St. Paul-based medical device developer Aria CV Inc. has wrapped up a $31 million Series B financing round to fund an early feasibility study, the company announced Tuesday.
The company will use the funds for the first clinical trial of its device aimed at treating pulmonary arterial hypertension, a deadly disease that can lead to heart failure. Aria will conduct the trial in the U.S. through the Food and Drug Administration’s Early Feasibility Study Program. The device has been successfully tested on eight patients in Vienna, Austria, in a “first-in-man acute study,” said Aria CEO and president Dan Gladney. He noted that this will not be a full clinical trial; the aim is simply to determine whether the product works.
“The plan is to start the early feasibility study here early in 2020. We would implant anywhere from 15 to 30 patients,” Gladney said. “We’ll have a number of measurements and metrics to make sure that the product is producing great benefits for the patients, such as increased cardiac output and lowering pressures in the pulmonary arteries.”
Led by Xeraya Capital, the funding round closed shortly after Aria secured FDA “breakthrough designation” for its device, known as the Aria CV Pulmonary Hypertension System. That means the FDA will streamline review of the device once the company starts pivotal trials, the next stage of clinical testing. Aria hopes to begin those trials in 2021, Gladney said.
Founded by doctors who were fellows at the University of Minnesota’s Medical Devices center, Aria has license to patents from the university that it used to create its pulmonary hypertension system. Going forward, Aria is also looking at expanding use of the device to help patients experiencing left heart failure, which is a much larger market, Gladney said.
“Our intention is to be able to show significant benefits to the patient for both quality of life and longevity of life,” he said.
During the feasibility study, Aria will insert the device into patients and track the effect for six months, but the company is still allowed to make product changes to the implant without having to restart the trial.
“We hope to see approval sometime in 2023, which is not that far away. So we’ve got a lot of work to do to get there,” Gladney said.