Devices & Diagnostics, Startups

Aria CV nets $31M to support first US clinical study of its implant

The implant — designated a breakthrough device by the FDA — would treat patients with pulmonary arterial hypertension. The progressive disease leads to heart failure but is usually treated with medication.

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Aria CV has landed $31 million in Series B funding that will support the first clinical study in the U.S. of the company’s lead device, which the company hopes to commercialize in 2023.

The device is designed to be implanted permanently in patients with pulmonary arterial hypertension, a progressive disease that is normally treated with medication, Dan Gladney, president and CEO of Aria CV said in a phone interview.

“This will be the first implant for the treatment of pulmonary arterial hypertension,” said Gladney, an early investor in Aria CV who has been its CEO since April. He had previously been on the company’s board.

The implant – known as the Aria CV Pulmonary Hypertension System and designated this month by the FDA as a breakthrough device – should at least match what medicine can do and improve on it, Gladney said. Patients with pulmonary arterial hypertension typically are expected to live for around seven years.

The latest funding round was led by the investment firm Xeraya Capital. Other participants included Longview Ventures, Catalyst Health Ventures, BioStar Ventures, Cedar Point Capital and Frontcourt Group, as well as three strategic investors who were not disclosed.

“We’ve worked with Aria CV for several years and are excited for the opportunity to lead this financing,” Jason Rushton, a partner at Xeraya Capital, said in a statement. “There is an unmet clinical need with patients suffering from pulmonary arterial hypertension, and we are impressed with the promising results the Aria CV PH System has demonstrated.”

Aria CV recently conducted the system’s first human procedure in Vienna, where the system was implanted for an hour, Gladney said. The test demonstrated the implant’s safety and its effectiveness in lowering blood pressure and increasing cardiac output. Pulmonary arterial hypertension leads to high blood pressure and low cardiac output. Drugs can loosen the artery but they don’t address blood pressure or cardiac output, Gladney said.

The next step, supported by the latest funding, is an early feasibility investigational study to be conducted with medical partners in the U.S., Gladney said. The study will last six months and involve 15 to 30 patients who will have the system implanted on a permanent basis. The results should come in 2021, followed by additional trials and commercialization by 2023.

The company is likely to seek additional funding in late 2021, Gladney added.

Aria’s system incorporates components that work together to mimic a healthy pulmonary artery, one that naturally opens and closes as the heart pumps and blood flows. In patients with pulmonary arterial hypertension, the pulmonary artery is rigid, forcing the heart to work harder and leading to terminal heart failure.

In the Aria system, a balloon inserted in the artery opens and closes the artery using gas drawn from a reservoir implanted in a patient’s upper abdominal wall. The gases are similar to what is already in the bloodstream, Gladney said.

“What we’ve done is we’ve taken the workload off the right heart, which increases cardiac output,” he said.

Founded in 2010 and based in St. Paul, Minnesota, Aria CV has nine employees but hopes to reach 20 by the end of the year, Gladney said. The company also plans to gauge its system’s use in treating other groups of heart-failure patients.

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