Ventripoint said it received marketing clearance from the FDA to expand the indication of its VMS heart analysis system to include any individual who suffers from heart disease and that it’s seeking to raise $700,000 in a private placement.
Ventripoint’s VMS, used for measuring right ventricle function, was previously indicated only for individuals with pulmonary arterial hypertension, which is diagnosed in approximately 200,000 new cases every year, the company said. The device’s new indication allows it to be used on more than 20,000,000 people with heart disease, Ventripoint added.
The heart’s right ventricle , which the VMS scans, is known to predict the course of heart disease, Seattle, Wash.-based Ventripoint said. Heart disease is a leading cause of death globally.
"This change in use criteria means physicians in the U.S. can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition. Accurate RV volume assessment is the key to the full understanding or treatment of many heart conditions, and the VMS is the only method on the market that provides results that are widely considered as accurate as the gold standard, MRI," vice president of clinical affairs & development Jim Bodtke said in a press release.
Ventripoint also said it’s opening up a $700,000 private placement to help pay for VMS commercialization. The company said the funding round is due to close June 4.