March was a busy month for VentriPoint Diagnostics, a Canadian based medical device company focused on revolutionary software for 3D heart analysis. The company was successful in completing several important steps in the development and approval of what is viewed as potentially transformative diagnostics technology.
March began with the announcement that the company had received acceptance from the FDA (U.S.) of its submission for right heart analysis in Pulmonary Arterial Hypertension (NYSE:PAH), meaning that all of the required information is present for the FDA to proceed with a substantive review. PAH is a devastating disease, which can affect individuals from infancy to the elderly, offering an average patient lifespan of less than 3 years after diagnosis if untreated. Although treatment started early after detection appears to be more effective than when started later, the majority of patients with PAH continue to be diagnosed too late for treatment to be fully effective. VentriPoint has created diagnostic tools to monitor patients with heart disease, and has a suite of applications for all major heart diseases and imaging modalities including congenital heart disease, left or right heart failure, and normal hearts.
Shortly after the positive notice from the FDA, VentriPoint announced intention to complete a private placement of up to $2 million, providing additional funds to continue progress in developing and moving its technologies to market. That was soon followed by the company's announcement of formal application for European and Canadian approval for its database for non-specific heart disease (NRV), a database that allows clinicians to rapidly and accurately assess the status of the right ventricle (RV) in all patients that do not have significant congenital heart defects or Pulmonary Arterial Hypertension, yet may have a variety of other conditions. The company expects to have a response from the European CE Mark and Health Canada offices in the next 30 days.
For additional information, visit VentriPoint.com
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