Aria CV, a St. Paul medical device company working on a therapy to treat a deadly form of high blood pressure that often affects middle-aged women, has completed a new round of fundraising amid the news that its treatment might be on a faster track for U.S. approval after more than a decade of effort.
Dan Gladney, CEO of Aria CV, said Wednesday that the company is wrapping up a $31 million Series B fundraising round that includes two "strategic" investors. Word of the successful Series B round comes five years after an $8 million Series A round that included several private-equity firms and another strategic investor.
In med-tech parlance, a "strategic investor" typically means a large, established medical device company whose financial contributions may or may not secure a right to acquire the startup or sell its products someday. Gladney on Wednesday declined to reveal details about Aria CV's latest investors or the terms of their investments.
The fundraising is taking place in the wake of an announcement earlier this month that Aria CV's device to treat pulmonary arterial hypertension has been granted "breakthrough device" status from the U.S. Food and Drug Administration. The designation is intended to lower administrative hurdles and speed up approvals of novel devices intended to address unmet medical needs.
Pulmonary arterial hypertension (PAH) is a "very serious" form of high blood pressure that happens when arteries inside the lungs become scarred and obstructed, increasing the workload for the heart's right chambers and potentially leading to heart failure, the American Lung Association said. Although PAH can be triggered by other health problems or exposure to toxins, the disease is especially prevalent among women of childbearing age in cases where the underlying cause is unknown.
Gladney said the most common PAH treatment today is a class of prescription drugs called vasodilators, which he said can cost $300,000 a year: "It's incredibly expensive, and it doesn't cure the disease," he said.
The Aria CV Pulmonary Hypertension System, based on intellectual property licensed from the University of Minnesota a decade ago, is intended to relieve the symptoms of PAH. The device may also extend patients' lives by reducing an abnormally high workload on the right heart — a hypothesis that will need to be tested in clinical trials. Gladney said the average patient lives about seven years after diagnosis.
Unlike many medical implants, the Aria CV doesn't run on a battery. The system includes a special medical balloon inserted into the pulmonary artery between the heart and lungs, which expands and contracts with each heartbeat to simulate the lost elasticity of the patient's native pulmonary artery. Restoring that arterial elasticity has the effect of evening out the workload for the heart and encouraging more-natural blood flow.
"There's no electronics in it, no batteries. It is driven by the beating of the heart," said Gladney, a veteran med-tech executive who said he personally invested in Aria CV a decade ago and became CEO of the company last year.
The FDA's breakthrough device designation means the device qualifies for expedited assessment and review by the agency, though it still requires well-designed clinical trials. Gladney said Aria CV hopes to "very shortly" begin an early feasibility trial with 15 to 30 patients, which could lead to a larger clinical trial and eventual approval.