of VMS. The company expects several sales to be agreed in the next quarter and has a number of new cardiac centres requesting a VMS-Angelo system for evaluation.
Unit Private Placement
The Company has issued an aggregate of 500 units ("Units") for gross proceeds of US$500,000 (the "Unit Private Placement"). Each Unit consists of USD$1,100 principal amount of non-convertible secured debentures ("Unit Debentures"), which shall mature three years from the date of issuance and 2,000 common shares in the capital of the Company (the "Common Shares").
Each Unit Debenture is subject to a 10% capital discount premium to the subscriber such that for every USD$1.00 Unit Debenture acquired, the Company shall owe, on the maturity date, an amount equal to USD$1.10 to the subscriber minus any payments of principal to date. Any interest due under the terms of the Unit Debentures shall only be paid and calculated against the principal amount actually provided to the Company (i.e. USD$1.00) by the subscriber and not calculated against the inflated principal paid on the maturity date (i.e. USD$1.10).
The Unit Debentures will bear interest at a rate of 12% per annum and shall be calculated on the initial Unit Debenture amount. Any accrued but unpaid interest under the Unit Debentures shall be due and payable on December 1st each calendar year. The December 1, 2013 interest may, subject to the approval of the TSX Venture Exchange ("Exchange"), be paid in Common Shares, with the number of Common Shares being determined by using the preceding 10 day volume-weighted average price of the Common Shares on the Exchange. All subsequent interest payments shall be made in cash and the final payment of accrued interest shall be payable upon maturity of the Unit Debentures.
If the Company prepays all of the outstanding principal on any of the Unit Debentures prior to the second anniversary date of the Unit Debentures, the Company shall pay any accrued interest and make an additional payment to the Unit Debenture holder equal to one year's interest (the "Additional Interest Payment").
The Unit Debenture holders shall receive a pro rata 20% first charge on gross revenues (net of any third party billings, such as shipping or taxes) (the "Revenue Payments") at the end of each calendar quarter from sales of VMS machines until the Unit Debentures are retired. The Revenue Payments shall not invoke the Additional Interest Payment and will be deducted from the principal paid upon the maturity date of the Unit Debentures.
The Unit Debentures are secured by a general security agreement against substantially all of the assets of the Company's wholly-owned subsidiary, Ventripoint, Inc., including its intellectual property, as a first charge. All Unit Debentures rank equally with one another.
The Company intends to use the proceeds from the Unit Private Placement for: (i) product and service commercialization of the VMS machines; (ii) clinical validation of VMS functionality, including applications for additional diagnoses and heart diseases; and (iii) for general working capital purposes and to repay debt and outstanding payables.
The Unit Private Placement is subject to the final approval of the Exchange. The securities issued pursuant to the Unit Private Placement are subject to a four-month hold period in accordance with applicable securities laws.
Share for Debt
The Company also announces it has received approval from the Exchange and has issued 694,425 Common Shares at a deemed price of $0.099 per Common Share in payment of $68,748.09 of accrued interest owing to a holder of a debenture of the Company. The 694,425 Common Shares have a hold period of four months from the date of issuance in accordance with applicable securities legislation.
About Ventripoint Diagnostics Ltd.
Ventripoint has created a diagnostic ultrasound tool to monitor patients with heart disease, a leading cause of death in developed countries. Management believes that VMS is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. Congenital heart disease in children and adults and Pulmonary Arterial Hypertension are the first applications in a suite of applications for all major heart diseases including cardiovascular disease and heart failure - a multi-billion dollar market potential. Canada and Europe (CE Mark) have granted approval for the sale of its VMS tool and the Company is pursuing the US-FDA marketing clearance through the 510(k) process.
FORWARD-LOOKING STATEMENTS: This news release may contain certain forward-looking information and statements, including without limitation, statements pertaining to the closing of the private placements including the Company's ability to obtain necessary approvals from the TSX Venture Exchange. All statements, other than statements of historical facts, which address Ventripoint's expectations, should be considered forward-looking statements. Such statements are based on management's exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words "may", "will", "anticipate", "believe", "estimate", "expect", "intend" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect a current view of future events and are subject to certain risks and uncertainties as contained in the Company's filings with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements. A description of assumptions used to develop such forward-looking information and a description of risk factors that may cause actual results to differ materially from forward-looking information can be found in Ventripoint's disclosure documents on the SEDAR website at www.sedar.com. The Company undertakes no obligation, and does not intend, to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of any unanticipated events. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release