Toronto-listed medtech firm VentriPoint Diagnostics Ltd (CVE:VPT) announced a major step forward for its breakthrough whole heart analysis system - a European CE mark.
It means the group's VMSplus device can now be sold to aid in heart treatment throughout the European Union.
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It uses data from a conventional 2D (two dimensional) eco-cardiogram (in other words an ultrasound test).
"This is great news as it allows the company to bring the capabilities of the VMSplus to cardiologists in Europe and improve cardiac care," said Dr George Adams, Ventripoint's chief executive.
"The quick acceptance of the VMSplus application is a credit to our development and regulatory groups."
Adams added that it means the firm can now go and meet with distributors in Europe with a focus on the larger markets of Germany, UK and France.
He noted that a recent report from the UK indicated there are 60,000 heart scans carried out each year, 12,000 of which are misdiagnosed, costing the NHS (National Health Service) a huge £600mln (US$1bn) in unnecessary operations.
Meanwhile, according to the European Heart Network, cardiovascular disease (CVD) causes 3.9mln deaths in Europe annually and accounts for 45% of all deaths in Europe.
Adams also noted that with the recent change in the definition of high-blood pressure by the AHA (American heart Asssociation), there were now over 100mln people in the USA alone with hypertension.
Currently it is estimated 44% of people with hypertension are not properly diagnosed.
"Europe is on track to change the definition of hypertension this year to match the AHA definition and so an additional 50 million people in Europe will now be deemed to have high-blood pressure," said Adams.
"We are working to educate physicians about the benefits of the VMS+ whole-heart analysis for acute and chronic heart conditions."
The CE mark is also recognized worldwide and will allow VentriPoint to register the VMSplus in many regions and countries, expanding the commercial opportunities.
The company filed for a CE mark for the new VMS+ system (both the device and the new 4-chamber software application) on December 20 last year (2017).