VentriPoint Diagnostics Ltd.

VentriPoint Diagnostics Ltd.

February 21, 2013 07:00 ET

VentriPoint Announces 3D Ultrasound Heart Analysis System and Prepares for Clinical Release

SEATTLE, WASHINGTON--(Marketwire - Feb. 21, 2013) - VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) is pleased to announce the completion of a software package for 3D Echocardiography (3DE) - the newest addition to the software capabilities of its knowledge-based-reconstruction (KBR) family of VMS™ heart analysis systems. The VMS-3DE™ product works with all existing KBR databases and so can be applied to Tetralogy of Fallot (TOF), dextro-Transposition of the Great Arteries (d-TGA), Pulmonary Arterial Hypertension (PAH) and most right ventricles (NRV) without congenital heart disease or PAH including normal hearts.

"The VMS-3DE™ heart analysis system addresses a direct need in the ultrasound community by providing fast and accurate analyses of 3D acquired images of the right ventricle, which, up until now, has presented a significant challenge," stated Dr. George Adams, CEO of VentriPoint. "3D echocardiographic imaging has continued to improve and for more and more patients (usually children) clinically-useful images can now be obtained. But there has been a void in available tools to accurately analyze the right ventricle. Our new product fills this void and positions Ventripoint as a leader in this emerging segment of the market".

Initial clinical evaluation of the VMS-3DE™ product was performed at the Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany. The evaluation yielded excellent results in functional analysis of the right ventricle in pediatric patients without congenital heart disease using the NRV database. The results of the initial study have been submitted for presentation at the 24th Annual Scientific Sessions of the American Society of Echocardiography.

"This study shows excellent accuracy and reproducibility of VMS-3DE™ for RV volumetry in children and young adults compared to the gold standard cardiac MRI", said Dr. K.T. Laser, cardiologist at Heart and Diabetes Center North Rhine-Westphalia.

Many cardiac centres have purchased 3D ultrasound machines in the last 5 years, but have struggled to use them due to image quality and time-consuming analysis tools. The VMS-3DE™ heart analysis system is a software-only version of the VMS™ family, which allows importation of 3D images acquired without the need for the addition of tracking hardware. The implication of analyzing 3D images allows the clinician an additional tool to utilize in managing their patients.

There are many applications where evaluating the right ventricle is key and where using our 3D analysis software could have a great impact on patient outcomes. In the U.S. alone, more than 10,000 newborns are treated in the neonatal intensive care units each year for persistent pulmonary hypertension. Many times treating these patients is complicated by not being able to obtain functional analysis of the right ventricle from traditional echocardiographic studies. Adding the ability to provide the clinician accurate right ventricular volumes and function should prove to have a positive impact on the outcomes in these patients.

The Company anticipates submitting the application for VMS-3DE™ for European CE Mark, Health Canada in the next 90 days and intends to seek FDA approval later this year.

About 3D Echocardiography

3D ultrasound captures in a single snapshot a complete 3D image of the heart. Like 2D ultrasound it has to be focused between the ribs and so has a narrow "window" to view the heart. The right heart is especially hard to image and often only a portion of the heart is captured making it impossible to analyze the beating heart functions. However, some people have good windows and small hearts and so a complete image can be obtained. Due to the complex shape of the right heart, it still requires an expert to identify the heart muscle from the blood in the heart. This can take many iterations and a lot of time. Nevertheless, Phillips, General Electric, Toshiba and Siemens have continued to improve their 3DE machines and they are now beginning to be used in paediatric centres to do quantitative analysis of the right ventricle.

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. 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: The statements made in this press release that are not historical facts contain forward-looking information that involves risk and uncertainties. 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 Corporation'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. The Corporation 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

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